A Dose-Response Study of Glimepiride in Patients With NIDDM Who Have Previously Received Sulfonylurea Agents

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作者：

Goldberg，R.，B.，Holvey，S.，M.，Schneider，J.

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摘要：

OBJECTIVE: To assess the efficacy, safety, and dose-response relationship of glimepiride in patients with NIDDM. RESEARCH DESIGN AND METHODS: After a 21-day placebo washout period, 304 patients were randomized to receive either placebo or glimepiride, 1, 4, or 8 mg once daily. Fasting plasma glucose (FPG), 2-h postprandial glucose (PPG), and HbA1c were measured at predetermined intervals during the washout period and the 14-week study. Adverse events were tabulated. RESULTS: At each patient visit, reduction from baseline FPG was greater in each glimepiride group than in the placebo group (P or = 8% were assessed, more patients who received 8 mg glimepiride had HbA1c values < 8% at endpoint compared with patients receiving 4 mg. Glimepiride had a favorable safety profile. CONCLUSIONS: Glimepiride in 1-, 4-, or 8-mg doses was effective and well tolerated. Although the 4- and 8-mg once-daily doses were significantly more potent than the 1-mg dose, all three doses yielded clinical improvement. Because the 8-mg dose controlled HbA1c values in a greater number of patients with high baseline HbA1c levels than did the 4-mg dose, this higher dose might be beneficial for patients who are difficult to treat.

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关键词：

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DOI：

10.2337/diacare.19.8.849

被引量：

352

年份：

1996