A new study shows that patients with pulmonary hypertension who receive a placebo during a clinical trial may experience clinical deterioration.
Researchers from Dwight David Eisenhower Army Medical Center in Georgia conducted a meta-analysis of 13 randomized, placebo-controlled clinical trials that included a total of 1,999 patients with pulmonary hypertension.
Of the patients, 1,131 were treated with a study drug, while 868 were treated with placebo. The analysis showed that placebo-treated patients were 1.81 times more likely to suffer a clinical worsening, including a decline in pulmonary hemodynamic parameters and a decrease in 6-minute walk distance. Placebo treatment was not associated with a difference in mortality.
Researchers suggest future studies involving patients with pulmonary hypertension should focus on evaluating existing medications against one another and comparing novel therapies with those currently accepted.
This study appears in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.