Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial

J F Paolini, Y B Mitchel, R Reyes, S Thompson-Bell, Q Yu, E Lai, D J Watson, J M Norquist, C McCrary Sisk, H E Bays, J F Paolini, Y B Mitchel, R Reyes, S Thompson-Bell, Q Yu, E Lai, D J Watson, J M Norquist, C McCrary Sisk, H E Bays

Abstract

Introduction: 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.

Trial registration: ClinicalTrials.gov NCT00533676.

Figures

Figure 1
Figure 1
Study design. Patients were randomised to one of four treatment sequence groups, represented by the group designations shown at the end of each sequence. The group designations represent the treatment received during the Initiation, Maintenance I and Maintenance II Phases of the study respectively. N1 = extended-release niacin 1 g; N2 = extended-release niacin 2 g; P = placebo
Figure 2
Figure 2
The Flushing Symptom Questionnaire©
Figure 3
Figure 3
Maximum Global Flushing Severity Score in first study week (Initiation Phase). p

Figure 4

Percentage of patients with ‘moderate…

Figure 4

Percentage of patients with ‘moderate or greater’ flushing (Global Flushing Severity Score ≥…

Figure 4
Percentage of patients with ‘moderate or greater’ flushing (Global Flushing Severity Score ≥ 4) by day in the first 7 days of treatment

Figure 5

Percentage of days with Global…

Figure 5

Percentage of days with Global Flushing Severity Score of moderate or greater, by…

Figure 5
Percentage of days with Global Flushing Severity Score of moderate or greater, by treatment group and study week (mean ± standard error)
Figure 4
Figure 4
Percentage of patients with ‘moderate or greater’ flushing (Global Flushing Severity Score ≥ 4) by day in the first 7 days of treatment
Figure 5
Figure 5
Percentage of days with Global Flushing Severity Score of moderate or greater, by treatment group and study week (mean ± standard error)

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Source: PubMed

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