title: Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain: results from a German observational study.
abstract: OBJECTIVE
  This study aimed to compare the effectiveness of duloxetine (DLX) and the anticonvulsants pregabalin (PGB) and gabapentin (GBP) for the treatment of diabetic peripheral neuropathic pain (DPNP) in routine clinical care.
  
  
  METHODS
  Data from a 6-month, noninterventional study involving 2575 patients in whom treatment of DPNP was initiated with or changed to DLX, PGB, or GBP (n=1523) were analyzed post hoc; patients treated with other medications or combinations were excluded from this analysis. Propensity scoring was used to compare patient groups, assessing Brief Pain Inventory (BPI), Clinical and Patient Global Impression (CGI/PGI), the Hospital Anxiety and Depression Scale (HADS), the Sheehan Disability Scale (SDS), and the Short Form Health Survey (SF 12).
  
  
  RESULTS
  Mean median daily dosage over 6 months was 53.9 mg for DLX (N=931), 173.5 mg for PGB (N=248), and 727.8 mg for GBP (N=351). BPI average pain severity (last observation carried forward, mean [SD]) decreased by 2.3 [2.30] points for DLX patients, and by 1.9 [2.22] in PGB, and 1.1 [2.15] in GBP patients. This difference remained statistically significant (DLX vs. PGB: P=0.029; DLX vs. GBP: P<0.001) after adjustment by propensity scores. Similar findings were also seen for the BPI interference score, CGI and PGI, the HADS anxiety score, the HADS depression score.
  
  
  CONCLUSIONS
  When compared with DLX, the low doses of PGB and GBP used in this noninterventional study might have contributed to the lower effectiveness found for both anticonvulsants in the treatment of patients with DPNP.
authors.affiliation: *Medical Department, Health Technology Appraisal Group †Regional Medical Affairs ‡Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg §Klinik und Poliklinik für Neurologie, Johannes Gutenberg Universität, Mainz ∥Institute for Clinical Diabetology, German Diabetes Center, Leibniz Institute for Diabetes Research, Heinrich Heine University ¶Department of Endocrinology and Diabetology, University Hospital, Düsseldorf, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Happich
authors.forename: Edith
authors.initials: E
authors.lastname: Schneider
authors.forename: Frank G
authors.initials: FG
authors.lastname: Boess
authors.forename: Stefan
authors.initials: S
authors.lastname: Wilhelm
authors.forename: Alexander
authors.initials: A
authors.lastname: Schacht
authors.forename: Frank
authors.initials: F
authors.lastname: Birklein
authors.forename: Dan
authors.initials: D
authors.lastname: Ziegler
mesh_terms: D000368:Aged; D000588:Amines / Q000627:therapeutic use*; D000700:Analgesics / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D000068736:Duloxetine Hydrochloride; D005260:Female; D000077206:Gabapentin; D005858:Germany; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D000069583:Pregabalin; D011446:Prospective Studies; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D013876:Thiophenes; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D000068736:Duloxetine Hydrochloride