Long-term safety and efficacy profile of simvastatin
| Autor: | J. Findlay Walker, Tomas S. Bocanegra, Maureen E. Keegan, Deborah R. Shapiro, Stephen J. Boccuzzi |
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| Rok vydání: | 1991 |
| Předmět: |
Male
medicine.medical_specialty Abdominal pain Simvastatin Population Hypercholesterolemia Coronary Disease Cataract Coronary artery disease Internal medicine medicine Humans Lovastatin education Aged education.field_of_study business.industry Anticholesteremic Agents Muscles Middle Aged medicine.disease Surgery Discontinuation Liver Cohort Cardiology Population study Female medicine.symptom Headaches Cardiology and Cardiovascular Medicine business medicine.drug Follow-Up Studies |
| Zdroj: | The American journal of cardiology. 68(11) |
| ISSN: | 0002-9149 |
| Popis: | Simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, has been administered to approximately 2,400 patients with primary hypercholesterolemia with a mean follow-up of 1 year in controlled clinical studies and their open extensions. Approximately 10% of this population received simvastatin for a period of ≥2 years. The population on whom this safety analysis is based had a mean age of 50 years; 62% were men and approximately 27% had preexisting coronary artery disease. Simvastatin was titrated to the maximal daily dose of 40 mg each evening in 56% of the study population (last recorded dose). The most frequently reported drug-related clinical adverse experiences were constipation (2.5%), abdominal pain (2.2%), flatulence (2.0%) and headaches (1%). Persistent elevations of serum transaminase levels >3 times the upper limit of normal were observed in only 1% of this cohort with only 0.1% of the total population requiring discontinuation of therapy. There were no clinically apparent episodes of hepatitis. Discontinuation of therapy due to myopathy was extremely rare (0.08%). Only minimal increases in the frequency of lens opacities (1%) were observed from baseline to the last lens examination during follow-up, consistent with the expected increase in lens opacity development due to normal aging. Patients who were ≥65 years old had a clinical and laboratory safety profile comparable to the nonelderly population. An evaluation of long-term efficacy indicates that the magnitude of total and low-density lipoprotein cholesterol reduction and high-density lipoprotein cholesterol increases initially observed were maintained after 3 years of chronic treatment with simvastatin. Long-term clinical experience with simvastatin continues to indicate that it is an efficacious and well-tolerated lipidlowering agent. |
| Databáze: | OpenAIRE |
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