Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

Phase 4 Completed 225 enrolled Bayer

RandomizedParallel-groupOpen-labelTreatment

Summary

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

Timeline

Start: 2017-01-11
Primary completion: 2020-01-29
Completion: 2020-03-03

Outcome

Met primary endpoint

registry analysis (equivalence test); Riociguat vs PDE-5i; p = 0.0007; Odds Ratio (OR) 2.78 (95% CI 1.526 to 5.060); Mantel Haenszel NCT02891850 ↗

Publications

Hoeper MM, Al-Hiti H, Benza RL, Chang SA, Corris PA, Gibbs JSR, Grunig E, Jansa P, Klinger JR, Langleben D, McLaughlin VV, Meyer GMB, Ota-Arakaki J, Peacock AJ, Pulido T, Rosenkranz S, Vizza CD, Vonk-Noordegraaf A, White RJ, Chang M, Kleinjung F, Meier C, Paraschin K, Ghofrani HA, Simonneau G; REPLACE investigators. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jun;9(6):573-584. doi: 10.1016/S2213-2600(20)30532-4. Epub 2021 Mar 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riociguat	Other / unclassified	0.5 mg	Oral
Subject	Riociguat	Other / unclassified	1 mg	Oral
Subject	Riociguat	Other / unclassified	1.5 mg	Oral
Subject	Riociguat	Other / unclassified	2 mg	Oral
Subject	Riociguat	Other / unclassified	2.5 mg	Oral
Comparator	Sildenafil	Unknown	60 mg	Oral
Comparator	Tadalafil	Small molecule	20 mg	Oral
Comparator	Tadalafil	Small molecule	40 mg	Oral