Moderate alcohol consumption and safety of lovastatin and warfarin among men: the post-coronary artery bypass graft trial.
OBJECTIVE
Although moderate drinking has been associated with lower mortality among patients with coronary heart disease, its safety among patients taking common cardiac medications is unknown.


METHODS
We studied 1244 men enrolled in the Post-Coronary Artery Bypass Graft (CABG) Trial who had undergone previous coronary bypass surgery. Participants were randomly assigned to lovastatin in low (mean 4 mg) or high (mean 76 mg) doses and to low-dose warfarin (mean international normalized ratio [INR] 1.4, goal INR <2.0) or placebo in a factorial design. Participants underwent routine measurement of alanine aminotransferase (ALT) and INR levels every 6 to 12 weeks for 4 to 5 years. We categorized weekly alcohol intake as abstention (<1 drink), light (1-6 drinks), moderate (7-13 drinks), and heavier (> or =14 drinks).


RESULTS
During follow-up, 66% of men taking warfarin had an INR of 2.0 or higher, and 7% of men had an ALT of 80 IU/L or higher. Maximum INR (P = .72) and ALT (P = .51) levels did not differ across categories of alcohol intake. The risks of an INR of 2.0 or higher were 67%, 66%, 68%, and 61% among non-, light, moderate, and heavier drinkers (P = .86), respectively. The corresponding risks of an ALT of 80 IU/L or more were 8%, 10%, 9%, and 6% (P = .70), respectively.


CONCLUSIONS
Moderate drinking did not adversely influence the safety of low-dose warfarin or even high-dose lovastatin among men in this randomized trial, as measured by INR and ALT levels.
Mukamal
Kenneth J
KJ
Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Mass 02215, USA. kmukamal@bidmc.harvard.edu
Smith
C Christopher
CC
Karlamangla
Arun S
AS
Moore
Alison A
AA
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000428:Alcohol Drinking / Q000009:adverse effects*; D000924:Anticholesteremic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000601:surgery; D004311:Double-Blind Method; D006801:Humans; D019934:International Normalized Ratio; D008148:Lovastatin / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014859:Warfarin / Q000009:adverse effects* / Q000627:therapeutic use
D000924:Anticholesteremic Agents; D000925:Anticoagulants; D010919:Placebos; D014859:Warfarin; D008148:Lovastatin; D000410:Alanine Transaminase