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Pharmacotherapy. 2006 Oct;26(10):1388-95.

Long-term safety of pioglitazone versus glyburide in patients with recently diagnosed type 2 diabetes mellitus.

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1
Endocrinology Division, Advanced Healthcare, SC, Milwaukee, Wisconsin, USA.

Abstract

STUDY OBJECTIVE:

To evaluate the long-term safety and efficacy of glyburide versus pioglitazone in patients with a recent diagnosis of type 2 diabetes mellitus.

DESIGN:

Prospective, randomized, multicenter, double-blind trial with a 16-week titration period and a 40-week maintenance period.

SETTING:

Sixty-five investigative sites in the United States and Puerto Rico.

PATIENTS:

Five hundred two subjects with a recent diagnosis of type 2 diabetes that was unsuccessfully treated with diet and exercise were randomly assigned to study treatment. Of the 251 patients in each treatment group, 128 (51.0%) glyburide-treated patients and 134 (53.4%) pioglitazone-treated patients completed the study.

INTERVENTIONS:

Dosages of randomly assigned glyburide and pioglitazone were titrated every 4 weeks for 16 weeks in 5-mg/day and 15-mg/day increments, respectively, until a fasting plasma glucose level between 69 and 141 mg/dl was achieved. The optimized regimen was maintained during the subsequent 40-week double-blind phase.

MEASUREMENTS AND MAIN RESULTS:

At week 56, glyburide and pioglitazone improved glucose control comparably (change in hemoglobin A(1c) -2.02% and -2.07%, respectively, p=0.669). Withdrawal due to lack of efficacy or adverse events occurred more frequently with glyburide (20.8%) than pioglitazone (12.8%, p<0.032). Significantly higher percentages of glyburide- than pioglitazone-treated patients had a hypoglycemic (24.3% vs 4.4%, p=0.0001) or cardiac (8.8% vs 4.4%, p=0.0478) event. Edema (4.8% vs 7.9%, p=0.1443) and weight gain (4.4% vs 4.0%, p=0.8238) did not differ significantly between the glyburide and pioglitazone groups. Only a few patients discontinued study drug because of weight gain (one glyburide, one pioglitazone), edema (one pioglitazone), or a cardiac event (two glyburide).

CONCLUSION:

With long-term treatment, both glyburide and pioglitazone resulted in comparable glycemic control; however, pioglitazone was associated with less hypoglycemia and fewer withdrawals due to lack of efficacy or adverse events.

PMID:
16999648
DOI:
10.1592/phco.26.10.1388
[Indexed for MEDLINE]
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