Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial.
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.
Paolini
J F
JF
Merck Research Laboratories, Rahway, NJ 07065, USA. john_paolini@merck.com
Mitchel
Y B
YB
Reyes
R
R
Thompson-Bell
S
S
Yu
Q
Q
Lai
E
E
Watson
D J
DJ
Norquist
J M
JM
Sisk
C McCrary
CM
Bays
H E
HE
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
D003692:Delayed-Action Preparations; D014665:Vasodilator Agents; D009525:Niacin