Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

Conditions

Pulmonary Arterial Hypertension

Brief summary

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Melendres-Groves LD, Channick RN, Chin KM, McLaughlin VV, MacDonald G, Martin N, Ong R, Sandros M, Kim NH.

2025-11-19

10.1007/s12325-025-03403-4

Macitentan and Tadalafil Combination Therapy in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities: Real-World Evidence from OPUS and OrPHeUS.

Kim NH, Chin KM, McLaughlin VV, Ong R, MacDonald G, Martin N, Senatore A, Channick R.

2025-05-19

10.1007/s12325-025-03180-0

Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies.

Chin KM, Channick R, Kim NH, Ong R, Turricchia S, Martin N, Mitchell L, McLaughlin VV.

2024-11-251 citations

10.1007/s40119-024-00386-1

Macitentan and Tadalafil Combination Therapy in Incident and Prevalent Pulmonary Arterial Hypertension: Real-World Evidence from the OPUS/OrPHeUS Studies.

Chin KM, Channick R, Kim NH, MacDonald G, Ong R, Martin N, Senatore A, McLaughlin VV.

2024-09-243 citations

10.1007/s12325-024-02964-0

Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset.

Channick R, Chin KM, McLaughlin VV, Lammi MR, Zamanian RT, Turricchia S, Ong R, Mitchell L, Kim NH.

2024-03-075 citations

10.1007/s40119-024-00361-w

Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies.

Kim NH, Chin KM, McLaughlin VV, DuBrock H, Restrepo-Jaramillo R, Safdar Z, MacDonald G, Martin N, Rosenberg D, Solonets M, Channick R.

2024-01-076 citations

10.1007/s41030-023-00251-x

Macitentan real-world experience in elderly patients over 75 years with pulmonary arterial hypertension (PAH)

N Kim, R Channick, K Chin, L Mitchell, S Turricchia et al. (7 authors)

13.01 - Pulmonary hypertension2022-09-04

10.1183/13993003.congress-2022.911

Epidemiology and Treatment Patterns of Pulmonary Arterial Hypertension (PAH) Patients Across US Regions Using Real-World Data from OPUS/OrPHeUS

Ashwin Ravichandran, R.T. Zamanian, Richard N. Channick, K. Chin, N. Kim et al. (9 authors)

2021-05-011 citations

10.1164/ajrccm-conference.2021.203.1_meetingabstracts.a3702

Combination therapy with macitentan and phosphodiesterase type-5 inhibitor (PDE5i) in pulmonary arterial hypertension (PAH): real-world data from OPUS and OrPHeUS

Vallerie V. McLaughlin, Richard N. Channick, N.H Kim, Megan Flynn, Sylvie Leroy et al. (7 authors)

European Heart Journal2020-11-012 citations

10.1093/ehjci/ehaa946.2297

Macitentan in incident and prevalent pulmonary arterial hypertension (PAH): OPUS/OrPHeUS real-world data

Lana Melendres‐Groves, Richard N. Channick, Kelly Chin, Vallerie V. McLaughlin, Megan Flynn et al. (8 authors)

2020-09-07

10.1183/13993003.congress-2020.1463

P3674Patient characteristics and treatment patterns in the multicentre, retrospective chart review of first-time Opsumit (macitentan) users in the United States (OrPHeUS)

Vallerie V. McLaughlin, Richard N. Channick, Kelly Chin, Peter J. Leary, Chad E. Miller et al. (10 authors)

European Heart Journal2019-10-01

10.1093/eurheartj/ehz745.0529

P4673Macitentan in chronic thromboembolic pulmonary hypertension (CTEPH): combined data from OPUS and OrPHeUS real-world data sets

Richard N. Channick, Kelly Chin, N Kim, John McConnell, David Poch et al. (9 authors)

European Heart Journal2019-10-01

10.1093/eurheartj/ehz745.1055

Macitentan in pulmonary hypertension (PH): Data from OPUS and OrPHeUS real-world data sets

Nick Kim, Richard N. Channick, Kelly Chin, Lana Melendres‐Groves, Ashwin Ravichandran et al. (10 authors)

2019-09-283 citations

10.1183/13993003.congress-2019.pa5458

Macitentan in portopulmonary hypertension (PoPH): Real-world data from OPUS and OrPHeUS

Nick Kim, Kelly Chin, Vallerie V. McLaughlin, Ricardo Restrepo‐Jaramillo, Zeenat Safdar et al. (10 authors)

2019-09-28

10.1183/13993003.congress-2019.pa5457

Interventions

OTHERNotapplicable

Not applicable as non-interventional study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive) * Patients whose medical charts are available for data collection

Exclusion criteria

* Patient participation in the OPUS registry * Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product

Design outcomes

Primary

Measure	Time frame	Description
Estimation of incidence rates of adverse events	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death

Secondary

Measure	Time frame	Description
Description of demographic characteristics of patients	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period
Description of clinical characteristics of patients	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period

Countries

Puerto Rico, United States

Outcome results

None listed