Prescription of Alendronate and Risedronate in Men: Off-label Use in a Health Area

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José Andrés Prado, Luisa Cabello Ballesteros" "autores" => array:5 [ 0 => array:4 [ "nombre" => "Fernando" "apellidos" => "León Vázquez" "email" => array:1 [ 0 => "fleonvaz@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Silvia" "apellidos" => "Herrero Hernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Cristina" "apellidos" => "Cuerpo Triguero" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "M. José" "apellidos" => "Andrés Prado" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 4 => array:3 [ "nombre" => "Luisa" "apellidos" => "Cabello Ballesteros" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Centro de Salud Universitario San Juan de la Cruz, Pozuelo de Alarcón, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Farmacia, Dirección Asistencial Noroeste, Gerencia de Atención Primaria, Servicio Madrileño de Salud, Majadahonda, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Unidad Docente Multidisciplinar de Atención Familiar y Comunitaria, Dirección Asistencial Noroeste, Gerencia de Atención Primaria, Servicio Madrileño de Salud, Majadahonda, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Prescripción de ácidos alendrónico y risedrónico en varones: uso fuera de la ficha técnica en un área de salud" ] ] "textoCompleto" => "IntroductionOsteoporosis is the alteration of the structure and bone mineral density that produces bone frailty and susceptibility to fractures. Although it mostly affects older women with risk factors for fracture, prevalence according to densitometric criteria of the World Health Organization<a class="elsevierStyleCrossRef" href="#bib0005">1</a> is important in Spanish men over 50 years of age: 4.8% for spinal osteoporosis and 4.4% for hip osteoporosis,<a class="elsevierStyleCrossRef" href="#bib0010">2</a> five times lower than in women. As for established osteoporosis, the prevalence of vertebral fracture in men over 60 years is 21% (slightly less than women, 25%)<a class="elsevierStyleCrossRef" href="#bib0010">2</a> and the incidence of hip fracture is 1.7 per 1000 inhabitants per year, a third compared to women.<a class="elsevierStyleCrossRef" href="#bib0015">3</a>There are fairly safe and effective treatments used to improve bone mineral density in men at high risk, such as oral bisphosphonates, alendronic4, and risedronic acid5. Both have a similar efficacy and safety profile,<a class="elsevierStyleCrossRef" href="#bib0030">6</a> and little difference in cost; however, while risedronic acid does have an indication for male osteoporosis in its data sheet<a class="elsevierStyleCrossRef" href="#bib0035">7</a> alendronate only indicates it in women for “prevention of postmenopausal osteoporosis.”<a class="elsevierStyleCrossRef" href="#bib0040">8</a>We intend to compare the gender distribution in dispensing alendronate, approved for the prevention of osteoporotic fractures in women but not in men in their technical insert versus risedronic acid, which has both indications.Patients and MethodsWe carried out a retrospective descriptive study that collected all of the prescriptions for risedronic and alendronic acid (with or without vitamin D) in any oral form, made in 2012, which were given out by family physicians in the northwest of the Community of Madrid and dispensed in pharmacies. The data was obtained through the information system of the pharmaceutical services of the Community of Madrid (Farmadrid), which records dispensed medications. Data for defined daily dose (DDD) and different patients were compared by gender, excluding those who did not collect the prescription.Qualitative variables are presented with their frequency distribution (absolute and relative). To establish whether there were significant differences in the selection of a drug, the χ method<a class="elsevierStyleCrossRef" href="#bib0010">2</a> was used. The Z test for normal distribution was used to compare alendronate and risedronate usage rates by gender.ResultsWe obtained data from 14,857 patients who used either of the two drugs, 1145 (7.7%) were men. 1 847 370 DDD were dispensed; alendronate was more prescribed with 979 104 doses (53%). 548 (0.03%) prescriptions were excluded for lack of a registered gender. <a class="elsevierStyleCrossRefs" href="#tbl0005">Tables 1 and 2</a> report the gender distribution by number of patients and DDD.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia>55% of women and 47.6% of men were treated with alendronate; the difference in proportions was statistically significant (P<.001). The difference was also statistically significant (P<.001) compared to alendronate DDD in women (53.6%) and men (46.2%).Women received 10% more alendronic than risedronic acid (55% versus 45%); on the contrary, among men, risedronic acid was prescribed 4.8% more than alendronic acid (52.4% versus 47.6%). These differences are similar when measured as DDD in favor of alendronate in women (53.6% versus 46.4%) and risedronate in men (53.8% versus 46.2%), with significant differences both for DDD (χ2=2913, P<.001) and for different patients χ2=23.31, p<0.001).DiscussionDrugs do not include an indication in the data sheet when they really have no such indication because they are ineffective or unsafe, when their effectiveness is difficult to prove (rare diseases) or if, having been proven, have not received or are pending administrative approval for the indication.<a class="elsevierStyleCrossRef" href="#bib0045">9</a> Alendronate has not obtained the indication for male osteoporosis in Spain, although it does have a certain degree of evidence in the prevention of vertebral fracture.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> Risedronic acid, with a similar efficacy,<a class="elsevierStyleCrossRefs" href="#bib0025">5,6</a> includes the indication in the insert.<a class="elsevierStyleCrossRef" href="#bib0035">7</a>Some clinical guidelines include specific recommendations for the prevention of osteoporotic fracture in men, recommending both alendronate and risedronic acid with a grade D recommendation (based on expert opinion)<a class="elsevierStyleCrossRef" href="#bib0050">10</a> and insisting that “drugs that have not been approved by regulatory agencies for osteoporosis in men should only be used if the authorized drugs cannot be used”.