The efficacy and safety of a coumarin-/troxerutin-combination (SB-LOT) in patients with chronic venous insufficiency: a double blind placebo-controlled randomised study.
BACKGROUND
The objective was to evaluate the oedema-protective effect of a vasoactive drug (coumarin/troxerutin [SB-LOT]) plus compression stockings in patients suffering from chronic venous insufficiency after decongestion of the legs as recommended by the new guidelines.


METHODS
231 patients were randomly assigned medical compression stockings plus SB-LOT (90 mg coumarin and 540 mg troxerutin per day) or medical compression stockings plus placebo for the first 4 weeks and SB-LOT or placebo for the second 12 weeks of the study. The primary efficacy endpoint was the lower leg volume measured by well-established water plethysmometry.


RESULTS
226 patients were evaluated. After ceasing compression stockings, an edema protective effect was detected in the SB-LOT-group but not in the controls. Recurrence of leg volume increase was by 6.5 +/- 12.1 ml and by 36.7 +/- 12.1 ml in the SB-LOT and placebo group, respectively (p = 0.0402). The local complaint score and general aspects of quality of life were also superior for the SB-LOT-group (p = 0.0041). Significant differences were also observed with regard to clinical global impression and therapeutic effect. No serious adverse drug reaction or clinically relevant impairment of laboratory parameters occur.


CONCLUSIONS
This study confirms the oedema-protective effect of SB-LOT in chronic venous insufficiency and provides a treatment option for patients who discontinue compression after a short time.
Vanscheidt
W
W
Dermatologic Clinic, University Freiburg, Germany. WolfgangVanscheidt@t-online.de
Rabe
E
E
Naser-Hijazi
B
B
Ramelet
A A
AA
Partsch
H
H
Diehm
C
C
Schultz-Ehrenburg
U
U
Spengel
F
F
Wirsching
M
M
Götz
V
V
Schnitker
J
J
Henneicke-von Zepelin
H H
HH
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001458:Bandages; D003131:Combined Modality Therapy; D003374:Coumarins / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004338:Drug Combinations; D004487:Edema / Q000188:drug therapy; D005260:Female; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014689:Venous Insufficiency / Q000188:drug therapy*
D003374:Coumarins; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D006896:Hydroxyethylrutoside; C013731:Venalot