Recent studies suggest more rigorous lipid-lowering goals in comparison to previous guidelines. Statin Rx can be associated with bothersome side effects, and alternative treatment regimens must, therefore, be considered.
Twelve patients (PTS) (8 F, 4 M) mean age 64 yr (range 42-84 yr), average weight 176 lb (range 139-264 lb) with total cholesterol, LDL-C, HDL-C, non HDL-C and Triglycerides (TRIG) of 270, 192, 50, 220 and 147 mg/dl, respectively, were randomized open label to receive oral colesevelam (WEL) 1.875 g b.i.d. or ezetimibe (ZET) 10 mg q.d. After 6 weeks, the alternative agent was added (COMBORx). Six weeks later, the second agent only was withdrawn. Lipid panels, ALT and CK levels were obtained twice and averaged at baseline, on each mono Rx, on COMBORx, and again on mono Rx 6 weeks after washout of the second agent.
Compared to baseline, LDL-C and non HDL-C fell by 20.3% (P<0.01) and 15.6% (p<0.01) and by 25.5% (p<0.001) and 22.5% (p<0.001), respectively, on mono Rx with WEL and ZET, respectively. In PTS on WEL, LDL-C and non HDL-C fell by an additional 19.1% (p<0.001) and 16.0% (p<0.001), respectively, when ZET was added. In PTS on ZET, LDL-C and non HDL-C fell by an additional 21.1% (p<0.005) and 16.4% (p<0.01), respectively, when WEL was added. Among the 8 PTS who took their WEL and ZET concomitantly, the additional decrease in LDL-C of 20.6% which occurred when the second drug was added did not differ from either the response of the remaining 4 PTS (19.1% decrease) or entire group of 12 PTS (20.1% decrease). WGT, HDL-C, TRIG, ALT, and CK were unchanged from baseline during any phase of study.
WEL and ZET (COMBORx) are additive in lowering LDL-C and non HDL-C in hypercholesterolemic PTS.
ComboRx is associated with a degree of LDL-C lowering [38.5%; (192 to 118 mg/dl)] and non HDL-C lowering [33.2%; (220 to 147 mg/dl)] which may represent an acceptable alternative for PTS intolerant of statin Rx.
M.J. Zema, None.