RESUMEN
BACKGROUND: Use of antiobesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after the time of marketing. In Europe, information about AEs reported for antiobesity medicines can be accessed in the EudraVigilance (EV) database. Therefore, we aimed to identify and characterise AEs associated with the use of antiobesity medicines in Europe. METHODS: AE reports submitted for antiobesity medicines (Anatomical Therapeutic Chemical (ATC) group A08A) from 2007 to 2014 and located in the EV database were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex of consumer, seriousness, system organ class and medicine. The unit of analysis was one AE and one AE report, respectively. RESULTS: We located 4941 AE reports corresponding to 13 957 AEs for antiobesity medicines in the EV database. More than 90% of all AE cases were serious, including 159 deaths. The majority of AE cases were reported for female adults. The majority of serious AEs was reported for orlistat (37%) and rimonabant (22%). The largest share of serious AEs was of the type 'cardiac disorders' (19%) and 'psychiatric disorders' (18%). Consumer AEs reporting differed from other sources with respect to share and seriousness of AEs, type of AEs (system organ class) and medicines (ATC level 5). CONCLUSIONS: Many serious AEs were found for antiobesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of antiobesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.
Asunto(s)
Fármacos Antiobesidad/efectos adversos , Enfermedades Cardiovasculares/inducido químicamente , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Obesidad/tratamiento farmacológico , Psicosis Inducidas por Sustancias/epidemiología , Adolescente , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Enfermedades Cardiovasculares/epidemiología , Niño , Participación de la Comunidad , Bases de Datos Factuales , Dinamarca/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Farmacovigilancia , Estudios Retrospectivos , Adulto JovenRESUMEN
OBJECTIVE: To elucidate the mathematical relationship between changes of visceral adipose tissue (VAT) and total body fat mass (FM) during weight loss. DESIGN: We hypothesized that changes of VAT mass are allometrically related to changes of FM, regardless of the type of weight-loss intervention, as defined by the differential equation dVAT/dFM=k x VAT/FM, where k is a dimensionless constant. We performed a systematic search of the published literature for studies that included measurements of VAT changes via magnetic resonance imaging (MRI) or computed tomography (CT) imaging along with measurements of FM changes by dual-energy X-ray absorptiometry, hydrodensitometry, air-displacement plethysmography or whole-body MRI or CT imaging. We then examined whether or not the data could be explained by the allometric model. RESULT: We found 37 published studies satisfying our search criteria, representing 1407 men and women of various ethnicities, degrees of adiposity and weight-loss interventions. The hypothesized allometric equation relating changes of VAT and FM accurately modeled the data for both men and women and for all methods of weight loss studied. The best-fit value for the dimensionless constant was k=1.3+/-0.1 and the resulting model had an R(2)=0.73. CONCLUSION: This is the first report to reveal an allometric relationship between changes of VAT and FM that holds for both genders as well as a wide variety of weight-loss interventions including bariatric surgery, caloric restriction with or without exercise and exercise alone. We conclude that changes of VAT are primarily determined by FM changes as well as the initial VAT to FM ratio.