A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes

Gerrits, Charles; Bhattacharya, Mondira; Manthena, Shivaji; Baran, Robert W.; Pérez, Alfonso; Kupfer, Stuart

doi:10.1002/pds.1470

Cited by 74 publications

(12 citation statements)

References 22 publications

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“…Our results are consistent with a previously suggested protective effect for metformin (18), more neutral effect for pioglitazone (16,17), and potential relative adverse cardiovascular safety profile for rosiglitazone (19,3,4,20). In particular, our results comparing rosiglitazone with pioglitazone complement other recent findings (19,20) and are not likely to be confounded by indication, given the similar prescribing patterns.…”

Section: Discussionsupporting

confidence: 92%

“…In particular, our results comparing rosiglitazone with pioglitazone complement other recent findings (19,20) and are not likely to be confounded by indication, given the similar prescribing patterns. Together, these findings demonstrate that methods for medical record surveillance may provide useful adjunct methods to assess postmarketing drug safety.…”

Section: Discussionsupporting

confidence: 86%

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Rapid Identification of Myocardial Infarction Risk Associated With Diabetes Medications Using Electronic Medical Records

et al. 2009

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OBJECTIVETo assess the ability to identify potential association(s) of diabetes medications with myocardial infarction using usual care clinical data obtained from the electronic medical record.RESEARCH DESIGN AND METHODSWe defined a retrospective cohort of patients (n = 34,253) treated with a sulfonylurea, metformin, rosiglitazone, or pioglitazone in a single academic health care network. All patients were aged >18 years with at least one prescription for one of the medications between 1 January 2000 and 31 December 2006. The study outcome was acute myocardial infarction requiring hospitalization. We used a cumulative temporal approach to ascertain the calendar date for earliest identifiable risk associated with rosiglitazone compared with that for other therapies.RESULTSSulfonylurea, metformin, rosiglitazone, or pioglitazone therapy was prescribed for 11,200, 12,490, 1,879, and 806 patients, respectively. A total of 1,343 myocardial infarctions were identified. After adjustment for potential myocardial infarction risk factors, the relative risk for myocardial infarction with rosiglitazone was 1.3 (95% CI 1.1–1.6) compared with sulfonylurea, 2.2 (1.6–3.1) compared with metformin, and 2.2 (1.5–3.4) compared with pioglitazone. Prospective surveillance using these data would have identified increased risk for myocardial infarction with rosiglitazone compared with metformin within 18 months of its introduction with a risk ratio of 2.1 (95% CI 1.2–3.8).CONCLUSIONSOur results are consistent with a relative adverse cardiovascular risk profile for rosiglitazone. Our use of usual care electronic data sources from a large hospital network represents an innovative approach to rapid safety signal detection that may enable more effective postmarketing drug surveillance.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 86%

Rapid Identification of Myocardial Infarction Risk Associated With Diabetes Medications Using Electronic Medical Records

et al. 2009

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“…A retrospective cohort study, which investigated the risk of AMI during 2003–2006, found that the crude incidence rates of MI were 933 for pioglitazone and 1,113 per 100,000 person-years for rosiglitazone patients [6]. The current study’s rate of MI, covering 2003–2010, was 454 per 100,000 person-years (Table 3), in agreement with a recognized—but not well understood—trend of a decline in CV events in recent years [33, 34].…”

Section: Discussionmentioning

confidence: 99%

“…Both TZDs improve insulin sensitivity through their action at PPAR gamma receptors—with similar effects on glucose levels—but pioglitazone demonstrates a different effect on lipid metabolism [4, 5] and further has been associated with a reduction in the risk of hospitalization for acute myocardial infarction (AMI) compared with rosiglitazone [6]. Results from the PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) study have shown that pioglitazone, in conjunction with standard treatments for diabetes and cardiovascular (CV) conditions, can reduce the risk of the composite endpoint of all-cause mortality, non-fatal myocardial infarction (MI) and stroke [7].…”

Section: Introductionmentioning

confidence: 99%

Comparing Pioglitazone to Insulin with Respect to Cancer, Cardiovascular and Bone Fracture Endpoints, Using Propensity Score Weights

