6533b85bfe1ef96bd12bbed6
RESEARCH PRODUCT
Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry
Shu-hao WuShih-hsien SungJacob Yih-jer WuIhab WehebaJuan Esteban GomezNoemi BrunoIveta FarkasovaStefania FarinaChin-chang ChengGeorgia PitsiouJens Erik Nielsen-kudskGraciela TuhayJoana SousaLuciano MelatiniMafalda EspinhaEvgeny Vladimirovich FilippovMyriam AlexandreRaquel YottiRalf EwertIrene LangJosefa Jiménez ArjonaEugene KotlyarIraklis TsangarisJulien GuiotPiergiuseppe AgostoniMauricio Orozco-leviMirta DiezHsueh-wei YenLampros K. MichalisP. SteeleSebastian De La PavaValentina GrazioliIsmail HantaLisa BarryPatrick EvrardH. ReesinkFrancisco Fernandez AvilésAlberto GarciaMichael NewnhamWen-hwa WangAndreia RochaSusanna ProudmanWilliam MartinezLuis JaraC. MeierMargarethe GruenbergerDébora RepolhoEvdokia SourlaBykov Aleksander NikolaevichMiguel-angel Gomez SanchezLy AntonAndrew J. PeacockGonçalves TaniaMichail FanaridisCarmine Dario VizzaBenjamin NgDmitry Yurievich PlatonovRepke J. SnijderChristian SchulzThierry RochatLuca SardellaSean GaineRafael Conde CamachoRemedios OteroFelix GerhardtRenato PredilettoSilvia UlrichMarcel SimonJean-luc VachieryHossein Ardeschir GhofraniJoan Albert BarberàVincent CottinAnco BoonstraMan-cai FongLisa MielniczukAbdullah Al DalaanCho-kai WuIoana TileaClaudio PicarielloKonstantinos PappasJiunn-lee LinFernando León MarreroGregorio Pérez PeñateAntonio SciortinoPatricia Villanueva RodríguezVieri VannucchiIvana PavlickovaLecue Pilar AlonsoJohn FeenstraChiara CresciGil WirtzBülent MutluSilvia FarruggioH. BoogaardIsabel AsencioMelanie LavenderIlona OlzikStavros KonstantinidesClaudio LunardiPaola ArgientoOlga Eduardovna YakovlevaJens KlotscheAnna CorreraLisa-theresa FeistmantlGeorge GiannakoulasElise Noël-savinaNathan DwyerSerena CostaPaul A. CorrisTatyana Nikolaevna ZverevaSusanne TaylerAntónio MarinhoMarion DelcroixRaquel LopezMarcela BohacekovaMartin BosioJan GrimmingerRaúl Menor AlmagroMaria Lujan TalaveraZeynep UnHussam SakkijhaDavid LanglebenHalil AtasA. S. GalyavichG. OngenAnna KotsiaLeon M. Van Den ToornGiulia MassolaJoanna Pepke-zabaMichel De PauwLuca ConteJ. MagerHeath AdamsDouglas S HelmersenElena Sergeevna SkripkinaTilmann KramerDimitrios GeorgopoulosGraça CastroTeresa EliasSabino DeleoAndrea Maria D'arminiIrina Fedorovna BukatovaJoão AgostinhoMichele D'altoWendy StevensPaula GarciaMichael HalankK. A. BoomarsDaria Viktorovna HegyaMario PetruzziGérald SimonneauAlan AltrajaSarferaz SaleemiSusanne Knoop-buschRoela Sadushi-koliciStephan RosenkranzJorge CánevaGiovanni Maria Di MarcoRoberto BadagliaccaTsung-hsien LinAnna NoldeSalvador Alcaraz GarcíaRudolf SpeichJudith Löffler-raggNorberto VulcanoAnna De LucaMaria José LoureiroIveta SimkovaSusana Maria Martins JesusPavel JansaAdriana AcostaAna OliveiraMarta CapinhaNicole ShearmanRui BaptistaLoris RonconHo-ming SuIoannis StanopoulosTobias J. LangeIoanna MitrouskaEkkehard GrünigChih-hsin HsuPatricia Parada TovarTuija VasankariChristine KulkaDavid Iturbe FernandezPing-hung KuoBenjamin EgenlaufStefan SöderbergR. B. MinsonPeter WodlinCarlos Andres QuezadaManuel LopezWei-chun HuangLars