Home > Journal Club > Journal Club 4 June 2014

Journal Club 4 June 2014

Paper

Riociguat for the Treatment of Pulmonary Arterial Hypertension

Presenter

DBC

Summary

BACKGROUND

Riociguat, a soluble guanylate cyclase stimulator, has been shown in a phase 2 trial
to be beneficial in the treatment of pulmonary arterial hypertension.

METHODS

In this phase 3, double-blind study, we randomly assigned 443 patients with symptomatic
pulmonary arterial hypertension to receive placebo, riociguat in individually adjusted
doses of up to 2.5 mg three times daily (2.5 mg–maximum group), or riociguat in
individually adjusted doses that were capped at 1.5 mg three times daily (1.5 mg–
maximum group). The 1.5 mg–maximum group was included for exploratory purposes,
and the data from that group were analyzed descriptively. Patients who were receiving
no other treatment for pulmonary arterial hypertension and patients who were
receiving endothelin-receptor antagonists or (nonintravenous) prostanoids were eligible.
The primary end point was the change from baseline to the end of week 12
in the distance walked in 6 minutes. Secondary end points included the change in pulmonary
vascular resistance, N-terminal pro–brain natriuretic peptide (NT-proBNP) levels,
World Health Organization (WHO) functional class, time to clinical worsening,
score on the Borg dyspnea scale, quality-of-life variables, and safety.

RESULTS

By week 12, the 6-minute walk distance had increased by a mean of 30 m in the
2.5 mg–maximum group and had decreased by a mean of 6 m in the placebo group
(least-squares mean difference, 36 m; 95% confidence interval, 20 to 52; P<0.001).
Prespecified subgroup analyses showed that riociguat improved the 6-minute walk
distance both in patients who were receiving no other treatment for the disease and
in those who were receiving endothelin-receptor antagonists or prostanoids. There
were significant improvements in pulmonary vascular resistance (P<0.001), NT-proBNP
levels (P<0.001), WHO functional class (P = 0.003), time to clinical worsening
(P = 0.005), and Borg dyspnea score (P = 0.002). The most common serious adverse
event in the placebo group and the 2.5 mg–maximum group was syncope (4% and
1%, respectively).

CONCLUSIONS

Riociguat significantly improved exercise capacity and secondary efficacy end points
in patients with pulmonary arterial hypertension.

Supplementary Material

Also presented: Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension.

The editorial is available here.

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