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HOME > Epilessia focale farmaco-resistente, ribadita l'efficacia di pregabalin add-on da nuova revisione Cochrane
Epilessia focale farmaco-resistente, ribadita l'efficacia di Pregabalin add-on da nuova revisione Cochrane
Pregabalin, quando usato come farmaco aggiuntivo per l'epilessia focale resistente al trattamento, è significativamente più efficace del placebo nel produrre una riduzione delle crisi del 50% o superiore e libertà dalle crisi. L'efficacia è crescente per dosi da 150 mg/die a 600 mg/die, con efficienza crescente a dosi di 600 mg, tuttavia sono stati riscontrati problemi di tollerabilità a dosi più elevate. Sono le conclusioni di una versione aggiornata di una revisione Cochrane su tema, di recente pubblicazione.
Pregabalin, quando usato come farmaco aggiuntivo per l'epilessia focale resistente al trattamento, è significativamente più efficace del placebo nel produrre una riduzione delle crisi del 50% o superiore e libertà dalle crisi. L'efficacia è crescente per dosi da 150 mg/die a 600 mg/die, con efficienza crescente a dosi di 600 mg, tuttavia sono stati riscontrati problemi di tollerabilità a dosi più elevate. Sono le conclusioni di una versione aggiornata di una revisione Cochrane su tema, di recente pubblicazione.
«Circa un terzo delle persone colpite da epilessia continua ad avere convulsioni nonostante il trattamento farmacologico» premettono gli autori, guidati da Mariangela Panebianco, del Dipartimento di Farmacologia Clinica e Molecolare all’Istituto di Medicina Traslazionale dell’Università di Liverpool. Pregabalin, come è noto, è uno dei nuovi farmaci antiepilettici che sono stati sviluppati per migliorare gli outcome.
Questa versione aggiornata di una revisione Cochrane pubblicata nel 2014 comprende tre nuovi studi e ha come obiettivo valutare l'efficacia e la tollerabilità di pregabalin quando usato come trattamento aggiuntivo per l'epilessia focale resistente ai farmaci.
Metodi della ricerca, criteri di selezione, raccolta dati e tipo di analisi
«Per questo ultimo aggiornamento abbiamo cercato nel Cochrane Register of Studies (CRS Web), che include il Cochrane Epilepsy Group Specialized Register e il Cochrane Central Register of Controlled Trials (CENTRAL) in data 5 luglio 2018, su MEDLINE (Ovid, 1946-5 luglio 2018 ), ClinicalTrials.gov (5 luglio 2018) e la World Health Organization International Clinical Trials Registry Platform (ICTRP, 5 luglio 2018)» spiegano.
Inoltre, abbiamo «contattato Pfizer Ltd, produttore di pregabalin, per identificare gli studi pubblicati, non pubblicati e in corso». Gli autori hanno incluso studi controllati randomizzati (RCT) che hanno confrontato pregabalin con placebo o un farmaco antiepilettico alternativo come componente aggiuntivo per persone di qualsiasi età con epilessia focale resistente ai farmaci.
«I trial in doppio cieco e in singolo cieco erano ammissibili per l'inclusione» specificano Panebianco e colleghi. «L'outcome primario era una riduzione del 50% o maggiore della frequenza delle crisi; gli outcome secondari erano la libertà da crisi, l'interruzione del trattamento per qualsiasi motivo, l'interruzione del trattamento a causa di effetti avversi e la quota di soggetti con effetti avversi».
Due autori di revisioni hanno selezionato e valutato in modo indipendente le prove di ammissibilità e i dati estratti. Le analisi erano intention-to-treat. «Abbiamo presentato i risultati come rapporti di rischio (RR, risk ratio) e rapporti di probabilità (OR, odds ratio) con intervalli di confidenza al 95% (IC). Due autori della revisione hanno valutato gli studi inclusi per il rischio di bias usando lo strumento "Rischio di bias" di Cochrane» specificano i ricercatori.
I risultati principali
Nella revisione sono stati inclusi nove RCT sponsorizzati dall’industria (3.327 partecipanti). Sette trial hanno confrontato pregabalin con placebo. Per l'outcome primario, i partecipanti randomizzati a pregabalin avevano significativamente più probabilità di ottenere una riduzione del 50% o maggiore della frequenza delle crisi rispetto al placebo (RR 2,28, IC 95% da 1,52 a 3,42, 7 studi, 2.193 partecipanti, prove di scarsa certezza).
