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

Research output: Contribution to journalArticlepeer-review

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)177-83
Number of pages7
JournalDiabetes and Vascular Disease Research
Volume5
Issue number3
DOIs
Publication statusPublished - Sep 2008

Keywords

  • Adult
  • Aged
  • Atorvastatin Calcium
  • Cholesterol, LDL
  • Diabetes Mellitus, Type 2
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases
  • Great Britain
  • Heptanoic Acids
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Ireland
  • Male
  • Middle Aged
  • Muscular Diseases
  • Practice Guidelines as Topic
  • Pyrroles
  • Time Factors
  • Treatment Outcome

Fingerprint Dive into the research topics of 'The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS)'. Together they form a unique fingerprint.

Cite this