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Bromocriptine mesylate approved for treatment of type 2 diabetes
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Patients with type 2 diabetes may have a new treatment option: bromocriptine mesylate, a drug that manages blood glucose via brain signals and targets the central nervous system. The drug has been approved by the FDA and will be marketed as Cycloset, according to drug maker VeroScience.
The dopamine receptor agonist is indicated as an adjunct to diet and exercise to improve glycemic control in adults with diabetes. Bromocriptine mesylate is not a new drug — it has been used in different formulations to treat conditions such as Parkinson’s disease.
Thirty-nine percent of patients with type 2 diabetes assigned to bromocriptine mesylate achieved target glycemic control compared with 11% of patients assigned to placebo in the Cycloset Safety Trial, a 52-week, placebo-controlled trial (n=3,070).
The specific mechanism by which bromocriptine mesylate improves glycemic control is not known. Development of this drug for the treatment of type 2 diabetes was based upon preclinical studies that have shown brain dopamine activity to be low in metabolic disease states, which contributes to multiple metabolic dysfunctions such as insulin resistance, according to VeroScience.
“For patients newly diagnosed with type 2 diabetes or those who cannot adequately control their blood sugar with currently available medications, Cycloset provides a completely new approach to treating diabetes,” J. Michael Gaziano, MD, cardiologist and associate professor in the Division of Aging at Brigham and Women’s Hospital, said in a press release. Gaziano was the lead investigator of the Cycloset Safety Trial.
Improvements in glycemic control, adverse events
Clinical data reveal that bromocriptine mesylate was not associated with an increase in adverse cardiovascular outcomes — a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure and revascularization surgery — compared with placebo (HR=0.58; 95% CI, 0.35-0.96).
The most common adverse events associated with bromocriptine mesylate were nausea, fatigue, dizziness, vomiting and headache, according to prescribing information. Clinical trial data reveal that bromocriptine mesylate at doses up to 4.8 mg per day was not associated with a different rate of all-cause adverse events compared with placebo. One example, the incidence of hypoglycemia, was 6.9% among bromocriptine mesylate-treated patients compared with 5.3% of patients receiving placebo.
According to VeroScience, patients with type 2 diabetes should take bromocriptine mesylate within two hours of waking in the morning. An initial daily dose of 0.8 mg should be titrated weekly until a maximum tolerated dose of 1.6 mg to 4.8 mg is achieved.
The daily dose provides a single, brief pulse of dopamine activity shortly after administration. In the morning, the drug improves postprandial glucose without increasing plasma insulin concentrations; improvements in postmeal glycemic control continue several hours after administration.
Bromocriptine mesylate is the first drug that has been approved by the FDA after initiation of new guidelines that require studies to demonstrate that diabetes drugs do not increase CV risk.