Psychosocial treatment within sex by ethnicity subgroups in the Enhancing Recovery in Coronary Heart Disease clinical trial.
OBJECTIVE
Intervening in depression and/or low perceived social support within 28 days after myocardial infarction (MI) in the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial did not increase event-free survival. The purpose of the present investigation was to conduct post hoc analyses on sex and ethnic minority subgroups to assess whether any treatment subgroup is at reduced or increased risk of greater morbidity/mortality.


METHODS
The 2481 patients with MI (973 white men, 424 minority men, 674 white women, 410 minority women) who had major or minor depression and/or low perceived social support were randomly allocated to usual medical care or cognitive behavior therapy. Total mortality or recurrent nonfatal MI (ENRICHD primary endpoint) and cardiac mortality or recurrent nonfatal MI (secondary endpoint) were analyzed as composite endpoints by group for time to first event using Cox proportional hazards regression.


RESULTS
There was a trend in the direction of treatment efficacy for white men for the primary endpoint (hazard ratio [HR], 0.80; 95% confidence interval, 0.61-1.05; p =.10) and a significant (p <.006, Bonferroni corrected) effect for the secondary endpoint (HR, 0.63; 95% CI, 0.46-0.87; p =.004). In contrast, the HRs for each of the other three subgroups were nonsignificant. The magnitude of differences in treatment effects between white men and the other subgroups remained significant for the secondary endpoint (p =.04) after adjustment for age, education, living alone, antidepressant use, comorbidity score, cardiac catheterization, ejection fraction, history of hypertension, and major depression.


CONCLUSIONS
White men, but not other subgroups, may have benefited from the ENRICHD intervention, suggesting that future studies need to attend to issues of treatment design and delivery that may have prevented benefit among sex and ethnic subgroups other than white men.
Schneiderman
Neil
N
Department of Psychology, University of Miami, P. O. Box 248185, Coral Gables, FL 33124-2070, USA. nschneid@miami.edu
Saab
Patrice G
PG
Catellier
Diane J
DJ
Powell
Lynda H
LH
DeBusk
Robert F
RF
Williams
Redford B
RB
Carney
Robert M
RM
Raczynski
James M
JM
Cowan
Marie J
MJ
Berkman
Lisa F
LF
Kaufmann
Peter G
PG
D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003866:Depressive Disorder / Q000175:diagnosis / Q000628:therapy*; D005006:Ethnicity / Q000523:psychology / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008913:Minority Groups / Q000523:psychology / Q000706:statistics & numerical data; D009203:Myocardial Infarction / Q000401:mortality* / Q000523:psychology; D010555:Personality Inventory; D016016:Proportional Hazards Models; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use; D020280:Sertraline / Q000627:therapeutic use; D012737:Sex Factors; D012944:Social Support; D016019:Survival Analysis; D016896:Treatment Outcome; D044465:White People / Q000523:psychology / Q000706:statistics & numerical data
D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline