Alflutop Russian longitudinal multicentre observational study: preliminary results (message 1)

Abstract

Evaluation of the effect of new drugs should be carried out in randomized controlled trials (RCTs), and observational studies (OSs) are carried out to confirm and refine the results obtained in RCTs, for example, to study the effectiveness of drugs in large groups of patients who were not included in RCTs or had comorbidities or older age.Objective: to evaluate the effectiveness of Alflutop (AF) via OS of patients with osteoarthritis (OA) of the knee and/or hip joints and/or low back pain (LBP) with or without comorbid diseases.Material and methods. A multicenter prospective cohort OS was conducted in 163 clinical centers in 58 cities of the Russian Federation and included 22,525 patients with OA and LBP who received AF as a part of a planned treatment prescribed by a doctor, or self-prescribed and purchased in a pharmacy. Pain, satisfaction with therapy, health assessment, need for non-steroidal anti-inflammatory drugs (NSAIDs), and quality of life were recorded using the EQ-5D questionnaire.Results and discussion. After one treatment course with AF, improvement was detected in 98% of cases, there was a rapid positive trend with a significant decrease in pain, the median time to clinical effect was 8 [5; 10] days. Assessment of general health status and satisfaction with therapy improved significantly. In 94.5% of patients, the daily requirement for NSAIDs decreased.Conclusion. The first results from the OS confirm the symptomatic effect of AF.

Keywords

• osteoarthritis
• alflutop
• observational study
• efficiency
• safety