Santanu Guha, Suhrita Paul, Mookerjee Soura, Tania Kundu, Mita Saha, Pramit Ghosh, Sharmila Guha, Miraj Mandal, Debdutta Majumder
Dept. of Cardiology, Medical College, Kolkata, West Bengal, India.
Indian Heart J. 2011 Sep-Oct;63(5):434-7.
The current study is a prospective, randomized controlled study with two parallel treatment groups done to assess the tolerability and efficacy of a combination of atorvastatin (10 mg) and extended release nicotinic acid (1G) in comparison to atorvastatin (20 mg) alone in modulating the lipid profile in patients of Ischemic Heart Disease in our population.
Patients were randomly allocated into two equal groups (n = 216) as per selection criteria. Group A received Atorvastatin 20 mg while Group B received combination of Atorvastatin -10 mg and extended release nicotinic acid (1G), both once daily at bed time, for a period of 24 weeks. Final end-of-study assessment and evaluation of tolerability and efficacy was done after 24 weeks. Comparison between the groups was performed with paired t-test. A p value < 0.05 was considered to be statistically significant. There was significant reduction in cholesterol, LDL & triglycerides in both the groups. Mean values of cholesterol and LDL were comparable in both groups where as there was increased reduction of triglycerides in Group B. Mean value of HDL cholesterol significantly increased only in group B thus the total cholesterol: HDL ratio was decreased more favorably. SGPT level was not significantly altered in either of the groups.
In the Indian perspective, where HDL is low and the LDL values are not very high, a combination of low dose atorvastatin with nicotinic acid may influence the lipid profile more favorably and reduce the cholesterol/HDL ratio in comparison to atorvastatin alone and is also fairly well tolerated.
本研究是一项前瞻性随机对照研究，设有两个平行治疗组，旨在评估阿托伐他汀（10毫克）与缓释烟酸（1克）联合用药相较于单独使用阿托伐他汀（20毫克）对我国缺血性心脏病患者血脂谱的耐受性和疗效。
根据入选标准，患者被随机分为两组（每组n = 216）。A组服用阿托伐他汀20毫克，B组服用阿托伐他汀10毫克与缓释烟酸（1克）的组合，两组均在睡前每日服用一次，持续24周。24周后进行最终的研究结束评估以及耐受性和疗效评价。组间比较采用配对t检验。p值< 0.05被认为具有统计学意义。两组的胆固醇、低密度脂蛋白和甘油三酯均显著降低。两组的胆固醇和低密度脂蛋白平均值相当，但B组甘油三酯的降低幅度更大。仅B组的高密度脂蛋白胆固醇平均值显著升高，因此总胆固醇：高密度脂蛋白比值的降低更有利。两组的谷丙转氨酶水平均无显著变化。
从印度的情况来看，在高密度脂蛋白水平较低且低密度脂蛋白值不是非常高的情况下，与单独使用阿托伐他汀相比，低剂量阿托伐他汀与烟酸联合用药可能更有利于影响血脂谱并降低胆固醇/高密度脂蛋白比值，且耐受性也相当良好。
