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Assessment Of Patient-Reported Health Status In Chronic Thromboembolic Pulmonary Arterial Hypertension Patients Treated With Riociguat: 2-Year Results From The Chest-2 Extension Study

2015; Elsevier BV; Volume: 18; Issue: 7 Linguagem: Inglês

10.1016/j.jval.2015.09.911

1524-4733

OA Minai, Nicola Bonner, SC Mathai, Dennis Busse, B. Brockmann, S. Teal, Adam Gater, M de la Orden Abad,

Pulmonary Hypertension Research and Treatments

Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe disease with high mortality, thus significantly affecting patient quality of life and health status. Almost 40% of patients are unsuitable for surgery and approximately 34% experience recurrent disease post-surgery. Riociguat has demonstrated clinical benefit for CTEPH patients within one year of treatment. This analysis sought to assess the long-term impact of riociguat treatment on patient-reported health status. CTEPH patients were randomized to placebo or riociguat dose titration up to 2.5mg TID (three times a day) in the CHEST-1 study. CHEST-2 is an open-label extension phase where patients from CHEST-1 received riociguat up to 2.5mg TID. Patient reported health status was assessed using the EQ-5D in both CHEST-1 (baseline and week 16), and CHEST-2 (long term extension (LTE) week 12, and LTE months 6, 9, 12 and 24). Responder analyses were performed to put EQ-5D scores into context with clinical outcomes (6-minute walk distance (6MWD) and WHO functional class). EQ-5D utility scores and response distributions were summarised. In the total sample patients demonstrated an increase in mean EQ-5D utility score between baseline (mean 0.646, n=235) and month 24 (mean 0.717, n=97); a trend mirrored by improvement in EQ-5D VAS score from baseline (mean 56.5, n=236) to month 24 (mean 71.4, n=97). At month 24 there were similar proportions of patients in the riociguat and former placebo groups reporting ‘No problems’ in all EQ-5D domains indicating improved health. A responder analysis confirmed that patients who had a greater improvement in 6MWD (>40m) at week 12 of the study had higher mean scores than those with lower improvement (<40m). Furthermore, patients with better functional ability according to WHO classification had higher EQ-5D utility scores than those with lower ability. Results demonstrate the positive impact of riociguat on patient-reported health status among CTEPH patients.