<a class="elsevierStyleCrossRef" href="#bib0055">11</a> The European Drug Agency in 2007-4 allowed EU countries to include, in a presentation of 10mg daily alendronate (rarely used), an indication for male osteoporosis,<a class="elsevierStyleCrossRef" href="#bib0060">12</a> but not in Spain, and not for the weekly 70mg dose.We know that men receive less treatment for osteoporosis than women: six times less in Norway,<a class="elsevierStyleCrossRef" href="#bib0065">13</a> 12 times less in our region. We found few studies that assess what bisphosphonates to use; in a French observational study of 210 osteoporotic men receiving bisphosphonates, 65% took alendronate and 18% risedronate,<a class="elsevierStyleCrossRef" href="#bib0070">14</a> reversing the observation of our study for the former, although the indication does not exist in France either.Without addressing what the indications of antiresorptive drug therapy in men with fracture risk are, if the decision to install it is made, taking into account two options of similar efficacy, safety and price,<a class="elsevierStyleCrossRef" href="#bib0030">6</a> the chosen drug must be the one with the indication expressly written in the data sheet. Not because it is prohibited, it is not forbidden to prescribe off-label, but because the enabling conditions to use them are not verified. One might therefore expect infrequent use of alendronate in men; however, doctors often have opted for it. Our study detected a preference in favor of risedronate in men versus alendronate, unlike women; although statistically significant, the difference is small in magnitude, 5%–10%. These differences persist if we compare the number of different patients or number of doses received, indicating that the doses received were similar in both genders.The use of drugs outside the approved indication in the data sheet is possible, even common, in specialties such as oncology, for compassionate use, but uncommon in primary care.<a class="elsevierStyleCrossRef" href="#bib0045">9</a> The National Health System regulates it by the Royal Decree 1015/2009 of 19 June, with three modes: compassionate use of investigational drugs, not marketing drug use in Spain and use of drugs in different conditions than authorized. In the latter case “conditions for prescribing approved medications when used other than authorized, which in any case will be considered as exceptional conditions” are set, such as the absence of authorized therapeutic alternatives, with respect to restrictions on prescribing and dispensing, following a therapeutic protocol of the clinic, exceptional and justified use expressed in the medical history by the prescribing physician, and ensuring the reporting of adverse reactions detected. Furthermore, information and the patient informed consent must be obtained, in accordance with Law 41/2002 of Patient Autonomy.The use of alendronate in men for osteoporosis does not meet all requirements; it is not exceptional, as we see, there are alternatives<a class="elsevierStyleCrossRef" href="#bib0030">6</a> and there is no therapeutic protocol, at least in the study centers. Our research did not examine whether the justification was contained in the medical history, or if patient consent was reported for off-label use obtained; however, from our experience, we doubt that these requirements were met.Why is there such a widespread use of alendronate in men? Our study does not allow causal hypotheses. We attribute, as possibilities, ignorance by the physician of off-label indications and prescription induced from hospital care, inadequate promotion by the pharmaceutical industry, the lack of drug alerts or that state and regional drug agencies assessment give priority of drug use among its recommendations to alendronate compared with other bisphosphonates, although a thorough reading shows that its conclusions are focused on postmenopausal women.<a class="elsevierStyleCrossRef" href="#bib0075">15</a>Nor is it justified for the treatment of corticosteroid osteoporosis, where risedronic acid has the indication in the data sheet, unlike alendronic acid.<a class="elsevierStyleCrossRefs" href="#bib0035">7,8</a>The use of drugs outside the licensed indication generates no direct legal consequences for the sake of the prescription, provided they do not harm the patient. However, if damage occurs, even a mild and expected side effect (for example, esophagitis), the injured party may demand accountability from the prescriber to repair the damage caused, as has already happened (Case Court Litigation 1 N. Sevilla, from February 6, 2006)<a class="elsevierStyleCrossRef" href="#bib0080">16</a>; the injured argued that the physician did not follow the conditions regulated for off-label prescribing, including lack of patient information, which created responsibility for the prescriber and the institution.While no indication for use in males is approved as an indication in the data sheet, alendronate should be reserved for older women with risk factors for fracture. There are alternatives like risedronic acid treatment when it is indicated, which is also effective and has a similar safety profile and posology. Only in rare cases should alendronate be used in men, duly informing the patient that the prescription is done off-label in the data sheet.Ethical ResponsibilitiesProtection of people and animalsThe authors declare this research did not perform experiments on humans or animals.Confidentiality of dataThe authors state that no patient data appears in this article.Right to privacy and informed consentThe authors state that no patient data appears in this article.Conflict of InterestFernando León Vazquez has imparted courses sponsored by MSD. There are no other conflicts of interests." "textoCompletoSecciones" => array:1 [ "secciones" => array:11 [ 0 => array:3 [ "identificador" => "xres436703" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec459939" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres436702" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Fundamento y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec459938" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Patients and Methods" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Discussion" ] 8 => array:3 [ "identificador" => "sec0025" "titulo" => "Ethical Responsibilities" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0030" "titulo" => "Protection of people and animals" ] 1 => array:2 [ "identificador" => "sec0035" "titulo" => "Confidentiality of data" ] 2 => array:2 [ "identificador" => "sec0040" "titulo" => "Right to privacy and informed consent" ] ] ] 9 => array:2 [ "identificador" => "sec0045" "titulo" => "Conflict of Interest" ] 10 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2014-02-11" "fechaAceptado" => "2014-05-23" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec459939" "palabras" => array:5 [ 0 => "Alendronate" 1 => "Risedronate" 2 => "Osteoporosis/drug therapy" 3 => "Male" 4 => "Off-label use" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec459938" "palabras" => array:5 [ 0 => "Ácido alendrónico" 1 => "Ácido risedrónico" 2 => "Osteoporosis/tratamiento farmacológico" 3 => "Varón" 4 => "Uso fuera de ficha técnica" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "Background and objectiveAlendronate and risedronate are both effective and safe treatments for osteoporosis in men, but only risedronate has this indication in its data-sheet. We compared their use by gender. Patients and methodsRetrospective descriptive study of prescriptions of risedronate and alendronate in 2012 in primary care in the northwest area of the Community of Madrid was conducted. We compared patients and defined daily doses (DDD) dispensed by gender. Results14,857 patients used 1,847,370 DDD of alendronate or risedronate, 1145 (7.7%) patients were men. In women alendronate was most prescribed (55% vs. 45%) than risedronate. Risedronate was preferred in men, 47.6% vs. 52.4%, resulting in a statistically significant difference (p<.001). ConclusionsRisedronate is preferred to alendronate in men, which is often used off-label, despite the existence of alternatives." