title: The safety and tolerability of atorvastatin 10 mg in the Collaborative Atorvastatin Diabetes Study (CARDS).
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.
authors.affiliation: 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.
authors.forename: Connie B
authors.initials: CB
authors.lastname: Newman
authors.forename: Michael
authors.initials: M
authors.lastname: Szarek
authors.forename: Helen M
authors.initials: HM
authors.lastname: Colhoun
authors.forename: D John
authors.initials: DJ
authors.lastname: Betteridge
authors.forename: Paul N
authors.initials: PN
authors.lastname: Durrington
authors.forename: Graham A
authors.initials: GA
authors.lastname: Hitman
authors.forename: H Andrew W
authors.initials: HA
authors.lastname: Neil
authors.forename: David A
authors.initials: DA
authors.lastname: Demicco
authors.forename: Sheila
authors.initials: S
authors.lastname: Auster
authors.forename: John H
authors.initials: JH
authors.lastname: Fuller
mesh_terms: D000328:Adult; D000368:Aged; D000069059:Atorvastatin; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D007494:Ireland; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced; D017410:Practice Guidelines as Topic; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin