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Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis.
N Engl J Med. 2005 Jul 21; 353(3):238-48.NEJM

Abstract

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.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany. wanner_c@medizin.uni-wuerzburg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16034009

Citation

Wanner, Christoph, et al. "Atorvastatin in Patients With Type 2 Diabetes Mellitus Undergoing Hemodialysis." The New England Journal of Medicine, vol. 353, no. 3, 2005, pp. 238-48.
Wanner C, Krane V, März W, et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005;353(3):238-48.
Wanner, C., Krane, V., März, W., Olschewski, M., Mann, J. F., Ruf, G., & Ritz, E. (2005). Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. The New England Journal of Medicine, 353(3), 238-48.
Wanner C, et al. Atorvastatin in Patients With Type 2 Diabetes Mellitus Undergoing Hemodialysis. N Engl J Med. 2005 Jul 21;353(3):238-48. PubMed PMID: 16034009.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. AU - Wanner,Christoph, AU - Krane,Vera, AU - März,Winfried, AU - Olschewski,Manfred, AU - Mann,Johannes F E, AU - Ruf,Günther, AU - Ritz,Eberhard, AU - ,, PY - 2005/7/22/pubmed PY - 2005/7/27/medline PY - 2005/7/22/entrez SP - 238 EP - 48 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 353 IS - 3 N2 - 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16034009/Atorvastatin_in_patients_with_type_2_diabetes_mellitus_undergoing_hemodialysis_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa043545?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -