Comparative analysis of edaravone add-on versus riluzole alone in amyotrophic lateral sclerosis

Suhasini Dehury; Chetna Kaushik; Ashok Kumar Mallik; Vedvyas Mishra

doi:10.18203/2319-2003.ijbcp20263768

Authors

Suhasini Dehury Department of Pharmacology, S.C.B. Medical College and Hospital, Cuttack, Odisha, India
Chetna Kaushik Department of Pharmacology, S.C.B. Medical College and Hospital, Cuttack, Odisha, India; Rare Diseases, Novo Nordisk India Pvt. Ltd., India
Ashok Kumar Mallik Department of Neurology, S.C.B. Medical College and Hospital, Cuttack, Odisha, India
Vedvyas Mishra Department of Pharmacology, S.C.B. Medical College and Hospital, Cuttack, Odisha, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20263768

Keywords:

ALS, ALSFRS-R score, Edaravone, Riluzole, ICER

Abstract

Background: Amylotropic Lateral Sclerosis (ALS) is a neurodegenerative progressive disorder affecting the motor neurons with a prevalence of 5 per 100000 population in India. Riluzole, a presynaptic glutamate receptor blocker, was the only treatment available for last 20 yrs. Recently Edaravone, a free radical scavenger, was approved in 2017 by FDA for its neuroprotective behaviour in ALS and is being used as an add-on drug. This study was undertaken to analyse the add-on beneficial effects of Edaravone with Riluzole in ALS patients and compare it with patients on Riluzole alone.

Methods: A prospective, analytical, hospital-based study of 2 years in duration was conducted in the Department of Pharmacology and Neurology, S.C.B. MCH, Cuttack. All adult patients diagnosed with ALS (based on neurogenic pattern with spontaneous activity in EMG) were included in the study. One study group received Riluzole orally alone while the other group received Edaravone IV infusion along with Riluzole. Efficacy was assessed using ALSFRS-R score, evaluated at baseline and at the end of each month till 6 months. Causality assessment was done by using the WHO-UMC Causality assessment scale and severity assessment was done using Modified Hartwig and Seigel severity scale. Cost effective analysis was done by calculating ICER (Increamental cost effective ratio).

Results: Each group had 70 study subjects with similar baseline characters. There was no significant difference observed studying the baseline characteristics. The ALSFRS-R scores were assessed for 6 months which showed deterioration. Mean ALSFRS-R score significantly decreased by – 5.12 and – 8.87 in Gr A and B respectively at the end of 6 months. A total of 80 ADRs were recorded in the study subjects which were of mild severity.

Conclusions: Edaravone add-on significantly improved functions in ALS patients in comparison to Riluzole alone therefore, it may be prescribed to ALS patients to reduce the disease progression.

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