[Riociguat for inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension after surgical treatment]

National Committee for Technology Incorporation (Conitec)
Record ID 32018001050
Portuguese
Original Title: Riociguate para hipertensão pulmonar tromboembólica crônica inoperável ou persistente/recorrente após tratamento cirúrgico
Authors' objectives: Is riociguat safe, effective and cost-effective when compared with placebo for patients with inoperable/residual/recurrent CTEPH?
Authors' results and conclusions: The CONITEC’s members present at the 86th Ordinary Meeting, on March 5th, 2020, unanimously decided not to recommend the incorporation of riociguat in the scope of SUS, for the treatment of patients with inoperable or persistent/recurrent CTEPH. The Deliberation Record No. 510/2020 was signed.
Authors' recommendations: Scientific evidence: The literature is limited to one randomized controlled trial (RCT) - the CHEST-1 study. This multicenter, double-blind study included 261 patients with inoperable or persistent/recurrent CTEPH, who were randomly assigned in a 1:2 ratio to receive placebo or riociguat. The primary endpoint was a change from baseline in 6-minute walking distance (6MWD) after 16 weeks of treatment. The 6MWD showed a mean increase of 39 meters from baseline in the riociguat group at week 16 compared with a mean decrease of 6 meters in the placebo group (least-squares mean difference, 46 meters; 95% confidence interval [CI]: 25 to 67; P
Details
Project Status: Completed
URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20200915_Report519_Riociguat_ChronicThromboembolicPulmonaryHypertension.pdf
Year Published: 2020
URL for published report: http://conitec.gov.br/images/Relatorios/2020/Relatorio_Riociguate_HPTEC_519_2020.pdf
URL for additional information: http://conitec.gov.br/recomendation-reports
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Brazil
MeSH Terms
  • Hypertension, Pulmonary
  • Pyrazoles
  • Pyrimidines
  • Enzyme Activators
  • Pulmonary Arterial Hypertension
  • Soluble Guanylyl Cyclase
Keywords
  • Riociguat
  • inoperable chronic thromboembolic pulmonary hypertension
  • persistent/recurrent chronic thromboembolic pulmonary hypertension
Contact
Organisation Name: National Committee for Technology Incorporation (CONITEC)
Contact Address: Esplanada dos Ministérios, Bl. G, Ed. Sede, 8º andar, CEP: 70058-900
Contact Name: Clarice Moreira Portugal
Contact Email: clarice.portugal@saude.gov.br
Copyright: 2021 Conitec
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