Evidence map›Paper›PMID 18558791›Full record

ArticleDrug safety2008

Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials.

Martin R Farlow, Stephen M Graham, Gustavo Alva

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
27.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Memantine for autism spectrum disorder.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Amantadine and rimantadine for influenza A in children and the elderly.The Cochrane database of systematic reviews · 2014
    Pooled it
  4. Dementia.BMJ clinical evidence · 2012
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Martin R FarlowDepartment of Neurology, Indiana University School of Medicine, Indianapolis, Indiana 46202-5111, USA. mfarlow@iupui.edu
Stephen M Graham
Gustavo Alva
ATP Clinical Research (United States) · USIndiana University School of Medicine

Funding

Research Education ComponentP30AG010133 · NIA · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI SAYKIN, ANDREW J · 1991 to 2020
$37.3M
NIA NIH HHS P30 AG10133
6 · The paper itself

Abstract

backgroundMemantine, a moderate-affinity, uncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors, is the first non-cholinergic agent approved for the treatment of Alzheimer's disease (AD), and the first medication approved in the US and Europe for the treatment of moderate to severe stages of the disease. The objective of this study was to analyse safety and tolerability data from phase III memantine trials and from the open-label extensions of those trials.

methodWe conducted an analysis of the pooled data for tolerability and safety from six double-blind, placebo-controlled, memantine trials with a minimum duration of 24 weeks (three trials in mild to moderate AD and three in moderate to severe AD; 20 mg/day; 2311 patients) and four open-label extensions of those trials (two in mild to moderate AD and two in moderate to severe AD; 20 mg/day, 1405 patients), for a total treatment period of up to 2 years.

resultsThe analysis revealed that adverse events occurring during both short- and long-term memantine treatment were minimal, and similar in type and frequency to those reported for placebo-treated patients. The most frequently reported adverse events in placebo-controlled trials included agitation (7.5% memantine vs 12.0% placebo), falls (6.8% vs 7.1%), dizziness (6.3% vs 5.7%), accidental injury (6.0% vs 7.2%), influenza-like symptoms (6.0% vs 5.8%), headache (5.2% vs 3.7%) and diarrhoea (5.0% vs 5.6%). Discontinuations due to adverse events were similar in memantine- and placebo-treated groups (8.9% vs 9.8%, respectively).

conclusionConsistent with the favourable tolerability profile of memantine observed in clinical use, this analysis of pooled safety data indicates that both short- and long-term memantine treatment of patients with AD is safe and well tolerated, with an adverse event profile similar to that of placebo.

Indexed as

AgedAlzheimer DiseaseClinical Trials as TopicElectrocardiographyExcitatory Amino Acid AntagonistsFemaleHumansMaleMemantineMiddle AgedReceptors, N-Methyl-D-AspartateExcitatory Amino Acid AntagonistsMemantineReceptors, N-Methyl-D-Aspartate

Identifiers

PMID18558791
OpenAlexW2001206572

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.