JNNP: Nabiximo drug suspension rate in patients with multiple sclerosis, an 18-month multi-center study.

Treatment options for MS spasms include pharmacological and non-pharmacological strategies.
anti-spasm drugs such as baclofen (oral), d'Anturin, tezzanidine, gaba spraying/prebarin, etc., were ineffective.
other treatments, such as botulinum toxin injections and intra-pyrofen injections, have been shown to be more effective but have limited use.
, a significant number of patients do not respond adequately to standard treatment or have adverse reactions, especially long-term use and high doses.
studies have shown that about one-third of patients do not respond fully to spasm therapy.
a significant proportion of patients and doctors are not fully satisfied with common anti-spasm drugs.
's recent launch of oral mucous membrane spray (Sativex) in the Italian market is another treatment for MS patients, and randomized clinical trials and observational studies conducted in routine clinical practice confirm that oral mucous membrane spray is an effective and well-to-resistant option for treating drug-resistant MS spasms.
over a six-month observation period, 39.5 percent of patients were suspended due to reduced efficacy or adverse events (AE).
addition, most patients stopped treatment within the first three months.
: Between January 2015 and June 2018, 32 MS centers collected data on all patients from the AIFA Sativex e-registration website.
ALL MS patients who met AIFA inclusion/exclusion criteria were included in the study queue.
data on spasm evolution and MS physical disability are available from the 0-10 NRS patient score scale (0 s no, 10 s maximum spasms) and the Extended Disability Scale (EDSS), respectively.
0-10 NRS is a patient assessment indicator used to evaluate MS spasms in a number of studies.
, in particular, NRS percentage changes (%) have been shown to be an effective and reliable indicator of outcomes in clinical trials of anticonvulsant drugs.
demographic and clinical data, tolerance, daily dose (daily suction), cause of suspension and stop date are collected through the patient's medical records.
, data were collected on adverse events and serious adverse events that occurred during the observation period.
, data on NRS values and the percentage of patients who stopped at each point in time were analyzed.
all this data is manually entered into a temporarily created database.
: After a four-week trial period (T1), 1,502 patients (81.4 percent in 1845) had NRS improvement of 20 percent (IR), while 814 patients (40.2 percent of 1845) had an average NRS improvement of 30 percent (CRR), with an average NRS score of 26.9 percent lower from baseline to T1.
after an 18-month observation period, only IR patients were considered, and 727 patients (48.3 percent of 1502 patients) stopped treatment.
, the reasons for stopping the drug during the observation period were a decrease in efficacy (n s 426, or 28.4% of 1502), adverse events (n s 256,17.1%), and non-compliance with medical advice (n s 256,17.1%)n s 8.0.5%), disappears during follow-up (n s 6.0.4%), the patient's autonomous choice (n s 5,0.3%) or unknown (n s 24.16%).
recorded the highest rates of drug suspension in T2 and T3, while the proportion of patients who interrupted THC from TH4 to T5 tended to decline slightly in the CBD.
main reasons for drug suspension were "loss of efficacy" in 164 and 139 patients in T2 and T3, respectively.
in T4 and T5, 86 and 47 patients had AEs, respectively, which was the cause of the interruption of THC: CBD treatment.
: Our results confirm that oral mucous membrane sprays (Sativex) are an effective option and an additional treatment with good long-term tolerance and safety in patients who do not fully respond to conventional spasm medications.
, special efforts should be made to improve communication between patients and doctors in order to achieve a common view of the therapeutic goals of oral mucous membrane sprays (Sativex) and strategies to achieve them.
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