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

Connie B. Newman, Michael Szarek, Helen M. Colhoun, D. John Betteridge, Paul N. Durrington, Graham A. Hitman, H. Andrew W. Neil, David A. Demicco, Sheila Auster, John H. Fuller, CARDS Investigators

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    Abstract

    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.

    Original languageEnglish
    Pages (from-to)177-183
    Number of pages7
    JournalDiabetes and Vascular Disease Research
    Volume5
    Issue number3
    DOIs
    Publication statusPublished - Sep 2008

    Keywords

    • adverse effects of treatment
    • CARDS
    • lipids
    • statin
    • trials
    • type 2 diabetes
    • RANDOMIZED CONTROLLED-TRIAL
    • PLACEBO-CONTROLLED TRIAL
    • HIGH-DOSE ATORVASTATIN
    • MRC/BHF HEART PROTECTION
    • ARM ASCOT-LLA
    • LOWERING TREATMENT
    • COMPLETED TRIALS
    • STATIN THERAPY
    • CORONARY
    • PREVENTION

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