Efficacy and tolerability of 12-weeks treatment with lipanthyl supra or trichol in Indonesian patients with dyslipidemia

Abstract

The  relation  of  dyslipidemia  with  the  development  and  progression  of  atherosclerosis  and  coronary  artery  diseases  has  been demonstrated.This study compared the lipid modifying effects of locally-manufactured fenofibrate (trichol) versus lipanthyl supra in a randomized  double-blind  controlled  study.A  total  of  sixty-eight  patients  with  levels  of  HDL  cholesterol≤40  mg/dL;  triglyceride  of 200–600 mg/dL; or LDL of ≥130 mg/dL were recruited to this study and were randomized to either receive trichol 300 mg once daily or lipanthyl 160 mg once daily. Sixty one patients completed the study. Lipid levels before and 4, 8, and 12 weeks after the treatments were measured and analyzed.Compared to baseline values, 12-weeks treatment with either lipanthyl or trichol significantly increased plasma  HDL  by  18.8%  and  14.3%  respectively  (P<0.001),  decreased  triglyceride  by  38.2% and  37.2%  (P<0.001),  but  with  no significant  change  in  LDL  levels. Furthermore,  we  observed  a decreasedin total  cholesterol  levels  compare  to  baseline by  8.4%(P<0.05)and 3.1% (P=0.114), intotal cholesterol/HDL ratio by17.6% and 18.4% (P<0.001), in fibrinogen level by 13.8% and 6.4% and an increase in ApoA-1 by 15.0% and 9.7%for lipanthyl and trichol, respectively. Interestingly, the decrease in total cholesterol level  is  significantly  higher  in  trichol  than  lipanthyl  groups  (P<0.05).The  adverse  events  of  both  treatments  were  comparable.The lipid-modifying effects of 300 mg daily dose of trichol is comparable to that of 160 mg daily dose of lipanthyl. Both drugs efficiently increased  the  plasma  HDL  levels  and  decreased  plasma  triglycerides  concentration.  Besides,  a  significant  reduction  of  total cholesterol was achieved after 12 weeks treatment with trichol, but not lipanthyl. (Med J Indones 2007; 16:159-67)