Does heparin prophylaxis prevent exacerbations of XXXX ?

@entity1659 @entity1 @entity19459 @entity113 @entity158 @entity395 @entity2981
BACKGROUND: @entity1659 ( @entity1659 ) is a @entity395 characterized by episodes of @entity113 of the skin, mucous membranes, and gastrointestinal tract resulting from a defect in the gene that produces @entity19459 . Although in vitro laboratory data and past reports suggested that heparin might be efficacious in preventing @entity1659 attacks, no controlled study has been reported to examine heparin's efficacy in this regard. OBJECTIVES: We sought to determine the safety and efficacy of inhaled and subcutaneous heparin versus that of placebo in the prevention of @entity1659 attacks. METHODS: We performed a double-blind, double-dummy, saline placebo-controlled, randomized, 3-way crossover study with 11 visits. RESULTS: The study was designed to enroll 24 @entity1 . Twenty-two @entity1 were randomized and received the study drug. @entity1 did not have a significant decrease in average flare intensity after they received injected or inhaled heparin compared with that seen after placebo, the primary endpoint. However, when @entity1 received injected heparin, they had a statistically significant decrease in average flare intensity compared with that seen with inhaled heparin after a normalizing transformation was applied. When the means are back transformed, this translates into median flare intensities of 9.2, 8.0, and 5.1 in the @entity1 treated with inhaled heparin, placebo, and injected heparin, respectively. There were no significant differences when individual symptoms were examined, when total numbers of flares over a 6-week observation period were examined, or when global evaluations by the @entity1 and investigators were evaluated. Adverse event severity was fairly uniform across treatments, with the majority of events classified as moderate and the remainder split between mild and severe. Injected heparin treatment was associated with higher rates of relatedness than other treatments, which was partially explained by 17 adverse events specifically related to the injection process itself (tenderness, @entity2981 , redness, @entity158 , and itching at the injection site). The injection treatment was also associated with a larger overall number of reported adverse events (70 vs 48 in the placebo treatment). Tenderness and @entity2981 at the injection site were entirely confined to the injected heparin treatment. CONCLUSIONS: Injected and inhaled heparin failed to attenuate average flare intensity, the primary endpoint, compared with placebo. Interestingly, after @entity1 injected heparin, they had a significant decrease in average flare intensity compared with that seen after inhalation of heparin. There were no differences among groups in other efficacy parameters. Taken together, these data indicate that commercial heparin was ineffective in preventing exacerbations of @entity1659 .
