The French Polidocanol Study on Long-Term Side Effects: A Survey Covering 3,357 Patient Years

Authors: GUEX, JEAN JEROME1; SCHLIEPHAKE, DOROTHEE E.2; OTTO, JOACHIM2; MAKO, SERGE3; ALLAERT, FRANCOIS ANDRE4

Source: Dermatologic Surgery, Volume 36, Supplement 2, June 2010 , pp. 993-1003(11)

Publisher: Wiley-Blackwell

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Abstract:

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.

This study was fully sponsored by Kreussler & Co (Germany). Dorothe. Schliephake, Joachim Otto, and Serge Mako are employees of Kreussler.

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1524-4725.2009.01407.x

Affiliations: 1: Cabinet de Phlébologie, Nice, France 2: Kreussler & Co. GmbH, Wiesbaden, Germany 3: Laboratoire Kreussler Pharma France, Paris, France 4: Chaire d'Evaluation médicale Ceren Esc & Cenbiotech/Dim University Hospital, Dijon, France

Publication date: June 1, 2010

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