Effects of selexipag: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Selexipag, an oral IP receptor agonist, is approved for the long-term treatment of pulmonary arterial hypertension (PAH). 2 An intravenous (IV) formulation of selexipag was developed to provide a treatment option for short-term interruptions to oral selexipag. 2 The safety, tolerability, and pharmacokinetics of temporarily switching between oral and IV selexipag were investigated in a prospective, multicenter, open-label study. 2 Selexipag was also investigated in the GRIPHON study, the largest clinical study ever conducted in PAH patients, providing long-term data from 1,156 patients. 5 Selexipag significantly reduced the risk of death or complications related to PAH compared with placebo. 17 Selexipag also showed a vasodilatory effect and inhibited the proliferation of pulmonary arterial smooth muscle cells. 17 Compared to other prostacyclin analogs, selexipag does not activate EP3 receptors and does not cause vasoconstriction. 20 This suggests that selexipag may reduce muscle pain caused by vasoconstriction in peripheral blood vessels. 20

Benefits and Risks

Benefits Summary

Selexipag is approved for the long-term treatment of pulmonary arterial hypertension (PAH). 2 Selexipag significantly reduced the risk of death or complications related to PAH compared with placebo. 17 Selexipag also showed a vasodilatory effect and inhibited the proliferation of pulmonary arterial smooth muscle cells. 17

Risks Summary

Common side effects of selexipag include headache, diarrhea, nausea, and rash. 2 Because selexipag selectively acts on the prostacyclin receptor (IP receptor), it may have fewer side effects than prostacyclin analogs. 20 However, serious side effects can occur in rare cases. 2 It is important to consult a doctor before using selexipag. 2

Comparison of Studies

Commonalities in Studies

All of these studies show that selexipag is effective in treating PAH. 5 17 These studies also show that selexipag is generally safe and well-tolerated. 2 5 17

Differences in Studies

These studies differ in the dosage and administration of selexipag, the type of PAH patients studied, and other factors. 2 5 17 Therefore, it is not possible to directly compare the results of these studies. 2 5 17

Consistency and Inconsistencies in the Results

These studies show that selexipag is effective in treating PAH, but the magnitude of the effect varies depending on the study. 5 17 The frequency and severity of side effects also vary depending on the study. 2 5 17

Important Considerations for Real-World Applications

Selexipag is an effective drug for treating PAH. 5 17 However, selexipag is not suitable for all PAH patients. 2 It is important to consult with a doctor before using selexipag. 2

Limitations of Current Research

These studies are all relatively small and do not evaluate long-term effects. 2 5 17 These studies also all target specific types of PAH patients. 2 5 17 Therefore, it is not possible to generalize the results of these studies to other PAH patients. 2 5 17

Future Research Directions

Studies evaluating the long-term effects of selexipag are needed. 2 Studies are also needed to evaluate whether selexipag is effective for other PAH patients. 2

Conclusion

Selexipag is an effective drug for treating PAH. 5 17 However, selexipag is not suitable for all PAH patients. 2 It is important to consult with a doctor before using selexipag. 2

Literature analysis of 24 papers
Positive Content
20
Neutral Content
0
Negative Content
4
Article Type
7
0
1
1
22
1.

Selexipag for Chronic Thromboembolic Pulmonary Hypertension in Japanese Patients　- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase II Study.

Author: TanabeNobuhiro, FukudaKeiichi, MatsubaraHiromi, NakanishiNorifumi, TaharaNobuhiro, IkedaSatoshi, KishiTakuya, SatohToru, HirataKen-Ichi, InoueTeruo, KimuraHiroshi, OkanoYoshiaki, OkazakiOsamu, SataMasataka, TsujinoIchizo, UenoShuichi, YamadaNorikazu, YaoAtsushi, KuriyamaTakayuki

Improved PVR
Improved cardiac index

Selexipag, an oral prostacyclin receptor agonist, was studied in Japanese patients with chronic thromboembolic pulmonary hypertension (CTEPH). While the primary endpoint (change in pulmonary vascular resistance) wasn't met, a significant decrease was observed in patients not using other pulmonary vasodilators.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Temporarily switching from oral to intravenous selexipag in patients with pulmonary arterial hypertension: safety, tolerability, and pharmacokinetic results from an open-label, phase III study.

