Long-term Safety of Pioglitazone versus Glyburide in Patients with Recently Diagnosed Type 2 Diabetes Mellitus
Article first published online: 6 JAN 2012
2006 Pharmacotherapy Publications Inc.
Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
Volume 26, Issue 10, pages 1388–1395, October 2006
How to Cite
Jain, R., Osei, K., Kupfer, S., Perez, A. T., Zhang, J. and Lannon, M.-M. (2006), Long-term Safety of Pioglitazone versus Glyburide in Patients with Recently Diagnosed Type 2 Diabetes Mellitus. Pharmacotherapy, 26: 1388–1395. doi: 10.1592/phco.26.10.1388
- Issue published online: 6 JAN 2012
- Article first published online: 6 JAN 2012
- Received January 9, 2006. Accepted February 15, 2006
- type 2 diabetes mellitus;
- drug safety
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 A1c −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.