Quick-release (QR) bromocriptine is a well tolerated and effective therapy for Type 2 diabetes and is not associated with increased cardiovascular (CV) risk, report researchers.

Bromocriptine, a D2 dopamine receptor agonist, is used to treat conditions such as pituitary tumors and Parkinson’s disease. It has recently been shown to significantly reduce glycated hemoglobin (HbA1c) levels by around 0.5% and is now indicated for treatment of patients with Type 2 diabetes.

However, previous studies have been underpowered to assess cardiovascular safety of the drug. To test the overall safety and tolerability of bromocriptine for treatment of Type 2 diabetes, J Michael Gaziano (Harvard Medical School, Boston, Massachusetts, USA) and colleagues randomly assigned 3095 patients with Type 2 diabetes in a 2:1 fashion to take QR bromocriptine (titrated to a maximum of 4.8 mg/day) or placebo, both in addition to their usual diabetes therapy, for a period of 52 weeks.

All adverse events were assessed, with a particular focus on CV disease events - including a combined endpoint of myocardial infarction, stroke, coronary revascularization, and hospitalization for angina or congestive heart failure.

As reported in the journal Diabetes Care, 89% of the bromocriptine group and 83% of the placebo group reported some form of adverse events. In addition, 176 (8.6%) people in the bromocriptine group reported serious adverse events and 98 (9.6%) in the placebo group.

The combined CV disease endpoint was reported by 37 (1.8%) of the bromocriptine group compared with 32 (3.2%) of the placebo group.

The most commonly reported bromocriptine associated adverse event was nausea, reported in 7.6% of the bromocriptine treated patients compared with only 1.0% of the placebo group.

“Nausea was the chief limiting adverse event in this trial. For the majority of patients experiencing nausea, the symptoms occurred during the initial titration of the drug and lasted less than 2 weeks,” write the authors.

“Bromocriptine-QR represents a new treatment modality for Type 2 diabetes,” conclude Gaziono et al. “This first-in-class therapy may provide a new approach to addressing the comorbidities associated with Type 2 diabetes.”

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