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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of cerivastatin for type 2 diabetes and hypercholesterolemia
European Journal of Preventive Cardiology, Volume 6, No. 6, Year 1999
Notification
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Description
The prevalence of coronary heart disease (CHD) is markedly increased in diabetic patients compared with non-diabetic individuals, and its prognosis is less good. Serum total and low-density lipoprotein (LDL) cholesterol concentrations have been shown to be powerful predictors of CHD morbidity and mortality in patients with type 2 diabetes. The available data suggest that the target cholesterol concentration in patients with diabetes should be similar to that in non-diabetic individuals with a previous myocardial infarction. This led us to investigate the efficacy, tolerability and safety of a new, highly potent statin, cerivastatin, in diabetic hyperlipidaemia. This was a multinational, multicentre, double-blind, randomized study in type 2 diabetic patients with hypercholesterolemia (LDL cholesterol <3.35 mmol/l; triglycerides = 4.56 mmol/l). Eligible patients were randomly assigned to groups to receive cerivastatin 0.1 mg or 0.3 mg or placebo in a ratio of 2:2:1 for 12 weeks. They were monitored in the clinic every 4 weeks. Of the 453 patients screened, 265 were allocated to the study groups. Fifty-one received placebo and 107 patients were assigned to each active treatment group (0.1 mg and 0.3 mg cerivastatin). At the close of the study, total cholesterol had decreased by 13.7% and 23.5%, LDL cholesterol decreased by 20.2% and 33.8%, and triglyceride concentrations decreased by 3.9% and 12.3% in the cerivastatin 0.1 mg and 0.3 mg groups, respectively. There was no significant difference between the groups in haemoglobin A>1cadverse events or increases in liver and muscle enzymes during the study period. Hypercholesterolaemic patients with type 2 diabetes had a significant reduction in LDL cholesterol and total cholesterol concentrations after cerivastatin treatment once daily. The dose of 0.3 mg cerivastatin is effective in diabetic hypercholesterolemia, with co-reduction of triglyceride concentrations. The effect of cerivastatin on coronary morbidity and mortality is currently being investigated in clinical trials. © 1999, European Society of Cardiology. All rights reserved.
Authors & Co-Authors
Rubinstein, Ardon
Israel, Tel Aviv-yafo
Tel Aviv Sourasky Medical Center
Maritz, Frans Jacobus
South Africa, Tygerberg
Tygerberg Hospital
Soule, Steven Grant
South Africa, Observatory
Groote Schuur Hospital
Markerl, Arie
Israel, Haifa
Rambam Health Care Campus Israel
Chajek-Shaul, Tova
Israel, Jerusalem
Hadassah University Medical Centre
Maislos, Maximo
Israel, Beer Sheva
Soroka University Medical Center
Tal, Sharon
Israel, Bnei Brak
Pharma Clinical Ltd
Stolero, Dan
Israel, Bnei Brak
Pharma Clinical Ltd
Statistics
Citations: 14
Authors: 8
Affiliations: 7
Identifiers
Doi:
10.1177/204748739900600607
ISSN:
20474873
e-ISSN:
20474881
Research Areas
Disability
Health System And Policy
Noncommunicable Diseases
Study Design
Cross Sectional Study