PHARMACY

Study: Increased dosage of Plavix may not help patients with ACS

BY Alaric DeArment

PARIS Patients with acute coronary syndrome didn’t fare better when receiving increased doses of a popular cardiovascular drug than those receiving the standard dose, according to a new study.

Bristol-Myers Squibb announced Monday the results of the 25,087-patient CURRENT-OASIS 7 trial, designed to determine whether ACS patients taking Plavix (clopidogrel) plus aspirin benefited when taking 600 mg of the drug the first day, followed by 150 mg doses for the next six days and 75 mg doses for the remaining 22 days. The standard dosing regimen comprises a 300 mg dose on the first day, followed by 75 mg doses for the next 29 days.

Overall, patients taking the increased dosage did not experience a significant reduction in heart attack, stroke or cardiovascular death after 30 days, but 70% of patients, who had received a type of heart surgery called percutaneous coronary intervention early on, did experience a 15% reduction in the risk of heart attack, stroke or cardiovascular death. Meanwhile, there was a 42% relative reduction in risk of blood clots forming around stents, metal mesh devices used to prop open narrowed arteries.

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PHARMACY

Japanese drug maker permitted to start clinical trials of diabetes drug

BY Alaric DeArment

OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.

Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.

The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.

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FDA rejects application for new epilepsy drug

BY Alaric DeArment

TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.

Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.

J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.

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