Frailty No Bar to Dapagliflozin in Heart Failure Patients

NEW YORK (Reuters Health) – Frailty should not be a reason to withhold dapagliflozin in patients with heart failure (HF), researchers say.

On the contrary, the SGLT2 inhibitor improves outcomes in HF patients regardless of frailty, with the greatest benefit seen in more frail patients, they report.

The findings “deserve emphasis considering the common reluctance of clinicians to introduce medications to patients perceived to be frail,” the researchers write in Annals of Internal Medicine.

The DAPA-HF trial previously demonstrated that dapagliflozin reduces the risk for worsening HF and death and improves symptoms when added to standard therapy. But frailty may modify the risk-benefit profile of certain drug therapies.

Dr. John McMurray with University of Glasgow, in the UK, and colleagues did a post hoc analysis of 4,742 participants in the DAPA-HF trial for whom a frailty index (FI) was calculated using the 32-item Rockwood frailty scale.

Half of the patients were frail – with 34% in FI class 2 (more frail) and 16% in FI class 3 (most frail) – and half were FI class 1 (not frail). Frailty was associated with more impairment in health status and worse clinical outcomes, including hospitalization and death.

Regardless of frailty status, use of dapagliflozin substantially reduced risk for worsening HF events and death and was associated with improved symptoms, physical function, and quality of life over median follow-up of about 18 months, the study team found.

“The absolute reductions in clinical events and improvements in health status were generally larger in the most frail patients,” they report.

Despite concerns that frail patients are more likely to discontinue treatment and have more adverse drug reactions than nonfrail patients, data on safety and tolerability in DAPA-HF are “reassuring,” the authors say.

“Not surprisingly, we found that frail patients overall were more likely to discontinue study treatment (including placebo) and more frequently had serious adverse events, although neither was common,” they point out.

“Importantly, study drug discontinuation and serious adverse events were not more frequently reported in the dapagliflozin group than in the placebo group in any of the frailty classes. These data underline the safety and tolerability of dapagliflozin in patients with HF with reduced ejection fraction, regardless of the degree of frailty,” they conclude.

The DAPA-HF trial was funded by AstraZeneca.

SOURCE: Annals of Internal Medicine, online April 25, 2022.

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