Two post-hoc analyses of a clinical trial found that patients with heart failure who received sacubitril/valsartan (Entresto) had lower reductions in health-related quality of life and lower risks of cardiovascular death and heart failure hospitalization.
The results were presented at the Heart Failure Society of America (HFSA) annual scientific meeting in Orlando Sept. 19.
The FDA approved sacubitril/valsartan in July 2015 to treat patients with New York Heart Association (NYHA) class II to IV heart failure. The approval was based on results of the PARADIGM-HF trial, which randomized 8,442 patients with heart failure who were taking an ACE inhibitor or ARB to either a twice daily dose of 200 mg sacubitril/valsartan or a twice daily dose of 10 mg enalapril.
The first poc-hoc analysis presented at the HFSA meeting analyzed 6,981 patients from the PARADIGM-HF study who completed a Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at eight months of treatment. Among the patients hospitalized for heart failure, patients who received sacubitril/valsartan had lower declines in health-related quality of life compared with those who received enalapril.
The second post-hoc analysis examined 7,155 patients who completed a KCCQ at baseline and at four months. It found that patients with a decline in health-related quality of life had a 24 percent higher risk of cardiovascular death and 28 percent higher risk of heart failure hospitalization.
Novartis, which manufactures sacubitril/valsartan, has launched a program that includes more than 40 clinical trials to examine the safety and efficacy of the medication as well as real world outcomes associated with the drug.
In July, Novartis announced that it planned on spending an additional $200 million on the twice-daily oral medication in an attempt to increase its sales. During the second quarter of 2016, Novartis reported $32 million in revenue for sacubitril/valsartan, which was higher than in the previous quarter but lower than analysts expected when the drug was approved.