Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F17%3A10367242" target="_blank" >RIV/00064165:_____/17:10367242 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1186/s12890-017-0563-7" target="_blank" >http://dx.doi.org/10.1186/s12890-017-0563-7</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s12890-017-0563-7" target="_blank" >10.1186/s12890-017-0563-7</a>

Result language

angličtina

Original language name

Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study

Original language description

Background: Following positive results from the Phase III CHEST-1 study in patients with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), the Phase IIIb CTEPH early access study (EAS) was designed to assess the safety and tolerability of riociguat in real-world clinical practice, as well as to provide patients with early access to riociguat before launch. Riociguat is approved for the treatment of inoperable and persistent/recurrent CTEPH. Methods: We performed an open-label, uncontrolled, single-arm, early access study in which 300 adult patients with inoperable or persistent/recurrent CTEPH received riociguat adjusted from 1 mg three times daily (tid) to a maximum of 2.5 mg tid. Patients switching from unsatisfactory prior pulmonary arterial hypertension (PAH)-targeted therapy (n = 84) underwent a washout period of at least 3 days before initiating riociguat. The primary aim was to assess the safety and tolerability of riociguat, with World Health Organization functional class and 6-min walking distance (6MWD) as exploratory efficacy endpoints. Results: In total, 262 patients (87%) completed study treatment and entered the safety follow-up (median treatment duration 47 weeks). Adverse events were reported in 273 patients (91%). The most frequently reported serious adverse events were syncope (6%), right ventricular failure (3%), and pneumonia (2%). There were five deaths, none of which was considered related to study medication. The safety and tolerability of riociguat was similar in patients switched from other PAH-targeted therapies and those who were treatment naive. In patients with data available, mean +/- standard deviation 6MWD had increased by 33 +/- 42 m at Week 12 with no clinically relevant differences between the switched and treatment-naive subgroups. Conclusions: Riociguat was well tolerated in patients with CTEPH who were treatment naive, and in those who were switched from other PAH-targeted therapies. No new safety signals were observed.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

BMC Pulmonary Medicine

ISSN

1471-2466

e-ISSN

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Volume of the periodical

17

Issue of the periodical within the volume

December

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

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UT code for WoS article

000418833700003

EID of the result in the Scopus database

2-s2.0-85039868768