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Safety and Feasibility of Transitioning Stable Patients With Pulmonary Arterial Hypertension From Infused Treprostinil to Inhaled Treprostinil
October 2010, Vol 138, No. 4_MeetingAbstracts
Poster Presentations: Tuesday, November 2, 2010 | October 2010
Safety and Feasibility of Transitioning Stable Patients With Pulmonary Arterial Hypertension From Infused Treprostinil to Inhaled Treprostinil Madhurmeet Singh, DO; Michael Mathier, MD; Linda M. Cadaret, MD University of Pittsburgh Medical Center, Pittsburgh, PA Chest. 2010;138(4_MeetingAbstracts):369A. doi:10.1378/chest.10496
Abstract PURPOSE: Inhaled treprostinil may offer a safe and less burdensome option for select patients with pulmonary arterial hypertension (PAH) who are receiving parenteral prostanoids. In this case series, we report preliminary results on the safety and feasibility of a protocol to transition patients from continuously infused treprostinil to inhaled treprostinil (4 times daily [q.i.d.]). METHODS: Two stable patients with PAH receiving intravenous and subcutaneous treprostinil, respectively, were transitioned to inhaled treprostinil at 3 breaths q.i.d. and up-titrated to a target dose of ≥9 breaths q.i.d. (54 µg per session) over a 4-day period. Simultaneously, the parenteral treprostinil dose was down-titrated by 25% daily. The patients had received parenteral treprostinil for 54 and 72 months, respectively, with no evidence of right heart failure. Safety, functional status, hemodynamic parameters, and exercise capacity were assessed before and after transition to inhaled treprostinil. RESULTS: At the time of transition, both patients were NYHA functional class II idiopathic PAH. Transition to inhaled treprostinil was performed because of a central line infection in 1 patient and subcutaneous infusion site discomfort in the other patient. Both patients were also receiving oral PAH therapy. Baseline doses of parenteral treprostinil were 46 and 50 ng/kg/min, respectively. Both patients were transitioned off of parenteral treprostinil and achieved a target inhaled treprostinil dose of ≥9 breaths q.i.d. by day 4. Neither patient deteriorated acutely after transitioning to inhaled treprostinil. Follow-up hemodynamic and 6-minute walk distance results will be presented. No significant adverse events requiring discontinuation were reported after transition to inhaled treprostinil. CONCLUSION: Transition from parenteral treprostinil to inhaled treprostinil appears feasible in select patients, as neither patient experienced acute clinical deterioration nor clinically significant adverse events. Follow-up safety and efficacy data will be presented. CLINICAL IMPLICATIONS: Inhaled treprostinil may have specific safety and convenience advantages compared with parenteral prostanoid treatment. This study may provide guidance to physicians considering inhalational therapy for select patients receiving parenteral prostanoids. DISCLOSURE: Madhurmeet Singh, Grant monies (from industry related sources) Michael A. Mathier received a grant from Actelion Pharmaceuticals Ltd to study pulmonary rehabilitation in patients with PAH.; Consultant fee, speaker bureau, advisory committee, etc. Dr Mathier is a consultant for Actelion Pharmaceuticals Ltd; Gilead Sciences, Inc; and United Therapeutics Corporation.; No Product/Research Disclosure Information 12:45 PM - 2:00 PM
Poster Presentations: Tuesday, November 2, 2010 | October 2010
Safety and Feasibility of Transitioning Stable Patients With Pulmonary Arterial Hypertension From Infused Treprostinil to Inhaled Treprostinil Madhurmeet Singh, DO; Michael Mathier, MD; Linda M. Cadaret, MD University of Pittsburgh Medical Center, Pittsburgh, PA Chest. 2010;138(4_MeetingAbstracts):369A. doi:10.1378/chest.10496
Abstract PURPOSE: Inhaled treprostinil may offer a safe and less burdensome option for select patients with pulmonary arterial hypertension (PAH) who are receiving parenteral prostanoids. In this case series, we report preliminary results on the safety and feasibility of a protocol to transition patients from continuously infused treprostinil to inhaled treprostinil (4 times daily [q.i.d.]). METHODS: Two stable patients with PAH receiving intravenous and subcutaneous treprostinil, respectively, were transitioned to inhaled treprostinil at 3 breaths q.i.d. and up-titrated to a target dose of ≥9 breaths q.i.d. (54 µg per session) over a 4-day period. Simultaneously, the parenteral treprostinil dose was down-titrated by 25% daily. The patients had received parenteral treprostinil for 54 and 72 months, respectively, with no evidence of right heart failure. Safety, functional status, hemodynamic parameters, and exercise capacity were assessed before and after transition to inhaled treprostinil. RESULTS: At the time of transition, both patients were NYHA functional class II idiopathic PAH. Transition to inhaled treprostinil was performed because of a central line infection in 1 patient and subcutaneous infusion site discomfort in the other patient. Both patients were also receiving oral PAH therapy. Baseline doses of parenteral treprostinil were 46 and 50 ng/kg/min, respectively. Both patients were transitioned off of parenteral treprostinil and achieved a target inhaled treprostinil dose of ≥9 breaths q.i.d. by day 4. Neither patient deteriorated acutely after transitioning to inhaled treprostinil. Follow-up hemodynamic and 6-minute walk distance results will be presented. No significant adverse events requiring discontinuation were reported after transition to inhaled treprostinil. CONCLUSION: Transition from parenteral treprostinil to inhaled treprostinil appears feasible in select patients, as neither patient experienced acute clinical deterioration nor clinically significant adverse events. Follow-up safety and efficacy data will be presented. CLINICAL IMPLICATIONS: Inhaled treprostinil may have specific safety and convenience advantages compared with parenteral prostanoid treatment. This study may provide guidance to physicians considering inhalational therapy for select patients receiving parenteral prostanoids. DISCLOSURE: Madhurmeet Singh, Grant monies (from industry related sources) Michael A. Mathier received a grant from Actelion Pharmaceuticals Ltd to study pulmonary rehabilitation in patients with PAH.; Consultant fee, speaker bureau, advisory committee, etc. Dr Mathier is a consultant for Actelion Pharmaceuticals Ltd; Gilead Sciences, Inc; and United Therapeutics Corporation.; No Product/Research Disclosure Information 12:45 PM - 2:00 PM