title: Efficacy of Mirogabalin (DS-5565) on Patient-Reported Pain and Sleep Interference in Patients with Diabetic Neuropathic Pain: Secondary Outcomes of a Phase II Proof-of-Concept Study.
abstract: OBJECTIVE
  To evaluate the effects of mirogabalin on patient-reported pain and sleep interference in diabetic peripheral neuropathic pain (DPNP).
  
  
  METHODS
  Adults (≥18 years) with type 1 or 2 diabetes, glycosylated hemoglobin of 10% or less at screening, and DPNP for six months or more were eligible for participation.
  
  
  METHODS
  Subjects (N = 452) were randomly assigned (2:1:1:1:1:1:1) to receive placebo, dose-ranging mirogabalin (5, 10, 15, 20, 30 mg/day), or pregabalin (300 mg/day) for five weeks. Secondary efficacy end points studied here included patient global impression of change (PGIC), modified brief pain inventory (BPI), and average daily sleep interference score (ADSIS). Correlation plots were generated to examine the relationship between ADSIS and average daily pain score (ADPS).
  
  
  RESULTS
  At week 5, significant reductions in ADSIS were observed in the mirogabalin 15, 20, and 30 mg/day groups, compared with placebo (P < 0.05). Baseline ADSIS and ADPS were strongly correlated (R2 = 0.4407), as were mean changes from baseline in ADSIS and ADPS at week 5 (R2 = 0.6694). The mirogabalin 30 mg/day group showed significant improvement compared with placebo in four of six BPI subscales at end point; the mirogabalin 15 mg/day group showed significant improvement in three of six BPI subscales (P < 0.05). At end of treatment, the percentage of subject with PGIC status of "much improved or better" was greater in all mirogabalin dose groups than in the placebo group (P < 0.05). A low incidence of treatment-related adverse events was reported for mirogabalin.
  
  
  CONCLUSIONS
  Results support the effectiveness of mirogabalin in improving patient-reported pain and sleep interference in DPNP.
authors.affiliation: Daiichi Sankyo Development Ltd, Gerrards Cross, Buckinghamshire, UK.
authors.forename: Domenico
authors.initials: D
authors.lastname: Merante
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas.
authors.forename: Julio
authors.initials: J
authors.lastname: Rosenstock
authors.affiliation: MMS Holdings Inc, Canton, Michigan.
authors.forename: Uma
authors.initials: U
authors.lastname: Sharma
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, New Jersey.
authors.forename: Karen
authors.initials: K
authors.lastname: Feins
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, New Jersey.
authors.forename: Ching
authors.initials: C
authors.lastname: Hsu
authors.affiliation: The Strelitz Diabetes Center, Eastern Virginia Medical School, Norfolk, Virginia, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Vinik
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D001643:Bridged Bicyclo Compounds / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010147:Pain Measurement; D000069583:Pregabalin / Q000627:therapeutic use; D012890:Sleep / Q000187:drug effects*; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D001643:Bridged Bicyclo Compounds; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; C000598618:mirogabalin
keywords: Mirogabalin; Neuropathy; Neuropathy Clinical Trials; Pain; Secondary Diabetic Complications; Sleep