On‐demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study

Abstract

BackgroundIn routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief.AimAs IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments.MethodsRome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6.ResultsA total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs.ConclusionsAfter 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.

Single Dose Study Assessing the Pharmacokinetic and Metabolic Profile of Alverine Citrate in Healthy Volunteers

“…Safety data collected during the study permitted to conclude that alverine citrate, administered in single 120 mg dose to healthy volunteers, was very well tolerated. This observation is line with the known good tolerability profile of the molecule, as ascertained in larger clinical studies (Wittmann et al, 2010;Martínez-Vázquez et al, 2012;Ducrotte et al, 2014).…”

“…Clinical efficacy data on alverine alone or in combination with simethicone is freely available (Wittmann et al, 2010;Martínez-Vázquez et al, 2012;Ducrotte et al, 2014). The sparse information regarding the metabolism of alverine available in scientific literature is solely centered on the pharmacokinetics of the parent compound and the active metabolite 4-hydroxy alverine (Gomes et al, 2009;Ghosh et al, 2010;Seelam et al, 2015;Rathod et al, 2017) and is only derived from studies conducted on Indian population, where intra-subject variability of the main pharmacokinetic parameters of the parent compound seems quite low based on the required sample size for successful demonstration of bioequivalence between distinct oral dosage forms.…”

Pharmacologic Agents for Chronic Diarrhea

“…Combined treatment with alverine citrate and simethicone reduces abdominal pain and discomfort in patients with IBS. 41 …”

Anxiolytic-like effects of alverine citrate in experimental mouse models of anxiety

“…Preclinical as well as safety and pharmacokinetic reports from clinical studies have evidenced that AVC is a well tolerable drug with no major side effects (Ducrotte et al, 2014). The undesirable effects reported for AVC include gastrointestinal disturbances, nausea, headache and dizziness, which are feeble and may be resolved on cessation of the treatment (http://www.mhra.gov.…”