Year-by-year analysis of cardiovascular events in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial.
OBJECTIVE
To assess the effect of raloxifene 60 mg/day (RLX) on year-by-year cardiovascular (CV) events in postmenopausal women participating in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, a double-blind, placebo-controlled osteoporosis treatment trial.


METHODS
Post hoc analysis, using data from participants receiving placebo (N = 2576) or RLX 60 mg/day (N = 2557) in MORE, was performed to determine the relative risk (RR, 95% CI) of CV events in each individual trial year. Analyses were performed for the overall cohort and for women in high and low risk subsets. Women were retrospectively assessed as high CV risk using established criteria and the remaining women were considered low CV risk.


RESULTS
The incidence of CV events did not differ between the RLX and placebo groups in the overall cohort (RR 0.86, 95% Cl 0.64-1.15), or the low CV risk subset (RR 1.01, 95% Cl 0.70-1.46). In the high-risk subset, the incidence of CV events was less in the RLX group (RR 0.60, 95% Cl 0.38-0.95). There was no significant increase in CV risk during any single year in the RLX group for either the overall cohort or the low or high CV risk subsets.


CONCLUSIONS
In this post hoc analysis, the risk of CV events was not increased in any single year of MORE in women taking RLX, either in the overall cohort or in the low and high CV risk subsets.
Keech
Cheryl A
CA
Eli Lilly and Company, Indianapolis, IN, USA.
Sashegyi
Andreas
A
Barrett-Connor
Elizabeth
E
D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology*; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D020849:Raloxifene Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D018570:Risk Assessment; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects* / Q000627:therapeutic use
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride