Inpharma 1648 - 26 Jul 2008

Services? However, they point out that the "addition ofTeaching an old dog new tricks:treatment options is good news for patients anddimebolin for Alzheimer’s disease clinicians", and note that further studies will be neededto establish the efficacy of dimebolin, particularly"All is not well in the care and treatment of people withcompared with established treatments.dementia in the UK", states a Lancet Editorial,1 included

in the same issue as a new study of an old drug, * funded by Medivationdimebolin, for Alzheimer’s disease, results of which 1. This unremembered state. Lancet 372: 177, No. 9634, 19 Jul 2008.appear promising. In this editorial, it is noted that in the 2. Doody RS, et al. Effect of dimebon on cognition, activities of daily living,

behaviour, and global function in patients with mild-to-moderate Alzheimer’sUK, only £11 is spent on research for every patient withdisease: a randomised, double-blind, placebo-controlled study. Lancet 372:dementia, compared with around £300 per patient for 207-215, No. 9634, 19 Jul 2008.

3. Burns A, et al. Dimebon in Alzheimer’s disease: old drug for new indication.cancer – and that the wait for effective drugs "leaves theLancet 372: 179-180, No. 9634, 19 Jul 2008.emphasis on sustaining health, activity, and

801099761independence in those at risk of dementia".

However, there may be some hope for patients whohave already developed mild-to-moderate Alzheimer’s,in the form of dimebolin, an old, non-selectiveantihistamine. In a double-blind study conducted at11 sites in Russia,* 183 such patients were randomisedto receive oral dimebolin 20 mg three times daily orplacebo for 6 months, with 134 patients continuing toreceive blinded treatment for an additional 6 months.2

Patient outcomes at week 26Dimebolin Placebo

(n = 89) (n = 94)

Outcome measures (mean change from baseline):ADAS-cog –1.9 2.1MMSE 1.8 –0.5ADCS-ADL 1.3 –2.0NPI –1.0 2.5CIBIC-plus 3.7 4.3

ADAS-cog: Alzheimer’s disease assessment scale - cognitive subscaleMMSE: mini mental state examinationADCS-ADL: Alzheimer’s disease cooperative study - activities of dailylivingNPI: neuropsychiatric inventoryCIBIC-plus: clinician’s interview-based impression of change pluscaregiver input

At 6 months, dimebolin treatment was associatedwith significant improvements on all five outcomemeasures [see table]. Furthermore, this benefit overplacebo was still seen at the end of 12 months, with awidening drug-placebo difference over time.Importantly, these between-group differences were notdriven by worsening function among placebo recipients.

Dimebolin was well tolerated in this study, with nodifferences between dimebolin and placebo recipientsin terms of number of patients with adverse events. Themain between-group differences were higher rates ofdry mouth and of depressed mood/depression indimebolin recipients (18% vs 1% and 15% vs 5%,respectively, at 1 year). However, dimebolin wasassociated with fewer serious adverse events thanplacebo (3% vs 12%).

Discussing this study, Alistair Burns (University ofManchester, UK) and Robin Jacoby (University ofOxford, UK), question the ethics of conducting such aplacebo-controlled trial, given that there are establishedtreatments available.3 However, they note that, inRussia, such treatments are only available to those whocan afford them; does this make it ethical? They pointout that this raises the question of whether placebo-controlled trials are now ethical in England and Wales inpeople with mild Alzheimer’s, in whom antidementiadrugs are now unavailable on the National Health

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