The French polidocanol study on long-term side effects: a survey covering 3,357 patient years.
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.
Guex
Jean Jerome
JJ
Cabinet de Phlébologie, Nice, France.
Schliephake
Dorothee E
DE
Otto
Joachim
J
Mako
Serge
S
Allaert
Francois Andre
FA
D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000009:adverse effects*; D012042:Registries; D012597:Sclerosing Solutions / Q000009:adverse effects*; D015911:Sclerotherapy / Q000009:adverse effects*; D013684:Telangiectasis / Q000628:therapy*; D014648:Varicose Veins / Q000628:therapy*
D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols