This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (82)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Lipids and Lipid Disorders  • Review  • Alert me on articles by topic

Donald M. Black, MD; Rebecca G. Bakker-Arkema, MS; James W. Nawrocki, MS

Arch Intern Med. 1998;158:577-584.

Background  Statins (3-hydroxy-3-methylglutaryl–coenzyme A [HMG-CoA] reductase inhibitors) have been used for a decade to lower low-density lipoprotein (LDL) cholesterol levels and to improve cardiovascular disease and clinical outcomes.

Objective  To evaluate the safety profile of atorvastatin (Lipitor).

Methods  Data were pooled for 21 completed (2502 patients) and 23 ongoing (1769 patients) clinical trials of atorvastatin conducted in US and international community- and university-based research centers. In these trials, patients with lipid disorders received atorvastatin at dosages of 10 to 80 mg/d. The majority of patients had moderate to severe hypercholesterolemia and were treated from 4 weeks to more than 24 months.

Main Outcome Measures  Transaminase and creatine phosphokinase levels and adverse events were recorded.

Results  Atorvastatin was well tolerated; fewer than 2% of the atorvastatin-treated patients withdrew due to drug-attributable adverse events. The overall adverse event profile for atorvastatin was similar to that observed with other statins. The most common adverse events with atorvastatin as well as with other statins tested were constipation, flatulence, dyspepsia, and abdominal pain. Approximately 5% of atorvastatin-treated patients had serious adverse events; only 2 of these events were possibly associated with treatment. Thirty patients (0.7%) had confirmed transaminase elevations greater than 3 times the upper limit of the normal range. Most elevations occurred within 16 weeks of beginning treatment. No patients had a conclusive characterization of drug-induced myopathy.

Conclusions  The safety profile of atorvastatin was consistent with that of all statins tested and was similar to that seen in all compounds of this class.

From the Parke-Davis Pharmaceutical Research Division, Warner-Lambert Co, Ann Arbor, Mich. Dr Black, Ms Bakker-Arkema, and Mr Nawrocki are employees of the Parke-Davis Pharmaceutical Research Division and own stock in the company.

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Efficacy and safety of rosuvastatin in treatment of dyslipidemia
McKenney
Am J Health Syst Pharm 2005;62:1033-1047.
ABSTRACT | FULL TEXT  

Comparison of two methods of presenting risk information to patients about the side effects of medicines
Knapp et al.
Qual Saf Health Care 2004;13:176-180.
ABSTRACT | FULL TEXT  

Pharmacokinetics of atorvastatin and its metabolites after single and multiple dosing in hypercholesterolaemic haemodialysis patients
Lins et al.
Nephrol Dial Transplant 2003;18:967-976.
ABSTRACT | FULL TEXT  

Drug-induced lupus-like syndrome associated with severe autoimmune hepatitis
Graziadei et al.
Lupus 2003;12:409-412.
ABSTRACT  

Screening for Statin-Related Toxicity: The Yield of Transaminase and Creatine Kinase Measurements in a Primary Care Setting
Smith et al.
Arch Intern Med 2003;163:688-692.
ABSTRACT | FULL TEXT  

Low-density lipoprotein lowering therapy: an analysis of the options
Sacks
J Am Coll Cardiol 2002;40:2135-2138.
FULL TEXT  

Aggressive Lipid Lowering Does Not Improve Endothelial Function in Type 2 Diabetes: The Diabetes Atorvastatin Lipid Intervention (DALI) Study: a randomized, double-blind, placebo-controlled trial
van Venrooij et al.
Diabetes Care 2002;25:1211-1216.
ABSTRACT | FULL TEXT  

Cholesterol absorption inhibition: filling an unmet need in lipid-lowering management
Leitersdorf
Eur Heart J Suppl 2001;3:E17-E23.
ABSTRACT  

Short-term effect of atorvastatin in hypercholesterolaemic renal-transplant patients unresponsive to other statins
Romero et al.
Nephrol Dial Transplant 2000;15:1446-1449.
ABSTRACT | FULL TEXT  

Efficacy of Atorvastatin Compared With Simvastatin in Patients With Hypercholesterolemia
Farnier et al.
J CARDIOVASC PHARMACOL THER 2000;5:27-32.
ABSTRACT  

Atorvastatin-Induced Cholestatic Hepatitis in a Young Woman With Systemic Lupus Erythematosus
Jimenez-Alonso et al.
Arch Intern Med 1999;159:1811-1812.
FULL TEXT