To assess the effect of statin therapy on the process of atherosclerosis in type 2 diabetes without manifest cardiovascular disease.
ID
Bron
Verkorte titel
Aandoening
Patients with type 2 diabetes without manifest cadiovascular disease.
Ondersteuning
The trial was supported by Bayer BV(Mijdrecht, the Netherlands). After the withdrawal of cerivastatin from the market, Merck, Sharp and Dome (Haarlem, the Netherlands) supplied the simvastatin/placebo tablets for the remaining study period.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change from baseline in mean intima-media thickness (IMT) of the common carotid artery.
Achtergrond van het onderzoek
The goal of the trial was to study the effect of statin therapy on vascular parameters for atherosclerosis in type 2 diabetes without manifest cardiovascular disease.
250 patients received statin therapy (cerivastatin 0.4 mg, later simvastatin 20 mg) or placebo for 2 years in this double blind placebo controlled trial. Endpoints were IMT,FMD, distensibility, 48 hour AECG and laboratory parameters.
Doel van het onderzoek
To assess the effect of statin therapy on the process of atherosclerosis in type 2 diabetes without manifest cardiovascular disease.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Cerivastatin 0.4 mg (Bayer BV, Mijdrecht, the Netherlands) daily or placebo for 2 years.
After the withdrawal of cerivastatin from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin (Merck, Sharp and Dome, Haarlem, the Netherlands), without deblinding the study.
Publiek
PO box 3015
E.D. Beishuizen
Zoetermeer 2700 KJ
The Netherlands
+ 31 79-3462626
beishue1@llz.nl
Wetenschappelijk
PO box 3015
E.D. Beishuizen
Zoetermeer 2700 KJ
The Netherlands
+ 31 79-3462626
beishue1@llz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with type 2 diabetes for at least 1 year;
2. Age 30-80 years;
3. Written informed consent;
4. With no prior cardiovascular disease;
5. Total cholesterol 4.0-6.9 mmol/l
triglycerides < 6.0 mmol/l.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Prior cardiovascular disease;
2. current/recent use of lipid lowering drugs;
3. Impaired renal function (<30 ml/min);
4. CK values > 3 ULN;
5. Uncontrolled thyroid disease;
6. Liver disease or ALAT > 2 ULN;
7. Inadequate contraception, pregnancy or lactation;
8. Life expectancy <2 years.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL868 |
| NTR-old | NTR882 |
| Ander register | : NTR288, ISRCTN51822988 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
2. Beishuizen et al: The effect of statin therapy on endothelial function in type 2 diabetes without manifest cardiovascular disease.Diabetes Care 28:1668-1674, 2005;<br>
3. Beishuizen et al: No effect of statin therapy on silent myocardial ischemia in patients with type 2 diabetes without manifest cardiovascular disease.
Diabetes Care 28: 1675-1679,2005;<br>
4. Ray et al:Vascular phenotype and subclinical inflammation in diabetic Asian Indians without overt cardiovascular disease
Diab.Res.Clin.Pract. (2006),doi:10.1016/j.diabres.2006.09.021.