Area Editoriale
Dopo i dati del recente studio ASCEND-III (vedi citazione in questa area tematica) , una rianalisi degli studi ASCEND-I ed ASCEND-II fornisce un ulteriore (parziale) elemento a favore dell'utilità dell'utilizzo di alti dosaggio di mesalazina orale nella colite ulcerosa in fase attiva. Quando confrontato al dosaggio di 2,4 gr/die (attualmente indicato come il dosaggio standard dalla maggior parte delle linee-guida) un dosaggio di 4,8 gr/die si è dimostrato in grado indurre la remissione clinica (e il miglioramento clinico) dopo 2 sole settimane di terapia in una percentuale significativamente superiore di pazienti. Si conferma in ogni caso che il proseguimento della terapia fino a 6 settimane è necessario per ottenere percentuali totali di remissione soddisfacenti, e nessuna informazione viene fornita su eventuali differenze di efficacia dei due regimi a 6 setttimane
Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther 2011; 33: 1028-1035
SUMMARY: Background Rapid resolution of rectal bleeding and stool frequency are important goals for ulcerative colitis therapy and may help guide therapeutic decisions. Aim To explore patient diary data from ASCEND I and II for their relevance to clinical decision making. Methods Data from two randomised, double-blind, Phase III studies were combined. Patients received mesalazine (mesalamine) 4.8 g/day (Asacol 800 mg MR) or 2.4 g/day (Asacol 400 mg MR). Time to improvement or resolution of rectal bleeding and stool frequency was assessed and the proportion of patients experiencing symptom improvement or resolution at day 14 evaluated using survival analysis. Symptoms after 14 days were compared to week 6. A combination of prespecified and post hoc analyses were used. Results Median times to resolution and improvement of both rectal bleeding and stool frequency were shorter with 4.8 g/day than 2.4 g/day (resolution, 19 vs. 29 days, P = 0.020; improvement, 7 vs. 9 days, P = 0.024). In total, 73% of patients experienced improvement in both rectal bleeding and stool frequency by day 14 with 4.8 g/day, compared to 61% with 2.4 g/day. More patients achieved symptom resolution by day 14 with 4.8 g/day than 2.4 g/day (43% vs. 30%; P = 0.035). Symptom relief after 14 days was associated with a high rate of symptom relief after 6 weeks. Conclusions: High-dose mesalazine 4.8 g/day provides rapid relief of the cardinal symptoms of moderately active ulcerative colitis. Symptom relief within 14 days was associated with symptom relief at 6 weeks in the majority of patients. Day 14 is a practical timepoint at which response to treatment may be assessed and decisions regarding therapy escalation made.