ABSTRACT
Selexipague e outros medicamentos de controle da Hipertensão Arterial Pulmonar grupo 1. Indicação: Tratamento de Hipertensão Arterial Pulmonar grupo 1. Pergunta: Há superioridade em eficácia e segurança da tripla terapia com selexipague, comparado a dupla terapia, disponível no SUS, no tratamento de Hipertensão Arterial Pulmonar grupo 1? Métodos: Revisão rápida de evidências (overview) de ensaios clínicos randomizados e revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada pela ferramenta risco de viés da Cochrane. Resultados: Foi selecionado um ensaio clínico randomizado, especificamente um artigo contendo análise de subgrupo de dados desse estudo. Conclusão: As evidências demonstraram redução do número de hospitalizações relacionadas à HAP e de eventos de progressão da doença no tratamento de selexipague em tripla terapia em pacientes na classe funcional II, quando comparada à dupla terapia sem selexipague. A tripla terapia é tão segura quanto a dupla terapia, pois tem riscos similares de eventos adversos e eventos adversos sérios. A tripla terapia não é diferente da dupla terapia no risco da mortalidade geral
Selexipag and other drugs for the control of Pulmonary Arterial Hypertension group 1. Indication: Treatment of Pulmonary Arterial Hypertension group 1. Question: Is there superiority in efficacy and safety of triple therapy with selexipag, compared to dual therapy, available in the SUS, in the treatment of ulmonary Arterial Hypertension group 1? Methods: Rapid review of evidence (overview) of randomized clinical trials and systematic reviews, with a bibliographic survey carried out in the PUBMED database, using a structured search strategy. Results: A randomized clinical trial was selected, specifically an article showing a subgroup analysis of data from this study. Conclusion: Evidence showed a reduction in the number of Pulmonary Arterial Hypertension related hospitalizations and disease progression events in the treatment of selexipag in triple therapy in patients in functional class II, when compared to dual therapy without selexipag. Triple therapy is as safe as dual therapy, as it has similar risks of adverse events and serious adverse events. Triple therapy is no different from dual therapy in the risk of overall mortality
Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Young Adult , Pyrazines/administration & dosage , Pulmonary Arterial Hypertension/drug therapy , Acetamides/administration & dosage , Antihypertensive Agents/administration & dosage , Randomized Controlled Trials as Topic , Treatment Outcome , Systematic Reviews as TopicABSTRACT
Selexipag i s a kind of oral highly selective prostacyclin （IP）receptor agonist ，which can inhibit the contraction and proliferation of pulmonary artery smooth muscle cells. Because of its good patient compliance and high receptor affinity ，it is currently used in the treatment of pulmonary hypertension （PH）. This article reviews the mechanism of action ，pharmacokinetics/ pharmacodynamics and application of selexipag in the treatment of PH. The results show that selexipag alone or in combination with endothelin receptor antagonists and （or）phosphodiesterase inhibitors can effectively reduce the risk of worsening/death events ， delay disease progression ，and improve patients ’life quality in patients with adult pulmonary arterial hypertension （PAH）of WHO cardiac function Ⅱ-Ⅲ grade. However ，its application in children with PAH and patients with chronic thromboembolic PH needs further exploration.
ABSTRACT
A headspace gas chromatography method was developed for the determination of six residual solvents including methanol, ethanol, acetone, dichloromethane, tetrahydrofuran and toluene residues in selexipag to provide the experimental basis for its quality control.The samples were separated on Kromat PC-624(V)silica capillary column(30.0 m ×0.32 mm,1.8 μm)using temperature programming.The column temperature was kept at 40 ℃ for 5 min initially,and then raised to 180 ℃ at the rate of 20 ℃ /min and subsequently sustained for 5 min.FID detector temperature was 250 ℃ and injection temperature was 200 ℃.The split ratio was 20 : 1. The six residual solvents are separated completely under the given chromatographic conditions with a good linearity (r=0.998 2-1.000);the results of precision,repeatability and stability experiments met the requirement,and the mean recoveries of all solvents were in the range of 96.67％-101.7％.The analytical method is simple,accurate and sensitive,and it can be used for the determination of residual solvents in selexipag.