Randomised study to compare the efficacy and safety of isapgol plus atorvastatin versus atorvastatin alone in subjects with hypercholesterolaemia.

Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).