United Therapeutics to test prostacyclin analog sepsis risk hypothesis
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
To defend Remodulin (treprostinil) after a Centers for Disease Control & Prevention analysis suggested a higher rate of bloodstream infections in patients taking the prostacyclin agent, United Therapeutics is planning a prospective clinical study of multiple agents. CDC researchers began studying bloodstream infection rates for intravenous prostacyclin agents after being notified in fall 2006 of a "possible increase in gram-negative bloodstream infection (BSI) in patients on IV treprostinil," according to CDC's Feb. 23 presentation. The CDC analysis, which covered January 2004-2006, found BSI rates from 0.28 to 2.1 per 1,000 medicine days for treprostinil and a range of .23 to 1.02 for GlaxoSmithKline's Flolan (epoprostenol). In response, the Pulmonary Hypertension Association urged physicians to be aware of the range of infectious organisms in patients with long-term central catheters and to initiate broad-spectrum antibiotics if BSI is suspected, until culture results are known. Both CDC and PHA called for further study; PHA called the analysis "hypothesis generating." United's study, to start "later this year," will enroll "several hundred patients," the firm said. The study will "test the hypothesis of whether there are differences in the risk of sepsis and sepsis sub-types" between parenteral prostacyclin agents...
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