HarbaumEdoardo AiròRenaud LouisElena TorricelliMaurizio PinDalyana Eduardovna AlexeevaAmaya Martinez-meñacaEvgenia WilliamsHaralambos KarvounisTatiana ValkovicovaChien-lung HuangDaniel CoutinhoAnna Viktorovna TregubovaSøren MellemkjærAnne KeoghLaurent TêtuCamila LemaWen-ter LaiRudina NdreuAntonio RomanShu-hung KuoGlenn E. M. ReevesAlessio GarceaKyundyul Ivanovich IvanovMassimiliano MulèJosé Manuel Cifrián MartínezRoberto PosciaFelipe CampoCarolina BauleoFederico PaneChun Yuan ChuBengt RundqvistSabine RegottaPo-chao HsuNatalia A. TsarevaAthanasios PappasEsther I. SchwarzColin ChurchAbeer Abeer AbdelsayedTatyana Mikhaylovna KolomeytsevaTsu-shiu HsuMarina Vadimovna BatalinaDavid PittrowAnton Vonk-noordegraafGiovanna ManziYen-hung LinMarco NaldiTim OquekaTeresa ShiangSofia MouratoglouS. BartfayTania CardosoWen-pin HuangHubert WirtzIsabel BlancoHans KloseGiuseppe PacioccoOlivier SitbonChi-sheng HungMarc HumbertTapani VihinenSanjay MehtaArne K. AndreassenMarius M. HoeperLucilla PiccariMark ToshnerMichele MackenzieTamila Vitalievna MartynyukSergey AvdeevSalvador López CárdenasPaola Marina Alessandra Gasche-soccalLaura SebastianWen-chol VoonRegina Steringer-mascherbauerMonthir AlfetlawiGiuseppe GalganoLorena MaldonadoFrédéric LadorFrancesco LombardiAlberto PesciAlejandro LondoñoSonia Fernandez RozasGulfer OkumusVictor Mora CuestaOlga Borisovna PavlovaHenning GallCharlotte HuberWan-jing HoPilar Escribano Subíassubject
Pulmonary and Respiratory Medicinemedicine.medical_specialtyRegistryMedDRAPeripheral edemaClinical practicePulmonary arterial hypertensionRiociguatlaw.inventionPulmonary hypertension03 medical and health sciences0302 clinical medicineRandomized controlled triallawInternal medicinemedicine030212 general & internal medicineAdverse effectHipertensió pulmonarRiociguatbusiness.industrymedicine.diseasePulmonary hypertensionClinical trial030228 respiratory systemPulmonary hemorrhagemedicine.symptomSafetybusinessmedicine.drugdescription
OBJECTIVE: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. METHODS: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits (usually every 3-6 months) and collated via case report forms. RESULTS: In total, 326 patients with PAH were included in the analysis. The most common AEs in these patients were dizziness (11.7%), right ventricular (RV)/cardiac failure (10.7%), edema/peripheral edema (10.7%), diarrhea (8.6%), dyspnea (8.0%), and cough (7.7%). The most common SAEs were RV/cardiac failure (10.1%), pneumonia (6.1%), dyspnea (4.0%), and syncope (3.4%). The exposure-adjusted rate of hemoptysis/pulmonary hemorrhage was 2.5 events per 100 patient-years. CONCLUSION: Final data from EXPERT show that in patients with PAH, the safety of riociguat in clinical practice was consistent with clinical trials, with no new safety concerns identified and a lower exposure-adjusted rate of hemoptysis/pulmonary hemorrhage than in the long-term extension of the Phase 3 trial in PAH. ispartof: RESPIRATORY MEDICINE vol:177 ispartof: location:England status: published
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-02-01 |