ABSTRACT
Tirzepatide is a novel antidiabetic medication a single-molecule, agonist to the glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors. It is approved in the USA and EU for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Due to the potential novelty represented by incorporating tirzepatide to clinical practice, we aim to review practical aspects of tirzepatide use in T2DM and the supporting scientific evidence. A group of ten endocrinologists involved as investigators in the phase 3 SURPASS clinical trial program followed a nominal group technique, a qualitative research methodology designed as a semi-structured group discussion to reach a consensus on the selection of a set of practical aspects. The scientific evidence for tirzepatide has been reviewed with respect to a number of patients' clinical profiles and care goals. Information of interest related to adverse events, special warnings and precautions, and other considerations for tirzepatide use has been included. Finally, information provided to the patients has been summarized. The practical aspects reported herein may be helpful in guiding physicians in the use of tirzepatide and contribute to optimizing the management of T2DM.
ABSTRACT
OBJECTIVE: To provide practical recommendations for the comprehensive approach of people with type 2 diabetes according to evidence-based medicine. PARTICIPANTS: Members of the Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition. METHODS: The recommendations were formulated according to the degrees of evidence of the Standards of Medical Care in Diabetes-2022. After reviewing the available evidence and formulating recommendations by the authors of each section, several rounds of comments were developed incorporating the contributions and voting on controversial points. Finally, the final document was sent to the rest of the members of the area for review and incorporation of contributions, to finally carry out the same process with the members of the Spanish Society of Endocrinology and Nutrition Board of Directors. CONCLUSIONS: The document establishes practical recommendations based on the latest available evidence for the management of people with type 2 diabetes.
Subject(s)
Diabetes Mellitus, Type 2 , Humans , Diabetes Mellitus, Type 2/therapy , Societies, Medical , SpainABSTRACT
OBJECTIVES: The Clarke questionnaire, validated in Spanish language, assesses hypoglycemia awareness in patients with type 1 diabetes. This study aimed to analyze its psychometric properties in patients with type 2 diabetes (T2DM). METHODS: This was a questionnaire validation study. Patients with T2DM and treated with insulin, sulfonylureas or glinides were consecutively recruited from six endocrinology consultations and six primary care centers. The internal structure of the 8-item Clarke questionnaire was analyzed by exploratory (training sample) and confirmatory (testing sample) factor analysis; the internal consistency using Omega's McDonald coefficient; and goodness of fit with comparative fit index (CFI, cutoff >0.9), Goodness of Fit Index (GFI, cutoff >0.9), and root mean-square error of approximation (RMSEA, cutoff <0.09), as well as unidimensionality indicators. RESULTS: The 265 participants (56.8% men) had a mean age of 67.8 years. Confirmatory factor analysis for one dimension obtained poor indicators: fit test (p < 0.001); CFI = 0.748; RMSEA = 0.122 and SRMR = 0.134. Exploratory factor analysis showed 2 or 3 dimensions with poor adjustment indicators. Omega's McDonald was 0.739. CONCLUSIONS: The Spanish version of the Clarke questionnaire was not valid or reliable for assessing hypoglycemia awareness in people with T2DM in Spanish population.
Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemia , Male , Humans , Aged , Female , Psychometrics , Reproducibility of Results , Language , Surveys and Questionnaires , Factor Analysis, StatisticalABSTRACT
OBJECTIVE: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. PARTICIPANTS: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodologist resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. CONCLUSIONS: The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.
Subject(s)
Bone Diseases, Metabolic , Osteoporosis , Female , Humans , Lactation , Minerals , Osteoporosis/therapy , PregnancyABSTRACT
Objective: To provide practical recommendations for the management of mineral and bone metabolism alterations in pregnancy and lactation. Participants: Members of the Working Group on Osteoporosis and Mineral Metabolism of the Spanish Society of Endocrinology and Nutrition. Methods: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. A systematic search was carried out in Medline of the available evidence for each pathology. Papers in English with publication date until 29 February 2020 were included. A methodology resolved the differences that arose during the process of reviewing the literature and formulating recommendations. The recommendations were discussed and approved by all members of the Working Group. Conclusions: The document establishes practical recommendations based on evidence about the management of mineral and bone metabolism disorders in pregnancy and lactation.
