Efficacy and safety of nabiximols (sativex®) in clinical practice

• Autores: L. Villamayor Blanco, Leticia Herrero Poch, José Carlos de Miguel Bouzas, María Carmen Freire Vázquez
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 17, Nº. 5, 2015, pág. 2
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Introduction: Nabiximols [delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)] (Sativex® ) was approved in Spain for Multiple Sclerosis (MS) spasticity in 2010. This drug is indicated as a treatment for symptoms of moderate to severe spasticity in MS patients that have not responded correctly to other antispasmodic drugs. The purpose of this study is to evaluate the effectiveness and safety pro-file of the Sativex® in clinical practice as treatment in patients with refractory spasticity in MS, and in patients prescribed Sativex® as an unlicensed medicine in neuropathic and mixed pain, fibromyalgia, spasticity in patients with cerebral palsy and nausea and vomiting induced by cytostatics.

    Method: This retrospective observational evaluated all patients treated with Sativex® in our hospital from the first time the treatment was used in October 200􀀛 up to October 2014. The primary outcome measures were the efficacy of THC:CBD in reducing spasticity, pain and chemotherapy-induced nausea and vomiting and the secondary outcome measures were drug tolerance and side effects. The effectiveness was evaluated based on the prescribing doctor’s analysis of change from baseline in the main spasticity, pain and vomiting/nausea Visual Analogue Scale (VAS) and Patient Global Impression of Change. Responders were defined as those subjects with > 􀂕30􀀈% improvement in mean VAS score from baseline.

    Results: During the study period, 57 patients began treatment with THC:CBD; 35 (6􀀙1.4%􀀈) were female, mean age 53 +􀂓24 years. The reasons for prescribing THC:CBD were spasticity 20 (35%􀀈), fibromyalgia three (5.2%􀀈), neuropathic pain 24 (42.1%􀀈), mixed pain nine (15.7%􀀈) and chemotherapy-induced nausea and vomiting one (1.7%􀀈), that were refractory to the usual treatments.

    Treatment of spasticity and pain with THC:CBD was effective in 􀀛0􀀈 of the patients, with a median optimum maintenance dose of five (2-10) sprays per day. The only patient included in this study with refractory chemotherapy-induced nausea and vomiting achieved a total response (TR = nausea intensity <5 mm visual analog scale, no vomiting/retching, no rescue antiemetic) when he was treated with THC:CBD.

    Twenty-nine (50.8%􀀛􀀈) patients experienced at least one Adverse Event (AE) during the course of the study. The most frequent AE were central nervous system related or gastrointestinal. Most were observed at onset of treatment, and in the majority described as moderate.

    Conclusion: Sativex® is effective in the relief of refractory pain, spasticity and chemotherapy-induced nausea and vomiting when given in addition to existing medication and has an acceptable toxicity profile