Physicians' Academy for Cardiovascular Education

Soluble guanylate cyclase (sGC) stimulator did not meet primary endpoint in HFpEF

Vericiguat in patients with worsening chronic heart failure and preserved ejection fraction: results of the SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED EF (SOCRATES-PRESERVED) study

Literature - Pieske B, Maggioni AP, Lam CSP, et al. - Eur Heart J. 2017;38(15):1119-112

Main results

Conclusion

In the phase 2 study SOCRATES-PRESERVED, vericiguat did not change the primary endpoints of NT-proBNP and LAV at 12 weeks compared with placebo in patients with HFpEF.

Editorial comment

In their editorial article [4], Cleland and Mueller note that there were errors in the randomisation process of the study published by Pieske et al. and they discuss the results of both phase 2 studies with vericiguat in HFrEF and HFpEF: ‘Neither study met its primary endpoint.’ ….’Clearly, the published studies of vericiguat do not provide a strong argument for progressing to large outcome trials.’ Going in more detail, the authors comment on the numerical increase in deaths with vericiguat and the improvement in quality of life, which was mainly due to self-reported symptom improvement in the 10 mg group, and they add: ‘Socrates was a classical Greek scholar who had a reputation for teaching by asking questions but not necessarily providing answers. Naming a randomized trial after him is tempting fate. You might just get what you ask for - questions but no clear answers!’

References

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