Patients with pulmonary arterial hypertension (PAH) can reach higher oral doses of treprostinil when a short induction treatment with injected treprostinil (Remodulin®) is used prior to the oral formulation (Orenitram®), according to top-line data just announced by United Therapeutics.
“We’re delighted with the preliminary results from the EXPEDITE study, which provided patients a way to reach efficacious doses in a shorter period of time without having to commit to long-term pump therapy,” said Meredith Broderick, PharmD, JD, senior director of global medical affairs at United Therapeutics. “Along with our other phase 4 studies, EXPEDITE demonstrates our commitment to optimize available treatment options in order to help PAH patients better manage their disease.”
Most (79%) participants in the EXPEDITE study reached the primary endpoint of a Orenitram total daily dose of 12 mg, with a 16.4 mg mean total daily dose at 16 weeks. Without the induction protocol, the average Orenitram daily dose at 16 weeks was approximately 6 mg, according to real-world data.
Treatment with treprostinil extended-release tablets taken 3 times daily was well tolerated. The safety profile was consistent with previous studies, and several treprostinil-related adverse events actually improved after patients transitioned to oral treprostinil.
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The director of the Pulmonary Hypertension Center at INTEGRIS Baptist Medical Center, John Kingrey, MD, expressed his satisfaction with the study results. “I’m so pleased with how my patients did with this approach, as it really did expedite (pun intended!) their path to achieving increased prostacyclin dosages.”
The phase 4 EXPEDITE trial enrolled 36 patients diagnosed with World Health Organization Group 1 PAH. The induction protocol implemented in the study included the administration of intravenous or subcutaneous Remodulin titrated to a minimum dose of 20 ng/kg/min over 2 to 8 weeks, followed by a 21-day period of Orenitram treatment.
United Therapeutics announces top line data from the EXPEDITE study of Remodulin induction prior to Orenitram therapy. News release. United Therapeutics Corporation; October 31, 2022.