Glimepiride, a new once-daily sulfonylurea - A double-blind placebo-controlled study of NIDDM patients

被引:96
作者
Rosenstock, J
Samols, E
Muchmore, DB
Schneider, J
Abelove, WA
Asplin, CM
Bergstrom, RW
Berhanu, P
Borowski, GD
Browning, GV
Comstock, JP
Friedman, NM
Gollapudi, GM
Graber, AL
Guthrie, RA
Henson, BE
Hershon, KS
Krosnick, A
Levin, SR
Levy, P
Lock, JP
Lodewick, PA
Mersey, JH
Michie, DD
Mather, SR
Musey, VC
Palmer, JP
Peters, PJ
Poulos, JT
Prendergast, JJ
Reynolds, LR
Roberts, VL
Rosenblatt, S
Rosenthal, AR
Cavanaugh, JJ
Schneider, SH
Snyder, JW
Sweet, RA
Vestal, RE
机构
[1] VET AFFAIRS MED CTR,PALO ALTO LIVERMORE DIV,LIVERMORE,CA
[2] SCRIPPS CLIN & RES FDN,LA JOLLA,CA 92037
[3] HOECHST MARION ROUSSEL,BRIDGEWATER,NJ
关键词
D O I
10.2337/diacare.19.11.1194
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE - To compare the efficacy and safety of two daily doses of the new sulfonylurea, glimepiride (Amaryl), each as a once-daily dose or in two divided doses, in patients with NIDDM. RESEARCH DESIGN AND METHODS - Of the previously treated NIDDM patients, 416 entered this multicenter randomized double-blind placebo-controlled fixed-dose study. After a 3-week placebo washout, patients received a 14-week course of placebo or glimepiride 8 mg q.d., 4 mg b.i.d., 16 mg q.d., or 8 mg b.i.d. RESULTS - Fasting plasma glucose (FPG) and HbA(1c) values were similar at baseline in all treatment groups. The placebo group's FPG value increased from 13.0 mmol/l at baseline to 14.5 mmol/l at the last evaluation endpoint (P less than or equal to 0.001). In contrast, FPG values in the four glimepiride groups decreased from a range of 12.4-12.9 mmol/l at baseline to a range of 8.6-9.8 mmol/l at endpoint (P less than or equal to 0.001, within-group change from baseline; P less than or equal to 0.001, between-group change [vs. placebo] from baseline). Two-hour postprandial plasma glucose (PPG) findings were consistent with FPG findings. In the placebo group, the HbA(1c) value increased from 7.7% at baseline to 9.7% at endpoint (P less than or equal to 0.001), whereas HbA(1c) values for the glimepiride groups were 7.9-8.1% at baseline and 7.4-7.6% at endpoint (P less than or equal to 0.001, within group change from baseline; P less than or equal to 0.001,between-group change from baseline). There were no meaningful differences in glycemic variables between daily doses of 8 and 16 mg or between once- and twice-daily dosing. Adverse events and laboratory data demonstrate that glimepiride has a favorable safety profile. CONCLUSIONS - Glimepiride is an effective and well-tolerated oral glucose-lowering agent. The results of this study demonstrate maximum effectiveness can be achieved with 8 mg q.d. of glimepiride in NIDDM subjects.
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页码:1194 / 1199
页数:6
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