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Patients and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "Fundamento y objetivoEl ácido alendrónico y ácido risedrónico son eficaces y seguros para la osteoporosis del varón, pero solo el ácido risedrónico recoge esta indicación en su ficha técnica. Compararemos su uso en ambos sexos. Pacientes y métodosEstudio descriptivo retrospectivo de prescripciones de ácido risedrónico y alendrónico en 2012 en atención primaria en el área noroeste de la Comunidad de Madrid. Comparamos la proporción de pacientes y dosis diarias definidas (DDD) dispensadas según género. ResultadosCatorce mil ochocientos cincuenta y siete pacientes utilizaron 1.847.370 de DDD de alendronato y risedronato, 1.145 (7.7%) varones. En mujeres, alendronato fue un 10% más prescrito que risedronato (55% vs. 45%). En varones, el risedronato fue el preferido, 47.6% vs. 52.4%, con una diferencia estadísticamente significativa (p<0,001). ConclusionesEl ácido risedrónico es preferido al alendrónico en varones, que se utiliza a menudo fuera de ficha técnica a pesar de existir alternativas." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Fundamento y objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Pacientes y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: León Vázquez F, Herrero Hernández S, Cuerpo Triguero C, Andrés Prado MJ, Cabello Ballesteros L. Prescripción de ácidos alendrónico y risedrónico en varones: uso fuera de la ficha técnica en un área de salud. Reumatol Clin. 2015;11:64–67." ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Female</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Male</th><th class="td" title="table-head " align="left" valign="top" scope="col">Total \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col">Difference of proportions% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col">P \t\t\t\t\t\t\n \t\t\t\t</th></tr><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">No. \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">N \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">N \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Alendronate \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7541 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">55.0 (54.15–55.83) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">545 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">47.6 (44.66–50.54) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">8086 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.4 (4.3–10.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">.000 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Risedronic acid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6171 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">45.0 (44.17–45.84) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">600 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">52.4 (49.47–55.34) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">6771 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Total treated \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">13 712 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1145 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">14 857 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab681829.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Gender Distribution and Consumption of Risedronic and Alendronic Acid, in a Number of Patients." ] ] 1 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "DDD: defined daily dose." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Female</th><th class="td" title="table-head " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Male</th><th class="td" title="table-head " align="left" valign="top" scope="col">Total \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col">Difference of proportions% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col">P \t\t\t\t\t\t\n \t\t\t\t</th></tr><tr title="table-row"><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">DDD \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">DDD \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">% (95%) \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">DDD \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="" valign="top" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Alendronate \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">912 212 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">53.6 (53.5–53.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">66 612 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">46.2 (45.9–46.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">978 824 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">7.4 (7.1–7.7) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">.000 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Risedronic acid \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">790 396 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">46.4 (46.3–46.5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">77 602 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">53.8 (53.6–54.1) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">867 998 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Total DDD \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 702 608 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">144 214 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">100 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">1 846 822 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="char" valign="top">– \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab681830.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Gender Distribution and Consumption of Risedronic and Alendronic Acid in DDD." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:16 [ 0 => array:3 [ "identificador" => "bib0005" 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Prescription of Alendronate and Risedronate in Men: Off-label Use in a Health Area

