lunedì 5 ottobre 2009

Studio Usa e Canada:
il litio carbonato non mostra effetti benefici sulla progressione della Sla
A Randomized Clinical Trial of Lithium Carbonate with Riluzole versus Placebo with Riluzole in ALS Shows No Benefit.
Nel febbraio 2008 il dottor Francesco Fornai ed i colleghi dell'Università di Pisa riportarono in uno studio pilota come il litio carbonato a dosaggi di 300-450 mg al giorno combinato con il riluzolo mostrasse un significativo effetto positivo nelle persone con Sla (Fornai, F., et al., Lithium delays progression of amyotrophic lateral sclerosis. PNAS, 2008.105(6): p. 2052-2057).
Per studiare ulteriormente il litio carbonato come possibile trattamento per la Sla, negli Stati Uniti ed in Canada è stato condotto su pazienti con Sla un trial di litio carbonato con riluzolo vs placebo con riluzolo. In quest'ultimo studio sono stati utilizzati dosaggi simili allo studio italiano. Lo studio americano e canadese è stato condotto dai consorzi Northeast ALS (NEALS) and Canadian ALS (CALS) e sponsorizzato dal National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health, dall'ALS Association e dall' ALS Society of Canada. Tra gli specialisti che hanno condotto lo studio anche i dottori Swati Aggarwal, Lorne Zinman, Jeremy Shefner e Merit Cudkowicz.
Una prima analisi è stata condotta dopo l'arruolamento degli 84 pazienti e presentata lo scorso settembre al NINDS Data and Safety Monitoring Board. Basandosi sui dati da essa ricavati il trial è stato fermato per inutilità.
Questo studio, infatti, non ha mostrato i medesimi effetti benefici del litio carbonato sulla progressione della Sla a differenza del primo studio condotto in Italia. Sebbene i risultati siano deludenti, era molto importante per la comunità dei pazienti Sla, dei loro famigliari e degli studiosi determinare in maniera veloce ed efficace se il benefico molto significativo osservato per il litio una prima volta potesse essere confermato in un trial ben controllato. Grazie alla continua collaborazione e all'impegno assicurato dai pazienti volontari, i ricercatori possono ora focalizzarsi su altri promettenti trial terapeutici destinati ai malati di Sla.
FONTE: ALSA.ORG

1 commento:

Fabio e Fabrizio ha detto...

A Randomized Clinical Trial of Lithium Carbonate with Riluzole versus Placebo with Riluzole in ALS Shows No Benefit.
In February 2008, Dr. Francesco Fornai and colleagues at the University of Pisa, Italy, reported in a pilot study that lithium carbonate at dosages of 300-450 mg daily (titrated to a plasma level of 0.4-0.8 mEq/liter) combined with riluzole showed a large positive effect in people with ALS (Fornai, F., et al., Lithium delays progression of amyotrophic lateral sclerosis. PNAS, 2008.105(6): p. 2052-2057).

To further investigate lithium carbonate as a possible treatment for ALS, a randomized, blinded, multicenter trial of lithium carbonate with riluzole versus placebo with riluzole was conducted in people with ALS in the U.S. and Canada. The study used similar dosing to the Italian study. The study was conducted by the Northeast ALS (NEALS) and Canadian ALS (CALS) Consortia and was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health, The ALS Association and the ALS Society of Canada. This unique collaboration between investigators and funding organizations resulted in a novel study design and expeditious execution of the trial to efficiently answer a critically important clinical question. Study leaders included Drs. Swati Aggarwal, Lorne Zinman, Jeremy Shefner and Merit Cudkowicz.

An interim analysis was conducted after enrollment of the 84th subject and presented to the NINDS Data and Safety Monitoring Board in September 2009. Based on the interim analysis the trial was stopped for futility. This study did not show the same beneficial effect of lithium carbonate on the progression of ALS as the prior pilot study conducted in Italy.

Although the results are disappointing, it was very important for the ALS community to quickly and efficiently determine if the large benefit first observed for lithium could be replicated in a well controlled trial. With the ongoing assistance and commitment of patient volunteers, researchers can now focus on other promising therapeutics for patients with ALS.