Author: KloseHans, ChinKelly M, EwertRalf, GallHenning, ParambilJoseph, PochDavid, SeyfarthHans-Jürgen, AxelsenLene N, Hsu SchmitzShu-Fang, SteinClaudia, PrestonIoana R

Oral selexipag treatment

This study examined the safety, tolerability, and pharmacokinetics of switching between oral and intravenous selexipag, a medication for pulmonary arterial hypertension, to manage temporary interruptions in treatment.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

5.

Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension.

Author: KrauseA, MachacekM, LottD, HurstN, BrudererS, DingemanseJ

PAH treatment

Selexipag, a drug for pulmonary arterial hypertension (PAH), showed no clinically significant drug interactions with other PAH medications. A study using PK/PD modeling revealed that exposure to selexipag and its metabolite had some statistically significant effects on exercise capacity, laboratory values, and prostacyclin-related side effects.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Association of N-Terminal Pro Brain Natriuretic Peptide and Long-Term Outcome in Patients With Pulmonary Arterial Hypertension.

Author: ChinKelly M, RubinLewis J, ChannickRichard, Di ScalaLilla, GaineSean, GalièNazzareno, GhofraniHossein-Ardeschir, HoeperMarius M, LangIrene M, McLaughlinVallerie V, PreissRalph, SimonneauGérald, SitbonOlivier, TapsonVictor F

PAH prognosis
PAH

NT-proBNP is a blood test used to assess the severity of pulmonary arterial hypertension (PAH). While it's part of the risk assessment for PAH, its role in predicting outcomes is unclear. This study aims to evaluate the prognostic value of NT-proBNP levels in the GRIPHON trial and how patients with different NT-proBNP levels respond to selexipag, a PAH treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Selexipag for the treatment of connective tissue disease-associated pulmonary arterial hypertension.

Author: GaineSean, ChinKelly, CoghlanGerry, ChannickRichard, Di ScalaLilla, GalièNazzareno, GhofraniHossein-Ardeschir, LangIrene M, McLaughlinVallerie, PreissRalph, RubinLewis J, SimonneauGérald, SitbonOlivier, TapsonVictor F, HoeperMarius M

Delayed PAH progression
Prostacyclin-related adverse events

Selexipag, a medication for pulmonary arterial hypertension (PAH), reduced the risk of morbidity/mortality events by 41% in patients with connective tissue disease-associated PAH. This study demonstrates the effectiveness and tolerability of selexipag in a specific patient population with PAH.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

8.

Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects.

Author: AxelsenLene Nygaard, PoggesiItalo, RasschaertFreya, Perez RuixoJuan Jose, BrudererShirin

Drug interaction

This study investigated the potential drug interaction between selexipag, a medication for pulmonary arterial hypertension, and clopidogrel, a CYP2C8 inhibitor.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Risk assessment in pulmonary arterial hypertension: Insights from the GRIPHON study.

Author: SitbonOlivier, ChinKelly M, ChannickRichard N, BenzaRaymond L, Di ScalaLilla, GaineSean, GhofraniHossein-Ardeschir, LangIrene M, McLaughlinVallerie V, PreissRalph, RubinLewis J, SimonneauGérald, TapsonVictor F, GalièNazzareno, HoeperMarius M

The study evaluated the French risk assessment approach and REVEAL 2.0 risk calculator for predicting morbidity/mortality in PAH patients. These methods were assessed in the GRIPHON trial, the largest PAH trial to date, to determine their prognostic and predictive value.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Biocomparison Study of Adult and Paediatric Dose Strengths of the Prostacyclin Receptor Agonist Selexipag.

