The Retrospective observational study ESAC (Effective and Sustainable Analgesia: Choice)

A.Е. Karateev, Ye.Yu. Pogozheva, A.M. Lila, V.N. Amirdzhanova, E.S. Filatova

V.A. Nasonova Research Institute of Rheumatology, Moscow

Diclofenac potassium sachet (DPS, Dialrapid) — a new analgesic agent intended for the rapid suppression of intense acute pain.

Aim: DPS efficacy and safety evaluation in patients with acute (less than 14 days) intense musculoskeletal pain in real clinical
practice.

Patients and Methods: 7300 histories analysis was conducted in which the information on results of the 3-day DPS administration in patients with osteoarthritis (OA) and/or nonspecific low back pain (NLBS) experiencing acute intense pain was presented. The severity of pain was assessed on the Numerical Pain Rating Scale (NPRS), where 0 points corresponded to the pain absence, and 10 points — unbearable pain. The study included patients with pain intensity NLT 7 points according to the NPRS. The study group was represented by 57.5% women and 42.5% men, average age — 51.96 ±14.72 years. DPS was prescribed 50 mg 3 times a day. Pain dynamics, general health condition and functional disorders, as well as the number and characteristics of adverse events (AE) were assessed by NPRS.

Results: the number of patients with improvement ≥50%, 20% — 50% and <20% related to pain intensity was 58.7%, 33.2% and 8.0%, respectively; in relation to general health condition —55 .9%, 32.5% and 11.9%, respectively; in relation to functional disorders — 51.3%, 33.6% and 15.0%, respectively. The pain reduction probability ≥50% was lower in subjects older than 65 years — odds ratio (OR) 0.865 (95% confidence interval, CI 0.773–0.968), p=0.012; with a body mass index ≥30 kg/m²— OR 0.738 (95% CI 0.656–0.830), p<0.001; diagnosed with OA — OR 0.713 (95% CI 0.648–0.785), p<0.001. Gastralgia and dyspepsia were observed in 12.1% of patients, arterial hypertension — in 5.9%, and edema — in 0.9%. No serious AE were reported.

Conclusion: DPS is an effective and fairly safe agent for acute intense musculoskeletal pain.

Keywords: NSAIDs, osteoarthritis, nonspecific low back pain, analgesic drug therapy, diclofenac potassium sachet, efficacy, safety.

For citation: Karateev A.Е., Pogozheva Ye.Yu., Lila A.M. et al. The Retrospective observational study ESAC (Effective and Sustainable Analgesia: Choice). RMJ. 2019;9:62–66.