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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
Insights
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.
Background:
Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.
Methods:
We conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.
Results:
After four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).
Conclusions:
Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.
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