Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies.

Abstract

BACKGROUND:

The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use.

OBJECTIVE:

A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment.

METHODS AND MEASUREMENTS:

A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile.

RESULTS:

Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study.

CONCLUSION:

Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.

• Authors: Anna D Holmes, Kimberly A Waite, Michael C Chen, Kiruthi Palaniswamy, Thomas H Wiser, Zoe D Draelos, Elyse S Rafal, W Philip Werschler, Alison E Harvey
• Journal: The Journal of clinical and aesthetic dermatology (J Clin Aesthet Dermatol) Vol. 8 Issue 8 Pg. 29-35 (Aug 2015) ISSN: 1941-2789 [Print] United States
• PMID: 26345379 (Publication Type: Journal Article, Review)