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Background Niacin has lipid-modifying efficacy and cardiovascular benefit, but is underutilised because of niacin-induced flushing ( NIF). This real-world, prospective, observational study characterised the severity and impact of NIF symptoms among participants who were newly prescribed extended-release ( ER) niacin. Methods Participants were surveyed daily during week 1 of therapy, at weeks 5, 9, 13, and at months 7, 10 and 13. Surveys included the Flushing Symptom Questionnaire ( FSQ), which includes the Global Flushing Severity Score ( GFSS) question, the Flushing Impact Questionnaire ( FIQ) and the Treatment Satisfaction Questionnaire for Medication ( TSQM). Results Overall, 306 participants were enrolled. During week 1, 30.0% of participants reported a maximum GFSS ≥ 4 (moderate or greater). Mean FIQ domain scores increased with increasing flushing severity, primarily driven by the Irritation/Frustration domain. By week 13, only 2.5% of participants had attained a 2 g ER niacin dose. By month 13, 43.5% ( n = 133) had discontinued ER niacin. At discontinuation, only 3.1% of participants had attained the 2 g dose. Over half of the participants who discontinued experienced flushing symptoms: 82% reported moderate to extreme flushing ( GFSS ≥ 4), and 68% reported severe to extreme flushing ( GFSS ≥ 7). Participants who discontinued and had flushing side effects reported high degrees of impact in the FIQ Irritation/Frustration domain, and high dissatisfaction as a result of side effects, as measured by the TSQM. Conclusion In a real-world setting, NIF side effects were bothersome and had an impact on the continuation of therapy. [ABSTRACT FROM AUTHOR]

Background: Niacin is currently the most effective approved agent for raising high-density lipoprotein cholesterol. However, niacin-induced cutaneous flushing (redness, warmth, tingling and/or itching) significantly limits patient acceptance. To further characterize flushing, a patient-reported Flushing Symptom Questionnaire (FSQ) was developed and validated.Methods: The FSQ was validated in an 8-week, randomized, double-blind, placebo-controlled trial of extended-release (ER) niacin and placebo. The primary flushing endpoint of the study was based on the single Global Flushing Severity Score (GFSS), an item within the FSQ, which assesses overall flushing severity on a 0-10 discretized analog scale.Results: A total of 175 patients were randomized to one of four treatment groups (sequences of placebo and ER niacin [given as niacin (NIASPAN) 1 g (N1) and 2g (N2)]. Test-retest reliability and reproducibility coefficients for the single-item GFSS were all above 0.75. Construct validity was supported by moderate to strong correlations (r > 0.5) with other FSQ items. All FSQ item scores and specifically the GFSS discriminated between treatment groups and demonstrated expected relationships with predefined known groups. The GFSS demonstrated high responsiveness in patients who switched from ER niacin to placebo. The ability of the GFSS and GFBS to discriminate changes in flushing symptoms in patients who increased drug dose was less than expected possibly due to accommodation to the flushing effects of niacin over time; differential drop-out due to flushing; and/or FSQ items not being sensitive enough to detect a change that was present.Conclusions: The FSQ items and specifically the Global Flushing Severity Score (GFSS), are reliable and valid measures to assess niacin-induced flushing. [ABSTRACT FROM AUTHOR]