Galantamin (Reminyl®) nützt Patienten mit leichtgradiger Alzheimer-Krankheit und deren Angehörigen

Zusammenfassung

Studienziel: Die Studie untersucht die Wirksamkeit und Sicherheit der Behandlung einer Alzheimer-Krankheit mit Galantamin (Reminyl®) unter besonderer Berücksichtigung der sekundären Effekte auf die betreuenden Angehörigen. Methode: In einer multizentrischen, offenen, einarmigen Studie wurden Patienten mit leicht- bis mittelgradiger Alzheimer-Krankheit nach NINCDS-ADRDA-Kriterien 26 Wochen mit Galantamin behandelt. Hauptzielkriterium war die Responderrate (Besserung oder Stabilisierung) im kognitiven Teil der Alzheimer's Disease Assessment Scale (ADAS-cog). Als sekundäre Wirksamkeitsparameter wurden die Tätigkeiten des täglichen Lebens (Bayer-ADL), das neuropsychiatrische Inventar (NPI), der klinische Gesamteindruck (CGI) sowie die Belastung der betreuenden Person (NPI und General Health Questionnaire [GHQ]) untersucht. Ergebnisse: Es wurden 245 Patienten (145 Frauen, 100 Männer) mit einem mittleren Alter von 72 Jahren (Bereich 48 - 94) behandelt. Nach den ICD-10-Kriterien lag bei 91,8 % der Patienten ein leichter Schweregrad der Demenz vor. Knapp zwei Drittel der Patienten erhielten maximal 16 mg, ein Drittel 24 mg Galantamin. Die Responderrate in der ADAS-cog lag bei 70,2 % (95 %-Konfidenzintervall: 64,1 - 75,9 %). Im Mittel verbesserte sich die ADAS-cog von anfangs 24,0 ± 10,0 nach 6-monatiger Behandlung um 1,9 ± 6,6 Punkte. Die Responderraten für die Bayer-ADL, das NPI und die CGI lagen bei 50,0 %, 68,6 % und 83,3 %. Für die betreuende Person betrugen die Responderraten bezüglich der Belastung im NPI 70,6 % und im GHQ 77,6 %. Die Behandlung mit Galantamin wurde im Allgemeinen gut vertragen. Die häufigsten unerwünschten Ereignisse waren Übelkeit, Schwindel und Kopfschmerzen. Ein Therapieabbruch wegen unerwünschter Ereignisse erfolgte bei 9 % der Patienten. Schlussfolgerung: Mit Galantamin kann eine leicht- bis mittelgradige Alzheimer-Krankheit über mindestens 6 Monate erfolgreich und sicher behandelt werden. Die positiven Effekte der Behandlung der Patienten mit Galantamin spiegeln sich in der Entlastung der Angehörigen wider.

Abstract

Aim: In this study efficacy and safety of treating Alzheimer's disease with galantamine (Reminyl®) was investigated under special consideration of secondary effects on caregivers. Methods: In a multicentre, open, one-arm study patients with mild to moderate Alzheimer's disease according to NINCDS-ADRDA criteria were treated with galantamine for 26 weeks. Main efficacy criterion was the responder rate (improvement or stabilization) in the cognitive part of the Alzheimer's Disease Assessment Scale (ADAS-cog). Secondary efficacy parameters were activities of daily living (Bayer-ADL), the neuropsychiatric inventory (NPI), the clinical global impressions (CGI) as well as the burden on caregivers (NPI and General Health Questionnaire [GHQ]). Results: A total of 245 patients (145 women, 100 men) with a mean age of 72 years (range 48 - 94) were treated. According to the ICD-10 criteria, 91.8 % of patients suffered from dementia of mild degree. In almost two thirds of patients the maximum daily dose was 16 mg galantamine and it was 24 mg in one third. The responder rate on the ADAS-cog was 70.2 % (95 %-confidence interval: 64.1 % to 75.9 %). On average, the score on the ADAS-cog improved from initially 24.0 ± 10.0 by 1.9 ± 6.6 points after six months of treatment. Responder rates for Bayer-ADL, NPI and CGI were 50.0 %, 68.6 % and 83.3 %, respectively. With regard to the caregiver's burden, responder rates were 70.6 % in the NPI and 77.6 % in the GHQ. In general, treatment with galantamine was well tolerated. The most frequently reported adverse events were nausea, dizziness and headache. Treatment was prematurely terminated because of adverse events in 9 % of patients. Conclusions: Treatment of mild to moderate Alzheimer's disease with galantamine is successful and safe for at least six months. The positive effects of treatment on the patient are reflected in a reduction of the caregiver's burden.

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