Although subcutaneous infusion of Remodulin (treprostinil) is an effective treatment for patients with severe pulmonary arterial hypertension (PAH), it can have undesired effects such as pain at the infusion site. But a study reports that speeding up Remodulin administration, and combining it with injection-site pain management, is an easily tolerated option that may help patients better adhere to treatment.
The study, “Safety, Tolerability And Clinical Effects Of A Rapid Dose Titration Of Subcutaneous Treprostinil Therapy In Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial,” was published in the journal Respiration.
Treatment with subcutaneous Remodulin has been shown to improve exercise capacity, symptoms, and hemodynamics in a dose-dependent manner, and may even improve long-term outcomes for patients with severe PAH. However, adverse effects related to the administration of the drug, particularly infusion site pain, can lead to treatment abandonment.
There is no known correlation between local adverse reactions and the drug’s dosing rates. “Up to now, a rapid dosing regimen of treprostinil has only been investigated in a small group of 12 patients,” the researchers wrote. “It is not clear whether this regimen, together with a proactive approach to infusion site pain management, can be well tolerated and effective in a larger patient cohort.”
Researchers investigated the safety and tolerability of a rapid dose administration of subcutaneous Remodulin, combined with proactive infusion site pain management, in a larger group of people with severe PAH.
They looked at 39 patients on stable treatment with oral PAH-approved drugs (90% on dual combination therapy), and evaluated the clinical effects of 16 weeks of treatment with Remodulin. Researchers aimed an escalating target doses of 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively; a median treprostinil dosage of 35.7 ng/kg/min was achieved after week 16.
Treatment had a good overall safety profile, they reported, with only three patients discontinuing therapy due to infusion site pain. In post-treatment clinical evaluations, patients showed improvement in several PAH parameters, such as the median 6-minute walking distance (a measure of exercise capacity), cardiac index, pulmonary vascular resistance, and tricuspid annular plane systolic excursion (a parameter of right ventricular function of the heart).
“Rapid dose titration was generally well-tolerated and led to a clinically effective dosage, as demonstrated by an improvement in exercise capacity and haemodynamics during the 16-week study period,” the authors concluded. “A rapid dose titration and proactive infusion site management may therefore improve the management of this therapy and contribute to an improved treatment outcome.”
According to Remodulin webpage, infusion site reactions typically include abnormal redness of the skin, inflammation, or rash, and are most intense two to five days after a change in injection site.
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