*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 antidiabetic regimen, which could consist of diet alone or no more than 2 agents (2 OADs or insulin + 1 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 CVD and CHF were included in the trial.
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CYCLOSET is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. CYCLOSET may be taken alone or in combination with other medications that also help control blood sugar. CYCLOSET has not been studied in children.
CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.
People who should NOT take CYCLOSET. CYCLOSET should not be taken by patients who take ergot medicines. A healthcare provider or pharmacist can provide a list of these medications. CYCLOSET should not be taken by anyone who is allergic to bromocriptine or any other ingredient of CYCLOSET. Patients with syncopal (fainting) migraine headaches should not take CYCLOSET, because it may cause very low blood pressure. Women who are breastfeeding should not take CYCLOSET. It may prevent them from producing milk. Some breastfeeding women taking bromocriptine, the active ingredient in CYCLOSET, have had strokes.
Warnings for patients taking CYCLOSET. CYCLOSET can cause very low blood pressure (hypotension) and fainting, especially when patients are starting treatment or have increased the dose of CYCLOSET. Patients taking medicines for high blood pressure (hypertension) should be careful when taking CYCLOSET because they may cause blood pressure to drop too much. CYCLOSET may worsen psychotic disorders or reduce the effectiveness of medicines that treat psychosis. CYCLOSET may cause sleepiness. Patients taking CYCLOSET who feel sleepy should not drive a car or operate other heavy machinery until they feel alert. Patients who are taking dopamine antagonist medications should talk to their healthcare provider before taking CYCLOSET. The combined use of these medicines is not recommended.
Safety of CYCLOSET. No antidiabetic drug, including CYCLOSET, has ever been proven to reduce the risk of having a heart attack or other cardiovascular problem such as stroke. However, a 52-week study showed that CYCLOSET did not increase the risk of major cardiovascular events. In clinical studies, the most common side effects that seemed to be caused by CYCLOSET were nausea, fatigue, dizziness, vomiting, and headache.
For full prescribing information, please see CYCLOSET Prescribing Information (Consumers or patients, please refer to section 17.2 on pages 12-13).
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Reference: Data on file, Santarus, Inc.