Safety Profile of Sclerosing Agents: An Analysis From the World Health Organization Pharmacovigilance Database VigiBase.
Adverse Drug Reaction Reporting Systems
/ statistics & numerical data
Databases, Factual
/ statistics & numerical data
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Ethanolamine
/ adverse effects
Humans
Pharmacovigilance
Polidocanol
/ adverse effects
Risk Assessment
/ methods
Sclerosing Solutions
/ adverse effects
Sodium Tetradecyl Sulfate
/ adverse effects
Telangiectasis
/ therapy
Varicose Veins
/ therapy
Vascular Malformations
/ therapy
World Health Organization
Journal
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
ISSN: 1524-4725
Titre abrégé: Dermatol Surg
Pays: United States
ID NLM: 9504371
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
pubmed:
5
3
2019
medline:
26
2
2020
entrez:
5
3
2019
Statut:
ppublish
Résumé
Several sclerosing agents are used to treat chronic venous diseases. Although they do not seem to differ in terms of efficacy, their safety profiles might differ. To compare the safety profile of sclerosing agents through an analysis of the World Health Organization pharmacovigilance database. The authors performed a disproportionality analysis using the proportional reporting ratio (PRR) method to compare pharmacovigilance signals between each sclerosing agent among 6 adverse event syndromes of interest: hypersensitivity reactions, arterial thromboembolic disorders, venous thromboembolic disorders, cardiac arrhythmias, visual/neurological disturbances, and skin ulcerations. The cutoff for signal detection was defined by a logPRR lower boundary 95% confidence interval (CI) ≥0 and number of cases n ≥3. Of 1,227 Individual Case Safety Reports (ICSRs) identified, after removal of ICSRs with unselected indications, the authors selected 472 reports for the analysis. The authors found that polidocanol is associated with more reporting of venous embolic/thrombotic events (logPRR = 1.38 [95% CI 1.27-1.49]), ethanolamine with the higher pharmacovigilance disproportionality signal of cardiac arrhythmias (logPRR = 0.80 [95% CI 0.51-1.09]), and STS with more reporting of allergic reactions (logPRR = 1.79 [95% CI 1.59-1.98]). The safety profile of sclerosing agents significantly differs and should guide benefit-risk ratio assessment of such agents.
Sections du résumé
BACKGROUND
Several sclerosing agents are used to treat chronic venous diseases. Although they do not seem to differ in terms of efficacy, their safety profiles might differ.
OBJECTIVE
To compare the safety profile of sclerosing agents through an analysis of the World Health Organization pharmacovigilance database.
METHODS
The authors performed a disproportionality analysis using the proportional reporting ratio (PRR) method to compare pharmacovigilance signals between each sclerosing agent among 6 adverse event syndromes of interest: hypersensitivity reactions, arterial thromboembolic disorders, venous thromboembolic disorders, cardiac arrhythmias, visual/neurological disturbances, and skin ulcerations. The cutoff for signal detection was defined by a logPRR lower boundary 95% confidence interval (CI) ≥0 and number of cases n ≥3.
RESULTS
Of 1,227 Individual Case Safety Reports (ICSRs) identified, after removal of ICSRs with unselected indications, the authors selected 472 reports for the analysis. The authors found that polidocanol is associated with more reporting of venous embolic/thrombotic events (logPRR = 1.38 [95% CI 1.27-1.49]), ethanolamine with the higher pharmacovigilance disproportionality signal of cardiac arrhythmias (logPRR = 0.80 [95% CI 0.51-1.09]), and STS with more reporting of allergic reactions (logPRR = 1.79 [95% CI 1.59-1.98]).
CONCLUSION
The safety profile of sclerosing agents significantly differs and should guide benefit-risk ratio assessment of such agents.
Identifiants
pubmed: 30829775
doi: 10.1097/DSS.0000000000001876
doi:
Substances chimiques
Sclerosing Solutions
0
Polidocanol
0AWH8BFG9A
Ethanolamine
5KV86114PT
Sodium Tetradecyl Sulfate
Q1SUG5KBD6
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1517-1528Commentaires et corrections
Type : CommentIn