Prescripción de ácidos alendrónico y risedrónico en varones: uso fuera de la ficha técnica en un área de salud

Fernando León Vázqueza,

Corresponding author

fleonvaz@gmail.com

Corresponding author.

, Silvia Herrero Hernándezb, Cristina Cuerpo Trigueroa, M. José Andrés Pradoc, Luisa Cabello Ballesterosc

a Centro de Salud Universitario San Juan de la Cruz, Pozuelo de Alarcón, Madrid, Spain

b Servicio de Farmacia, Dirección Asistencial Noroeste, Gerencia de Atención Primaria, Servicio Madrileño de Salud, Majadahonda, Madrid, Spain

c Unidad Docente Multidisciplinar de Atención Familiar y Comunitaria, Dirección Asistencial Noroeste, Gerencia de Atención Primaria, Servicio Madrileño de Salud, Majadahonda, Madrid, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Osteoporosis is the alteration of the structure and bone mineral density that produces bone frailty and susceptibility to fractures&#46; Although it mostly affects older women with risk factors for fracture&#44; prevalence according to densitometric criteria of the World Health Organization<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> is important in Spanish men over 50 years of age&#58; 4&#46;8&#37; for spinal osteoporosis and 4&#46;4&#37; for hip osteoporosis&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> five times lower than in women&#46; As for established osteoporosis&#44; the prevalence of vertebral fracture in men over 60 years is 21&#37; &#40;slightly less than women&#44; 25&#37;&#41;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> and the incidence of hip fracture is 1&#46;7 per 1000 inhabitants per year&#44; a third compared to women&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">There are fairly safe and effective treatments used to improve bone mineral density in men at high risk&#44; such as oral bisphosphonates&#44; alendronic4&#44; and risedronic acid5&#46; Both have a similar efficacy and safety profile&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> and little difference in cost&#59; however&#44; while risedronic acid does have an indication for male osteoporosis in its data sheet<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> alendronate only indicates it in women for &#8220;<span class="elsevierStyleItalic">prevention of postmenopausal osteoporosis&#46;</span>&#8221;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">We intend to compare the gender distribution in dispensing alendronate&#44; approved for the prevention of osteoporotic fractures in women but not in men in their technical insert versus risedronic acid&#44; which has both indications&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Patients and Methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">We carried out a retrospective descriptive study that collected all of the prescriptions for risedronic and alendronic acid &#40;with or without vitamin D&#41; in any oral form&#44; made in 2012&#44; which were given out by family physicians in the northwest of the Community of Madrid and dispensed in pharmacies&#46; The data was obtained through the information system of the pharmaceutical services of the Community of Madrid &#40;Farmadrid&#41;&#44; which records dispensed medications&#46; Data for defined daily dose &#40;DDD&#41; and different patients were compared by gender&#44; excluding those who did not collect the prescription&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Qualitative variables are presented with their frequency distribution &#40;absolute and relative&#41;&#46; To establish whether there were significant differences in the selection of a drug&#44; the <span class="elsevierStyleItalic">&#967;</span> method<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> was used&#46; The <span class="elsevierStyleItalic">Z</span> test for normal distribution was used to compare alendronate and risedronate usage rates by gender&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0030" class="elsevierStylePara elsevierViewall">We obtained data from 14&#44;857 patients who used either of the two drugs&#44; 1145 &#40;7&#46;7&#37;&#41; were men&#46; 1 847 370 DDD were dispensed&#59; alendronate was more prescribed with 979 104 doses &#40;53&#37;&#41;&#46; 548 &#40;0&#46;03&#37;&#41; prescriptions were excluded for lack of a registered gender&#46; <a class="elsevierStyleCrossRefs" href="#tbl0005">Tables 1 and 2</a> report the gender distribution by number of patients and DDD&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">55&#37; of women and 47&#46;6&#37; of men were treated with alendronate&#59; the difference in proportions was statistically significant &#40;<span class="elsevierStyleItalic">P</span>&#60;&#46;001&#41;&#46; The difference was also statistically significant &#40;<span class="elsevierStyleItalic">P</span>&#60;&#46;001&#41; compared to alendronate DDD in women &#40;53&#46;6&#37;&#41; and men &#40;46&#46;2&#37;&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Women received 10&#37; more alendronic than risedronic acid &#40;55&#37; versus 45&#37;&#41;&#59; on the contrary&#44; among men&#44; risedronic acid was prescribed 4&#46;8&#37; more than alendronic acid &#40;52&#46;4&#37; versus 47&#46;6&#37;&#41;&#46; These differences are similar when measured as DDD in favor of alendronate in women &#40;53&#46;6&#37; versus 46&#46;4&#37;&#41; and risedronate in men &#40;53&#46;8&#37; versus 46&#46;2&#37;&#41;&#44; with significant differences both for DDD &#40;<span class="elsevierStyleItalic">&#967;</span><span class="elsevierStyleSup">2</span>&#61;2913&#44; <span class="elsevierStyleItalic">P</span>&#60;&#46;001&#41; and for different patients <span class="elsevierStyleItalic">&#967;</span><span class="elsevierStyleSup">2</span>&#61;23&#46;31&#44; <span