Objetivo: Proporcionar unas recomendaciones prácticas para el manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia. Participantes: Miembros del Grupo de Metabolismo Mineral de la Sociedad Española de Endocrinología y Nutrición. Métodos:Las recomendaciones se formularon de acuerdo con el sistema Grading of Recommendations Assessment, Development, and Evaluation (GRADE) para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en Medline de la evidencia disponible para cada patología. Se revisaron artículos escritos en inglés con fecha de inclusión hasta 29 de febrero del 2020. Un metodólogo resolvió las diferencias que surgieron durante el proceso de revisión de bibliografía y formulación de recomendaciones. Tras la formulación de las recomendaciones éstas se discutieron en una reunión conjunta del Grupo de Trabajo. Conclusiones: El documento establece unas recomendaciones prácticas basadas en la evidencia acerca del manejo de las alteraciones del metabolismo mineral y óseo en la gestación y la lactancia.
Subject(s)
Humans , Female , Osteoporosis/therapy , Bone Diseases, Metabolic , Lactation , Pregnancy , MineralsABSTRACT
OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 30 November 2019 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.
Subject(s)
Diabetes Mellitus , Endocrinology , Hypoglycemia , Diabetes Mellitus/therapy , Humans , Hypoglycemia/diagnosis , Hypoglycemia/therapy , SpainABSTRACT
OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 28 February 2020 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.
ABSTRACT
La medición de la densidad mineral ósea mediante la absorciometría radiológica de doble energía es la técnica de elección para la valoración ósea y un predictor importante del riesgo de fractura. Sin embargo, la mayoría de las fracturas por fragilidad ocurren en personas sin osteoporosis densitométrica, especialmente en enfermedades endocrinológicas. Las herramientas para la estimación del riesgo de fracturas como FRAX han mejorado la sensibilidad diagnóstica aunque no consideran otras características óseas adicionales. La investigación de la microarquitectura ósea supone una mejoría en el abordaje de estos pacientes. En este documento elaborado por miembros del grupo de trabajo de Metabolismo Mineral y Óseo de la Sociedad Española de Endocrinología y Nutrición se revisan los nuevos avances en absorciometría radiológica de doble energía y otras técnicas más complejas para el estudio de la microarquitectura ósea así como los datos disponibles en diabetes tipo 2 y patología paratiroidea
Bone mineral density using dual-energy X-ray absorptiometry is the gold standard for the assessment of bone and an important predictor of fracture risk. However, most fragility fractures occur in people without densitometric osteoporosis, especially in endocrinological diseases. Fracture risk estimation tools such as FRAX have improved diagnostic sensitivity but do not include additional skeletal features. Bone microarchitecture research represents an improvement in the treatment of these patients. In this document members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review new advances in dual-energy X-ray absorptiometry and other complex techniques for the study of bone microarchitecture as well as the available data on type 2 diabetes and parathyroid pathology
Subject(s)
Humans , Male , Female , Middle Aged , Osteogenesis Imperfecta/diagnosis , Technology Assessment, Biomedical/methods , Health Status Indicators , Bone Density , Absorptiometry, Photon , Diabetes Mellitus, Type 2/diagnosis , Hyperparathyroidism, Primary/diagnosis , Societies, Medical/standards , Spinal Fractures/diagnosis , Spinal Fractures/prevention & control , Risk FactorsABSTRACT
Bone mineral density using dual-energy X-ray absorptiometry is the gold standard for the assessment of bone and an important predictor of fracture risk. However, most fragility fractures occur in people without densitometric osteoporosis, especially in endocrinological diseases. Fracture risk estimation tools such as FRAX have improved diagnostic sensitivity but do not include additional skeletal features. Bone microarchitecture research represents an improvement in the treatment of these patients. In this document members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review new advances in dual-energy X-ray absorptiometry and other complex techniques for the study of bone microarchitecture as well as the available data on type 2 diabetes and parathyroid pathology.
