Division of Internal Medicine, Endocrinology and Metabolic Diseases, University of Bari, Bari, Italy.
Clin Drug Investig. 2002 Nov;22(Suppl 1):23-8. doi: 10.2165/00044011-200222001-00004.
To investigate the effects of L-carnitine, coadministered with simvastatin, on hypercholesterolaemia and hypertriglyceridaemia in patients with diabetes.
Randomised, open, parallel-group study.
One investigational centre (hospital).
Thirty-two patients with type 2 diabetes mellitus and hyperlipidaemia (total cholesterol levels > 200 mg/dl and triglyceride levels >150 mg/dl).
PATIENTS were randomised to receive simvastatin alone (n = 16) or simvastatin plus L-carnitine (n = 16) for 60 days. Both treatments were given orally. Simvastatin was administered, in both groups, at a dosage of 20 mg/day, while L-carnitine was administered at a dosage of 2000 mg/day twice daily.
Plasma levels of triglycerides, total cholesterol and high-density lipoprotein (HDL) cholesterol were measured at baseline and at 30 and 60 days after starting treatment. In both groups, there was a progressive improvement in all measured parameters during the study period. However, triglyceride levels decreased to a significantly greater extent in patients co-treated with L-carnitine (from 266.8 mg/dl at baseline to 153.8 mg/dl at 60 days) compared with those receiving simvastatin alone (from 300.2 to 227.8 mg/dl, respectively; p = 0.012 vs combined treatment). HDL-cholesterol levels increased from 49.8 mg/dl at baseline to 51.8 mg/dl at 60 days in the combined treatment group, and decreased from 51.2 to 47.8 mg/dl, respectively in simvastatin recipients, with a trend in favour of the combined treatment (p = 0.076), while no significant differences between groups were observed for total cholesterol levels.
Combined treatment with L-carnitine and simvastatin resulted in greater antihyperlipidaemic effects (i.e. a less atherogenic plasma lipid profile) than with simvastatin alone. The results of this preliminary study strongly suggest that L-carnitine may have a role among antihyperlipidaemic strategies.
研究左旋肉碱与辛伐他汀联合应用对糖尿病患者高脂血症和高甘油三酯血症的影响。
随机、开放、平行分组研究。
一家研究中心(医院)。
32 例 2 型糖尿病合并高脂血症(总胆固醇>200mg/dl,甘油三酯>150mg/dl)患者。
患者被随机分为辛伐他汀单药治疗组(n=16)或辛伐他汀+左旋肉碱联合治疗组(n=16),疗程均为 60 天。两组均口服药物治疗。辛伐他汀在两组中均采用 20mg/天的剂量,左旋肉碱采用 2000mg/天,分两次服用。
分别在治疗前、治疗后 30 天和 60 天测量患者的血浆甘油三酯、总胆固醇和高密度脂蛋白胆固醇水平。在研究期间,两组所有测量参数均逐渐改善。然而,与辛伐他汀单药治疗组相比,联合治疗组的甘油三酯水平下降更为显著(从基线时的 266.8mg/dl 降至 60 天时的 153.8mg/dl,p=0.012)。辛伐他汀单药治疗组和联合治疗组的高密度脂蛋白胆固醇水平分别从基线时的 49.8mg/dl 增加至 60 天时的 51.8mg/dl 和从 51.2mg/dl 降至 47.8mg/dl,联合治疗组呈升高趋势(p=0.076),但两组总胆固醇水平无显著差异。
与辛伐他汀单药治疗相比,左旋肉碱与辛伐他汀联合治疗可产生更强的抗高脂血症作用(即形成更不易致动脉粥样硬化的血脂谱)。这项初步研究的结果强烈提示,左旋肉碱可能在抗高脂血症策略中发挥作用。