Cycloset (Bromocriptine) Finally on the Shelves at Your Pharmacy

More than a year after the U.S. Food and Drug Administration approved Cycloset (bromocriptine mesylate) for treatment of type 2 diabetes, it’s now available at pharmacies.  I updated my brief  bromocriptine drug review of May 14, 2009.

I assume it’s the same bromocriptine that’s been available for years to treat Parkinson’s disease and acromegaly.  Parlodel for Parkinson’s is sold as 2.5 and 5 mg tablets; Cycloset is 0.8 mg.  [Update December 3, 2010: Cycloset is not the same formulation of bromocriptine used to treat other diseases.  See first comment below.]  

Steve Parker, M.D.

7 Comments

Filed under Drugs for Diabetes

7 responses to “Cycloset (Bromocriptine) Finally on the Shelves at Your Pharmacy

  1. Dear Dr. Parker,

    Thank you for updating the community on Cycloset. However, I wanted to provide some clarification about Cycloset. Although the parent compound in Cycloset is bromocriptine the formulation is uniquely different from traditional formulations of bromocriptine. A close inspection of the package insert of Cycloset vs. traditional formulations reveals one significant difference in that the absorption efficiency of Cycloset is 2-3 times greater than traditional formulations of bromocriptine. The unique formulation was created to provide a discrete interval of drug circulating levels to mimic the naturally occurring peak of dopamine activity that is present in the non-diabetic, insulin sensitive person. There is no therapeutic substitution for Cycloset as there is no other formulation that provides the same blood circulating levels which are essential to how this therapy improves metabolism.

    Here is an abstract of a recent review of Cycloset:
    Diabetes Obes Metab. 2010 Dec;12(12):1048-57. doi: 10.1111/j.1463-1326.2010.01304.x.
    Bromocriptine: old drug, new formulation and new indication.
    Holt RI, Barnett AH, Bailey CJ.
    Endocrinology and Metabolism Sub-division, Developmental Origins of Adult Health and Disease Division, University of Southampton School of Medicine, Southampton, UK. righ@soton.ac.uk
    Abstract
    Bromocriptine is an ergot alkaloid dopamine D(2) receptor agonist that has been used extensively in the past to treat hyperprolactinaemia, galactorrhoea and Parkinsonism. It is known that hypothalamic hypodopaminergic states and disturbed circadian rhythm are associated with the development of insulin resistance, obesity and diabetes in animals and humans. When administered in the early morning at the start of the light phase, a new quick release (QR) formulation of bromocriptine appears to act centrally to reset circadian rhythms of hypothalamic dopamine and serotonin and improve insulin resistance and other metabolic abnormalities. Phase II and III clinical studies show that QR-bromocriptine lowers glycated haemoglobin by 0.6-1.2% (7-13 mmol/mol) either as monotherapy or in combination with other antidiabetes medications. Apart from nausea, the drug is well tolerated. The doses used to treat diabetes (up to 4.8 mg daily) are much lower than those used to treat Parkinson’s disease and have not been associated with retroperitoneal fibrosis or heart valve abnormalities. QR-bromocriptine (Cycloset™) has recently been approved in the USA for the treatment of type 2 diabetes mellitus (T2DM). Thus, a QR formulation of bromocriptine timed for peak delivery in the early morning may provide a novel neurally mediated approach to the control of hyperglycaemia in T2DM.

  2. Many thanks for the clarification and additional information, Dr. Scranton. I stand corrected.
    -Steve

  3. Joe Melcher

    I have been using cycloset for about 2 months now , I went up to dosing of 4 pills but found little difference in my sugars between 3 and 4 pills. The drug does leave you with a low appetite . I did find myself eating smaller meals as my use of he drug increased and found the slight stomach discomfort if I ate a larger meal. I am already on a regiment of exercise. I also find my mood to more positive and an increase in energy since I started using the drug. I am trying to see if I can wean myself off of my glybutrin/metformin over time . I have not been successful as of yet but my glucose between meals has started to come down faster and with in normal tolerances .
    I hope this helps I am pretty proactive in my treatment and have tried many of the new drugs this has helped so far. I think that since it has altered my eating patterns this has help keep my glucose under better control.

  4. Edward Sooy

    I was just prescribed cycloset and am doing some research. My first impression is the high price compounded by the dose adjustment by pill quantity not size. It seems that Veroscience is manipulating price to the patient’s detriment. My second impression is that QR concentrates the medication at first light to match the circadian rhythm. Why then can not a higher dose of bromocryptine ( say 5 mg) be taken at first light to reduce A1C; or does such a dose increase risk of cardiovascular side affects?

    • Hi, Edward.
      My sense is that we have very limited studies looking at bromocriptine as a treatment for diabetes. The manufacturer has to stay within the prescribing guidelines allowed by the US Food and Drug Administration. For what it’s worth, I run across very few patients (none yet, actually) using it for diabetes.
      -Steve

  5. Barb Barton

    I have been on Cycloset for a few months now and have found it to be quite effective at lowering by blood sugars. I am on the 6 pills a day and find them very easy to swallow in one dose. My A1C went from an 8.9 to a 6.9 in three months. I think this drug is a life saver. I too would like to be weaned off the other diabetic meds Metformin and Glipizide. The side effects are nausea and very tired. They are tolerable and compared to the results are well worth it! It seems they have subsided somewhat as time goes by. I too have had a better mood since being on this new drug. Very costly even on insurance.