RESUMEN
AIMS: Previously, a retrospective cohort study found no increased risk of acute pancreatitis with current or recent use of exenatide twice daily compared with use of other anti-diabetic drugs. This follow-up study investigated incident acute pancreatitis, with the use of a different data source and analytic method, in patients exposed to exenatide twice daily compared with patients exposed to other anti-diabetic medications. METHODS: A large US health insurance claims database was used. Eligible patients had ≥ 9 months continuous enrollment without a claim for pancreatitis and a claim for a new anti-diabetic medication on or after 1 June 2005 to 31 March 2009. Cases of acute pancreatitis were defined as hospitalized patients with an Internation Classification of Disease 9 code of 577.0 in the primary position. A discrete time survival model was used to evaluate the relationship between exenatide twice daily and acute pancreatitis. RESULTS: Of 482,034 eligible patients, 24,237 initiated exenatide twice daily and 457,797 initiated another anti-diabetic medication. Initiators of exenatide twice daily had more severe diabetes compared with initiators of other anti-diabetic medications. After adjustments for propensity score, insulin and use of medication potentially associated with acute pancreatitis, the odds ratio with exenatide twice daily exposure was 0.95 (95% CI 0.65-1.38). A secondary analysis that examined current, recent and past medication exposure found no increased risk of acute pancreatitis with exenatide twice daily, regardless of exposure category. CONCLUSION: This study indicates that exposure to exenatide twice daily was not associated with an increased risk of acute pancreatitis compared with exposure to other anti-diabetic medications. These results should be interpreted in light of potential residual confounding and unknown biases.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Pancreatitis/inducido químicamente , Péptidos/administración & dosificación , Péptidos/efectos adversos , Ponzoñas/administración & dosificación , Ponzoñas/efectos adversos , Enfermedad Aguda , Adolescente , Adulto , Anciano , Niño , Preescolar , Diabetes Mellitus Tipo 2/epidemiología , Esquema de Medicación , Exenatida , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Seguro de Salud , Clasificación Internacional de Enfermedades , Masculino , Persona de Mediana Edad , Pancreatitis/epidemiología , Estudios Retrospectivos , Riesgo , Estados Unidos/epidemiología , Adulto JovenRESUMEN
AIM: Reports of acute pancreatitis associated with exenatide treatment prompted this study to estimate the association between acute pancreatitis and exenatide use relative to other antihyperglycaemic drugs. METHODS: This cohort study included patients without claims for prior pancreatic disease who initiated exenatide or other antihyperglycaemic drugs between June 2005 and December 2007. Acute pancreatitis was identified with diagnosis codes and confirmed through review of blinded medical records. Poisson regression models provided estimates of rate ratios (RRs) and 95% confidence intervals (CIs) comparing the rate of acute pancreatitis during periods of current (days supplied + 31 days), recent (current definition + 31 days) and past use (≥32 days beyond current definition) of exenatide relative to other antihyperglycaemic drugs, adjusted for propensity scores. A prespecified nested case-control analysis provided RR estimates adjusted for patient characteristics abstracted from medical records. RESULTS: Initiators of exenatide (N = 25719) had more baseline claims for obesity and concomitant diabetes drugs than comparators (N = 234536). There were 40 confirmed cases of acute pancreatitis in the exenatide cohort and 254 among other antihyperglycaemic drug initiators. Compared to other antihyperglycaemic drugs, the propensity score-adjusted RR for exenatide was 0.5 (95% CI 0.2-0.9) for current use, 1.1 (95% CI 0.4-3.2) for recent use and 2.8 (95% CI 1.6-4.7) for past use. The case-control analysis resulted in a RR of 0.2 for current use (95% CI 0.0-1.4) and 0.1 for recent use (95% CI 0.0-1.3), but an attenuated RR in the past use association (RR 1.1; 95% CI 0.1-11.0). CONCLUSIONS: Exenatide use was not associated with an increased risk of acute pancreatitis.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/efectos adversos , Pancreatitis/inducido químicamente , Péptidos/efectos adversos , Ponzoñas/efectos adversos , Enfermedad Aguda , Adolescente , Adulto , Anciano , Niño , Preescolar , Estudios de Cohortes , Bases de Datos Factuales , Diabetes Mellitus Tipo 2/complicaciones , Exenatida , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Pancreatitis/etiología , Medición de Riesgo , Factores de Riesgo , Adulto JovenRESUMEN
Household environmental tobacco smoke (ETS) exposure accounts for substantial morbidity among young children, but the ETS-associated morbidity burden among school-age children is less well defined. Illness-related school absenteeism is a measure of a broad spectrum of adverse effects of ETS exposure in school-age children. The authors investigated the relations between ETS exposure, asthma status, and illness-related school absenteeism in a cohort of 1,932 fourth-grade schoolchildren from 12 southern California communities during January-June 1996. Incidence rates and adjusted relative risks of illness-related absences were determined by using an active surveillance system. The effects of ETS exposure on absenteeism were assessed by using stratified incidence rates and Poisson regression to adjust for sociodemographic factors. ETS exposure was associated with an increased risk of respiratory-illness-related school absences (relative risk (RR) = 1.27, 95% confidence interval (CI): 1.04, 1.56). Children living in a household with two or more smokers were at increased risk of such absences (RR = 1.75, 95% CI: 1.33, 2.30). Children's asthma status affected their response to ETS. Compared with unexposed children without asthma, children with asthma were at increased risk of respiratory-illness-related school absences when exposed to one (RR = 2.35, 95% CI: 1.49, 3.71) or two or more (RR = 4.45, 95% CI: 2.80, 7.07) household smokers. Children without asthma also had an increased risk if exposed to two or more smokers (RR = 1.44, 95% CI: 1.04, 2.00). Therefore, ETS exposure is associated with increased respiratory-related school absenteeism among children, especially those with asthma.