20.11.2012 - British BTG has reported positive results of pivotal Phase III trials. Its drug Varisolve improved the symptoms of varicose veins in 80% of the cases.
PEM (Polidocanol endovenous microfoam) works in varicose veins, veins that have become enlarged and tortuous. BTG International Ltd., London (UK) announced on 19 November that full data from the two US pivotal Phase III trials VANISH-1 and VANISH-2 support previous positive results on PEM. PEM causes fibrosis inside varicose veins, occluding the lumen of the vessel, and reducing the appearance of the varicosity. BTG sells the compound under the brand name Varisolve. VANISH-2 data, presented at the 26th Annual Congress of the American College of Phlebology in Hollywood, Florida (USA) show that 80% of patients treated with PEM 0.5% or 1.0% dose concentrations, reported an improvement of symptoms compared to 20% in the placebo arm. In addition, 85% of patients demonstrated elimination of saphenofemoral junction reflux and/or occlusion of the great saphenous vein (GSV) and all incompetent veins, compared with 2% in the placebo arm.
Patients varied from young (21) to old (73) and baseline GSV diameters from intermediate (3 mm) to wide (19 mm). Side effects were mostly mild or moderate. Out of 230 PEM-treated patients, 24 experienced thrombi. However, all were small and most (77%) were asymptomatic, and – most importantly – all resolved or stabilised in a median time of 29 days. Also, VANISH-1 results support the efficacy of the polyethylen glycol compound. Here PEM treatment led to an improvement of the appearance of varicose veins as assessed by scrutinising photos of them before and after ultrasound-guided delivery of PEM into the incompetent vein.
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