Risk of Cardiovascular Events and All-Cause Mortality in Patients Treated With Thiazolidinediones in a Managed-Care Population

Abstract

Background-This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone-and rosiglitazone-treated patients in a managed-care population. Methods and Results-Patients Ն18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had Ͻ1 year continuous eligibility preindex or a preindex insulin claim. Primary outcome measure was time to composite event of AMI, AHF or death among pioglitazone-and rosiglitazone-treated patients. The National Death Index database was accessed to obtain date of death for patients who died during the study period. Propensity score matching was used to control for potential confounders. The Cox proportional hazards model was used to evaluate effects of exposure to rosiglitazone and pioglitazone on time to event. A total of 36 628 patients (58% male; mean age, 54 years) were identified. Of the rosiglitazone-treated patients, 602 (4.16%) had an AMI, AHF, or death compared with 599 (4.14%) propensity score-matched pioglitazone-treated patients. No significant difference was observed between matched groups for risk of composite event (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15; Pϭ0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. Conclusions-In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score-matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death. (Circ Cardiovasc Qual Outcomes. 2010;3:538-545.)

Addressing Limitations in Observational Studies of the Association Between Glucose-Lowering Medications and All-Cause Mortality: A Review

“…Similarly, information on future exposures and particular events occurring during follow-up should not inform cohort inclusion or exclusion criteria. Several studies included or excluded patients on the basis of information collected during follow-up, such as the use of insulin after cohort entry [6,24,32,34], use of glucose-lowering combinations [34,40] or switching to other glucose-lowering therapy [24,41]. By conditioning inclusion or exclusion criteria on the basis of future information, these studies have the potential for bias arising from immortal time acting through selection.…”

Introduction to Competitive Intelligence

“…Other publications have reported quite different fi ndings. In a retrospective cohort study, Wertz et al directly compared Avandia and Actos and found no signi fi cant differences in their risk of AMI [12], acute heart failure or death, fi ndings echoed by Bilik et al [13]. The Wellpoint Study, using an insurance company database and published in August 2010, appeared to show no difference between Avandia and Actos regarding key cardiac adverse events, including heart attack.…”

Role of Peroxisome Proliferator-Activated Receptor-.GAMMA. in Atherosclerosis - An Update -

“…111 A recent casematching cohort study suggests that the risks of MI, heart failure or death are about the same in diabetic patients taking either pioglitazone or rosiglitazone, challenging a number of reports that the cardiovascular risks differ between the 2 drugs. 112 …”