Subject(s)
Absorptiometry, Photon , Bone Density , Osteoporosis , Diabetes Mellitus, Type 2 , Humans , Osteoporosis/diagnosis , Osteoporotic FracturesABSTRACT
The 3-year placebo-controlled FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial established the antifracture efficacy of denosumab in postmenopausal women with osteoporosis. The 7-year open-label extension demonstrated that denosumab treatment for up to 10 years was associated with low rates of adverse events and low fracture incidence. The extension lacked a long-term control group, thus limiting the ability to fully evaluate long-term efficacy. This analysis provides a quantitative estimate of the long-term antifracture efficacy of denosumab based on two approaches: comparison with FRAX®- (Fracture Risk Assessment Tool-) and virtual twin-estimated 10-year fracture rates. Subjects who were randomized to denosumab in the FREEDOM trial, continued into the Extension study, completed the 10-year visit, and missed ≤1 dose in the FREEDOM trial and ≤1 dose in the Extension (n = 1278) were included in the analysis. The 10-year observed cumulative incidence of major osteoporotic fracture (MOF) and hip fractures was compared with the 10-year fracture probability predicted at baseline by FRAX, a computer-based fracture risk algorithm, and with that estimated for a hypothetical cohort of 10-year placebo controls (virtual twins). The observed 10-year fracture incidence was lower than the 10-year probability predicted by FRAX for both MOF (10.75% [95% CI, 9.05 to 12.46] versus 15.63% [95% CI, 15.08 to 16.18], respectively), and hip fractures (1.17% [95% CI, 0.58 to 1.76] versus 5.62% [95% CI, 5.28 to 5.97], respectively). The observed fracture incidence was also lower than the fracture rate estimated in a hypothetical cohort of 10-year placebo controls for MOF (23.13% [95% CI, 17.76 to 28.87]; relative risk 0.49 [95% CI, 0.36 to 0.64]). These data support the long-term efficacy of denosumab in reducing MOF and hip fractures in postmenopausal women with osteoporosis. © 2020 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
ABSTRACT
La concentración sérica de fósforo oscila entre 2,5 y 4,5 mg/dl (0,81-1,45 mmol/l) en adultos, con niveles más altos en la infancia, la adolescencia y durante la gestación. El fosfato intracelular está implicado en el metabolismo intermediario y otras funciones celulares esenciales, mientras que el extracelular es fundamental para la mineralización de la matriz ósea. La fosforemia se mantiene en un estrecho rango mediante la regulación de la absorción intestinal, la redistribución y la reabsorción tubular renal de fósforo. La hipofosfatemia y la hiperfosfatemia son situaciones clínicas frecuentes, aunque, en la mayoría de las ocasiones, se trata de alteraciones leves y poco sintomáticas. Sin embargo, pueden presentarse cuadros agudos y severos que requieren tratamiento específico. En este documento elaborado por miembros del Grupo de Trabajo de Metabolismo Mineral y Óseo de la Sociedad Española de Endocrinología y Nutrición se revisan los trastornos del fosfato y se proporcionan algoritmos de manejo clínico de la hipofosfatemia y la hiperfosfatemia
Serum phosphorus levels range from 2.5 and 4.5 mg/dL (0.81-1.45 mmol/L) in adults, with higher levels in childhood, adolescence, and pregnancy. Intracellular phosphate is involved in intermediary metabolism and other essential cell functions, while extracellular phosphate is essential for bone matrix mineralization. Plasma phosphorus levels are maintained within a narrow range by regulation of intestinal absorption, redistribution, and renal tubular absorption of the mineral. Hypophosphatemia and hyperphosphatemia are common clinical situations, although changes are most often mild and oligosymptomatic. However, acute and severe conditions that require specific treatment may occur. In this document, members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review phosphate disorders and provide algorithms for adequate clinical management of hypophosphatemia and hyperphosphatemia
Subject(s)
Humans , Phosphates/metabolism , Hypophosphatemia/etiology , Hypophosphatemia/physiopathology , Hyperphosphatemia/etiology , Hyperphosphatemia/therapy , Hypophosphatemia/therapy , Phosphorus, Dietary , Rickets, Hypophosphatemic/diagnosis , Diagnosis, DifferentialABSTRACT
To evaluate numerous publications that question the bone and extraosseous benefits of vitamin D diet supplementation based on results, which often transcend to public opinion, but are not well interpreted. This may have negative consequences on compliance of patients under vitamin D supplementation. Critical appraisal of several articles on vitamin D supplementation and its relationship with fractures, falls, cardiovascular diseases, and cancer incidence. Such publications have certain limitations (i.e. patients excluded because of a diagnosis of osteoporosis, or at a higher risk for fractures and falls, or because they have a vitamin D deficiency, etc.), and conclusions and/or subsequent recommendations should be approached with caution. Our research shows that patients with osteoporosis, vitamin D deficiency, and at high risk of fractures and falls should not discontinue vitamin D supplementation (often associated with calcium). It is becoming increasingly evident that patients with hypovitaminosis D are those that gain a maximal benefit from vitamin D supplementation.
