NEW YORK (Reuters Health) – Drugs currently available for patients with heart failure with preserved ejection fraction (HFpEF) have no mortality benefit, according to a meta-analysis published in the Journal of the American College of Cardiology.
Still, the authors note that because HFpEF patients are on average older than other patients with heart failure, improving symptoms may be a more important goal than decreasing mortality rates.
Established treatments have shown to be effective in patients with systolic heart failure (SHF), but there is a lack of evidence that they benefit those with HFpEF, Dr. Thomas Marwick from the Cleveland Clinic and colleagues note.
To address that gap in the literature, they gathered data from 30 published reports, including a total of 53,878 patients. Eighteen of those studies were randomized controlled trials, enrolling 11,253 patients; the other 12 were observational studies, which included 42,625 patients.
In each study, patients taking drugs including beta blockers, ACE inhibitors, and statins were compared to a control group taking either a placebo or diuretics.
The primary endpoint of the review was all-cause mortality. Secondary endpoints were diastolic function, measured as the ratio of early to late diastolic transmitral flow (E/A ratio), and exercise tolerance assessed by a treadmill test.
In six RCTs including 183 patients, exercise tolerance was improved in patients on combined therapy (weighted MD = 51.5, p < 0.001), and vasodilator therapy and chronotropic agents improved exercise capacity when analyzed independently.
Diastolic function was not improved among intervention patients in nine RCTs including a total of 472 patients (weighted MD = -0.01, p = 0.54). Breaking down the analysis by individual drug class also failed to show an effect on E/A ratio for any drug.
Combined treatment did not improve all-cause mortality in RCTs over a mean follow-up of 18.6 months (RR = 0.11265, p = 0.70); there was also no effect by individual drug class. In an adjusted analysis, there was similarly no reduction in all-cause mortality shown by observational studies (RR = 0.93, p = 0.103).
Marwick and colleagues note that limited data were available on exercise capacity in HFpEF patients and that this factor needs more investigation. They also call for stricter criteria in selecting patients for clinical trials, noting the poor correlation between established criteria for the condition and the selection process used by most clinical trials.
If these measures are achieved, the authors note, a lack of mortality benefit does not necessarily mean that heart drugs are ineffective in patients with HFpEF. They conclude,
