FDA-approved sodium tetradecyl sulfate (STS) versus compounded STS for venous sclerotherapy.
BACKGROUND
In the area of endovenous chemical ablation (sclerotherapy), there has been much debate regarding sclerosant quality and efficacy. Only sodium tetradecyl sulfate (STS) has garnered Food and Drug Administration (FDA) approval in the United States.


OBJECTIVE
The primary objective of this study was to compare clinical performance measures of compounded STS from 27% industrial-strength stock (compounded STS) versus FDA-approved Sotradecol (Bioniche Pharma USA, Inc., Belleville, Ontario, Canada).


METHODS
Phase I of this study focused on the chemical composition of the drugs, whereas Phase II studied the ablative abilities of the two drugs at comparable concentrations of 3%.


RESULTS
We documented the presence of various impurities in compounded STS. No impurities in AngioDynamics STS were found. Our studies suggest that compounded STS may have significant variation in concentration. The AngioDynamics STS concentration was found to be manufactured within a tight tolerance. Segments of incomplete ablation were more frequent in the compounded STS group when compared to the AngioDynamics STS group. This reached statistical significance (p=.02). Primary closure using the Kaplan-Meier statistic demonstrated a trend in the favor of AngioDynamics STS when compared to compounded STS.


CONCLUSIONS
When product quality, efficacy, and liability are carefully considered, we conclude that it would behoove physicians to use pharmaceutical-grade, FDA-approved sclerosant when treating their patients.
Almeida
Jose I
JI
Miami Vein Center, University of Miami Miller School of Medicine, Miami, Florida 33129, USA.
Raines
Jeffrey K
JK
D017277:Drug Approval; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000737:chemistry; D012981:Sodium Tetradecyl Sulfate / Q000008:administration & dosage* / Q000737:chemistry; D014481:United States; D014689:Venous Insufficiency / Q000188:drug therapy
D012597:Sclerosing Solutions; D012981:Sodium Tetradecyl Sulfate