Comparative adherence of macitentan versus ambrisentan and bosentan in Australian patients with pulmonary arterial hypertension: a retrospective real-world database study

Abstract

Aim

Bosentan, ambrisentan, and macitentan are endothelin receptor antagonists (ERAs), currently available in Australia for treatment of pulmonary arterial hypertension (PAH). This study assessed the comparative adherence of these ERAs for PAH in Australian patients.

Methods

This retrospective, observational study used data for adults with PAH from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset (01/2006-10/2020). The primary outcome was treatment adherence (i.e. receiving ≥80% of ERA doses over 12 months). Secondary outcomes were time to treatment change (add-on or switch) and overall survival.

Results

The study included 436 patients who took bosentan (n = 200), ambrisentan (n = 69), or macitentan (n = 167). Treatment adherence was significantly greater in patients who received macitentan (65.3%) versus ambrisentan (56.5%) and bosentan (58.0%), with odds ratios (ORs; 95% CI) of 0.51 (0.30–0.88; p = 0.016) for bosentan versus macitentan and 0.48 (0.24–0.96; p = 0.037) for ambrisentan versus macitentan. The median time to treatment change was 47.2 and 43.4 months for bosentan and ambrisentan, respectively (not calculated for macitentan because of insufficient duration of data).

Limitations and conclusions

Real-world data for Australian patients with PAH showed that treatment adherence for ERAs was suboptimal. Adherence was higher for macitentan compared with ambrisentan and bosentan.

Keywords:

• Pulmonary arterial hypertension
• endothelin receptor antagonist
• Australian
• treatment adherence
• observational study

JEL CLASSIFICATION CODES:

• I10
• I1
• I
• I19

Transparency

 

Declaration of funding

This study was funded by Janssen Asia Pacific Medical Affairs. The Sponsor was involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Declaration of financial/other interests

EL and EK have received research support, honoraria, and speaking fees from Janssen, GlaxoSmithKline, and Pfizer. YM, DYY, JYT, and DBW are employees of Janssen Pharmaceuticals. MHK, JC, and SL are employees of Prospection, which received funding from Janssen to conduct the study analyses. PB was an employee of Janssen Pharmaceuticals at the time of the analysis.

Author contributions

All authors contributed to the study conception and design and interpretation of the data. Data analysis was performed by SL, MHK, and JC. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgement

Medical writing support was provided by Alaina Mitsch, PhD, of Lumanity Communications Inc., and was funded by Janssen Asia Pacific Medical Affairs.

Data availability statement

The de-identified participant data will not be shared.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

IRB information

The study was conducted in accordance with the International Conference on Harmonisation’s Good Clinical Practice Guidelines, the Declaration of Helsinki, and local and regional regulations. Because of its retrospective design and use of de-identified data, ethics approval, and informed consent were not required for this study. This study and publication of subsequent results were also approved by Services Australia (External Request Evaluation Committee Approval Number RMS3592). The Australian Government Department of Human Services External Request Evaluation Committee functions essentially as an ethics committee that reviews the purpose, anonymity, consent, secrecy, resource use, reputation, and other policies of research being conducted.