class="elsevierStyleItalic">p</span>&#60;0&#46;001&#41;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0045" class="elsevierStylePara elsevierViewall">Drugs do not include an indication in the data sheet when they really have no such indication because they are ineffective or unsafe&#44; when their effectiveness is difficult to prove &#40;rare diseases&#41; or if&#44; having been proven&#44; have not received or are pending administrative approval for the indication&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Alendronate has not obtained the indication for male osteoporosis in Spain&#44; although it does have a certain degree of evidence in the prevention of vertebral fracture&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Risedronic acid&#44; with a similar efficacy&#44;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a> includes the indication in the insert&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">Some clinical guidelines include specific recommendations for the prevention of osteoporotic fracture in men&#44; recommending both alendronate and risedronic acid with a grade D recommendation &#40;based on expert opinion&#41;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> and insisting that &#8220;<span class="elsevierStyleItalic">drugs that have not been approved by regulatory agencies for osteoporosis in men should only be used if the authorized drugs cannot be used</span>&#8221;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> The European Drug Agency in 2007-4 allowed EU countries to include&#44; in a presentation of 10<span class="elsevierStyleHsp" style=""></span>mg daily alendronate &#40;rarely used&#41;&#44; an indication for male osteoporosis&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> but not in Spain&#44; and not for the weekly 70<span class="elsevierStyleHsp" style=""></span>mg dose&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">We know that men receive less treatment for osteoporosis than women&#58; six times less in Norway&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> 12 times less in our region&#46; We found few studies that assess what bisphosphonates to use&#59; in a French observational study of 210 osteoporotic men receiving bisphosphonates&#44; 65&#37; took alendronate and 18&#37; risedronate&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> reversing the observation of our study for the former&#44; although the indication does not exist in France either&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Without addressing what the indications of antiresorptive drug therapy in men with fracture risk are&#44; if the decision to install it is made&#44; taking into account two options of similar efficacy&#44; safety and price&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> the chosen drug must be the one with the indication expressly written in the data sheet&#46; Not because it is prohibited&#44; it is not forbidden to prescribe off-label&#44; but because the enabling conditions to use them are not verified&#46; One might therefore expect infrequent use of alendronate in men&#59; however&#44; doctors often have opted for it&#46; Our study detected a preference in favor of risedronate in men versus alendronate&#44; unlike women&#59; although statistically significant&#44; the difference is small in magnitude&#44; 5&#37;&#8211;10&#37;&#46; These differences persist if we compare the number of different patients or number of doses received&#44; indicating that the doses received were similar in both genders&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">The use of drugs outside the approved indication in the data sheet is possible&#44; even common&#44; in specialties such as oncology&#44; for <span class="elsevierStyleItalic">compassionate use</span>&#44; but uncommon in primary care&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> The National Health System regulates it by the Royal Decree 1015&#47;2009 of 19 June&#44; with three modes&#58; compassionate use of investigational drugs&#44; not marketing drug use in Spain and use of drugs in different conditions than authorized&#46; <span class="elsevierStyleItalic">In the latter case &#8220;conditions</span> for prescribing approved medications when used other than authorized&#44; which in any case will be considered as exceptional conditions&#8221; are set&#44; such as the absence of authorized therapeutic alternatives&#44; with respect to restrictions on prescribing and dispensing&#44; following a therapeutic protocol of the clinic&#44; exceptional and justified use expressed in the medical history by the prescribing physician&#44; and ensuring the reporting of adverse reactions detected&#46; Furthermore&#44; information and the patient informed consent must be obtained&#44; in accordance with Law 41&#47;2002 of Patient Autonomy&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The use of alendronate in men for osteoporosis does not meet all requirements&#59; it is not exceptional&#44; as we see&#44; there are alternatives<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> and there is no therapeutic protocol&#44; at least in the study centers&#46; Our research did not examine whether the justification was contained in the medical history&#44; or if patient consent was reported for off-label use obtained&#59; however&#44; from our experience&#44; we doubt that these requirements were met&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Why is there such a widespread use of alendronate in men&#63; Our study does not allow causal hypotheses&#46; We attribute&#44; as possibilities&#44; ignorance by the physician of off-label indications and prescription induced from hospital care&#44; inadequate promotion by the pharmaceutical industry&#44; the lack of drug alerts or that