Hormonal treatment with vigabatrin beats infantile spasms faster
medwireNews: Combining hormonal treatment and vigabatrin is significantly more effective at stopping infantile spasms than hormonal treatment alone, ICISS study findings indicate.
The International Collaborative Infantile Spasms Study conducted in 102 hospitals in five countries showed that, after starting treatment, 15% more patients taking combination therapy than hormonal therapy were spasm free on and between days 14 and 42. And the median response time was 2 versus 4 days.
“This study suggests a modality of treatment that will stop spasms faster and in more children than has previously been achieved with existing treatment strategies,” say Finbar O’Callaghan (Institute of Child Health, University College London, UK) and colleagues.
“It will therefore potentially lessen the long-term detrimental impact of this devastating epileptic encephalopathy on both developmental outcomes and future epilepsy control in this population.”
Between 2007 and 2014, 377 infants aged 2–14 months with clinically diagnosed infantile spasms were randomly assigned to receive hormonal therapy (up to 20 mg prednisolone three times a day or up to 0.75 mg tetracosactide depot on alternate days) with or without vigabatrin up to 150 mg/kg per day.
Spasms stopped between days 14 and 42 in 72% of 186 infants taking combined therapy, compared with 57% of 191 infants on hormonal therapy alone, a significant difference.
And this favorable treatment effect remained significant after adjustment for developmental impairment and type of hormonal treatment, giving an odds ratio of 2.1.
The best response to combination therapy, at 88%, was seen among infants considered at low risk for developmental impairment, which is “remarkable” say the researchers, “given the perceived difficulty in treating this disorder.”
High risk of developmental impairment was the only other single variable independently associated with outcome, at an odds ratio of 0.4.
Combination therapy also resulted in a shorter time to cessation of spasms, by 2 days, and more infants achieving electroclinical response, at 66% versus 55%.
The researchers note inThe Lancet Neurology that adverse reactions are a clinically significant problem with both types of treatment, and severe adverse reactions did occur in 33 patients overall, but the numbers were similar for both groups.
The most common severe adverse effects were infections or movement disorders that prompted dose reductions, and there were no deaths attributed to treatment.
“This study represents a clinically relevant step forward in the treatment of infantile spasms,” acknowledges Raili Riikonen (Kuopio University Hospital, Finland) in a related comment.
She adds: “Although many clinicians will consider these results when deciding on a therapy schedule for infantile spasms, others will want to wait until the long-term data—including the frequency of spasm relapse and cognitive outcomes—regarding these intensive treatments are available,” she predicts.
By Lucy Piper
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