Mirvaso Gel Judged Safe and Efficacious Long Term

mirvaso-tube

This just published paper, in the peer-reviewed Journal of Drugs in Dermatology, again asserts that Mirvaso is “efficacious and safe“ for daily use over 1 year.

This study details a trial of 345 users over a year, whilst the Mirvaso Prescribing Information quotes results from 276 users over 1 year.

The previously published long term trial results suggested that around 10% of trialists experienced flushing, 8% redness, 5% rosacea and 5% nasophyaryngitis (cold like symptoms).

Whilst the abstract doesn’t detail exactly how many adverse events were seen in the group, the Brimonidine Tartrate Gel 0.5% was judged as safe.

Some bits of information are available though

  • adverse events were higher at the beginning of the study, but decreased over time.
  • using other therapies for the papules and pustules of rosacea at the same time did not affect the number of bad reactions.
  • no tachyphylaxis was observed, which means that it Mirvaso didn’t suddenly stop working.

Note that this study mentions Brimonidine Tartrate Gel 0.5%, whereas Mirvaso is quoted as containing 0.33% of Brimonidine. This is because each gram of gel contains 5 mg of brimonidine tartrate, which is equivalent to 3.3 mg of brimonidine free base.

The Real World

What does this mean for the real world where new users of Mirvaso are starting to fill their prescriptions?

Well even though these studies are of high quality, the reports emerging online are not matching the low rates of adverse events detailed here.

This disparity has yet to be explained, so some caution is to be advised. Use Mirvaso carefully. Withe the support of your doctor watch out for the official adverse events for Mirvaso and also rebound redness.

Article Abstract

Long-Term Safety and Efficacy of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-Year Open-Label Study

J Drugs Dermatol. 2014; 13(1):56-61.

Angela Moore MD,a Steven Kempers MD,b George Murakawa MD,c Jonathan Weiss MD,d Amanda Tauscher MD,e Leonard Swinyer MD,f Hong Liu MSc,g and Matthew Leoni MDg on behalf of the Brimonidine LTS Study Group

aArlington Center for Dermatology, Arlington, TX
bMinnesota Clinical Study Center, Fridley, MN
cDermcenter PC, Troy, MI
dGwinnett Clinical Research, Snellville, GA
eCompliant Clinical Research, Olathe, KS
fDermatology Research Center, Salt Lake City, UT
gGalderma R&D, Princeton, NJ

Abstract

Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase.

In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment.

Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated.

Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea.

Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed.

In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea.

Introduction

Rosacea is a common inflammatory skin disorder estimated to affect 16 million Americans.Although it is usually observed in patients with light skin phototype, rosacea has also been diagnosed in patients with darker skins.Persistent erythema is the primary feature of rosacea and presents ubiquitously among rosacea patients.In addition, other cutaneous signs such as telangiectasia, papules, and pustules may also be present.Several topical and oral medications are currently approved for the treatment of papules and pustules of rosacea, including metronidazole, azelaic acid and anti-inflammatory dose doxycycline. However, there is currently no approved medication for the treatment of erythema of rosacea, making it a key unmet medical need.

Brimonidine tartrate (BT), a highly selective α2-adrenergic receptor agonist, was recently shown to reduce erythema of rosacea when applied topically.

BT possibly acts through its vasoconstrictive activity, leading to a constriction of the abnormal dilation of facial blood vessels in patients presenting with erythema.

BT ophthalmic solution has been approved for the treatment of open-angle glaucoma, with a well-documented good safety profile.

The efficacy and safety of topical BT gel 0.5% were assessed in previous randomized, double-blind and controlled Phase II and pivotal Phase III studies, in which BT gel 0.5% was applied once daily for 4 weeks. The results demonstrated that topical BT gel 0.5% provided significantly greater efficacy and a faster onset of action compared to the vehicle gel, with a good overall safety profile. In the present long-term study, we aimed to evaluate the safety and efficacy of topical BT gel 0.5% when the medication is applied once daily for up to 12 months.

[purchase article for more details].

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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