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| |  WelChol (colesevelam HCl)/Zocor (simvastatin) Combo Better Than Zocor Alone PARSIPPANY, NJ -- April 30, 2001 -- WelChol™ (colesevelam HCl) and Zocor® (simvastatin), taken in combination can lower LDL-cholesterol levels by 42 percent in patients with moderately high cholesterol -- a reduction superior to either therapy alone -- according to a new study published in the April 1 issue of American Journal of Medicine. The additional reduction of LDL-cholesterol levels from this combination of WelChol* (3.8 grams) and Zocor (10 milligrams), compared to Zocor (10 milligrams) alone, was twice the magnitude seen with doubling the dose of Zocor(1). "This study demonstrates that combination therapy is a safe and effective approach to cholesterol management," said Howard H. Knapp, MD, PhD, principal study investigator and executive director, Deaconess Billings Clinic Research Division, Billings, Montana. There is no change in the adverse event profile with the co-administration of atorvastatin (Lipitor®), simvastatin (Zocor) or lovastatin (Mevacor®). These results are consistent with other clinical trials that demonstrate that co-administration with WelChol reduces LDL-cholesterol levels more dramatically than either therapy alone. New data from a study to be published later this year showed that WelChol 3.8 grams per day combined with Lipitor 10 milligrams a day resulted in a 48 percent average reduction in LDL-cholesterol(2). The study showed that patients taking this combination achieved LDL-cholesterol reductions that were not statistically, significantly different from taking 80 milligrams of Lipitor (eight times the commonly prescribed Lipitor dose)(3). WelChol, available by prescription only, effectively lowers LDL-cholesterol (or "bad" cholesterol) and is the only lipid-lowering agent that is FDA-approved for combination use with a statin. Administered alone or in combination with a statin, WelChol is indicated as adjunctive therapy to diet and exercise for the reduction of elevated cholesterol in patients with primary hypercholesterolemia when diet and exercise alone are not adequate. In a six-week multicenter, randomized, double-blind placebo-controlled trial, patients suffering from hypercholesterolemia were monitored to determine the efficacy and safety of WelChol when co-administered with starting doses of Zocor. Study investigators found that WelChol taken in combination with Zocor offers a novel therapeutic alternative to achieve recommended goals of lipid-lowering and may be particularly beneficial for high-risk patients who require the greatest reductions in LDL-cholesterol levels. At the end of the trial, the mean LDL-cholesterol levels declined by 4 percent in the placebo group. Treatment with WelChol (3.8 grams daily) decreased LDL-cholesterol levels by 16 percent, and Zocor (10 milligrams daily) reduced mean LDL-cholesterol levels by 26 percent; the combination appeared to be additive, with a 42 percent reduction. Because WelChol is not absorbed into the blood stream, it has few side effects. The most common side effects (>5 percent) versus placebo are gas (12 percent vs. 14 percent), constipation (11 percent vs. 7 percent), infection (10 percent vs. 13 percent), upset stomach (8 percent vs. 3 percent), and headache (6 percent vs. 8 percent). WelChol should not be taken by patients who have bowel obstruction. Liver-function monitoring is not required with WelChol, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.
References: SOURCE: Sankyo Pharma
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