Atorvastatin for severe treatment refractory hypercholesterolemia
(2000) Heart — Vol. 83, n° SUPPL. 2 (2000)
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- Abstract
- Objective: The aim of this multicenter, open label, compassionate use study was to assess the efficacy and safety of atorvastatin up to 80 mg in patients with severe hypercholesterolemia refractory to conventional therapy. Methods: Overall. 62 patients with persisting hypercholesterolemia (low-density lipoprotein cholesterol (LDL-C) > 200 mg/dl) despite receiving maximally tolerated lipid-lowering therapy were included. After an optional wash-out period of two weeks, patients were enrolled in an initial 8 weeks dose-finding phase, during which an optimal dosage regimen was elaborated for each patient. Atorvastatin dosage could be increased every 4 weeks if needed. Fifty-seven patients completed this 8-weeks period. If response to atorvastatin was adequate, patients could enter a long-term extension phase. Results: Mean LDL-C on previous lipid-lowering therapy was 277 mg/dl. At baseline (after an optional two weeks wash-out) lipid levels were as follows: LDL-C 339 mg/dl, triglycerides (TG) 201mg/dl, high-density lipoprotein cholesterol (HDL-C) 51 mg/dl. At week 8, LDL-C and TG decreased to respectively 188 and 134 mg/dl; HDL-C increased to 53 mg/dl. Mean LDL-C reductions from baseline in the 20, 40 and 80 mg groups were 46%(n=9), 41%(n=32) and 49%(n=16). The corresponding reductions in TG were 18%, 20% and 38%. HDL-C levels increased by resp. 0,2%, 5% and 9%. Overall treatment was well tolerated. Conclusion: In patients with treatment refractory hypercholesterolemia atorvastatin results in significant additional LDL-C lowering (32% compared to previous maximally tolerated therapy) and is well tolerated.
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Heller, F., Descamps, O., & Boland, B. (2000). Atorvastatin for severe treatment refractory hypercholesterolemia. Heart, 83(SUPPL. 2). https://hdl.handle.net/2078.5/191021 (Original work published 2000)