state and regional drug agencies assessment give priority of drug use among its recommendations to alendronate compared with other bisphosphonates&#44; although a thorough reading shows that its conclusions are focused on postmenopausal women&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p><p id="par0080" class="elsevierStylePara elsevierViewall">Nor is it justified for the treatment of corticosteroid osteoporosis&#44; where risedronic acid has the indication in the data sheet&#44; unlike alendronic acid&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;8</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">The use of drugs outside the licensed indication generates no direct legal consequences for the sake of the prescription&#44; provided they do not harm the patient&#46; However&#44; if damage occurs&#44; even a mild and expected side effect &#40;for example&#44; esophagitis&#41;&#44; the injured party may demand accountability from the prescriber to repair the damage caused&#44; as has already happened &#40;Case Court Litigation 1 N&#46; Sevilla&#44; from February 6&#44; 2006&#41;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a>&#59; the injured argued that the physician did not follow the conditions regulated for off-label prescribing&#44; including lack of patient information&#44; which created responsibility for the prescriber and the institution&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">While no indication for use in males is approved as an indication in the data sheet&#44; alendronate should be reserved for older women with risk factors for fracture&#46; There are alternatives like risedronic acid treatment when it is indicated&#44; which is also effective and has a similar safety profile and posology&#46; Only in rare cases should alendronate be used in men&#44; duly informing the patient that the prescription is done <span class="elsevierStyleItalic">off-label in the data sheet&#46;</span></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Ethical Responsibilities</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Protection of people and animals</span><p id="par0100" class="elsevierStylePara elsevierViewall">The authors declare this research did not perform experiments on humans or animals&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Confidentiality of data</span><p id="par0105" class="elsevierStylePara elsevierViewall">The authors state that no patient data appears in this article&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Right to privacy and informed consent</span><p id="par0110" class="elsevierStylePara elsevierViewall">The authors state that no patient data appears in this article&#46;</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conflict of Interest</span><p id="par0115" class="elsevierStylePara elsevierViewall">Fernando Le&#243;n Vazquez has imparted courses sponsored by MSD&#46; There are no other conflicts of interests&#46;</p></span></span>"
    "textoCompletoSecciones" => array:1 [
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              "titulo" => "Protection of people and animals"
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              "titulo" => "Right to privacy and informed consent"
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          "titulo" => "References"
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    "fechaRecibido" => "2014-02-11"
    "fechaAceptado" => "2014-05-23"
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec459939"
          "palabras" => array:5 [
            0 => "Alendronate"
            1 => "Risedronate"
            2 => "Osteoporosis&#47;drug therapy"
            3 => "Male"
            4 => "Off-label use"
          ]
        ]
      ]
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
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          "palabras" => array:5 [
            0 => "&#193;cido alendr&#243;nico"
            1 => "&#193;cido risedr&#243;nico"
            2 => "Osteoporosis&#47;tratamiento farmacol&#243;gico"
            3 => "Var&#243;n"
            4 => "Uso fuera de ficha t&#233;cnica"
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    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objective</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Alendronate and risedronate are both effective and safe treatments for osteoporosis in men&#44; but only risedronate has this indication in its data-sheet&#46; We compared their use by gender&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Patients and methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Retrospective descriptive study of prescriptions of risedronate and alendronate in 2012 in primary care in the northwest area of the Community of Madrid was conducted&#46; We compared patients and defined daily doses &#40;DDD&#41; dispensed by gender&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">14&#44;857 patients used 1&#44;847&#44;370 DDD of alendronate or risedronate&#44; 1145 &#40;7&#46;7&#37;&#41; patients were men&#46; In women alendronate was most prescribed &#40;55&#37; vs&#46; 45&#37;&#41; than risedronate&#46; Risedronate was preferred in men&#44; 47&#46;6&#37; vs&#46; 52&#46;4&#37;&#44; resulting in a statistically significant difference &#40;<span class="elsevierStyleItalic">p</span>&#60;&#46;001&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Risedronate is preferred to alendronate in men&#44; which is often used off-label&#44; despite the existence of alternatives&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Background and objective"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Patients and methods"
          ]
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            "identificador" => "abst0015"
            "titulo" => "Results"
