Derosa Giuseppe, Mereu Roberto, Salvadeo Sibilla A T, D'Angelo Angela, Ciccarelli Leonardina, Piccinni Mario N, Ferrari Ilaria, Gravina Alessia, Maffioli Pamela, Cicero Arrigo F G
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
Intern Med. 2009;48(5):265-71. doi: 10.2169/internalmedicine.48.1670. Epub 2009 Mar 2.
Metformin is the drug of choice to treat obese type 2 diabetes patients because it reduces either insulin-resistance and body weight. We aimed to comparatively test the efficacy and tolerability of pioglitazone and sibutramine in metformin-intolerant obese type 2 diabetic patients treated with sibutramine.
Five hundred and seventy-six consecutive Caucasian obese type 2 diabetic patients were evaluated during a 12-months period and fifty-two patients were resulted intolerant to metformin at maximum dosage (3,000 mg/day). All intolerant patients to metformin received a treatment with pioglitazone (45 mg/day) and sibutramine (10 mg/day) and they were compared with fifty-three patients treated with metformin (3,000 mg/day) and sibutramine (10 mg/day) for 6 months in a single-blind controlled trial. We assessed body mass index, waist circumference, glycated hemoglobin, Fasting Plasma glucose, postprandial plasma glucose, fasting plasma insulin, postprandial plasma insulin, lipid profile, systolic blood pressure, diastolic blood pressure and heart rate at baseline and after 3, and 6 months.
No body mass index change was observed at 3, and 6 months in pioglitazone + sibutramine group, while a significant reduction of body mass index and waist circumference was observed after 6 months in metformin + sibutramine group (p<0.05). A significant decrease of glycated hemoglobin, Fasting Plasma glucose, postprandial plasma glucose, fasting plasma insulin, postprandial plasma insulin and HOMA index was observed after 3, and 6 months in both groups (p<0.05, and p<0.01, respectively). A significant Tg reduction was present after 6 months (p<0.05) in both groups respect to the baseline values. No systolic blood pressure, diastolic blood pressure and heart rate change was obtained after 3, and 6 months in both groups.
Pioglitazone and sibutramine combination appears to be a short-term equally efficacious and well-tolerated therapeutic alternative respect to metformin-intolerant obese type 2 diabetic patients treated with sibutramine.
二甲双胍是治疗肥胖型2型糖尿病患者的首选药物，因为它能降低胰岛素抵抗和体重。我们旨在比较吡格列酮和西布曲明在对二甲双胍不耐受的肥胖型2型糖尿病患者（接受西布曲明治疗）中的疗效和耐受性。
在12个月期间对576例连续的白种人肥胖型2型糖尿病患者进行评估，其中52例患者在最大剂量（3000毫克/天）时对二甲双胍不耐受。所有对二甲双胍不耐受的患者接受吡格列酮（45毫克/天）和西布曲明（10毫克/天）治疗，并在一项单盲对照试验中与53例接受二甲双胍（3000毫克/天）和西布曲明（10毫克/天）治疗6个月的患者进行比较。我们在基线、3个月和6个月时评估体重指数、腰围、糖化血红蛋白、空腹血糖、餐后血糖、空腹血浆胰岛素、餐后血浆胰岛素、血脂谱、收缩压、舒张压和心率。
吡格列酮+西布曲明组在3个月和6个月时未观察到体重指数变化，而二甲双胍+西布曲明组在6个月后观察到体重指数和腰围显著降低（p<0.05）。两组在3个月和6个月后糖化血红蛋白、空腹血糖、餐后血糖、空腹血浆胰岛素、餐后血浆胰岛素和HOMA指数均显著降低（分别为p<0.05和p<0.01）。两组在6个月后相对于基线值甘油三酯均显著降低（p<0.05）。两组在3个月和6个月后收缩压、舒张压和心率均无变化。
对于接受西布曲明治疗的对二甲双胍不耐受的肥胖型2型糖尿病患者，吡格列酮和西布曲明联合使用似乎是一种短期疗效相当且耐受性良好的治疗选择。
