title: [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].
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.forename: M A
authors.initials: MA
authors.lastname: Uberall
authors.forename: U
authors.initials: U
authors.lastname: Essner
authors.forename: G H H
authors.initials: GH
authors.lastname: Müller-Schwefe
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000631:Aminopyridines / Q000009:adverse effects / Q000627:therapeutic use*; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001416:Back Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D012189:Retrospective Studies
chemical_list: D000631:Aminopyridines; D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D004008:Diclofenac; C034161:flupirtine