title: Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial.
abstract: BACKGROUND
  Niacin is underutilised because of flushing. Lack of a quantitative tool to assess niacin-induced flushing has precluded the objective evaluation of flushing associated with extended-release (ER) niacin formulations. We developed the Flushing Symptom Questionnaire((c)) (FSQ), a quantitative tool to assess patient-reported flushing, and assessed its ability to characterise ER niacin-induced flushing.
  
  
  METHODS
  This study focused on the responses to one question in the FSQ, the Global Flushing Severity Score (GFSS), reported on a 0-10 scale (none = 0, mild = 1-3, moderate = 4-6, severe = 7-9 and extreme = 10) to assess flushing during ER niacin initiation (week 1) and maintenance (weeks 2-8).
  
  
  RESULTS
  Flushing severity with ER niacin was greatest during week 1 and remained greater than placebo for the study duration. During weeks 2-8, 40% of patients on ER niacin vs. 8% of those on placebo had > 1 day/week with 'moderate or greater' GFSS.
  
  
  CONCLUSIONS
  In conclusion, the GFSS component of the FSQ was a sensitive and responsive quantitative measure of ER niacin-induced flushing that will aid in the objective comparison of novel strategies intended to improve tolerability and adherence to niacin, an agent proven to reduce cardiovascular risk.
authors.affiliation: Merck Research Laboratories, Rahway, NJ 07065, USA. john_paolini@merck.com
authors.forename: J F
authors.initials: JF
authors.lastname: Paolini
authors.forename: Y B
authors.initials: YB
authors.lastname: Mitchel
authors.forename: R
authors.initials: R
authors.lastname: Reyes
authors.forename: S
authors.initials: S
authors.lastname: Thompson-Bell
authors.forename: Q
authors.initials: Q
authors.lastname: Yu
authors.forename: E
authors.initials: E
authors.lastname: Lai
authors.forename: D J
authors.initials: DJ
authors.lastname: Watson
authors.forename: J M
authors.initials: JM
authors.lastname: Norquist
authors.forename: C McCrary
authors.initials: CM
authors.lastname: Sisk
authors.forename: H E
authors.initials: HE
authors.lastname: Bays
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D005260:Female; D005483:Flushing / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D014665:Vasodilator Agents; D009525:Niacin