7:05AM Santarus and VeroScience announce publication of AACE expert panel recommendations for CYCLOSET; 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 (SNTS) 15.33 : Co 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.
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%. 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 yielded the following results: in the subgroup treated with metformin, 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.
The large (n=3,070) placebo-controlled 12-month safety study provides the most detailed and systematic information on the long-term tolerability of CYCLOSET in the treatment of type 2 diabetes. Nausea was the most common adverse event (32.2%), and was associated with premature study discontinuation in 7.6% of patients
