Reduction in Cardiovascular Events With Atorvastatin in 2,532 Patients With Type 2 Diabetes

Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm (ASCOT-LLA)

  1. Peter S. Sever, FRCP1,
  2. Neil R. Poulter, FRCP1,
  3. Björn Dahlöf, MD2,
  4. Hans Wedel, PHD3,
  5. Rory Collins, FRCP4,
  6. Gareth Beevers, FRCP5,
  7. Mark Caulfield, FRCP6,
  8. Sverre E. Kjeldsen, MD78,
  9. Arni Kristinsson, MD9,
  10. Gordon T. McInnes, FRCP10,
  11. Jesper Mehlsen, MD11,
  12. Markku Nieminen, FESC12,
  13. Eoin O’Brien, FRCP13,
  14. Jan Ostergren, MD14 and
  15. for the ASCOT Investigators
  1. 1Imperial College, London, U.K
  2. 2Sahlgrenska University Hospital/Östra, Gothenburg, Sweden
  3. 3Nordiska Hälsovårdshagskolan, Gothenburg, Sweden
  4. 4University of Oxford, Oxford, U.K
  5. 5City Hospital, Birmingham, U.K
  6. 6St. Bartholomew’s and the Queen Mary’s School of Medicine, London, U.K
  7. 7University of Michigan, Ann Arbor, Michigan
  8. 8University Hospital, Ulleval, Oslo, Norway
  9. 9University Hospital, Reykjavik, Iceland
  10. 10University of Glasgow, Glasgow, U.K
  11. 11H.S. Frederiksberg Hospital, Frederiksberg, Denmark
  12. 12University Central Hospital, Helsinki, Finland
  13. 13Beaumont Hospital, Dublin, Ireland
  14. 14Karolinska Hospital, Stockholm, Sweden
  1. Address correspondence and reprint requests to Neil R. Poulter, International Centre for Circulatory Health, NHLI, Faculty of Medicine, Imperial College London, St. Mary’s Campus, 59 N. Wharf Rd., London W2 1PG, U.K. E-mail: n.poulter{at}imperial.ac.uk

Abstract

OBJECTIVE—This study aims to establish the benefits of lowering cholesterol in diabetic patients with well-controlled hypertension and average/below-average cholesterol concentrations, but without established coronary disease.

RESEARCH DESIGN AND METHODS—In the lipid-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA), 10,305 hypertensive patients with no history of coronary heart disease (CHD) but at least three cardiovascular risk factors were randomly assigned to receive 10 mg atorvastatin or placebo. Effects on total cardiovascular outcomes in 2,532 patients who had type 2 diabetes at randomization were compared.

RESULTS—During a median follow-up of 3.3 years, concentrations of total and LDL cholesterol among diabetic participants included in ASCOT-LLA were ∼1 mmol/l lower in those allocated atorvastatin compared with placebo. There were 116 (9.2%) major cardiovascular events or procedures in the atorvastatin group and 151 (11.9%) events in the placebo group (hazard ratio 0.77, 95% CI 0.61–0.98; P = 0.036). For the individual components of this composite end point, the number of events occurring in the diabetes subgroup was small. Therefore, although fewer coronary events (0.84, 0.55–1.29; P = 0.14) and strokes (0.67, 0.41–1.09; P = 0.66) were observed among the patients allocated atorvastatin, these reductions were not statistically significant.

CONCLUSIONS—Atorvastatin significantly reduced the risk of major cardiovascular events and procedures among diabetic patients with well-controlled hypertension and without a history of CHD or markedly elevated cholesterol concentrations. The proportional reduction in risk was similar to that among participants who did not have diagnosed diabetes. Allocation to atorvastatin prevented ∼9 diabetic participants from suffering a first major cardiovascular event or procedure for every 1,000 treated for 1 year.

Footnotes

  • P.S.S. is a member of advisory panel for and has received honoraria from Pfizer. N.R.P. and B.D. are members of an advisory panel for and have received honoraria from Pfizer. H.W. and G.T.M. have received honoraria from Pfizer. R.C. has received grants from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Sanofi, and Schering-Plough. G.B. is a member of an advisory panel for and has received honoraria from Merck Sharp & Dohme. M.C. has received grants from Pfizer. S.E.K. has received honoraria from AstraZeneca, Bayer, Merck, Novartis, Pharmacia, and Pfizer. J.M. has received honoraria from Pfizer, AstraZeneca, Servier, and Novartis. J.O. has received consulting fees from AstraZeneca, Novartis, Aventis, and Pfizer; has received honoraria from AstraZeneca, Pfizer, Novartis, Aventis, Boehringer-Ingelheim, Merck AG, and Merck Sharp & Dohme; and has received grant support from AstraZeneca, Pfizer, and Aventis.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    • Accepted January 31, 2005.
    • Received October 19, 2004.
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