Once-Daily Dosing of Memantine in Alzheimer's Disease as Safe as Twice-Daily Dosing: Presented at ECNP

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Title: Once-Daily Dosing of Memantine in Alzheimer's Disease as Safe as Twice-Daily Dosing: Presented at ECNP
URL: http://www.pslgroup.com/dg/22A97E.htm
Doctor's Guide
September 3, 2008

By Judith Moser, MD

BARCELONA, Spain -- September 3, 2008 -- The safety and tolerability of a once-daily memantine regimen are at least as good as those of the twice-daily regimen in patients with Alzheimer's disease (AD), according to a pooled safety analysis presented here at the 21st European College of Neuropsychopharmacology Congress (ECNP).

"Memantine was first launched on the basis of twice-daily dosing," explained study presenter Roy Jones, MD, The Research Institute for the Care of Older People, Royal United Hospital, Bath, United Kingdom, at a poster presentation on September 2. "However, for older patients it is much simpler if we give the drug once a day."

In their analysis, Dr. Jones and colleagues compared the safety profiles of memantine QD and BID dosing regimens for the treatment of patients with AD.

The analysis was performed in a pooled population of patients with mild to severe AD from 5 randomised, double-blind studies, in which the participants received memantine at a fixed daily dose of 20 mg, either QD or BID, using 1-step or 3-step titration regimens.

Safety comparisons were made between the QD and the BID groups across the whole treatment period (titration plus maintenance phase) in 592 patients and during the titration phase only in 808 patients. The researchers also compared the results in the memantine QD and placebo groups in 641 patients.

The main outcome measure was the clinical incidence and relevance of treatment-emergent adverse events.

Across the whole study period, the incidence of treatment-emergent adverse events was similar in the QD and the BID groups (70.7% and 70.4%, respectively).

The most commonly reported treatment-emergent adverse events in the QD group were nasopharyngitis (7.3%) and falls (6.5%); and in the BID group they were urinary tract infections (9.4%) and falls (9.0%).

Medically-relevant differences in the incidences of adverse events between the 2 groups did not occur.

Overall, the QD group had a lower incidence than the BID group of serious treatment-related adverse events (9.8% vs 17.9%), fatal serious events (1.1% vs 2.7%), and events leading to treatment discontinuation (7.0% vs 9.4%).

In the analysis of the titration-phase-only patients, the researchers found a slightly lower overall incidence of treatment-related adverse events in the QD group than in the BID group (35.7% vs 41.3%).

As for the placebo-controlled population, the incidence of treatment-related adverse events was similar to that of the placebo group (77.3% vs 76.2%); the nature of the events was also similar across groups.

"Memantine is generally well tolerated, but the once-daily dosing regimen does not seem to cause any problems and should make the treatment simpler for the patients," Dr. Jones concluded.

Funding for this study was provided by Merz Pharma.

[Presentation title: Safety Comparison of Once-Daily vs Twice-Daily Memantine for the Treatment of Alzheimer's Patients: A Pooled Analysis. P5a006]

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