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      "es" => array:3 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Fundamento y objetivo</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">El &#225;cido alendr&#243;nico y &#225;cido risedr&#243;nico son eficaces y seguros para la osteoporosis del var&#243;n&#44; pero solo el &#225;cido risedr&#243;nico recoge esta indicaci&#243;n en su ficha t&#233;cnica&#46; Compararemos su uso en ambos sexos&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Pacientes y m&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Estudio descriptivo retrospectivo de prescripciones de &#225;cido risedr&#243;nico y alendr&#243;nico en 2012 en atenci&#243;n primaria en el &#225;rea noroeste de la Comunidad de Madrid&#46; Comparamos la proporci&#243;n de pacientes y dosis diarias definidas &#40;DDD&#41; dispensadas seg&#250;n g&#233;nero&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Catorce mil ochocientos cincuenta y siete pacientes utilizaron 1&#46;847&#46;370 de DDD de alendronato y risedronato&#44; 1&#46;145 &#40;7&#46;7&#37;&#41; varones&#46; En mujeres&#44; alendronato fue un 10&#37; m&#225;s prescrito que risedronato &#40;55&#37; vs&#46; 45&#37;&#41;&#46; En varones&#44; el risedronato fue el preferido&#44; 47&#46;6&#37; vs&#46; 52&#46;4&#37;&#44; con una diferencia estad&#237;sticamente significativa &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">El &#225;cido risedr&#243;nico es preferido al alendr&#243;nico en varones&#44; que se utiliza a menudo fuera de ficha t&#233;cnica a pesar de existir alternativas&#46;</p></span>"
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            "titulo" => "Resultados"
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        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Le&#243;n V&#225;zquez F&#44; Herrero Hern&#225;ndez S&#44; Cuerpo Triguero C&#44; Andr&#233;s Prado MJ&#44; Cabello Ballesteros L&#46; Prescripci&#243;n de &#225;cidos alendr&#243;nico y risedr&#243;nico en varones&#58; uso fuera de la ficha t&#233;cnica en un &#225;rea de salud&#46; Reumatol Clin&#46; 2015&#59;11&#58;64&#8211;67&#46;</p>"
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Female</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Male</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Total&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Difference of proportions&#37; &#40;95&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col"><span class="elsevierStyleItalic">P</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">No&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">&#37; &#40;95&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">N&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">&#37; &#40;95&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">N&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top">Alendronate&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7541&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">55&#46;0 &#40;54&#46;15&#8211;55&#46;83&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">545&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">47&#46;6 &#40;44&#46;66&#8211;50&#46;54&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">8086&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;4 &#40;4&#46;3&#8211;10&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#46;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top">Risedronic acid&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">6171&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">45&#46;0 &#40;44&#46;17&#8211;45&#46;84&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">600&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">52&#46;4 &#40;49&#46;47&#8211;55&#46;34&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">6771&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " align="left" valign="top">Total treated&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">13 712&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1145&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">14 857&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Female</th><th class="td" title="table-head  " colspan="2" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Male</th><th class="td" title="table-head  " align="left" valign="top" scope="col">Total&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">&#37; &#40;95&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">912 212&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">53&#46;6 &#40;53&#46;5&#8211;53&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">66 612&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">46&#46;2 &#40;45&#46;9&#8211;46&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">978 824&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">7&#46;4 &#40;7&#46;1&#8211;7&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">790 396&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">46&#46;4 &#40;46&#46;3&#8211;46&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">77 602&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">53&#46;8 &#40;53&#46;6&#8211;54&#46;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">867 998&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1 702 608&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">144 214&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">100&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">1 846 822&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8211;&nbsp;\t\t\t\t\t\t\n
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                            0 => "Centro de Informaci&#243;n online de Medicamentos CIMA"
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Article information

