2-week efficacy and tolerability of flupirtine MR and diclofenac in patients with acute low/back pain--results of a post-hoc subgroup analysis of patient-level data from four non-interventional studies

• Published in: MMW Fortschritte der Medizin 2013-12, Vol.155 Suppl 4, p.115-123
• Main Authors: Uberall, M A, Essner, U, Müller-Schwefe, G H H
• Format: Article
• Language: ger
• Subjects: Acute Disease; Adult; Aged; Aminopyridines - adverse effects; Aminopyridines - therapeutic use; Analgesics - adverse effects; Analgesics - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Back Pain - drug therapy; Delayed-Action Preparations; Diclofenac - adverse effects; Diclofenac - therapeutic use; Evidence-Based Medicine; Female; Germany; Humans; Male; Middle Aged; Pain Measurement - drug effects; Retrospective Studies
• ISSN: 1438-3276

Current restrictions in use of flupirtine-containing medicines for a maximum of 14 days endorsed by the European Medicines Agency were followed by uncertainty/ambiguity of its analgesic efficacy for the treatment of acute low/back pain. Post-hoc selection of patient-level data from non-interventional studies with flupirtine MR and diclofenac with respect to patient age (> or = 18 years), duration of treatment (14 +/- 2 days), indication (acute/subacute low/back pain) and first-line use. Primary endpoint: average 24-hr. pain intensity; secondary endpoints: pain-related disabilities in daily life, 30/50/70% response with respect to pain and pain-related restrictions, frequency of untoward side effects/treatment emergent adverse events. 318/31 patients treated with flupirtine MR/diclofenac fulfilled the inclusion criteria for this subgroup analysis. Starting from comparable demographic and baseline characteristics both treatments were followed by significant effects (p < 0.001). Subgroup comparisons revealed superior effects for flupirtine MR vs. diclofenac for pain relief (p = 0.001), improvement of pain-related restrictions in daily life (p = 0.023), and gastrointestinal/overall tolerability (p < 0.001). Even for short-term use in patients suffering from muscle-related acute low/back pain, flupirtine MR is superior effective and tolerated compared with the nsaid diclofenac.