An analysis of data from patients in the DELIVER and DAPA-HF trials in the Americas provides an overview of the benefits of dapagliflozin in Black patients relative to White patients.
A pooled analysis of the DAPA-HF and DELIVER trials offers new insight into the safety and efficacy of dapagliflozin (Farxiga) in the treatment of heart failure for Black patients.
Results of the study indicate the relative benefits of dapagliflozin were consistent in Black and White patients across the spectrum of ejection fraction, with a greater absolute benefit in Black patients due to an elevated absolute risk.1
“Collectively, these data underscore the substantial and clinically important benefits, and favorable tolerability and safety profile, of dapagliflozin in patients with [heart failure], across the spectrum of ejection fraction, irrespectiveofrace,” wrote investigators.1 “However,despitethewell-established, and substantial, benefits of these drugs in [heart failure], chronic kidney disease, and diabetes (all of which are more prevalent in Black individuals), Black patients with diabetes are less likely to receive anSGLT2 inhibitor than others with this condition.”
Given the increased risk of heart failure and negative outcomes among Black patients, the current study, which was led by John McMurray, MD, deputy director of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow, was launched with the intent of exploring the response to dapagliflozin among Black patients relative to White patients within the phase 3 DAPA-HF and DELIVER trials, which examined the SGLT2 inhibitor in patient populations with heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced ejection fraction (HFmrEF)/ heart failure with preserved ejection fraction (HFpEF).1
As most self-identified Black patients within the trials were rolled in the Americas, investigators limited their trial to the 3526 patients in the trials randomized in these regions.1
Of the 3526 patients included in the current analyses, 74.5% (n=2626) identified as White and 10.8% (n=381) identified as Black. Analysis of baseline characteristics among this cohort indicated Black patients were younger (64.3±11.1 vs 70.0±10.4; P <.001), more often women (40.5% vs 34.3%), had greater systolic blood pressure (126.7±19.6 vs 123.6±16.6; P=.001), and greater body mass index (31.4±7.8 vs 30.7±6.3; P =.03).1
For the purpose of analysis, investigators used a composite of worsening heart failure or cardiovascular death as their primary outcome of interest.
Upon analysis, results indicated a total of 606 primary outcome events occurred among the study cohort, with observed among 19.2% of White patients and 26.5% of Black patients. The rate of primary outcome events among Black patients was 16.8 (95% confidence interval [CI], 13.8-20.4) per 100 person-years and 11.6 (95% CI, 10.6=12.) events per 100 person-years among White patients (Adjusted hazard ratio [aHR], 1.27 [95% CI, 1.01=1.59]).1
When examining effects of dapagliflozin, results indicated use of dapagliflozin was associated with a consistent reduction in the primary endpoint among Black patients (HR, 0.69 [95% CI, 0.47-1.02]) and White patients (HR, 0.73 [95% CI, 0.61-0.88]) (P for interaction=.73). Investigators pointed out this resulted in a number needed to treat to prevent 1 primary outcome event with dapagliflozin was 12 in Black patients and 17 in White patients. Further analysis suggested the effects of dapagliflozin were consistent across subgroups based on range of left ventricular ejection fractions in both Black and White patients.1
In an editorial, Ersilia M. DeFilippis, MD, and Ruben A. Salazar, MD, both of the Columbia University Irving Medical Center, wrote they were encouraged by the results of the study, given the unmet need among this patient population, but concluded their editorial by underlining the need for more equitable access to GDMT in heart failure.2
“Given significant cardio-renal benefits and potential differences in the calculation of glomerular filtration rates as evidenced by Butt et al, it is imperative to ensure that Black patients are not unnecessarily excluded from eligibility for these therapies,” wrote the pair.2 “Ensuring pharmacoequity through concerted efforts to improve prescribing patterns and reduce drug prices can help us DELIVER the best care to our patients with [heart failure].”