Prostacyclin therapy is an established, efficacious treatment for patients with PAH1,2

 

THE ROLE OF PROSTACYCLIN THERAPY AND ITS CLINICAL
BENEFIT FOR PATIENTS1,2

Prostacyclin therapy addresses the underlying pathophysiology of PAH by1,2:

  • Inducing vasodilation of pulmonary arteries
  • Inhibiting platelet aggregation
  • Exerting anti-proliferative and anti-inflammatory effects

Clinical benefits of prostacyclin therapy are well established and include1,2:

  • Reduction in symptoms of PAH
  • Improved prognostic measures of risk, such as exercise capacity and functional class
  • Delayed disease progression

A RETROSPECTIVE ANALYSIS REPORTED LOW PROSTACYCLIN USE AMONG THE 13,633 PATIENTS WITH PAH WHO WERE ANALYZED3

In patients with PAH in the Truven Medicare and Commercial databases (N = 13,633)*

Prostacyclin use across calendar-year cohorts ranged from 19.9% to 22.6%.

Icon showing only 22% of patients received prostacyclin therapy

Data from a retrospective study of adult patients with PAH who were included in the Truven Commercial and Medicare databases between January 1, 2010, and October 31, 2015. Patients were identified based on claims with ICD-9-CM diagnoses indicative of PAH and claims for PAH-specific medications and PAH-related procedures. Annual cohorts of patients were identified for analysis.

PAH = pulmonary arterial hypertension

 

PREVIOUSLY EXISTING DELIVERY OPTIONS FOR PROSTACYCLIN THERAPY HAVE LIMITATIONS4,5

These limitations may make it difficult to initiate treatment and titrate to doses that provide full therapeutic benefit4,5

Oral6,7

KEY BENEFIT: CONVENIENT

LIMITATIONS

  • Gastrointestinal, nervous, and vascular system side effects
  • Requires up-titration, which may be challenging given side effects

Nebulized5,8

KEY BENEFIT: TARGETED

LIMITATIONS

  • Burdensome, requiring time and effort
  • Frequent administration and multiple breaths are required to achieve a therapeutic dose
  • Few patients are prescribed more than 12 breaths QID

DPI9,10

KEY BENEFIT: CONVENIENT

LIMITATIONS

  • High resistance/high effort device, placing burden on the patient’s inspiratory ability to deagglomerate the dry powder, which may result in drug particles of various sizes
  • Position-dependent device, which may increase the risk of patient error, spillage, or wasted medication

Parenteral6,7,11

KEY BENEFIT: EFFECTIVE

LIMITATIONS

  • Potential to cause systemic toxicities and infection
  • Can result in injection site pain and lifestyle limitations

DPI = dry-powder inhaler; IV = intravenous; QID = four times daily; SC = subcutaneous

 

IN A RETROSPECTIVE CLINICAL ANALYSIS, HIGHER DOSES OF INHALED TREPROSTINIL SOLUTION WAS SHOWN TO IMPROVE DISEASE CONTROL5

In patients with PAH in a specialty pharmacy database (N = 5000), those taking >9 breaths QID had5,†,‡:

  • Higher survival
    rates
  • Longer time to transition
    to parenteral therapy
  • Greater drug
    persistence
Icon showing only 28.5% of patients were taking >9 breaths QID

Data from a Phase 4, retrospective, real-world analysis of patients prescribed inhaled treprostinil solution from a specialty pharmacy database between September 2009 and June 2018. Of the 6709 patients who met all study eligibility criteria, a random sample of 5000 patients was selected for further analysis using simple random sampling with equal probability.5

Compared with patients taking ≤9 breaths QID.5

References

  1. Gomberg-Maitland M, Olschewski H. Prostacyclin therapies for the treatment of pulmonary arterial hypertension. Eur Respir J. 2008;31(4):891-901. doi:10.1183/09031936.00097107
  2. Mitchell JA, Ahmetaj-Shala B, Kirkby NS, et al. Role of prostacyclin in pulmonary hypertension. Glob Cardiol Sci Pract. 2014;2014(4):382-393. doi:10.5339/gcsp.2014.53
  3. Burger CD, Pruett JA, Lickert CA, Berger A, Murphy B, Drake W 3rd. Prostacyclin use among patients with pulmonary arterial hypertension in the United States: a retrospective analysis of a large health care claims database. J Manag Care Spec Pharm. 2018;24(3):291-302. doi:10.18553/jmcp.2017.17228
  4. Hill NS, Feldman JP, Sahay S, et al; INSPIRE study investigators. INSPIRE: safety and tolerability of inhaled Yutrepia (treprostinil) in pulmonary arterial hypertension (PAH). Pulm Circ. 2022;12(3):e12119. doi:10.1002/pul2.12119
  5. Shapiro S, Mandras S, Restrepo-Jaramillo R, et al. Survival and drug persistence in patients receiving inhaled treprostinil at doses greater than 54 μg (nine breaths) four times daily. Pulm Circ. 2021;11(4):20458940211052228. doi:10.1177/20458940211052228
  6. Lang IM, Gaine SP. Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension. Eur Respir Rev. 2015;24(138):630-641. doi:10.1183/16000617.0067-2015
  7. Coons JC, Miller T, Simon MA, Ishizawar DC, Mathier MA. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients transitioned from parenteral or inhaled prostacyclins: case series and treatment protocol. Pulm Circ. 2016;6(1):132-135. doi:10.1086/685111
  8. Hill NS, Preston IR, Roberts KE. Inhaled therapies for pulmonary hypertension. Respir Care. 2015;60(6):794-805. doi:10.4187/respcare.03927
  9. TYVASO® DPI. Instructions for use. United Therapeutics Corporation; 2022.
  10. Berkenfeld K, Lamprecht A, McConville JT. Devices for dry powder drug delivery to the lung. AAPS PharmSciTech. 2015;16(3):479-490. doi:10.1208/s12249-015-0317-x
  11. Burger CD, D'Albini L, Raspa S, Pruett JA. The evolution of prostacyclins in pulmonary arterial hypertension: from classical treatment to modern management. Am J Manag Care. 2016;22(suppl 1):S3-S15.