A clinical study of drug –drug and drug-food study interactions on the management of hyperlipidemic disease: simvastatin, ezetimibe and omega-3-fatty acids.

ABSTRACT

This study was designed to investigate the effects of combination of ezetimibe, simvastatin and omega-3-fatty acids on lipoproteins in patients with mixed dyslipidemia. Among the 102 patients were screened 98 who met the inclusion and exclusion criteria after 6 weeks on a strict diet therapy were grouped into four treatment groups (2 patients left out in between). The inclusion criteria were mixed dyslipidemia with a high triglyceride level (200-499 mg per 100 ml) and a total cholesterol level more than 200 mg per 100 ml. Present study was conducted on dyslipidemic patients receiving ezetimibe (10 mg) alone, simvastatin (20 mg) alone, omega-3-fatty acids (4 g) alone and combination of simvastatin (20 mg) and ezetimibe (10 mg) and omega-3-fattyacids (4g) daily for 12weeks. After 12 weeks treatment (Tc, LDL)was found decreased, Tg level reduced significantly and HDL level increased in the combination therapy (Simvastatin, ezetimibe and omega-3-fattyacids) than monotherapy. From the result it is concluded that combination therapy of these three may be considered as an optimal treatment option for patients with mixed dyslipidemia.