Subject(s)
Accidental Falls , Dietary Supplements , Fractures, Bone/prevention & control , Vitamin D , HumansABSTRACT
Serum phosphorus levels range from 2.5 and 4.5mg/dL (0.81-1.45 mmol/L) in adults, with higher levels in childhood, adolescence, and pregnancy. Intracellular phosphate is involved in intermediary metabolism and other essential cell functions, while extracellular phosphate is essential for bone matrix mineralization. Plasma phosphorus levels are maintained within a narrow range by regulation of intestinal absorption, redistribution, and renal tubular absorption of the mineral. Hypophosphatemia and hyperphosphatemia are common clinical situations, although changes are most often mild and oligosymptomatic. However, acute and severe conditions that require specific treatment may occur. In this document, members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review phosphate disorders and provide algorithms for adequate clinical management of hypophosphatemia and hyperphosphatemia.
Subject(s)
Hyperphosphatemia/diagnosis , Hyperphosphatemia/therapy , Hypophosphatemia/diagnosis , Hypophosphatemia/therapy , Decision Trees , Homeostasis , Humans , Phosphates/physiologyABSTRACT
Objetivo: El tratamiento de la diabetes tipo 2 (DM2) es complejo y su propósito es reducir la morbimortalidad, por lo que su manejo tiene que incluir: un control glucémico individualizado precoz (mediante una adecuada educación diabetológica, modificaciones del estilo de vida y tratamiento farmacológico), el control de los factores de riesgo cardiovascular (CV), la detección y tratamiento precoz de las complicaciones y la evaluación de las comorbilidades asociadas. El objetivo fue elaborar un documento para unificar los aspectos necesarios para el abordaje integral de las personas con DM2. Participantes: Miembros del Grupo de trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición. Métodos: Se realizó una revisión de la evidencia disponible relativa a cada aspecto del manejo de la diabetes: objetivos de control glucémico, dieta y ejercicio, tratamiento farmacológico, tratamiento y control de factores de riesgo, detección de complicaciones y manejo del paciente frágil con DM2. Las recomendaciones se formularon según los grados de evidencia recogidos en los Standards of Medical Care in Diabetes 2018. Tras la formulación de las recomendaciones el documento fue consensuado por los miembros del Grupo de trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición. Conclusiones: El objetivo de este documento es proporcionar, desde el punto de vista del endocrinólogo clínico, unas recomendaciones prácticas basadas en la evidencia acerca de todos los aspectos necesarios para el abordaje integral de la DM2
Objective: Treatment of type 2 diabetes mellitus (T2DM) is complex and is intended to decrease morbidity and mortality. Management should therefore include adequate diabetes education, lifestyle changes, drug treatment to achieve early blood glucose control and reduction of cardiovascular (CV) risk factors, early detection and treatment of complications, and assessment of associated comorbidities. The objective was to prepare a document including all aspects required for a comprehensive approach to T2DM. Participants: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology. Methods: The available evidence regarding each aspect of diabetes management (blood glucose control goals, diet and exercise, drug treatment, risk factor management and control, detection of complications, and management of frail patients) was reviewed. Recommendations were formulated based on the grades of evidence stated in the 2018 Standards of Medical Care in Diabetes. Recommendations were discussed and agreed by the working group members. Conclusions: This document is intended to provide evidence-based practical recommendations for comprehensive management of T2DM by clinical endocrinologists
Subject(s)
Humans , Diabetes Mellitus, Type 2/therapy , Diabetes Mellitus, Type 2/complications , Risk Factors , Societies, Medical/standards , 36448 , Glycemic Index , Life Style , Societies, Medical/organization & administration , eHealth Strategies , Exercise/physiologyABSTRACT
CONTEXT: Semaglutide, a once-weekly glucagon-like peptide-1 analog approved for use in patients with type 2 diabetes (T2D), demonstrated superior body weight (BW) reductions and decreased insulin resistance (IR) vs comparators across the Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 1-3 clinical trials. OBJECTIVE: To investigate the relationship between IR and BW across the SUSTAIN 1-3 trials. DESIGN: Post hoc analysis of the SUSTAIN 1-3 trials. SETTING: Three hundred and eleven sites in 30 countries. PATIENTS OR OTHER PARTICIPANTS: 2432 subjects with T2D. INTERVENTIONS: Semaglutide 0.5 or 1.0 mg, placebo or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg). MAIN OUTCOME MEASURE: To assess the extent of the effect on IR that is mediated (indirect effect) and not mediated (direct effect) by the effect on BW. RESULTS: Across SUSTAIN 1-3, mean BW was significantly reduced with semaglutide 0.5 mg (3.7 kg to 4.3 kg; P < 0.0001) and semaglutide 1.0 mg (4.5 kg to 6.1 kg; P < 0.0001) vs comparators (1.0 kg to 1.9 kg). There were greater reductions in IR with semaglutide 0.5 mg (27% to 36%) and semaglutide 1.0 mg (32% to 46%) vs comparators (17% to 28%). Greater reductions in BW were generally associated with greater decreases in IR. The effect on IR was primarily mediated by weight loss (70% to 80% and 34% to 94%, for semaglutide 0.5 mg and 1.0 mg, respectively, vs comparator). CONCLUSIONS: Semaglutide consistently reduced BW and IR in subjects with T2D in SUSTAIN 1-3. In this analysis, IR improvement was positively associated with, and primarily mediated by, the effect of semaglutide on BW.
