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Published on: October 2, 2020
Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis
Christoph Wanner1, Vera Krane, Winfried März
1Division of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany. wanner_c@medizin.uni-wuerzburg.de
The New England Journal of Medicine
|July 22, 2005
Summary
Atorvastatin did not significantly reduce cardiovascular events in patients with type 2 diabetes on hemodialysis. This study found no statistically significant effect on the primary composite endpoint of cardiovascular death, heart attack, or stroke.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- Statins are known to reduce cardiovascular events in type 2 diabetes mellitus patients.
- Patients with type 2 diabetes mellitus on hemodialysis face high cardiovascular risks.
- The efficacy of statins in this specific high-risk population was previously unexamined.
Purpose of the Study:
- To investigate the effectiveness of atorvastatin in reducing cardiovascular events in patients with type 2 diabetes mellitus undergoing maintenance hemodialysis.
- To assess the impact of atorvastatin on a composite primary endpoint and secondary endpoints including mortality and specific cardiovascular events.
Main Methods:
- A multicenter, randomized, double-blind, prospective study involving 1255 participants with type 2 diabetes mellitus on maintenance hemodialysis.
- Participants were assigned to receive either 20 mg of atorvastatin daily or a placebo.
- The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction, and stroke, with secondary endpoints including all-cause mortality and combined cardiac/cerebrovascular events.
Main Results:
- Atorvastatin significantly reduced low-density lipoprotein cholesterol by 42% compared to placebo.
- The primary composite endpoint occurred in 37% of patients, with no significant difference between atorvastatin and placebo groups (relative risk, 0.92; P=0.37).
- Atorvastatin showed a nominal significant reduction in all cardiac events combined (RR, 0.82; P=0.03) but not in cerebrovascular events or total mortality. A significant increase in fatal stroke was observed (RR, 2.03; P=0.04).
Conclusions:
- Atorvastatin did not demonstrate a statistically significant benefit for the composite primary endpoint in patients with type 2 diabetes mellitus receiving hemodialysis.
- While atorvastatin reduced LDL cholesterol and all cardiac events nominally, it did not significantly impact overall mortality or cerebrovascular events.
- The study highlights the need for further research into cardiovascular event prevention strategies for this vulnerable patient group.
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