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Bayer AG Announces Interim Results From CHEST-2 Study Support Benefits Of Bayer HealthCare’s Riociguat


Monday, 4 Mar 2013 02:57am EST 

Bayer AG’s Bayer HealthCare announced positive data from the interim analysis of the on-going CHEST-2 trial with riociguat, the open-label long-term extension of the pivotal Phase III study CHEST-1, at the fifth World Symposium of Pulmonary Hypertension (WSPH) in Nice, France. The results of the CHEST-2 trial support the positive data of the pivotal CHEST-1 trial, showing long-term safety and sustained clinical benefits in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent CTEPH after a surgical procedure called pulmonary endarterectomy (PEA). In the first interim analysis in CHEST-2, riociguat was shown to be well tolerated with a good long-term safety profile in patients with CTEPH. The most frequent drug-related adverse events were dizziness, dyspepsia and hypotension. After 12 weeks in CHEST-2, the six minute walking distance (6MWD) had increased by 63 meters in former riociguat patients and 35 meters in former placebo patients compared with baseline of the pivotal CHEST-1 trial. Also WHO functional class (FC) had improved in both patient groups. Sustained effects in 6MWD and WHO FC have been observed in a cohort of patients that had reached one year of study treatment. 

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