ABSTRACT
OBJECTIVE: Treatment of type 2 diabetes mellitus (T2DM) is complex and is intended to decrease morbidity and mortality. Management should therefore include adequate diabetes education, lifestyle changes, drug treatment to achieve early blood glucose control and reduction of cardiovascular (CV) risk factors, early detection and treatment of complications, and assessment of associated comorbidities. The objective was to prepare a document including all aspects required for a comprehensive approach to T2DM. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology. METHODS: The available evidence regarding each aspect of diabetes management (blood glucose control goals, diet and exercise, drug treatment, risk factor management and control, detection of complications, and management of frail patients) was reviewed. Recommendations were formulated based on the grades of evidence stated in the 2018 Standards of Medical Care in Diabetes. Recommendations were discussed and agreed by the working group members. CONCLUSIONS: This document is intended to provide evidence-based practical recommendations for comprehensive management of T2DM by clinical endocrinologists.
Subject(s)
Diabetes Mellitus, Type 2/therapy , Algorithms , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cardiovascular Diseases/prevention & control , Clinical Trials as Topic , Combined Modality Therapy , Comorbidity , Cost-Benefit Analysis , Diabetes Complications/prevention & control , Diet, Diabetic , Disease Management , Dyslipidemias/epidemiology , Dyslipidemias/therapy , Evidence-Based Medicine , Exercise , Glycated Hemoglobin/analysis , Humans , Hypertension/epidemiology , Hypertension/therapy , Hypoglycemic Agents/economics , Hypoglycemic Agents/therapeutic use , Insulin/administration & dosage , Insulin/therapeutic use , Life Style , Non-alcoholic Fatty Liver Disease/diagnosis , Non-alcoholic Fatty Liver Disease/epidemiology , Patient Education as Topic , Sleep Apnea Syndromes/epidemiologySubject(s)
Cardiovascular Diseases/etiology , Cardiovascular Diseases/prevention & control , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Liraglutide/therapeutic use , Age Factors , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Male , Middle Aged , Risk FactorsABSTRACT
Objetivo: Proporcionar unas recomendaciones prácticas para la evaluación y tratamiento de la osteoporosis del varón. Participantes. Miembros del Grupo de Metabolismo Mineral de la Sociedad Española de Endocrinología y Nutrición. Métodos: Las recomendaciones se formularon de acuerdo con el sistema Grading of Recommendations, Assessment, Development and Evaluation (GRADE) para establecer tanto la fuerza de las recomendaciones como el grado de evidencia. Se realizó una búsqueda sistemática en Medline de la evidencia disponible sobre la osteoporosis del varón usando las siguientes palabras claves asociadas: osteoporosis, men, fractures, bone mineral density, treatment, hypogonadism y prostate cancer. Se revisaron artículos escritos en inglés y español con fecha de inclusión hasta el 30 de agosto del 2017; cada tema fue revisado por 2 personas del grupo. Tras la formulación de las recomendaciones, estas se discutieron en una reunión conjunta del grupo de trabajo. Conclusiones: El documento establece unas recomendaciones prácticas basadas en la evidencia acerca del diagnóstico, evaluación y tratamiento de la osteoporosis del varón y situaciones especiales como el hipogonadismo y el tratamiento con terapia de déficit androgénico en el carcinoma de próstata
Objective: To provide practical recommendations to assess and treat osteoporosis in males. Participants. Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology. Methods: Recommendations were formulated using the GRADE system (Grading of Recommendations, Assessment, Development, and Evaluation) to describe both the strength of recommendations and the quality of evidence. A systematic search was made in Medline (PubMed) using the following associated terms: «osteoporosis», «men», «fractures», «bone mineral density», «treatment», «hypogonadism», and «prostate cancer». Papers in English and Spanish with publication date before 30 August 2017 were included. Current evidence for each disease was reviewed by 2 group members. Finally, recommendations were discussed in a meeting of the working group. Conclusions: The document provides evidence-based practical recommendations for diagnosis, assessment, and management of osteoporosis in men and special situations such as hypogonadism and prostate cancer