Author: BoehlerMargaux, BrudererShirin, UlčIvan, DingemanseJasper

Effective treatment for PAH

This study compares the pharmacokinetics of selexipag in adults after taking a single 200µg tablet versus four 50µg paediatric tablets. This research explores the potential for selexipag to be an effective treatment for children with PAH.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

Selexipag for the treatment of pulmonary arterial hypertension.

Author: NoelZachary R, KidoKazuhiko, MacaulayTracy E

Improved PAH symptoms
Reduced PAH complications
Reduced hospitalization risk
Diarrhea
Headache
Musculoskeletal pain
Nausea
Vomiting

Selexipag, an oral prostacyclin IP receptor agonist, is effective in treating pulmonary arterial hypertension (PAH). It is convenient and has a longer half-life compared with conventional prostanoid therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

[Pharmacological characteristics and clinical study results of Selexipag (Uptravi<sup>&#174;</sup> tablets), a selective prostacyclin receptor agonist].

Author: KuwanoKeiichi, KosugiKeiji, FuchikamiChiaki, FunakiShunji

PAH treatment
Survival rate improvement

This study highlights selexipag, a new drug approved for pulmonary arterial hypertension (PAH). Selexipag has shown efficacy in improving PAH symptoms and reducing the risk of death or PAH complications, suggesting a promising treatment option for PAH patients.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Japanese

18.

Prostanoid EP₂ Receptors Are Up-Regulated in Human Pulmonary Arterial Hypertension: A Key Anti-Proliferative Target for Treprostinil in Smooth Muscle Cells.

Author: PatelJigisha A, ShenLei, HallSusan M, BenyahiaChabha, NorelXavier, McAnultyRobin J, MoledinaShahin, SilversteinAdam M, WhittleBrendan J, ClappLucie H

Anti-proliferative effect
PAH treatment

Treprostinil, a drug used for pulmonary arterial hypertension (PAH), works differently than other prostacyclins. It primarily acts through EP₂ receptors to reduce cell proliferation, unlike other drugs which target the IP receptor. This suggests EP₂ receptors could be a novel target for PAH treatment.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

19.

Targeted therapy in pulmonary veno-occlusive disease: time for a rethink?

Author: LuoQin, JinQi, ZhaoZhihui, ZhaoQing, YuXue, YanLu, ZhangYi, XiongChangming, LiuZhihong

Improved PVOD outcome

This study aimed to evaluate the role of targeted therapy in patients with pulmonary veno-occlusive disease (PVOD) and assess its long-term outcomes. PVOD has a poor prognosis, and lung transplantation is the only curative treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

23.

Effect of gemfibrozil and rifampicin on the pharmacokinetics of selexipag and its active metabolite in healthy subjects.

Author: BrudererShirin, Petersen-SyllaMarc, BoehlerMargaux, RemeňováTatiana, HalabiAtef, DingemanseJasper

Drug interaction

Selexipag metabolism is influenced by CYP2C8. This study investigated possible interactions with CYP2C8 inhibitors (gemfibrozil) and inducers (rifampicin) to understand how other medications might affect selexipag's effectiveness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

24.

Selexipag treatment in patients with systemic sclerosis-associated pulmonary arterial hypertension in clinical practice, a case series.

Author: LemmersJacqueline Mj, FretheimHåvard, KnaapenHanneke Ka, van den HoogenFrank Hj, van Haren-WillemsJolanda Hgm, DuijnhouwerAnthony L, van DijkArie P, van den EndeCornelia Hm, Hoffmann-VoldAnna-Maria, VonkMadelon C

Symptom stabilization
Side effects

Selexipag provided sustained stabilization of symptoms in patients with systemic sclerosis-associated pulmonary arterial hypertension. Improvement was observed in only two patients. Further research is needed.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

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