Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study
Francesca Clerici1, Nicola Vanacore, Antonietta Elia
1Centre for Research and Treatment on Cognitive Dysfunctions, University of Milan, "L. Sacco" Hospital, Milan, Italy. francesca.clerici1@unimi.it
Background:
Postmarketing surveillance studies (PMS) are an important tool for evaluating a drug's effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimer's disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association criteria has been conducted to date.
Objective:
The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice.
Methods:
A total of 451 patients with moderately-severe-to-severe AD (mean age 77 +/- 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response ('no deterioration' and 'improvement'), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs).
Results:
At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia.
Conclusion:
The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.
Insights
This study found memantine effective for Alzheimer's disease (AD) in real-world settings, with outcomes similar to clinical trials. Safety and tolerability were also comparable, supporting its use in broader patient populations.
Area of Science:
- Neuroscience
- Pharmacology
- Geriatrics
Background:
- Postmarketing surveillance studies (PMS) are crucial for assessing drug efficacy and safety in clinical practice.
- No prior PMS has evaluated memantine monotherapy for moderately-severe-to-severe Alzheimer's disease (AD) using specific diagnostic criteria.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of memantine in treating moderately-severe-to-severe Alzheimer's disease (AD).
- To assess memantine's tolerability and identify adverse events in a clinical practice setting.
Main Methods:
- A postmarketing surveillance study involving 451 patients with moderately-severe-to-severe AD receiving memantine monotherapy (10 mg twice daily).
- Effectiveness was measured by 'no deterioration' and 'improvement' criteria after 6 months, using standardized scales (CGIC, MMSE, NPI, ADL).
- Safety was assessed by the frequency and type of adverse events (AEs).
Main Results:
- After 6 months, 26.8% of patients showed no deterioration, and 3.8% showed improvement.
- Early response at 3 months predicted a higher likelihood of response at 6 months (aOR=8.54).
- 15.5% of patients experienced at least one AE, with 8.6% discontinuing treatment due to AEs; behavioral symptoms were common.
Conclusions:
- Memantine's effectiveness in this PMS mirrors findings from randomized clinical trials.
- The rate of treatment discontinuation due to adverse events was comparable to previous trial data.
- This study supports the transferability of memantine's efficacy and tolerability into routine clinical practice for Alzheimer's disease patients.
Related Concept Videos
01:22Alzheimer's Disease: Treatment
01:26Alzheimer's Disease: Overview
The clinical diagnosis of AD hinges on the presence of memory and other cognitive impairments. Biomarkers, such as changes in Aβ and tau...
01:30Cognitive Enhancers: Cholinesterase Inhibitors and NMDA Receptor Antagonists
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:24Parkinson's Disease: Treatment
Parkinson's Disease is primarily a result of the loss of dopaminergic neurons in the substantia nigra pars compacta. The cornerstone of its...