ETOXISCLEROL

OBJECTIVES: To assess the efficacy and safety of polidocanol (POL) in comparison to sodium tetradecyl sulphate (STS) and isotonic saline (placebo) for sclerotherapy of telangiectases or reticular veins by means of standardized digital imaging system, independent medical observers and detailed monitoring.

METHODS: Of 316 randomized patients, 160 with telangiectases were randomly assigned to 0.5% POL, 1% STS or placebo, and 156 with reticular veins received 1% POL, 1% STS or placebo. Veins selected for injection were clearly visible telangiectases or reticular veins in a predefined treatment area (10x10 cm). Exact retrieval of the location was guaranteed by a newly established digital imaging system. Images were taken before first injection and 12 and 26 weeks after the last of three possible injection visits, and evaluated by the investigator and two blinded independent observers. The detailed safety monitoring included ultrasound screening for 'silent' deep vein thrombosis, electrocardiograms and clinical laboratory tests.

RESULTS: POL demonstrated a statistically significant superiority versus placebo (P < 0.0001) for the primary criterion 'improvement of veins'. Significantly more patients were satisfied with POL at 12 or 26 weeks (84%, 88%) compared to STS (64%, 63%; P < 0.0001) and placebo (14%, 11%; P < 0.0001). POL was safe and well tolerated apart from expected local symptoms at the injection site.

CONCLUSION: Sclerotherapy of telangiectases and reticular veins with detergent-like sclerosants such as polidocanol (POL) or sodium tetradecyl sulphate (STS) is a well-established technique. However, evidence from clinical trials comparing these substances with a non-active solution is sparse and does not live up to expectations of modern clinical trial concepts necessary for authorisation purposes. The presented multicentre EASI study fulfils these requirements and clearly demonstrates that Sclerotherapy of C1 veins with POL is highly effective and deserves the adjunct 'gold standard'.

BACKGROUND: AIMS Short- and mid-term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow-up registry was to evaluate the long-term incidence of adverse events with polidocanol.

METHODS: The physicians involved in the initial French registry were contacted and asked to partake in the follow-up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey.

RESULTS: Data on 1,605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy).

CONCLUSIONS: Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term.