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Atorvastatin, a New HMG-CoA Reductase Inhibitor, Does Not Affect Glucocorticoid Hormones in Patients with Hypercholesterolemia

Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio

Rebecca G. Bakker-Arkema

Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Michigan

Rana Fayyad

Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Michigan

Randall Whitcomb

Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Michigan

Donald M. Black

Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Michigan

Background: Atorvastatin calcium (Lipitor) is a new 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The present study was conducted to examine the effect of pronounced cholesterol lowering on adrenal function in patients with severe hypercholes terolemia.

Methods and Results: Adrenal function was examined under basal conditions and following adrenal corticotropin hormone stimulation in 40 patients (36 with heterogeneous familial and 4 with polygenic hypercholesterolemia). The study was part of a larger study comparing the efficacy and safety of atorvastatin, colestipol, atorvastatin + colestipol, and simvastatin + colestipol treatment over a 1-year period. Maximum doses of all agents were studied: 80 mg atorvastatin once daily, 40 mg simvastatin once daily, and 20 g/day colestipol. At the end of the 1-year treatment period, reductions in low-density lipoprotein cholesterol were 57%, 54%, and 49% for the atorvastatin, colestipol + atorvastatin, and colestipol + simvastatin groups, respectively. No clinically significant changes in basal serum cortisol levels were seen in any treatment group during the 1-year treatment period. Mean serum cortisol concen trations and area under the curve for cortisol concentration versus time data following adrenal corticotropin hormone stimulation were not clinically different during treatment compared with values obtained at baseline for any of the treatment groups.

Conclusions: Treatment with maximum doses of atorvastatin for 1-year did not have any adverse effects on adrenal function under basal conditions or during maximum stimulation. Similarly, colestipol therapy alone and in combination with either atorvastatin or simvastatin did not appear to affect adrenal function.

Key Words: atorvastatin • HMG-CoA reductase inhibitors • hypercholesterolemia • cortisol.

Journal of Cardiovascular Pharmacology and Therapeutics, Vol. 2, No. 4, 243-249 (1997)
DOI: 10.1177/107424849700200402


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