Transition from IV XXXX to subcutaneous @entity13992 in @entity120 : a controlled trial.

@entity1 @entity120 @entity4770 @entity13992 @entity3337
BACKGROUND: We determined the relative efficacy of subcutaneous (SC) @entity13992 in stable World Health Organization class II and III @entity1 transitioned from IV @entity4770 . METHODS: This was an 8-week, multicenter, randomized study in which @entity1 were transitioned from IV @entity4770 to SC @entity13992 or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration. @entity1 with clinical deterioration were returned promptly to @entity4770 . Placebo or SC @entity13992 doses were titrated in response to symptoms. Time to adjudicated clinical deterioration was compared between treatment groups, and exercise capacity, symptoms of disease, and safety were assessed throughout the study. RESULTS: Twenty-two @entity1 were enrolled and completed the study. Seven of 8 @entity1 (88%) [corrected] withdrawn to placebo had clinical deterioration, while only 1 of 14 @entity1 (7%) [corrected] withdrawn to SC @entity13992 had clinical deterioration (p = 0.00023 based on a treatment comparison of time to deterioration). Analyses of exercise capacity and symptoms strongly supported the efficacy of SC @entity13992 in @entity4770 -treated @entity1 . Adverse events consisted of painful @entity3337 and anticipated prostacyclin side effects. CONCLUSIONS: SC @entity13992 is effective in @entity120 and prevents clinical deterioration and maintains functional status in @entity1 transitioned from @entity4770 .
