Pilot trial of oral @entity3446 for recalcitrant XXXX .

@entity1 @entity2298 @entity75 @entity256 @entity3446 @entity854 @entity1431
BACKGROUND: @entity3446 -coated stents are a promising new therapy for @entity256 . We treated a select group of @entity1 at especially high risk for @entity256 with oral @entity3446 . METHODS AND RESULTS: @entity1 were treated with an oral @entity3446 -loading dose of 6 mg after coronary angioplasty, followed by 2 mg/d for 4 weeks. Serum electrolytes, lipid profile, renal panel, and complete blood cell count were measured at 1, 3, and 5 weeks after drug initiation. Oral @entity3446 was prescribed to 22 @entity1 who had a total of 28 lesions and were at high risk for @entity256 . Of the 22 study @entity1 , 11 (50%) discontinued oral @entity3446 early because of side effects or @entity854 . @entity2298 and @entity1431 were the most frequent adverse events, occurring in 3 @entity1 each. All adverse drug effects were reversible after discontinuation. Follow-up was obtained in 100% of @entity1 at a mean of 9.9+/-1.8 months, ranging from 6.5 to 11.8 months. @entity75 revascularization (TLR) occurred in 15 of 28 lesions (53.6%) and 13 of 22 @entity1 (59.1%). There was no difference in TLR for @entity1 receiving a complete course of @entity3446 (n=8; 72.7%) compared with @entity1 who terminated treatment prematurely (n=5; 45.5%; P=NS). Clinically driven repeat cardiac catheterization was obtained in 15 (68.2%) @entity1 ; @entity256 (>50% diameter stenosis at follow-up) was present in 13 (86.7%). CONCLUSIONS: Oral @entity3446 does not appear to provide benefit to @entity1 with recalcitrant @entity256 . Adverse drug effects are frequent, underscoring the importance of local drug delivery to achieve high tissue concentrations without systemic adverse drug effects.
