Long-term efficacy and safety of neridronate treatment in patients with complex regional pain syndrome type 1

Varenna M, Gatti D, Zucchi F, Crotti C, Braga V, Iolascon G, Frediani B, Nannipieri F, Rossini M.
Long-term efficacy and safety of neridronate treatment in patients with complex regional pain syndrome type 1: a pre-specified, open-label, extension study.
Ther Adv Musculoskelet Dis. 2022 Dec 19;14:1759720X221142274. doi: 10.1177/1759720X221142274.

Abstract

Background: No data on the permanent and curative effect of bisphosphonate treatment in patients with complex regional pain syndrome type-1 (CRPS-1) are currently available. The aim of this pre-specified, open-label, observational study was to evaluate the long-term efficacy and safety of neridronate treatment.

Design: A pre-specified, open-label, extension study.

Methods: Patients treated with intramuscular (IM) placebo in the double-blind phase of the study were assigned to 100 mg intravenous (IV) neridronate treatment administered 4 times over 10 days. These patients, together with those previously treated with 400 mg IM neridronate, were followed for 1 year. Efficacy was assessed using a visual analogue scale (VAS) pain score. Changes in clinical signs and symptoms, quality of life (QoL) using the Short Form Health Survey (SF-36), and the McGill Pain Questionnaire were also assessed.

Results:

Benefits on pain, clinical and functional measures were maintained and further improved over 12 months in most patients treated with neridronate administered either IM or IV. In IM-treated patients, the percentage of those defined as responders (VAS score reduction ≥ 50%) progressively increased up to day 360 to 32 of 35 patients (91.4%). Among the 27 patients referred to as responders at the end of the double-blind phase, 26 reported the same result at day 360 (96.3%). In IV-treated patients, a responder rate of 88% (22 out 25) was found at day 360 (p = 0.66 between groups). Consistent improvements were also observed for all clinical signs and functional questionnaire. No drug-related adverse events were reported during the study.

Conclusion: In patients with acute CRPS-1, the benefit in pain, clinical, and functional measures observed a few weeks after neridronate treatment administered either IM or IV is maintained and further improved over 12 months. Parenteral neridronate induces permanent disease remission preventing chronic pain and motor dysfunction.

Associazione Italiana per lo Studio del Dolore ETS
Email: info@aisd.it 
Pec: associazionestudiodolore@pec.it
Sede legale: Via Tacito 7 - 00193 Roma
Codice Fiscale 80027230483 -  P.IVA: 14600111000


Articoli, notizie, comunicati possono essere inviati a: redazione@aisd.it

Per informazioni riguardanti le iscrizioni: soci@aisd.it

 

L'Associazione Italiana per lo Studio del Dolore è il capitolo italiano dell'International Association for the Study of Pain IASP® e della European Pain Federation EFIC®

      

Realizzazione Geniomela.it