Derosa Giuseppe, Cicero Arrigo F G, Gaddi Antonio, Mugellini Amedeo, Ciccarelli Leonardina, Fogari Roberto
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Clin Ther. 2003 May;25(5):1429-39. doi: 10.1016/s0149-2918(03)80130-3.
A previous study has demonstrated that L-carnitine reduces plasma lipoprotein(a) (Lp[a]) levels in patients with hypercholesterolemia.
To test a tolerable Lp(a)-reducing agent in diabetic patients, we assessed the effect of a dietary supplementation of L-carnitine on plasma lipid levels, particularly Lp(a), of patients with type 2 diabetes mellitus (DM) and hypercholesterolemia.
In this 6-month, randomized, double-masked, placebo-controlled clinical trial, patients were enrolled, assessed, and followed up at the Diabetic and Metabolic Diseases Center of the Department of Internal Medicine and Therapeutics at the University of Pavia, Pavia, Italy. All study patients had newly diagnosed type 2 DM that was managed through dietary restriction alone throughout the study, as well as hypercholesterolemia. Patients were randomized to 1 of 2 groups. One group received L-carnitine, one 1-g tablet BID. The other group received a corresponding placebo. We assessed body mass index, fasting plasma glucose, postprandial plasma glucose, glycosylated hemoglobin, fasting plasma insulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein (apo) A-I, apo B, and Lp(a) at baseline and at 1, 3, and 6 months of treatment.
This study included 94 patients. The treatment group included 24 men and 22 women (mean [SD] age, 52 [6] years). The placebo group included 23 men and 25 women (mean [SD] age, 50 [7] years). The baseline characteristics of the groups did not differ significantly. The mean (SD) body weight, height, and body mass index were 78.2 (5.8) kg, 1.70 (0.04) m, and 27.3 (2.5) kg/m(2), respectively, in the L-carnitine group and 77.6 (6.4) kg, 1.71 (0.05) m, and 26.8 (2.2) kg/m(2), respectively, in the placebo group. In the treatment group, Lp(a) was significantly reduced at 3 and 6 months compared with baseline (P < 0.05) and P < 0.01, respectively). We observed a significant improvement after 6 months (P < 0.05) in the Lp(a) value in patients taking L-carnitine compared with those taking placebo. Between-group differences in other variables did not reach a level of significance at months 3 and 6. No drug-related adverse events were reported or observed.
In this preliminary study, after 3 and 6 months, L-carnitine significantly lowered the plasma Lp(a) level compared with placebo in selected hypercholesterolemic patients with newly diagnosed type 2 DM.
先前的一项研究表明，左旋肉碱可降低高胆固醇血症患者的血浆脂蛋白(a)[Lp(a)]水平。
为了在糖尿病患者中测试一种可耐受的降低Lp(a)的药物，我们评估了饮食补充左旋肉碱对2型糖尿病（DM）和高胆固醇血症患者血脂水平，尤其是Lp(a)的影响。
在这项为期6个月的随机、双盲、安慰剂对照临床试验中，患者在意大利帕维亚大学内科与治疗学系糖尿病与代谢疾病中心登记、评估并随访。所有研究患者均为新诊断的2型DM，在整个研究过程中仅通过饮食限制进行管理，同时患有高胆固醇血症。患者被随机分为2组中的1组。一组接受左旋肉碱，每日2次，每次1片1 g片剂。另一组接受相应的安慰剂。我们在基线以及治疗1、3和6个月时评估体重指数、空腹血糖、餐后血糖、糖化血红蛋白、空腹血浆胰岛素、总胆固醇、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇、甘油三酯、载脂蛋白（apo）A-I、apo B和Lp(a)。
本研究纳入了94例患者。治疗组包括24名男性和22名女性（平均[标准差]年龄，52[6]岁）。安慰剂组包括23名男性和25名女性（平均[标准差]年龄，50[7]岁）。两组的基线特征无显著差异。左旋肉碱组的平均（标准差）体重、身高和体重指数分别为78.2（5.8）kg、1.70（0.04）m和27.3（2.5）kg/m²，安慰剂组分别为77.6（6.4）kg、1.71（0.05）m和26.8（2.2）kg/m²。在治疗组中，与基线相比，Lp(a)在3个月和6个月时显著降低（分别为P<0.05和P<0.01）。与服用安慰剂的患者相比，服用左旋肉碱的患者在6个月后Lp(a)值有显著改善（P<0.05）。在3个月和6个月时，其他变量的组间差异未达到显著水平。未报告或观察到与药物相关的不良事件。
在这项初步研究中，与安慰剂相比，在选定的新诊断2型DM的高胆固醇血症患者中，左旋肉碱在3个月和6个月后显著降低了血浆Lp(a)水平。
