Mirvaso in the real world: 10-20% have rebound redness

Written by on January 31, 2015 in Mirvaso Gel (Brimonidine 0.33%) with 13 Comments
mirvaso-gel-tube-30gm

This just published paper in the Journal of Drugs in Dermatology has an interesting statement that is an admission that Mirvaso in the real world is not performing as well as seen in the Phase III Clinical Trials.

This fact will come as no surprise to those following the online reviews for Mirvaso – there has been a high level of bad reactions to Mirvaso reported ever since it was publicly available. Indeed the precursors to Mirvaso were also poorly received by rosacea sufferers who tried them.

The admission reads

For example, real-world use has shown that a percentage of patients (in our experience, approximately 10 to 20%) treated with brimonidine experience a worsening of erythema that has been called “rebound.”

The clinical trial data would suggest that we should expect only around 8% of users to experience redness and 10% experience flushing.

The paper proposes to “set patient expectations, optimize treatment initiation, and minimize potential problems”.

The exact details of the proposed strategy is not detailed in the article abstract. If you get to read the whole article, please let us know in the comment below what is proposed.

Optimizing the Use of Topical Brimonidine in Rosacea Management: Panel Recommendations

Tanghetti EA, Jackson JM, Belasco KT, Friedrichs A, Hougier F, Johnson SM, Kerdel FA, Palceski D, Hong HC, Hinek A, Cadena MJ.

J Drugs Dermatol. 2015 Jan 1;14(1):33-40.

Rosacea is a chronic inflammatory disease with a complex pathophysiology that manifests with central facial redness with or without papulopustular lesions.

Often, patients with rosacea present with a constellation of signs and symptoms; for best results, the treatment plan should take into account all symptoms manifesting in the individual patient.

The first available pharmacologic treatment to address the redness associated with rosacea is topical brimonidine. In the United States, brimonidine topical gel 0.33% is indicated for persistent facial erythema of rosacea; approval was based on clinically significant efficacy and good safety data from large-scale clinical trials.

Use of brimonidine in routine clinical practice has yielded new insights that elaborate on the findings from clinical trials. For example, real-world use has shown that a percentage of patients (in our experience, approximately 10 to 20%) treated with brimonidine experience a worsening of erythema that has been called “rebound.”

Our routine use of this agent for >1 year has yielded strategies to set patient expectations, optimize treatment initiation, and minimize potential problems; this article details those strategies. Because we believe that the term “rebound” has been used to describe several physiologically distinct events, we have also proposed more specific terminology for such events.

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

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13 Reader Comments

  1. Emily Kingstron says:

    Thanks for posting this. I’d say “vindicated” or something like that, but we haven’t really been. The label says “redness or flushing” as a side effect, as if it’s just our normal redness or flushing, like we might get from a lotion with an irritant, or cooking over a hot stove. Instead, rebound redness was an extraordinary, extreme experience for people, whole faces beet red, days taken off work, profound discomfort, anxiety, and in some situations, worsening of the underlying condition. To me the lack of warning to patients was dishonest, and while I’m excited to try Soolantra, and appreciate that Galderma is making products for us that help a lot of people, I hold a grudge about it. I know the expenses of bringing a product to market are huge, but it’s our faces that we’re talking about, they could have shown greater regard for our situation. It backfired on them, I don’t know how they couldn’t have predicted the backfire. Thankful for the Internet and this site, and every rosacean out there sharing their experiences. Together we mitigate these risks.

  2. Scarlet says:

    I agree with Emily and think that even the estimation of 10-20% here is an understatement. For my rosacea blog (scarletnat) I have gathered all the patient responses I could find for Mirvaso for a long time, both good and bad, and regardless of the psychology behind who is more likely to post about their experiences (those with success or failure), it seems the overwhelming majority seems to have had pretty ghastly rebound redness and flushing from Mirvaso. Something to be weary of for everyone still out there to try this medication.

    • Kim says:

      Oh, I’m aware of your “blog”
      You recommend beta blockers so strongly that I convinced my doctor to prescribe them. I ended up in the hospital because of heart block and almost died. YOU ARE NOT A DOCTOR. STOP PRETENDING YOU ARE. If you were in the US, I would sue you.

      • James says:

        lol if you get beta blockers you need to make sure your blood pressure is ok beforehand.

        Dont “convince” your doctor to give them to you against their better judgement

      • joey r says:

        I know. I’ve read her blog as well and it is pure crap!

      • Emily Kingstron says:

        Exactly, you should not be trying to sue Scarlett, you should be wondering why you convinced a doctor against their better judgement (if you have low blood pressure and that is even what really happened, since blood pressure is something any standard doctor knows to consider when prescribing beta-blockers, at any dose). That said, beta-blockers are a common medication, and safe for most people, so I would be inclined to suspect that your doctor wouldn’t even be to blame here, you probably had a rare reaction. Bottom line, you shouldn’t be publicly attacking someone who didn’t do anything wrong.

        • S.R says:

          Thank you James and Emily. If you don’t like it, don’t read it I guess.. It’s just a blog where I gather info that’s out there on rosacea, patient experiences, and share my own experiences. Beta blockers are used by many more people with facial flushing. Some have success, some don’t. Some get unacceptable side effects, some don’t. It’s up to any person themselves and their doctors to see if you are a candidate for it and to keep a good eye on your response to such medication. Suing me for saying propranolol helps me?

  3. mariane maher says:

    has anyone tried Zenmed products? i have been for a couple of months and i like it a lot. i use the roseacea products for dry skin and my face is moisturized and smooth.

  4. James says:

    There is an often overlooked instruction in the Mirvaso insert. It is important to wash and dry ones face prior to using Mirvaso. I have found better results and more consistently good results when my patients carefully and thoroughly wash to remove make-up, creams, grime and any environmental agents from their face. If a make-up remover or any persistent soap is used, it should be followed by a clean water rinse and pat dry prior to using Mirvaso. This will improve your results.

  5. George says:

    Come on 10-20% ??? Pretty much every review i have ever read is very negative. I would say 70-80% would be more realistic.

  6. Becky says:

    They do suggest that with any gel or product that you apply to your face that you should apply it to only a 2 cm area, that way if you do have a reaction it is minimal. Every skin is different and I feel for those having bad reactions to this gel. It is tragic that what works for some doesn’t for others.

    However, for myself, it has been a bit of a saviour. I apply it after my face washing routine and if my face is more on the dry side I rub in a little bit of moisturizer over the top of it once it has dried. Some have even suggested mixing it with a hypoallergenic moisturizer prior to applying it.

    Hopefully one day there will be something that we can all use that will wipe this horrendous condition out for good! I value the people that keep trying to pursue this vision though, I know it isn’t easy and a lot of negativity can come from it but the fact that there is someone attempting this endeavor … thank you!

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