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Aug 11, 2017Article Details
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Main Article Content
A 6-month trial of simvastatin (HMG-CoA reductase inhibitor) in the treatment of hypercholesterolaemia
Abstract
The aim of this study was to evaluate the long-term efficacy and tolerability of the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor simvastatin, over a 24week period. Patients (108) with primary hypercholesterolaemia were clinically, haematologically and biochemically evaluated and established on a cholesterol-lowering diet. After a wash-out period free from other lipid-lowering drugs and a baseline period on placebo of 1 month each, 10 mg simvastatin was introduced at night. The dose was increased to 20 mg and 40 mg at 6 and 12 weeks' follow-up respectively if the total cholesterol (TC) level was still above 5,17 mmolll. Follow-up took place every 6 weeks and included lipid, haematological, biochemical and clinical evaluation. A full ophthalmological evaluation was conducted at baseline and at 24 weeks' follow-up.
Overall the TC level was reduced below the baseline level by 34,3% at week 18 of follow-up and 32,5% at week 24. Patients with higher initial TC levels showed greater TC lowering in response to simvastatin than did those with lower initial TC levels. A group of 45 patients was followed up for an additional 12 weeks after the end of the trial and maintained TC reductions similar to those at the end of the trial.
Fourteen patients experienced adverse effects which were thought to be drug-related. One patient was withdrawn from the trial after developing conjunctivitis that proved to be related to the use of simvastatin. The rest of the adverse experiences were not severe enough to terminate the use of simvastatin and included gastro-intestinal tract symptoms, dizziness, conjunctivitis, pruritus and the aggravation of eczema. Aspartate aminotransferase, alanine aminotransferase and creatine kinase values were raised in a significant number of patients but no patient was withdrawn from the trial. A dose of 40 mg simvastatin was associated with a rise in the abovementioned enzymes more often than were lower doses.
