Results of European Phase III Randomised Controlled Trial Comparing Varisolve ® with Surgery or Sclerotherapy Published in Phlebology
London, UK, 13 December 2006: BTG plc (LSE: BGC), the medical innovations company, announces that the full results of the Phase III European trial of Varisolve®, the novel microfoam treatment for varicose veins, have been published in the journal Phlebology 1, confirming the non-inferiority of Varisolve® to the alternative treatments.
The trial was an open-label, multi-centre, randomised, prospective study comparing Varisolve® to surgery and sclerotherapy in the management of patients with moderate to severe varicose veins. The results of the trial showed that Varisolve® met the study objective in that overall it was shown to be non-inferior to alternative treatments, with 83.4% efficacy for Varisolve® and 88.1% efficacy for alternative treatments at three months, and 78.9% efficacy for Varisolve® and 80.4% efficacy for alternatives at 12 months.
"These full data from the one-year follow-up of the European Phase III trial confirm that Varisolve® is an effective and well tolerated treatment for varicose veins, with significant advantages for patients over alternative treatments," commented Louise Makin, BTG's CEO. "We continue to believe Varisolve® has significant commercial potential, and are continuing its US development with the phase II safety study."
In the trial, patients were treated in two randomised cohorts - Varisolve® vs surgery (178 Varisolve® patients) and Varisolve® vs sclerotherapy (259 Varisolve® patients) - to receive either the Varisolve® procedure or the alternative treatment in a ratio of 2:1 in favour of the Varisolve® technique. Efficacy and safety were assessed by duplex scanning on days 7 and 28, and at months 3 and 12.
The primary endpoint was the response to treatment at month 3, defined as the occlusion of incompetent trunk vein(s) and the elimination of reflux in the treated vein(s). To be a responder, both occlusion (or for surgery the absence) of the treated vein and elimination of junctional reflux were required.
Secondary endpoints included: severity of post-procedure pain, time taken to return to normal activities, number of treatment sessions required and month 12 response rate.
Analysing the cohorts separately at month 3, the response rates were 68.2% for Varisolve® and 87.2% for surgery in the Varisolve® vs surgery cohort, and 93.8% for Varisolve® and 88.8% for sclerotherapy in the Varisolve® vs sclerotherapy cohort. At month 12, the superiority of surgery over Varisolve® was maintained in the Varisolve® vs surgery cohort (86.2% versus 63.1%), while Varisolve® was superior to sclerotherapy in the Varisolve® vs sclerotherapy cohort (89.6% versus 76%). The authors of the paper conclude that the reduced efficacy of Varisolve® when delivered by vascular surgeons resulted in part from the lack of experience of this group in using sclerotherapy for large veins.
In terms of the secondary endpoints, surgery was associated with more pain than Varisolve® (day 6: surgery median score 9, Varisolve® median score 2 on the visual analogue scale). The median time to resume normal activities was 2 days following treatment with Varisolve® compared with 13 days following surgical treatment in the Varisolve® vs surgery cohort. No difference was observed in the time to resume normal activities between the patients treated with Varisolve® or sclerotherapy in the Varisolve® vs sclerotherapy cohort. More patients completed treatment in a single session in the Varisolve® group than in the sclerotherapy group (92.2% versus 74.4%).
The most common adverse events relating to Varisolve® use were mild contusion, skin discolouration and limb pain. There were six reports of neurological symptoms occurring within 24 h of treatment, which were short-lived and resulted in no clinical findings during follow-up examinations. Deep vein thromboses (DVT) occurred in 11 patients treated with the Varisolve® procedure, prompting technique changes and following which no further DVTs have been found in 150 patients treated subsequently in this and other studies.
The authors conclude that Varisolve® is capable of sclerosing major incompetent trunk veins and tributaries, usually in a single outpatient session. It is effective in over 80% of cases and is well tolerated, which support the Varisolve® technique as an appropriate future treatment for patients with varicose veins and trunk vein incompetence.
For further information
Andy Burrows, Director of Investor Relations
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1 Wright D et al. Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006; 21 ;4:180-90
BTG in-licenses, develops and commercialises pharmaceuticals and other medical technologies. With a substantial and growing revenue stream of royalties and milestone payments from out-licensed products, BTG continues to strengthen its pipeline of preclinical and clinical development programmes. Active in the fields of oncology, diseases of ageing, neuroscience, drug repositioning and medical devices, BTG works from its offices in London, Philadelphia and Osaka with a global partner network of healthcare companies and research organisations. For further information, visit: www.btgplc.com.Back to press releases