November - 3 - 2009
Quick-release bromocriptine mesilate (Cycloset[TM]), a dopamine D2 agonist, was approved by the FDA earlier this year for the treatment of type 2 diabetes. In the Cycloset Safety Trial, 3,070 type 2 diabetes patients were randomized to bromocriptine or placebo in addition to usual diabetes treatment, with the study period lasting 52 weeks. Analysis of data from the 79 patients who were failing thiazolidinedione therapy at baseline showed that the addition of bromocriptine to treatment led to large reductions in HbA1c which persisted throughout the trial. Fasting plasma glucose was also reduced. The between-group difference in HbA1c was significant for patients with baseline HbA1c of at least 7.5% (-0.5%) and for those with baseline HbA1c of at least 8.0% (-0.7%). The greatest benefit appeared to accrue to patients with the least control at baseline. Weight also decreased in bromocriptine-treated patients and increased in the placebo group. It was also noted that, in the overall study population, bromocriptine was associated with a significant reduction in blood pressure compared to placebo, which may have played a role in the 40% reduction in cardiovascular event rate seen in bromocriptine-treated patients in this trial (Scranton, R. et al. 20th World Diabet Congr (Oct 18-22, Montreal) 2009, Abst D-0770).
Quick-release bromocriptine mesilate (Cycloset[TM]), a dopamine D2 agonist, was approved by the FDA earlier this year for the treatment of type 2 diabetes. In the Cycloset Safety Trial, 3,070 type 2 diabetes patients were randomized to bromocriptine or placebo in addition to usual diabetes treatment, with the study period lasting 52 weeks. Analysis of data from the 79 patients who were failing thiazolidinedione therapy at baseline showed that the addition of bromocriptine to treatment led to large reductions in HbA1c which persisted throughout the trial. Fasting plasma glucose was also reduced. The between-group difference in HbA1c was significant for patients with baseline HbA1c of at least 7.5% (-0.5%) and for those with baseline HbA1c of at least 8.0% (-0.7%). The greatest benefit appeared to accrue to patients with the least control at baseline. Weight also decreased in bromocriptine-treated patients and increased in the placebo group. It was also noted that, in the overall study population, bromocriptine was associated with a significant reduction in blood pressure compared to placebo, which may have played a role in the 40% reduction in cardiovascular event rate seen in bromocriptine-treated patients in this trial (Scranton, R. et al. 20th World Diabet Congr (Oct 18-22, Montreal) 2009, Abst D-0770).