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| Format: | Artículo científico |
| Langue: | en |
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Centro Nacional de Investigaciones Científicas
2003
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| Accès en ligne: | https://www.redalyc.org/articulo.oa?id=181226142002 |
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- Comparative efficacy, safety and tolerability of policosanol versus statins in patients with type II hypercholesterolemia: emphasis on muscle function indicators Gladys Castaño Rosa Mas Julio C. Fernández Lilia Fernández José Illnait Melbis Mesa Biología Lowering elevated total (TC) and low-density lipo-protein-cholesterol (LDL-C) reduces the frequency of coronary events, so that cholesterol-lowering drugs are indicated to prevent coronary heart disease (CHD). Nevertheless, myo-pathy and rhabdomyolysis are related with the use of these drugs, mainly with HMGCoA reductase inhibitors (statins). Policosanol is a cholesterol-lowering drug purified from sugar cane wax, which inhibits cholesterol biosynthesis through the regulation of the activity of HMGCoA reductase. Short and long-term satisfactory efficacy of policosanol (5 – 20 mg/d) has been demonstrated, being notorious its excellent safety and tolerability, so that no drug-related adverse experiences (AE) have proven up to date. Nevertheless, considering its effects on cholesterol biosynthesis, it is convenient to discard whether policosanol can induce muscular AE similarly to statins. This study was undertaken to compare the effects of policosanol and statins on patients with Type II Hypercholesterolemia (HC), with emphasis on safety and effects on muscle function indi-cators. After 4 weeks on a baseline cholesterol-lowering diet period, 411 eligible patients randomly re-ceived, under double-blind con-ditions, policosanol 10 mg/d or statins (lovastatin 20 mg/d or simvastatin 10 mg/d). Tablets were taken once a day with the evening meal for 8 weeks. Physical examination and laboratory tests were done at baseline and study completion, while requests for AE and compliance assessment were done at final visit. Policosanol at 10 mg/d for 8 weeks significantly (p < 0.00001) lowered LDL-C (23.3 %), TC (16.5 %) and triglycerides (p < 0.0001) (10.1 %), while statins reduced (p < 0.00001) LDL-C (21.8 %), TC (17.4 %) and triglycerides (p < 0.001) (5.5 %). Policosanol, but not statins, significantly increased (p < 0.001) HDL-C (9.6 %). The frequency of patients reaching LDL-C reductions ≥ 15 % was sig-nificantly greater (p < 0.05) in policosanol (144/206, 70.0 %) than in statins group (120/205,58.5 %) Both treatments were well tolerated. None of them affected physical safety indicators. Policosanol signi-ficantly lowered (p < 0.05) aspartate aminotransferase (AST) and (p < 0.01) creatinphosphokinase (CPK) values, while unchanged other blood biochemistry indicators. Statins significantly (p < 0.05) increased CPK levels. Twenty-eight (28) patients (7 policosanol, 21 statin) discontinued from the study, Two policosanol patients withdrew from the trial due to AE consisting of abdominal pain and lower limb edema, respectively. Eleven (11) statin-patients discontinued the study due to a serious AE (unstable angina) and other 10 non-serious AE. Three patients reported mus-cular AE (cramps and/or myalgia), 5 suffered gastrointestinal distur-bances (abdominal pain; diarrhea, nauseas, gastric discomfort and/or vomiting), 2 referred cardiovascular AE (arrythmia, uncontrolled hyper-tension) and other patient reported dizziness + headache. In addition, three of these pa 2003 artículo científico 0253-5688 https://www.redalyc.org/articulo.oa?id=181226142002 en http://www.redalyc.org/revista.oa?id=1812 Revista CENIC. Ciencias Biológicas application/pdf Centro Nacional de Investigaciones Científicas Revista CENIC. Ciencias Biológicas (Cuba) Num.3 Vol.34