Le probabilità di risposta sono raddoppiate con un aumento della dose da 300 mg/die a 600 mg/die (OR 1,99, IC 95% 1,74-2,28), indicando una relazione dose-risposta. Pregabalin era significativamente associato alla libertà di convulsioni (RR 3,94, IC 95% da 1,50 a 10,37, 4 studi, 1.125 partecipanti, prove di moderata certezza).
I partecipanti avevano significativamente più probabilità di interrompere il trattamento per qualsiasi motivo con pregabalin rispetto al placebo (RR 1,35, IC 95% da 1,11 a 1,65, 7 studi, 2.193 partecipanti, prove di moderata certezza) e per effetti avversi (RR 2,65, IC al 95% da 1,88 a 3,74, 7 studi, 2.193 partecipanti, prove di moderata certezza).
Tre studi hanno confrontato pregabalin con tre farmaci di controllo attivo: lamotrigina, levetiracetam e gabapentin. I partecipanti assegnati a pregabalin avevano significativamente più probabilità di ottenere una riduzione del 50% o maggiore della frequenza delle crisi rispetto a quelli assegnati a lamotrigina (RR 1,47, IC 95% da 1,03 a 2,12, 1 studio, 293 partecipanti) ma non rispetto a quelli assegnati a levetiracetam (RR 0,94 , IC 95% da 0,80 a 1,11, 1 studio, 509 partecipanti) o a gabapentin (RR 0,96, IC 95% da 0,82 a 1,12, 1 studio, 484 partecipanti).
«Non abbiamo trovato differenze significative tra pregabalin e lamotrigina (RR 1,39, IC 95% da 0,40 a 4,83) per la libertà dalle crisi, tuttavia, un numero significativamente inferiore di partecipanti ha raggiunto la libertà dalle convulsioni con pregabalin in add-on rispetto a levetiracetam (RR 0,50, IC 95% da 0,30 a 0,85)» proseguono gli autori. Non sono stati riportati dati per questo risultato per pregabalin contro gabapentin.
«Non abbiamo trovato differenze significative tra pregabalin e lamotrigina (RR 1,07, IC 95% da 0,75 a 1,52), levetiracetam (RR 1,03, IC 95% da 0,71 a 1,49) o gabapentin (RR 0,78, IC al 95% da 0,57 a 1,07) per l'interruzione del trattamento per qualsiasi motivo o per effetti avversi (pregabalin contro lamotrigina: RR 0,89, IC 95% da 0,53 a 1,48; contro levetiracetam: RR 1,29, IC 95% da 0,66 a 2,54; contro gabapentin: RR 1,07, IC al 95% da 0,54 a 2,11)» specificano Panebianco e colleghi.
Atassia, vertigini, sonnolenza, aumento di peso e affaticamento erano significativamente associati a pregabalin. «Abbiamo valutato il rischio complessivo di bias negli studi inclusi come basso o non chiaro a causa della possibilità di bias di pubblicazione e della mancanza di dettagli metodologici forniti» scrivono gli autori. «Abbiamo inoltre valutato la certezza delle prove da molto bassa a moderata usando l'approccio GRADE».
I messaggi chiave
«I partecipanti che assumevano pregabalin avevano una probabilità più che doppia di avere una frequenza di convulsioni ridotta del 50% o più durante un periodo di trattamento di 12 settimane rispetto a quelli che assumevano placebo, e avevano quasi quattro volte più probabilità di essere completamente privi di convulsioni» sintetizzano Panebianco e colleghi.
Inoltre, «pregabalin ha dimostrato di essere efficace in un intervallo di dosi (da 150 mg a 600 mg), con efficacia crescente a dosi più elevate. Vi è stata anche una maggiore probabilità di interruzione del trattamento con pregabalin».
«Gli studi inclusi in questa revisione sono stati di breve durata e sono necessari studi a più lungo termine per informare il processo decisionale clinico» specificano infine gli autori.
Scritto da Arturo Zenorini su Pharmastar
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