A meta-analysis of previous research suggests that use of Pioglitazone ( Actos ), a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of myocardial infarction, stroke and death, but increases the risk for serious heart failure.

Michael A Lincoff and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of Pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of Pioglitazone use ranged from 4 months to 3.5 years.

The researchers found that myocardial infarction, stroke or death occurred in 375 ( 4.4 percent ) of 8,554 patients receiving pioglitazone and 450 ( 5.7 percent ) of 7,836 patients treated with control therapy, an 18 percent relative reduction.
These outcomes were all reduced by a similar magnitude with Pioglitazone treatment.
Serious heart failure was reported in 200 ( 2.3 percent ) of Pioglitazone-treated patients and 139 ( 1.8 percent ) of control patients.

“ These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications, ” the authors write.

Patients with type 2 diabetes or impaired glucose tolerance who take the medication Rosiglitazone ( Avandia ) appear to be at increased risk for a heart attack or heart failure.

Sonal Singh, of the Wake Forest University School of Medicine, Winston-Salem, and colleagues reviewed research to examine the risk of myocardial infarction, heart failure and cardiovascular death with long-term Rosiglitazone use. There have been recent reports of serious adverse events with Rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.

The researchers compiled data from four randomized trials that included 14,291 patients ( n = 6,421 receiving Rosiglitazone; n = 7,870 receiving control therapy ). Follow-up for these studies was 1-4 years.

The pooled data from the trials indicated that Rosiglitazone, compared with controls, significantly increased the risk of myocardial infarction by 42 percent ( 94 of 6,421 patients who received Rosiglitazone vs. 83 of 7,870 patients who received control therapy ) and doubled the risk of heart failure ( 102 of 6,421 patients vs. 62 of 7,870 patients ). Use of Rosiglitazone was not associated with a significant increase in risk of cardiovascular death.

“ Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available, ” the authors conclude.

Source: Journal of American Medical Association, 2007

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