A multinational study of the effects of low-dose pravastatin in patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia
Autor: | Michael Bergman, Bruce D. Behounek, S. Jeffrey Markowitz, Mark E. McGovern, Kenneth Kassler-Taub |
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Rok vydání: | 1994 |
Předmět: |
medicine.medical_specialty
business.industry Cholesterol nutritional and metabolic diseases General Medicine medicine.disease Placebo Hydroxymethylglutaryl-CoA reductase law.invention chemistry.chemical_compound Endocrinology Randomized controlled trial chemistry law Internal medicine Diabetes mellitus medicine lipids (amino acids peptides and proteins) Hemoglobin Cardiology and Cardiovascular Medicine business Adverse effect Pravastatin medicine.drug |
Zdroj: | Clinical Cardiology. 17:558-562 |
ISSN: | 1932-8737 0160-9289 |
DOI: | 10.1002/clc.4960171009 |
Popis: | This multinational, 16-week, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of low-dose pravastatin in 325 patients with non-insulin-dependent diabetes mellitus (NIDDM) and hypercholesterolemia [serum total cholesterol concentrations of 5.2-7.8 mmol/l (200 to 300 mg/dl)]. Patients were randomized to receive pravastatin 10 mg or matching placebo with doubling of the dose after 8 weeks if predefined target levels for total cholesterol [(i.e., 15% decrease from baseline] had not been achieved. At Week 16, pravastatin-treated patients showed a 21.4% decrease in serum low-density lipoprotein cholesterol (LDL-C) and a 13.5% reduction in serum total cholesterol (TC) concentrations (p < 0.001 compared with placebo). Levels of triglycerides (TG) were reduced 9.6% during pravastatin treatment (p < 0.05 compared with placebo) while high-density lipoprotein cholesterol (HDL-C) levels were increased 4.4% (p = NS). Adverse events and laboratory test abnormalities were similar among patients treated with pravastatin or placebo. Glycosylated hemoglobin (HbA1C) levels remained unchanged. The results of this study demonstrate that low-dose pravastatin is effective and well tolerated for lowering elevated cholesterol concentrations during short-term treatment of patients with NIDDM and hypercholesterolemia. |
Databáze: | OpenAIRE |
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