PMID- 18777490 OWN - NLM STAT- MEDLINE DCOM- 20081003 LR - 20220330 IS - 1479-1641 (Print) IS - 1479-1641 (Linking) VI - 5 IP - 3 DP - 2008 Sep TI - The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS). PG - 177-83 LID - 10.3132/dvdr.2008.029 [doi] AB - 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. FAU - Newman, Connie B AU - Newman CB AD - Department of Medicine, New York University School of Medicine, VA Hospital, 423 East 23rd Street, Dept of Medicine -11093 South, New York, NY 10010, USA. FAU - Szarek, Michael AU - Szarek M FAU - Colhoun, Helen M AU - Colhoun HM FAU - Betteridge, D John AU - Betteridge DJ FAU - Durrington, Paul N AU - Durrington PN FAU - Hitman, Graham A AU - Hitman GA FAU - Neil, H Andrew W AU - Neil HA FAU - Demicco, David A AU - Demicco DA FAU - Auster, Sheila AU - Auster S FAU - Fuller, John H AU - Fuller JH CN - Cards Investigators LA - eng SI - ClinicalTrials.gov/NCT00327418 GR - Department of Health/United Kingdom PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Diab Vasc Dis Res JT - Diabetes & vascular disease research JID - 101234011 RN - 0 (Cholesterol, LDL) RN - 0 (Heptanoic Acids) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Pyrroles) RN - A0JWA85V8F (Atorvastatin) SB - IM MH - Adult MH - Aged MH - Atorvastatin MH - Cholesterol, LDL/blood MH - Diabetes Mellitus, Type 2/*drug therapy/metabolism MH - Double-Blind Method MH - Female MH - Gastrointestinal Diseases/chemically induced MH - Heptanoic Acids/administration & dosage/*adverse effects MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/*adverse effects MH - Ireland MH - Male MH - Middle Aged MH - Muscular Diseases/chemically induced MH - Practice Guidelines as Topic MH - Pyrroles/administration & dosage/*adverse effects MH - Time Factors MH - Treatment Outcome MH - United Kingdom EDAT- 2008/09/09 09:00 MHDA- 2008/10/04 09:00 CRDT- 2008/09/09 09:00 PHST- 2008/09/09 09:00 [pubmed] PHST- 2008/10/04 09:00 [medline] PHST- 2008/09/09 09:00 [entrez] AID - 3115 [pii] AID - 10.3132/dvdr.2008.029 [doi] PST - ppublish SO - Diab Vasc Dis Res. 2008 Sep;5(3):177-83. doi: 10.3132/dvdr.2008.029.