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Long‐term Safety of Pioglitazone versus Glyburide in Patients with Recently Diagnosed Type 2 Diabetes Mellitus
Author(s) -
Jain Rajeev,
Osei Kwame,
Kupfer Stuart,
Perez Alfonso T.,
Zhang Jeff,
Lan MaryMargaret
Publication year - 2006
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1592/phco.26.10.1388
Subject(s) - pioglitazone , medicine , regimen , diabetes mellitus , type 2 diabetes mellitus , type 2 diabetes , adverse effect , placebo , dose , glycemic , peripheral edema , endocrinology , alternative medicine , pathology
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.