Tags

Type your tag names separated by a space and hit enter

The collaborative atorvastatin diabetes study: preliminary results.
Int J Clin Pract. 2005 Jan; 59(1):121-3.IJ

Abstract

The Collaborative AtoRvastatin Diabetes Study (CARDS) is the first large primary prevention study to focus specifically on the role of a statin in patients aged 40-75 years with type 2 diabetes, but no signs or symptoms of pre-existing vascular disease and who had only average or below average cholesterol levels. The trial was a prospective double-blind randomised trial with 2383 type 2 diabetic subjects randomised to either 10-mg atorvastatin daily or placebo. Originally designed to run for 5 years, the trial was terminated over a year early in June 2003 on account of a clear benefit demonstrated for the intervention group. Over half of patients had a low-density lipoprotein cholesterol (LDL-C) below 3.3 mmol/l at entry and a quarter had an LDL-C <2.6 mmol/l. Atorvastatin 10 mg reduced LDL-C by 40% (1.2 mmol/l) on average. Results at 4 years showed a 37% relative risk reduction (p <0.001) for atorvastatin 10 mg in the primary endpoint (acute coronary heart disease death, fatal or non-fatal myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, coronary revascularisation procedures and stroke). Among the secondary endpoints, total mortality was reduced by 27% (p=0.05), acute coronary events by 36%, coronary revascularisation by 31% and stroke by 48%. The same magnitude of benefit was observed among patients with LDL-C above or below 3 mmol/l. Results observed were against a background where 9% of placebo patients had been permitted to start statin therapy after enrolment and 15% of patients on active treatment had discontinued atorvastatin. The true benefit of the intervention is therefore probably around 25% greater than the intention to treat analysis reports.

Authors

No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15707477

Citation

Owen, Olwen Glynn. "The Collaborative Atorvastatin Diabetes Study: Preliminary Results." International Journal of Clinical Practice, vol. 59, no. 1, 2005, pp. 121-3.
Owen OG. The collaborative atorvastatin diabetes study: preliminary results. Int J Clin Pract. 2005;59(1):121-3.
Owen, O. G. (2005). The collaborative atorvastatin diabetes study: preliminary results. International Journal of Clinical Practice, 59(1), 121-3.
Owen OG. The Collaborative Atorvastatin Diabetes Study: Preliminary Results. Int J Clin Pract. 2005;59(1):121-3. PubMed PMID: 15707477.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The collaborative atorvastatin diabetes study: preliminary results. A1 - Owen,Olwen Glynn, PY - 2005/2/15/pubmed PY - 2005/4/9/medline PY - 2005/2/15/entrez SP - 121 EP - 3 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 59 IS - 1 N2 - The Collaborative AtoRvastatin Diabetes Study (CARDS) is the first large primary prevention study to focus specifically on the role of a statin in patients aged 40-75 years with type 2 diabetes, but no signs or symptoms of pre-existing vascular disease and who had only average or below average cholesterol levels. The trial was a prospective double-blind randomised trial with 2383 type 2 diabetic subjects randomised to either 10-mg atorvastatin daily or placebo. Originally designed to run for 5 years, the trial was terminated over a year early in June 2003 on account of a clear benefit demonstrated for the intervention group. Over half of patients had a low-density lipoprotein cholesterol (LDL-C) below 3.3 mmol/l at entry and a quarter had an LDL-C <2.6 mmol/l. Atorvastatin 10 mg reduced LDL-C by 40% (1.2 mmol/l) on average. Results at 4 years showed a 37% relative risk reduction (p <0.001) for atorvastatin 10 mg in the primary endpoint (acute coronary heart disease death, fatal or non-fatal myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, coronary revascularisation procedures and stroke). Among the secondary endpoints, total mortality was reduced by 27% (p=0.05), acute coronary events by 36%, coronary revascularisation by 31% and stroke by 48%. The same magnitude of benefit was observed among patients with LDL-C above or below 3 mmol/l. Results observed were against a background where 9% of placebo patients had been permitted to start statin therapy after enrolment and 15% of patients on active treatment had discontinued atorvastatin. The true benefit of the intervention is therefore probably around 25% greater than the intention to treat analysis reports. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/15707477/The_collaborative_atorvastatin_diabetes_study:_preliminary_results_ L2 - https://doi.org/10.1111/j.1742-1241.2004.00367.x DB - PRIME DP - Unbound Medicine ER -