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Antipsikotik ilaçlar öldürmeye devam ediyor

Lancet Neurology’nin son sayısında (online) yayınlanan yeni araştırmada antipiskotik ilaçların Alzheimer Hastalığında ölüm oranını iki misli artırdığı ortaya çıktı. Daha önce ABD de (2005) yapılan araştırmalarda benzer sonuçlar alınmasına ve FDA tarafından kara kutu konulmasına rağmen yaşlılarda demans ve Alzheimer hastalığında antipsikotik ilaç kullanımının ölüm riskini artırdığı biline bile kullanılmasına devam edilmekte ve Türkiyede bu ilaçlar, birçok ülkede bu endikasyonlarda kontrendike olmalarına karşın, SGK tarafından bedelleri ödenmekte.

Araştırma 2001-2004 yılları arasında 67-100 yaşlarında, orta ve şiddetli AH hastaları üzerinde yapılmış ve antipsikotik ilaç kullanaların ilaca başladıktan 1 sene veya biraz daha sonra öldüklerini göstermiş. İlaç kullanımına başladıktan iki sene sonra antipsikotik kullananların %54’ü, plasebo (yalancı ilaç) kullananların %29’u ölmüş, 3. Sene sonunda antipiskotik kullanların %70’i ölmüş. Bu çalışmada kullanılan antipsikotikler başta Johnson ve Johnon’un RİSPERDAL’i (risperidon) olmak üzere tioridazin, klorpromazin, haloperidol ve trifluorperazin (STİLİZAN)dir.

The Lancet Neurology, Early Online Publication, 9 January 2009

Editors' note: Antipsychotics do not improve cognitive or neuropsychiatric outcomes in most patients with dementia, and serious concerns have been raised about their side effects in the very old. Increased mortality rate and risk of cerebrovascular events have been reported by previous studies of relatively short duration (usually 12 weeks). In this article, the DART-AD investigators report long-term mortality rates among patients with Alzheimer's disease in residential care after 12-months of neuroleptic treatment, adding to the growing evidence against the use of antipsychotics in this vulnerable population.

The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial

Clive Ballard MD a, Maria Luisa Hanney PhD b, Megan Theodoulou MRCPsych c, Simon Douglas BSc d, Rupert McShane MRCPsych e, Katja Kossakowski BSc a, Randeep Gill MBBS a, Edmund Juszczak MSc f, Ly-Mee Yu MSc f, Robin Jacoby DM c, for the DART-AD investigators

Background
Data from 12-week placebo-controlled trials have led to mounting concerns about increased mortality in patients with Alzheimer's disease (AD) who are prescribed antipsychotics; however, there are no mortality data from long-term placebo-controlled trials. We aimed to assess whether continued treatment with antipsychotics in people with AD is associated with an increased risk of mortality.
Methods
Between October, 2001, and December, 2004, patients with AD who resided in care facilities in the UK were enrolled into a randomised, placebo-controlled, parallel, two-group treatment discontinuation trial. Participants were randomly assigned to continue with their antipsychotic treatment (thioridazine, chlorpromazine, haloperidol, trifluoperazine, or risperidone) for 12 months or to switch their medication to an oral placebo. The primary outcome was mortality at 12 months. An additional follow-up telephone assessment was done to establish whether each participant was still alive 24 months after the enrolment of the last participant (range 24—54 months). Causes of death were obtained from death certificates. Analysis was by intention to treat (ITT) and modified intention to treat (mITT). This trial is registered with the Cochrane Central Registry of Controlled Trials/National Research Register, number ISRCTN33368770.
Findings
165 patients were randomised (83 to continue antipsychotic treatment and 82 to placebo), of whom 128 (78%) started treatment (64 continued with their treatment and 64 received placebo). There was a reduction in survival in the patients who continued to receive antipsychotics compared with those who received placebo. Cumulative probability of survival during the 12 months was 70% (95% CI 58—80%) in the continue treatment group versus 77% (64—85%) in the placebo group for the mITT population. Kaplan—Meier estimates of mortality for the whole study period showed a significantly increased risk of mortality for patients who were allocated to continue antipsychotic treatment compared with those allocated to placebo (mITT log rank p=0•03; ITT p=0•02). The hazard ratio for the mITT group was 0•58 (95% CI 0•35 to 0•95) and 0•58 (0•36 to 0•92) for the ITT population. The more pronounced differences between groups during periods of follow up longer than 12 months were evident at specific timepoints (24-month survival 46% vs 71%; 36-month survival 30% vs 59%).
Interpretation
There is an increased long-term risk of mortality in patients with AD who are prescribed antipsychotic medication; these results further highlight the need to seek less harmful alternatives for the long-term treatment of neuropsychiatric symptoms in these patients.
Funding
UK Alzheimer's Research Trust.