ISSN: 21735743
Original language: English

DOI:10.1016/j.reumae.2014.05.004

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Year/Month	Html	Pdf	Total

2024 November	5	2	7
2024 October	65	40	105
2024 September	74	26	100
2024 August	77	44	121
2024 July	107	38	145
2024 June	69	44	113
2024 May	80	38	118
2024 April	56	23	79
2024 March	46	31	77
2024 February	48	28	76
2024 January	45	21	66
2023 December	49	25	74
2023 November	49	37	86
2023 October	43	32	75
2023 September	82	34	116
2023 August	46	17	63
2023 July	38	29	67
2023 June	54	27	81
2023 May	61	21	82
2023 April	42	5	47
2023 March	58	26	84
2023 February	52	23	75
2023 January	37	25	62
2022 December	77	41	118
2022 November	45	34	79
2022 October	70	37	107
2022 September	52	37	89
2022 August	34	38	72
2022 July	51	42	93
2022 June	55	30	85
2022 May	47	59	106
2022 April	49	63	112
2022 March	68	57	125
2022 February	60	31	91
2022 January	52	41	93
2021 December	50	40	90
2021 November	65	50	115
2021 October	87	48	135
2021 September	80	48	128
2021 August	51	38	89
2021 July	41	29	70
2021 June	54	48	102
2021 May	67	50	117
2021 April	188	57	245
2021 March	100	24	124
2021 February	61	25	86
2021 January	66	22	88
2020 December	69	34	103
2020 November	47	27	74
2020 October	29	10	39
2020 September	58	34	92
2020 August	47	19	66
2020 July	49	7	56
2020 June	53	19	72
2020 May	40	17	57
2020 April	53	29	82
2020 March	26	12	38
2020 February	2	0	2
2018 December	2	0	2
2018 May	5	1	6
2018 April	52	6	58
2018 March	120	6	126
2018 February	37	4	41
2018 January	24	9	33
2017 December	34	8	42
2017 November	39	8	47
2017 October	34	8	42
2017 September	55	4	59
2017 August	56	7	63
2017 July	56	9	65
2017 June	90	15	105
2017 May	75	12	87
2017 April	67	4	71
2017 March	46	26	72
2017 February	23	7	30
2017 January	24	6	30
2016 December	64	17	81
2016 November	52	11	63
2016 October	72	14	86
2016 September	73	7	80
2016 August	60	5	65
2016 July	37	12	49
2015 December	2	0	2
2015 November	1	17	18
2015 October	1	17	18
2015 September	2	0	2
2015 August	2	0	2
2015 July	24	8	32
2015 June	49	13	62
2015 May	77	19	96
2015 April	78	29	107
2015 March	65	21	86
2015 February	9	3	12

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