Comparison of Vildagliptin and Rosiglitazone Monotherapy in Patients Willi Type 2 Diabetes  

Oleh:

Rosenstock, Julio ; Baron, Michelle A ; Dejager, Sylvie ; Mills, David ; Schweizer, Anja

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Diabetes Care vol. 30 no. 02 (Feb. 2007), page 217.

Ketersediaan

Perpustakaan FK Nomor Panggil: D05.K.2007.01 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

OBJECTIVE - To compare the efficacy and tolerability of vildagliptin and rosiglitazone during a 24-week treatment in drug-naive patients with type 2 diabetes. RESEARCH DESIGN AND METHODS - This was a double-blind, randomized, aclive-controlled, parallel-group, multicenter study of 24-week treatment with vildagliptin (100 mg daily, given as equally divided doses; n = 519) or rosiglitazone (8 mg daily, given as a once-daily dose; n = 267). RESULTS - Monotherapy with vildagliptin and rosiglitazone decreased AlC (baseline = 8.7%) to a similar extent during the 24-week treatment, with most of the A1 C reduction achieved by weeks 12 and 16, respectively. At end point, vildagliptin was as effective as rosiglitazone, improvingAIC by -1.1 :!:: 0.1% (P < 0.001) and -1.3 :!:: 0.1% (P < 0.001), respectively, meeting the statistical criterion for noninferiority (upper-limit 95% Cl for between-treatment difference SO.4%). Fasting plasma glucose decreased more with rosiglitazone (- 2.3 mmolll) than with vildagliptin (-1.3 mmolll). Body weight did not change in vildagliptin-treated palIents (-0.3 :!:: 0.2 kg) but increased in rosiglitazone-treated patients ( + 1.6 :!:: 0.3 kg, P < 0.001 vs. vildagliptin). Relative to rosiglitazone, vildagliptin significantly decreased triglycerides, total cholesterol, and LDL, non-HDL, and total-to-HDL cholesterol (-9 to -16%, all P S 0.01) but produced a smaller increase in HDL cholesterol (+4 vs. +9%, P = 0.003). The proportion of patients experiencing an adverse event was 61.4 vs. 64.0% in patients receiving vildagliptin and rosiglitazone, respectively. Only one mild hypoglycemic episode was experienced by one patient in each treatment group, while the incidence of edema was greater with rosiglitazone (4.1 %) than vildagliptin (21 %). CONCLUSIONS - Vildagliptin is an effective and well-tolerated treatment option in patients with type 2 diabetes, demonstrating similar glycemic reductions as rosiglitazone but without weight gain

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