15 February 2020 by Michele Cole

Characteristics of patients with pulmonary arterial hypertension newly treated with macitentan using two US data sets: Opsumit (OPUS) Registry and Medicare

Rationale

Elderly are increasingly treated for pulmonary arterial hypertension (PAH); however, few are included in clinical trials.  Real world evidence is used to characterize underrepresented populations.  We aim to describe clinical characteristics, and demographics, of elderly PAH patients using this data.

Methods

Medicare provides health insurance for Americans >65 years old. Using Medicare data (01JAN2013-31DEC2016), patients who had ≥2 diagnoses claims for pulmonary hypertension on or before the first claim date for macitentan (index date) were included.  Patients were assessed until disenrollment, death, or end of study period. Patients with medical claims for left-sided heart failure during baseline period were excluded.

The OPUS Registry (NCT02126943) is an ongoing, US-based, prospective, multicenter, longitudinal, observational drug registry of newly treated macitentan patients. patients (01JAN2014-17OCT2018) were followed for at least 1 year.  

All baseline variables were analyzed descriptively. 

Results

In the Medicare dataset, 812 newly treated macitentan patients >65were identified. Most were female (72.3%). Mean exposure to macitentan was 18 months. The most common baseline comorbidities were hypertension (87.7%), COPD (43.0%), diabetes (39.7%), renal insufficiency (35.5%), lower respiratory disease (34.0%); and obesity (31%).  Concomitant baseline PAH medications were PDE5is (44.6%), parenteral vasodilators (7.6%), and inhaled vasodilators (6.9%). 

OPUS enrolled 751 newly treated macitentan patients >65 years of age. Most were female (71.4%). Mean exposure to macitentan was 14.2 months. The most common baseline comorbidities were hypertension, (64.6%), edema (29.6%), diabetes (29.4%), anemia (20.2%) renal insufficiency (17.3%), signs of right heart failure (14.8%). At macitentan initiation, 47.8% of patients were treated with macitentan alone; 39.6% of patients were treated in combination with PDE5is or SGC-S; parenteral prostacyclins, 6.5%; inhaled prostacyclins, 5.7%.

Conclusion(s)

Medicare and OPUS provide real-world data of elderly PAH patients on macitentan.  Although age and gender were similar, the frequency of some comorbidities was higher in the Medicare cohort.

Key Contributors

Authors: Nick Kim, MD1, Kelly Chin, MD2, Vallerie McLaughlin, MD3, Michele Cole, PharmD, MS4, Cassandra Lickert, MD4, Megan Flynn, PhD4, Carol Zhao, MS4, Richard Channick, MD5 1. University of California San Diego, La Jolla, CA, USA; 2. UT Southwestern Medical Center, Dallas, TX, USA; 3. University of Michigan, Ann Arbor, MI, USA; 4. Actelion Pharmaceuticals US, Inc, South San Francisco, CA, USA; 5. University of California Los Angeles, Los Angeles, CA, USA


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