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Mon-122 - Evaluation of Temporary Conversion of Parenteral Brand Remodulin to Generic Treprostinil in Patients with Pulmonary Hypertension During Hospitalization: A Quasi-Experimental Study

Scientific Poster Session III - Original Research

Original Research
  Monday, November 13, 2023
  01:00 PM–02:30 PM

Abstract

Introduction: Treprostinil (Remodulin) is a parenteral prostacyclin analog used for treatment of pulmonary arterial hypertension (PAH). Guidelines recommend that treprostinil dose adjustments and monitoring be coordinated under the care of a PAH specialist. Abrupt changes in dosing can result in patient harm. Generic treprostinil was FDA approved in 2019 and replaced brand Remodulin at our health system’s formulary. Generic drugs are considered pharmaceutical equivalence if the area under the curve (AUC) is between 80-125% of the brand.

Research Question or Hypothesis: The purpose of this study is to evaluate the short-term safety and efficacy of converting from parenteral Remodulin to generic treprostinil during hospitalization.

Study Design: This IRB-approved retrospective, quasi-experimental study included adult patients on parenteral Remodulin at home admitted to a quaternary medical center between 1/1/17-2/28/23. The pre-group continued brand Remodulin, while the post-group switched to generic treprostinil.

Methods: The primary outcome was clinical deterioration up to 72 hours after initiating a hospital supplied medication. Clinical deterioration was defined as one or more of the following: 10% decrease in mean arterial pressure, 20% increase in heart rate, or escalation of respiratory support from initiation of hospital supplied medication. Secondary outcomes included rate of prostacyclin-related adverse effects and cost. Descriptive data was analyzed using measures of central tendency. Continuous data was assessed with Mann-Whitney U test, and nominal and categorical with Chi-square or Fisher’s Exact test. Statistical analysis completed with SPSS software.

Results: 104 patients were included in the study. Clinical deterioration occurred in 43 of 70 patients (61.4%) in the pre-group and 15 of 34 patients (44.1%) in the post-group (p-value=0.095). Adverse event occurred in 57 (81%) vs 30 (88.2%) patients (p-value=0.379). Average cost per patient was $2,924.66 vs $1,013.62 (p-value=0.001).

Conclusion: Converting hospitalized patients to generic treprostinil is safe and effective while resulting in decreased inpatient costs. Rates of adverse effects were similar.

Presenting Author

Zowda Hassan PharmD
Henry Ford hospital

Authors

Kristin Griebe PharmD
Nisha Patel PharmD
Henry Ford hospital

Zachary Smith PharmD, BCPS, BCCCP
Henry Ford Hospital