http://www.mdlinx.com/internal-medicine/medical-news-article/2016/06/10/dextromethorphan-quinidine-pseudobulbar-affect-dementia-brain/6712770/?news_id=881&newsdt=061116&subspec_id=488&utm_source=WeeklyNL&utm_medium=newsletter&utm_content=Weeks-Best-Article&utm_campaign=article-section&category=latest-weekly
In
this open–label study, the physicians aim to assess the effectiveness
of dextromethorphan/quinidine (DM/Q) for pseudobulbar affect (PBA) in
patients with dementia, stroke or traumatic brain injury (TBI). This
research found that DM/Q was an effective and well–tolerated treatment
for PBA secondary to dementia, stroke, or TBI.
Methods
- A total of 367 patients participated with PBA secondary to dementia, stroke, or TBI.
- Participants received DM/Q 20/10 mg twice daily in this open-label, multicenter, 90-day trial.
- The primary outcome was the Center for Neurologic Study-Lability Scale (CNS-LS), assessing change in PBA episode frequency and severity.
- The authors compared the CNS-LS final visit score to baseline (primary analysis) and to the response in a previously conducted placebo-controlled trial with DM/Q in patients with ALS or MS.
- Secondary outcomes included change in PBA episode count and Clinical Global Impression of Change with respect to PBA as rated by a clinician (CGI-C) and by the patient or caregiver (PGI-C).
Results
- Mean (standard deviation [SD]) CNS-LS score improved significantly from 20.4 (4.4) at baseline to 12.8 (5.0) at Day 90/Final Visit (change, -7.7 [6.1]; P < .001, 95 % CI: -8.4, -7.0).
- This magnitude of improvement was consistent with DM/Q improvement in the earlier phase-3, placebo-controlled trial (mean [95 % CI] change from baseline, -8.2 [-9.4, -7.0]) and numerically exceeds the improvement seen with placebo in that study (-5.7 [-6.8, -4.7]).
- Reduction in PBA episode count was 72.3 % at Day 90/Final Visit compared with baseline (P < .001).
- Scores on CGI-C and PGI-C showed that 76.6 and 72.4 % of participants, respectively, were “much” or ”very much” improved with respect to PBA.
- IN this study the most frequently occurring adverse events (AEs) were diarrhea (5.4 %), headache (4.1 %), urinary tract infection (2.7 %), and dizziness (2.5 %); 9.8 % had AEs that led to discontinuation.
- Serious AEs were reported in 6.3 %; however, none were considered treatment related.
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