Azmarda Outperforms Generic Sacubitril/Valsartan in HFrEF Management, says new study
The results revealed findings which include:
1. Changes in GLS measurements
- At baseline, the mean GLS score was –12.8 ± 1.7% in the Azmarda group and –13.1 ± 1.4% in the generic sacubitril/valsartan group. Over the 16-week period, patients receiving Azmarda showed consistently greater improvement in GLS scores across all follow-up visits.
- From baseline to week 4, the Azmarda group improved by –0.9 ± 0.1% compared to –0.2 ± 0.2% in the generic group. By week 8, the change was –1.7 ± 0.3% with Azmarda versus –0.5 ± 0.1% with the generic sacubitril/valsartan ( p<0.05).
From weeks 8 to 12, GLS improved by –0.7 ± 0.2% with Azmarda vs –0.2 ± 0.2% with the generic sacubitril/valsartan, and by week 16, the change was –1.4 ± 0.2% vs –0.4 ± 0.1% , for Azmarda and Generic group respectively. The difference observed in the change in GLS score between the Azmarda and the Generic group at weeks 12 and 16 (P =<0.05) was statistically significant.(Fig. 1)
Fig. 1. Mean GLS score and change in GLS score: The mean GLS score of patients in the Azmarda group (N=6) and Generic (sacubitril/valsartan) group (N=6) at baseline, and week 4,8,12 and 16.
2. Change in TTP measurements:
- At baseline, the mean TTP was 373.7 ± 102.3 ms in the Azmarda group and 330.0 ± 44.1 ms in the Generic group (p = 0.42). By week 4 to 8, both groups showed reduced TTP, with a greater decline in the Azmarda group.
- After crossover, Azmarda group showed a significant drop at week 12 (297.0 ± 13.7 ms) and week 16 (283.4 ± 16.7 ms), while the generic group showed an increase to 347.6 ± 20.9 ms and 352.2 ± 24.0 ms, respectively (p < 0.05). Byweek 16 the mean change in TTP score was –34.2 ± 36.7 ms for Azmarda versus +29.0 ± 25.3 ms for generic sacubitril/valsartan, showing significantly better myocardial contractile improvement with Azmarda.
3. Safety Assessments of both the groups: Over the 16-week study period, sacubitril/valsartan was well-tolerated, with no serious adverse events reported in either group.
This study demonstrated the superior efficacy of Azmarda, developed with unique co-crystal technology, over the generic sacubitril/valsartan formulation while displaying enhanced LV reverse remodeling in patients with HFrEF and further highlighted the value of GLS as a sensitive and reliable parameter for early detection of left ventricular systolic dysfunction.
“ Further studies with larger cohorts and long-term follow-up are required to confirm the long-term clinical benefits,” the authors further noted
Reference: Patel S. "Comparative Efficacy and Safety of Azmarda vs. Generic Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction: A Prospective, Randomized, Active-Controlled Crossover Study." Eur J Cardiovasc Med. 2025;15(4): 928–934