Subject(s)
Humans , Male , Osteoporosis/drug therapy , Androgen Antagonists/adverse effects , Practice Patterns, Physicians' , Osteoporosis/etiology , Prostatic Neoplasms/complications , Hypogonadism/complications , Osteoporotic Fractures/prevention & controlABSTRACT
BACKGROUND: Previous bisphosphonate treatment attenuates the bone-forming effect of teriparatide. We compared the effects of 12 months of romosozumab (AMG 785), a sclerostin monoclonal antibody, versus teriparatide on bone mineral density (BMD) in women with postmenopausal osteoporosis transitioning from bisphosphonate therapy. METHODS: This randomised, phase 3, open-label, active-controlled study was done at 46 sites in North America, Latin America, and Europe. We enrolled women (aged ≥55 to ≤90 years) with postmenopausal osteoporosis who had taken an oral bisphosphonate for at least 3 years before screening and alendronate the year before screening; an areal BMD T score of -2·5 or lower at the total hip, femoral neck, or lumbar spine; and a history of fracture. Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 µg once daily). The primary endpoint was percentage change from baseline in areal BMD by dual-energy x-ray absorptiometry at the total hip through month 12 (mean of months 6 and 12), which used a linear mixed effects model for repeated measures and represented the mean treatment effect at months 6 and 12. All randomised patients with a baseline measurement and at least one post-baseline measurement were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01796301. FINDINGS: Between Jan 31, 2013, and April 29, 2014, 436 patients were randomly assigned to romosozumab (n=218) or teriparatide (n=218). 206 patients in the romosozumab group and 209 in the teriparatide group were included in the primary efficacy analysis. Through 12 months, the mean percentage change from baseline in total hip areal BMD was 2·6% (95% CI 2·2 to 3·0) in the romosozumab group and -0·6% (-1·0 to -0·2) in the teriparatide group; difference 3·2% (95% CI 2·7 to 3·8; p<0·0001). The frequency of adverse events was generally balanced between treatment groups. The most frequently reported adverse events were nasopharyngitis (28 [13%] of 218 in the romosozumab group vs 22 [10%] of 214 in the teriparatide group), hypercalcaemia (two [<1%] vs 22 [10%]), and arthralgia (22 [10%] vs 13 [6%]). Serious adverse events were reported in 17 (8%) patients on romosozumab and in 23 (11%) on teriparatide; none were judged treatment related. There were six (3%) patients in the romosozumab group compared with 12 (6%) in the teriparatide group with adverse events leading to investigational product withdrawal. INTERPRETATION: Transition to a bone-forming agent is common practice in patients treated with bisphosphonates, such as those who fracture while on therapy. In such patients, romosozumab led to gains in hip BMD that were not observed with teriparatide. These data could inform clinical decisions for patients at high risk of fracture. FUNDING: Amgen, Astellas, and UCB Pharma.
ABSTRACT
OBJECTIVE: To provide recommendations on the effect of antidiabetic drugs on bone fragility to help select the most adequate antidiabetic treatment, especially in diabetic patients with high risk of fracture. PARTICIPANTS: Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology. METHODS: The GRADE system (Grading of Recommendations, Assessment, Development, and Evaluation) was used to establish both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (Pubmed) using the following terms associated to the name of each antidiabetic drug: AND "osteoporosis", "fractures", "bone mineral density", "bone markers", "calciotropic hormones". Papers in English with publication date before 30 April 2016 were reviewed. Recommendations were jointly discussed by the Working Group. CONCLUSIONS: The document summaries the data on the potential effects of antidiabetic drugs on bone metabolism and fracture risk.
