SADHART-CHF: Sertraline safe but provided no benefits for patients with HF, depression vs. placebo
Goodlin S. J Am Coll Cardiol. 2010;56:700-701.
O’Connor C. J Am Coll Cardiol. 2010;56:692-699.
Sertraline vs. placebo was safe in patients with HF and depression, but did not provide greater reduction in depression or improved CV status, study results suggested.
The Sertraline Against Depression and Heart Disease in Chronic Heart Failure (SADHART-CHF) trial was a randomized, double blind, placebo-controlled trial, which compared 50 to 200 mg/day of sertraline vs. matching placebo for 12 weeks. Patients (n=469) were at least 45 years of age and had HF (left ventricular ejection fraction ≤45%, NYHA Class II-IV) and clinical depression (DSM-IV criteria for current major depressive disorder). Primary endpoints were change at 12 weeks in depression severity determined by the Hamilton Depression Rating Scale total score and composite CV status.
According to study results, the mean ± SE change from baseline to 12 weeks for the sertraline patients (n=234) was–7.1 ± 0.5, and for those in the placebo arm (n=235), it was –6.8 ± 0.5 (mean change between groups, 0.4; 95% CI,–1.7 to 0.92). Additional statistics in the sertraline group indicated that the percentage of patients with a composite CV score that worsened was 29.9%, improved was 40.6% and unchanged was 29.5%; in the placebo group, the percentages were 31.1% for those with worsened scores, 43.8% for those whose scores improved and 25.1% for those whose scores did not change.
“Sertraline did not adversely affect CV outcomes in this population, and it may be an appropriate therapeutic strategy in patients who remain depressed despite nonpharmacologic interventions and who otherwise have an indication for sertraline,” researchers concluded.
In an accompanying editorial, Sarah J. Goodlin, MD, with Patient-Centered Education and Research, Salt Lake City, summarized the key findings from the trial.
“The SADHART-CHF trial tells us that discontinuation or adverse event rates were a bit higher with low-dose sertraline than with placebo, that low to moderate doses of sertraline are not associated with increased HF decompensation or death, and that supportive nursing interventions seem as effective as low-dose sertraline for HF patients with moderate depressive symptoms,” she said. “Further research is needed to tell us whether higher doses of sertraline or other antidepressants are both safe and effective.”
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Binge drinking in patients with hypertension associated with high risk for CV mortality
Sull JW. Stroke. 2010;doi:10.1161/strokeaha.110.586347.
Older adult Koreans with hypertension and habits of binge drinking had a markedly higher risk for CV mortality, which was increased nearly threefold in those considered heavy binge drinkers.
Researchers conducted this study with residents (n=6,100) of Kangwha County, Korea, who were at least 55 years old as of March 1985. They followed participants for a maximum of 20.8 years until Dec. 31, 2005, and calculated HRs for CV mortality by BP and binge drinking habits. Binge drinking was defined as having at least six drinks on one occasion, and heavy binge drinking was defined as having at least 12 drinks on one occasion.
During follow-up, 759 patients died of CVD. Compared with nondrinkers with normal BP, male heavy binge drinkers with grade 3 hypertension had a 12-fold higher risk of CV mortality (HR=12.7; 95% CI, 3.47-46.5), whereas male binge drinkers with the same grade hypertension had a fourfold increased risk for CV mortality (HR=4.41; 95% CI, 1.38-14.1). Conversely, the separate effects on CV mortality risk for heavy binge drinking (HR=1.88; 95% CI, 1.10-3.20) and hypertension (HR=2.00; 95% CI, 1.70-2.35) when compared with nondrinkers with normal BP were considerably lower than when combined.
Limitations with this study, in particular the study population of people aged at least 55 years living in an agricultural community with a small population of female drinkers, led the researchers to propose that future studies examine the joint effects of hypertension and binge drinking in a population more inclusive of both genders.