P179 A non-interventional, prospective, multicenter study for evaluation of the herbal medicinal product canephron® n use in paediatric outpatient population in russia

Abstract

Background and aimsA non-interventional study (NIS) was performed by Bionorica LLC company to collect data on the use of the herbal medicinal product (HMP) Canephron® N in routine paediatric practice in Russia.MethodsChildren of 1–17 years of age with confirmed diagnoses of urinary system disease and who were prescribed treatment with the HMP participated in the study at 26 polyclinics and out-patient departments. Exclusion criteria comprised hypersensitivity to any components of HMP, unsigned informed consent form, gastric ulcer and duodenal ulcer in the acute stage, participation in another clinical trial simultaneously or during 3 months before enrolment. Observational period included study treatment and follow-up period and was limited to a maximum of 6 weeks. Key parameters were prescribed indications, prescribed/actual treatment regimen, duration of treatment, co-medications, global assessments of HMP effectiveness and tolerability by physician and patient/parent, analysis of Adverse Events/Adverse Drug Reactions (AE/ADR). The NIS was approved by the local ethics committees and conducted with site monitoring by a contract research organisation.Results636 children aged 1–17 years were enrolled and 634 (470 girls) of them comprised Safety Set: 61 in the age of 1–2 years, 227 in 2–5 years, 234 in 6–11 years and 112 in 12–17 years. The main indications for HMP prescription were urinary tract infection (34.1%), pyelonephritis (30.0%), dysmetabolic nephropathy (18.9%), cystitis (11.5%), urolithiasis (4.1%) and nephritis (3.6%). HMP was prescribed for treatment in 307 (48.3%) patients, for prophylaxis in 157 (24.7%) and both for treatment and prophylaxis in 172 (27%) of patients. HMP in oral solution was prescribed in 66.4% of patients and tablets in 33.6%. Any concomitant medication was reported in 61.8% of patients. Effectiveness assessments by physician and patient/parent at visit 2 were ‘good’ and ‘very good’ in 88.2% and 87.9% and at visit 3 in 89.1% and 89.1%, correspondingly. Tolerability assessments as ‘good’ and ‘very good’ at visits 2 and 3 varied from 98.1% to 99.2%. In total, 100 AEs were registered and 5 AEs were evaluated as ADRs (including 1 serious ADR (renal colic)).ConclusionsEffectiveness and good tolerability of the HMP in the treatment and prophylaxis of urinary diseases in children of 1–17 years was confirmed. According to registered safety data, the HMP can be considered safe and well tolerated for children of the studied age.