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The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS)

Department of Medicine, New York University School of Medicine, VA Hospital, 423 East 23rd Street, Dept of Medicine –11093 South, New York, NY 10010, US.

Michael Szarek

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, US.

Helen M Colhoun

Division of Medicine & Therapeutics, Level 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.

D John Betteridge

Department of Medicine, Royal Free and University College Medical School, Jules Thorn Institute, Middlesex Hospital, Mortimer St, London, W1N 8AA, UK.

Paul N Durrington

Cardiovascular Research Group, University of Manchester, 46 Grafton Street, Manchester, M13 9NT, UK.

Graham A Hitman

Centre for Diabetes and Metabolic Medicine, Queen Mary's School of Medicine, University of London, London, E1 1BB, UK.

H Andrew W Neil

Division of Public Health and Primary Health Care, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.

David A Demicco

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, US.

Sheila Auster

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, US.

John H Fuller

Department of Epidemiology & Public Health, University College, 1–19 Torrington Place, London, WC1E 6BT, UK.

The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the Collaborative Atorvastatin Diabetes Study (CARDS) and followed for 3.9 years.

The percentages of patients experiencing treatment-associated adverse events (AEs), serious AEs and discontinuations due to AEs in the atorvastatin (n=1,428) and placebo (n=1,410) groups were 23.0% vs. 25.4%, 1.1% vs. 1.1% and 2.9% vs. 3.4%, respectively. The most common treatment-associated AEs in the atorvastatin and placebo groups were digestive system-related (8.9% vs. 10.0%). All-cause and treatment-associated myalgia were reported in 4.0% and 1.0% of atorvastatin-treated patients, and 4.8% and 1.2% of placebo-treated patients. An analysis of selected AEs by tertiles of baseline low-density lipoprotein (LDL) cholesterol showed no relationship between LDL cholesterol levels and the incidence of myalgia, cancer or nervous system AEs in either treatment group.

Overall, these data demonstrate that atorvastatin 10 mg was well tolerated in patients with type 2 diabetes during long-term treatment.

Key Words: adverse effects of treatment • CARDS • lipids • statin • trials • type 2 diabetes

Diabetes and Vascular Disease Research, Vol. 5, No. 3, 177-183 (2008)
DOI: 10.3132/dvdr.2008.029


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