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New Long-Term Study Suggests Lower Mortality in Alzheimer's Patients Treated with Galantamine Versus Placebo
Date:12/5/2012

activity may also be a manifestation of Alzheimer's disease. In clinical trials, there was no increase in the incidence of convulsions with galantamine HBr compared with placebo.

Pulmonary conditions

Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Deaths in subjects with mild cognitive impairment (MCI)

In controlled trials in elderly subjects with MCI, 13 subjects on RAZADYNE® (n=1026) and 1 subject on placebo (n=1022) died of various causes. About half of the RAZADYNE® deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE® and RAZADYNE® ER are not indicated for the treatment of MCI.

Hepatic or renal impairment

In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE® or RAZADYNE® ER in patients with severe hepatic impairment or severely impaired renal function (Cl cr < 9 mL/min) is not recommended.

Most common Adverse Events

The most common adverse events in clinical studies occurring at rate of at least 5% and at least twice that of placebo at the recommended maintenance dose of either 16 or 24 mg/day under conditions of every 4 week dose escalation for each 8-mg increase were nausea, vomiting, diarrhea, anorexia, and weight decrease.

About Janssen Research & Development, LLC

At Janssen Research & Development, LLC, we are united and energized by one mission—to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time. As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science
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