CYCLOSET (bromocriptine mesylate) Included in American Association of Clinical Endocrinologists Comprehensive Diabetes Management Algorithm
CYCLOSET is recommended for dual therapy for patients with entry HbA1c ≥ 7.5%
- For patients with entry hemoglobin A1c (HbA1c) ≥ 7.5%, the AACE algorithm recommends dual therapy to include CYCLOSET as one option in combination with metformin or another first-line agent.
- CYCLOSET is also listed as a treatment option for patients that need triple therapy and for those patients without symptoms that present with an HbA1c > 9.0%.
In support of the new treatment algorithm, AACE provides a matrix profiling attributes of several anti-diabetes medications. The matrix highlights the demonstrated cardiovascular safety profile of CYCLOSET and provides a "neutral" rating for CYCLOSET for hypoglycemia, weight gain, renal function, congestive heart failure and bone loss, and a "moderate" rating for GI effects.
"Choosing appropriate therapies for patients with type 2 diabetes is challenging and must be individualized based on a number of patient risk factors. CYCLOSET is an interesting and useful therapy, both because of its beneficial impact on HbA1c and the fact that in clinical testing it was not associated with increased risk for adverse cardiovascular events,"* according to
"We believe that the addition of CYCLOSET to the AACE comprehensive diabetes management algorithm will increase awareness and exposure for CYCLOSET with endocrinologists and other physicians who as of yet may not prescribe it for their adult patients with type 2 diabetes," said
Important Safety Information
CYCLOSET is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CYCLOSET is contraindicated in:
- Patients with known hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in CYCLOSET.
- Patients with syncopal migraine. Bromocriptine increases the likelihood of a hypotensive episode among patients with syncopal migraine. Loss of consciousness during a migraine may reflect dopamine receptor hypersensitivity. CYCLOSET is a dopamine receptor agonist, and may, therefore, potentiate the risk for syncope in these patients.
- Women who are nursing their children. CYCLOSET may inhibit lactation. There are postmarketing reports of stroke in this patient population although causality has not been proven.
Warnings and Precautions
- Hypotension: Can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking anti-hypertensive medications. Assess orthostatic vital signs prior to initiation of CYCLOSET and periodically thereafter. Advise patients during early treatment to avoid situations that could lead to injury if syncope was to occur.
- Psychosis: May exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended.
- Somnolence: May cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.
- Interaction with dopamine antagonists: Concomitant use with dopamine antagonists such as neuroleptic agents may diminish the effectiveness of both drugs. Concomitant use is not recommended.
- Other dopamine receptor agonists: Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications. Concomitant use is not recommended.
- Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with CYCLOSET or any other anti-diabetes drug. CYCLOSET does not increase the risk of macrovascular events.
In controlled clinical trials, adverse reactions reported in ≥5% of patients treated with CYCLOSET and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache.
Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.
- May increase the unbound fraction of highly protein-bound therapies, altering their effectiveness and safety profiles.
- May increase ergot-related side effects or reduce ergot effectiveness for migraines if co-administered within 6 hours of ergot-related drugs.
- Extensively metabolized by CYP3A4. Use caution when co-administering strong inhibitors, inducers, or substrates for CYP3A4.
The Important Safety Information does not include all the information needed to use CYCLOSET safely and effectively. See Full Prescribing Information for CYCLOSET for additional information, available at www.cycloset.com or by contacting
*Findings from a 52-week, 74-center, randomized placebo-controlled trial to evaluate the safety of CYCLOSET. 3,070 patients were randomized 2:1 to add either CYCLOSET or placebo, respectively, to their current anti-diabetes regimen, which could consist of diet alone or no more than two agents; two oral anti-diabetes (OAD) medications or insulin + one OAD. Inclusion criteria: age 30-80, BMI < 43 kg/m2, diagnosis of type 2 diabetes of > 6 months with an A1c ≤10.0% with no lower A1c boundary. Patients with a history of cardiovascular disease and congestive heart failure were included in the trial.
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