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Pioglitazone Reduces Risk of Second Stroke in Diabetic Patients; No Impact Seen on Risk of First Ever Events: Presented at WCC

By Cameron Johnston

BARCELONA, SPAIN -- September 6, 2006 -- Patients with type 2 diabetes who have experienced a stroke may have a significantly reduced risk of subsequent strokes when their diabetes is treated with the peroxisome proliferator-activated receptor (PPAR)-agonist pioglitazone, according to research presented here at the European Society of Cardiology World Congress of Cardiology (WCC).

The same study also showed, however, that the results did not carry over to patients who had never had a stroke. For unknown reasons, pioglitazone did not appear to prevent the first ever strokes among these patients, the researchers said in a presentation on September 3^rd.

Discussing the results of the study, Robert Wilcox, MD, professor of cardiovascular medicine, Queen's Medical Centre, Nottingham, United Kingdom, pointed out that while blood pressure and lipid control are 2 of the most successful strategies for preventing stroke in the general population, no studies have ever demonstrated a benefit to glucose-lowering therapies among patients with type 2 diabetes.

The present study involved more than 5,200 patients with type 2 diabetes and macrovascular disease in 19 sites across Europe. Of the original cohort, 984 had history of stroke (ie, more than 6 months prior to enrollment in the trial), while 4254 had never had any form of stroke. Of those who had had a prior stroke, 486 were treated with pioglitazone as well as the usual diet and drug regimens to treat their diabetes, while 498 received a placebo in addition to their usual diabetic therapy.

Patients were followed for a median of 2.85 years. The primary endpoints of the study were all-cause mortality, nonfatal strokes, acute coronary syndrome, and/or myocardial infarction (MI).

While patients were more or less matched for demographic factors, those with no history of prior stroke were more likely to have had coronary artery bypass surgery, a prior MI, peripheral artery disease, or acute coronary syndrome compared with patients who had had a prior stroke.

As far as laboratory parameters go, there were significant improvements in hemoglobin A1c, serum triglycerides, and high-density lipoprotein among patients who had already had a stroke and were taking pioglitazone compared with those who had had a prior stroke but were receiving a placebo.

There were clear differences (P = .008) in time to fatal or nonfatal strokes between the 2 groups, with 27 of 486 who received pioglitazone having an event within 3 years of enrollment compared with 51 of 498 who received placebo.

Among patients who had not had a prior event, there were no differences in time to first event regardless of whether they were taking a placebo or pioglitazone.

Overall, there were numerical differences in the numbers of patients who achieved the primary endpoints and main secondary endpoints, as well as those who had fatal or nonfatal stroke or fatal or nonfatal MI, but in no case were these differences statistically significant, Dr. Wilcox reported.

In fact, of the entire cohort of more than 5,200 patients, prior stroke was the strongest predictor of a second event, and pioglitazone or statin use were shown to be the only factors that reduced this risk.

Age, poor glucose control, kidney disease, and peripheral artery disease were the strongest predictors of stroke among those who had never experienced a cerebrovascular event.

In conclusion, Dr. Wilcox said it remains to be seen whether pioglitazone use would show a benefit in terms of reducing the risk of first stroke among patients who had never had a stroke if treatment was continued long enough. Another question is whether pioglitazone use would reduce the risk of stroke among nondiabetic patients at high risk of macrovascular disease.


[Presentation title: Effect of Pioglitazone in Stroke Prevention in Type 2 Diabetes: a Prespecified Subgroup Analysis of PROactive. Abstract 120]

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