Santarus and VeroScience Announce Publication of AACE Expert Panel Recommendations for CYCLOSET ^® (bromocriptine mesylate) for the Management of Type 2 Diabetes

Experts conclude that favorable cardiovascular profile of CYCLOSET suggests it may be useful in the treatment of patients with type 2 diabetes with significant risk factors or history of cardiovascular disease

SAN DIEGO & TIVERTON, R.I.–(BUSINESS WIRE)– Santarus, Inc. (NAS: SNTS) and VeroScience, LLC today announced publication of a review article and recommendations of an American Association of Clinical Endocrinologists (AACE) expert panel on the role of bromocriptine-QR in the management of type 2 diabetes. The panel concluded that treatment with CYCLOSET^® (bromocriptine mesylate), also referred to as bromocriptine-QR, may be useful in the treatment of patients with type 2 diabetes, both early and late in the life cycle of the disease, and especially for patients with a history of cardiovascular disease or who have significant risk factors for cardiovascular disease. The article, titled The Role of Bromocriptine-QR in the Management of Type 2 Diabetes Expert Panel Recommendations will appear in print form in the January/February issue of Endocrine Practice, a peer-reviewed medical journal published by AACE, and can be found in the online edition of the journal at http://aace.metapress.com/home/main.mpx.

The expert panel also made the following observations and recommendations:

• CYCLOSET has a novel mechanism of action that appears to involve enhancement of morning central nervous system dopaminergic activity, which is reduced in obese individuals with type 2 diabetes. This improvement can potentially lead to improved insulin sensitivity and reduced hepatic glucose output.
• Adjunctive administration of CYCLOSET in the dosing range of 1.6 mg/day to 4.8 mg/day may result in a mean reduction in A1c levels of 0.69% (95% Confidence Interval: 0.97%, 0.41%).
  • A 24-week completer analysis performed among efficacy subgroups of patients from the CYCLOSET safety study stratified based on the patient’s baseline A1c levels (≥7.5 to <8.0 versus 8.0 to 8.5 versus ≥8.5).(Vinik et al, Endo. Practice Vol18, p 931-943, 2012) yielded the following results: in the subgroup treated with metformin (with or without another oral hypoglycemic agent), treatment with bromocriptine-QR was associated with a significantly higher proportion of subjects achieving a Week 24 A1c level ≤7 compared with placebo when baseline A1c levels were ≥7.5 to <8.0 or 8.0 to 8.5 (47% versus 4% and 42% versus 6%, respectively). In the subgroup treated …read more
    Source: FULL ARTICLE at DailyFinance