Nolomirole 5 mg b.i.d. did not significantly reduce the time to all-cause death or hospitalization for heart failure compared to placebo (46.5% vs 41.7%; p=0.1).
RCT (n=1,000)
Double-blind
parallel group
Yes
Does nolomirole 5 mg b.i.d. reduce the composite of all cause death or hospitalisation for heart failure in patients with severe left ventricular systolic dysfunction and NYHA class III/IV?
Nolomirole 5 mg twice daily did not significantly reduce the composite of all-cause death or heart failure hospitalization in patients with severe left ventricular systolic dysfunction.
Absolute Event Rate: 46.5% vs 41.7%
p-value: p=0.1
BACKGROUND: By pre-synaptic stimulation of DA(2)-dopaminergic and alpha(2)-adrenergic receptors, nolomirole inhibits norepinephrine secretion from sympathetic nerve endings. We performed a clinical study with nolomirole in patients with heart failure (HF). METHODS: The study was designed as a multicentre, double blind, parallel group trial of 5 mg b.i.d. of nolomirole (n=501) versus placebo (n=499) in patients with severe left ventricular systolic dysfunction, recently in New York Heart Association (NYHA) class III/IV. The primary endpoint was time to all cause death or hospitalisation for HF, whichever came first. The study was event driven and required 420 primary events. The study was completed as scheduled. RESULTS: Mean age of patients was 70 years, and 73% were male. Heart rate and blood pressure were not different in the two treatment groups. There were no changes in blood pressure. There were 233 primary events in the nolomirole group versus 208 in the placebo group (p=0.1). There were 142/145 deaths and 369/374 all cause hospitalisations in the nolomirole/placebo groups. There were no differences in walking distance, quality of life or NYHA class. CONCLUSION: A dose of 5 mg b.i.d. of nolomirole was not beneficial (or harmful) in patients with heart failure.
Torp‐Pedersen et al. (Tue,) conducted a rct in heart failure (n=1,000). nolomirole vs. placebo was evaluated on time to all cause death or hospitalisation for HF, whichever came first (p=0.1). Nolomirole 5 mg b.i.d. did not significantly reduce the time to all-cause death or hospitalization for heart failure compared to placebo (46.5% vs 41.7%; p=0.1).