et al. 2013

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BackgroundDiabetes is an important global disease, associated with significant morbidity and an increased risk of death due to chronic end-organ complications. The thiazolidinediones, used mainly as third-line agents in type 2 diabetes mellitus (T2DM), have been associated with some safety concerns, such as an increased risk of bladder cancer, an increased risk of bone fracture and heterogeneous effects on cardiovascular events.ObjectiveThis study aimed to evaluate safety data on pioglitazone for several outcomes and examine them in context with each other as well as with insulin, another third-line treatment for T2DM.MethodsThis retrospective cohort study extracted data from May 1, 2000 until June 30, 2010, from the i3 InVision Data Mart™ database. To adjust for the testing of multiple hypotheses, the Holm method was applied to endpoints representing potential harm from pioglitazone treatment, separately from those representing potential benefit from pioglitazone. The study population included patients with T2DM ≥ 45 years old who were new users of either pioglitazone or insulin. Key outcomes were incident cases of a composite of myocardial infarction (MI) or stroke requiring hospitalization; bone fracture requiring hospitalization; bladder cancer; and a composite of nine other selected cancers. Kaplan–Meier curves were generated and hazard ratios (HRs) for pioglitazone versus insulin were estimated from Cox proportional hazards models adjusted with inverse probability of treatment weights derived from propensity scores.ResultsA total of 56,536 patients (pioglitazone group 38,588; insulin group 17,948) qualified for the study. The mean follow-up was 2.2 years for pioglitazone and 1.9 years for insulin patients. Weighted survival analysis of the composite of MI and stroke, as well as the composite of nine cancers, yielded significant differences in favour of pioglitazone. For the composite of MI and stroke, the HR for pioglitazone versus insulin was 0.44 (95 % confidence interval [CI] 0.39–0.50, p < 0.0001). Modelling of the composite of nine selected cancers produced an HR of 0.78 (95 % CI 0.71–0.85, p < 0.0001). A non-statistically significant difference in favour of pioglitazone was observed in the incidence rate of bone fracture requiring hospitalization (HR 0.86, 95 % CI 0.74–1.01, p = 0.058). For bladder cancer, the overall incidence rates were relatively low and showed no significant difference between the two groups; the HR for pioglitazone versus insulin was 0.92 (95 % CI 0.63–1.33, p = 0.64).ConclusionCompared with insulin, pioglitazone was associated with a significant reduction in the risk of MI and stroke requiring hospitalization, and a significant reduction in the risk of other selected cancers. While pioglitazone treatment may be linked with a lower risk of bladder cancer and bone fracture relative to insulin, these differences were not statistically significant.

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“…Another study found a significant difference in the risk of MI and coronary revascularization between sulfonylureas (higher risk) and metformin (lower) risk, but no significant difference when either agent was compared with rosiglitazone, which appeared to impart a level of risk somewhere between the two [76]. A retrospective cohort study comparing rosiglitazone and pioglitazone appears to support the results of the meta-analyses [77]. The risk of hospitalization for MI was significantly lower for pioglitazone compared with rosiglitazone (HR=0.78, 95% CI [0.63, 0.96]), as was the risk of the composite of MI and coronary revascularization (HR=0.85, 95% CI [0.75, 0.98]).…”

Section: What Are the Observed Effects Of Tzds On Actual Clinical Outmentioning

confidence: 89%

Thiazolidinediones and Cardiovascular Risk — A Question of Balance

Erdmann

Charbonnel²,

Wilcox³

2009

CCR

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Background:Several recent meta-analyses of adverse event data from randomized controlled trials with rosiglitazone reveal a possible association between this thiazolidinedione and an increased risk of ischemic myocardial events. This has led to debate on the overall clinical benefit of glitazone therapy for type 2 diabetes. Pioglitazone, on the other hand, has the most extensive cardiovascular outcomes database of all current glucose-lowering therapies, including a large prospective randomized controlled trial designed specifically to assess cardiovascular outcomes (PROactive). The available data suggest that pioglitazone is associated with a reduction in macrovascular risk. Aims:In this review, we highlight some of the key factors that need to be considered when assessing the net clinical benefit of thiazolidinediones, focussing on both class effects and those specific to either rosiglitazone or pioglitazone.Results:For pioglitazone there appears to be no increase in the risk of overall macrovascular events and no adverse clinical consequences of developing signs of heart failure. Furthermore, there is good evidence of significant benefit regarding the composite of death, MI or stroke. Conclusion:The benefits seen with pioglitazone appear to outweigh the risks.

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A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes

Abstract: This retrospective cohort study showed that pioglitazone, in comparison with rosiglitazone, is associated with a 22% relative risk reduction of hospitalization for AMI in patients with type 2 diabetes.

Cited by 74 publications

References 22 publications

Rapid Identification of Myocardial Infarction Risk Associated With Diabetes Medications Using Electronic Medical Records

Rapid Identification of Myocardial Infarction Risk Associated With Diabetes Medications Using Electronic Medical Records

Comparing Pioglitazone to Insulin with Respect to Cancer, Cardiovascular and Bone Fracture Endpoints, Using Propensity Score Weights

Thiazolidinediones and Cardiovascular Risk — A Question of Balance

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