Krempf M, Berthezène F, Wemeau J L, Moinade S, Desriac I, Amelineau E, Passa P
Clinique d'Endocrinologie, Hôtel Dieu, Nantes, France.
Diabetes Metab. 1997 Apr;23(2):131-6.
A 16 week, randomized, double-blind, parallel, placebo-controlled study was designed to determine the effects of low-dose pravastatin on cholesterol concentrations in patients with mild hypercholesterolemia and non-insulin-dependent diabetes mellitus (NIDDM). Following a 6-to 8-week dietary run-in period, a mean serum total cholesterol (TC) level > 5.2 mmol/L (200 mg/dL), but < 7.8 mmol/L (300 mg/dL) was required for entry. Metabolic control of diabetes was determined by a hemoglobin Alc (HbAlc) level less than twice the upper limit of normal on two occasions. Eighty six (86) patients recruited in 5 French diabetic clinics, were randomized in a ratio of 1:1 (pravastatin 10 mg or placebo), and 74 completed the study. There were 12 discontinuations: 5 (11.6%) in the pravastatin group and 7 (16.3%) in the placebo group. Drop-out was due to an adverse event in 1 patient (2.3%) in the pravastatin group and in 5 patients (11.6%) in the placebo group. Thirty five (35) placebo patients and 14 pravastatin patients had their dose of treatment doubled at week 8: the dose of treatment was to be doubled at week 8 in the event of non-response to treatment (TC at week 7 > 5.2 mmol/L and TC decrease < 15% from baseline). At week 16, pravastatin lowered TC from 6.4 to 5.6 mmol/L (-13.8%, p < 0.001 versus placebo), low-density lipoprotein cholesterol (LDL-C) from 4.3 to 3.4 mmol/L (-20.4%, p < 0.001 versus placebo) and slightly increased high-density lipoprotein cholesterol (HDL-C) from 1.18 to 1.25 mmol/L (+6.7%). Side effects were similar in both groups. Blood glucose control was not altered as assessed by serial HbAlc measurements which were unchanged during treatment. This study demonstrated that low-dose pravastatin is effective in lowering cholesterol levels in patients with hypercholesterolemia and NIDDM.
一项为期16周的随机、双盲、平行、安慰剂对照研究旨在确定低剂量普伐他汀对轻度高胆固醇血症和非胰岛素依赖型糖尿病（NIDDM）患者胆固醇浓度的影响。在为期6至8周的饮食导入期后，要求进入研究的患者平均血清总胆固醇（TC）水平>5.2 mmol/L（200 mg/dL）但<7.8 mmol/L（300 mg/dL）。糖尿病的代谢控制通过两次血红蛋白Alc（HbAlc）水平低于正常上限的两倍来确定。在5家法国糖尿病诊所招募的86名患者按1:1的比例随机分组（普伐他汀10 mg或安慰剂），74名患者完成了研究。有12名患者退出：普伐他汀组5名（11.6%），安慰剂组7名（16.3%）。退出是由于普伐他汀组1名患者（2.3%）和安慰剂组5名患者（11.6%）出现不良事件。35名安慰剂组患者和14名普伐他汀组患者在第8周将治疗剂量加倍：如果对治疗无反应（第7周时TC>5.2 mmol/L且TC较基线下降<15%），则在第8周将治疗剂量加倍。在第16周时，普伐他汀使TC从6.4降至5.6 mmol/L（-13.8%，与安慰剂相比p<0.001），低密度脂蛋白胆固醇（LDL-C）从4.3降至3.4 mmol/L（-20.4%，与安慰剂相比p<0.001），高密度脂蛋白胆固醇（HDL-C）略有升高，从1.18升至1.25 mmol/L（+6.7%）。两组的副作用相似。通过治疗期间未改变的连续HbAlc测量评估，血糖控制未改变。这项研究表明，低剂量普伐他汀对降低高胆固醇血症和NIDDM患者的胆固醇水平有效。
