Page last updated: 2024-10-23

aspirin and Flushing

aspirin has been researched along with Flushing in 25 studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Flushing: A transient reddening of the face that may be due to fever, certain drugs, exertion, or stress.

Research Excerpts

ExcerptRelevanceReference
"Novel regimens of niacin and aspirin, including orally dissolved aspirin, were effective in reducing niacin-induced flushing in a small sample of healthy adult volunteers."9.24Randomized controlled trial of different aspirin regimens for reduction of niacin-induced flushing. ( Banka, SS; Kaafarani, H; Lee, J; Levine, A; Lin, H; Thachil, R, 2017)
"Niacin extended-release (NER) is safe and effective for treatment of dyslipidemia."9.14Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. ( Jiang, P; Kashyap, ML; Krause, SL; Lewin, AJ; Padley, RJ; Thakkar, RB, 2009)
" To increase the probability of flushing, subjects received a single dose of reformulated niacin ER 2,000 mg, which is the upper limit of the approved dosage range."9.12Aspirin reduces cutaneous flushing after administration of an optimized extended-release niacin formulation. ( Cefali, EA; Kissling, CJ; McGovern, ME; Simmons, PD; Stanek, EJ, 2007)
"The usefulness of niceritrol as a lipid-lowering agent is limited by a prostaglandin-mediated flushing reaction after each dose occurring in the early stages of treatment."9.06Effects of aspirin upon the flushing reaction induced by niceritrol. ( Betteridge, DJ; Dickson, AC; Jay, RH, 1990)
"Niacin is the most effective lipid-modifying agent for raising high-density lipoprotein cholesterol levels, but it also causes cutaneous vasodilation with flushing."8.86A "hot" topic in dyslipidemia management--"how to beat a flush": optimizing niacin tolerability to promote long-term treatment adherence and coronary disease prevention. ( Jacobson, TA, 2010)
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."7.81Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
"The objective of this study was to determine the incidence and severity of niacin-induced flushing and their relationship to niacin discontinuation and skipping or delaying niacin doses in clinical practice."7.75Patients' experiences of niacin-induced flushing in clinical practice: a structured telephone interview. ( Ambegaonkar, BM; Kamal-Bahl, S; Watson, DJ, 2009)
"The relation of plasma levels of prostaglandins to the occurrence of flushing induced by niceritrol was investigated."7.67Increased compliance of niceritrol treatment by addition of aspirin: relationship between changes in prostaglandins and skin flushing. ( Kameda, K; Kihara, S; Kubo, M; Matsuzawa, Y; Nozaki, S; Tarui, S, 1987)
"Niacin is an effective lipid-modifying therapy whose use has been limited by suboptimal tolerability."6.74Effects of aspirin when added to the prostaglandin D2 receptor antagonist laropiprant on niacin-induced flushing symptoms. ( Atiee, GJ; Dishy, V; Ebel, DL; Lai, E; Liu, F; Paolini, JF; Reilley, S; Royalty, J; Wagner, JA, 2009)
"Facial flushing was markedly reduced in the flushing group, but was slightly increased in the non-flushing Occidentals."5.27Aspirin attenuation of alcohol-induced flushing and intoxication in Oriental and Occidental subjects. ( Gaynor, CR; Mehl, DL; Truitt, EB, 1987)
" Aspirin pretreatment reduced the incidence and intensity of flushing without affecting GI events or the DR-DMF PK profile."5.17Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. ( Dawson, KT; Huang, R; Milne, GL; Nestorov, I; Novas, M; O'Gorman, J; Russell, H; Scannevin, RH; Sheikh, SI, 2013)
"Niacin extended-release (NER) is safe and effective for treatment of dyslipidemia."5.14Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. ( Jiang, P; Kashyap, ML; Krause, SL; Lewin, AJ; Padley, RJ; Thakkar, RB, 2009)
"To investigate the effect of low-dose aspirin administered in the morning or evening on the rate of discontinuation of prolonged-release nicotinic acid (Niaspan) due to flushing in patients at elevated cardiovascular risk."5.13Influence of the timing of low-dose aspirin on tolerability of prolonged-release nicotinic acid in patients at elevated cardiovascular risk. ( Alves, JD; Darioli, R; Hostalek, U; Steinhagen-Thiessen, E; Vogt, A, 2008)
"The symptom scores for flushing, itching, tingling, and warmth were all significantly reduced by both aspirin regimens (p < ."5.08Effect of two aspirin pretreatment regimens on niacin-induced cutaneous reactions. ( Campbell, JR; Jungnickel, PW; Maloley, PA; Peddicord, TE; Vander Tuin, EL, 1997)
"It appears from this pilot study that preceding niacin with 325 mg of aspirin will decrease the warmth and flushing associated with niacin."5.07The effect of aspirin on niacin-induced cutaneous reactions. ( Fowler, SF; Hainer, BL; Price, SO; Whelan, AM, 1992)
"Niacin is the most effective lipid-modifying agent for raising high-density lipoprotein cholesterol levels, but it also causes cutaneous vasodilation with flushing."4.86A "hot" topic in dyslipidemia management--"how to beat a flush": optimizing niacin tolerability to promote long-term treatment adherence and coronary disease prevention. ( Jacobson, TA, 2010)
" The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events."3.81Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015)
"The objective of this study was to determine the incidence and severity of niacin-induced flushing and their relationship to niacin discontinuation and skipping or delaying niacin doses in clinical practice."3.75Patients' experiences of niacin-induced flushing in clinical practice: a structured telephone interview. ( Ambegaonkar, BM; Kamal-Bahl, S; Watson, DJ, 2009)
"The relation of plasma levels of prostaglandins to the occurrence of flushing induced by niceritrol was investigated."3.67Increased compliance of niceritrol treatment by addition of aspirin: relationship between changes in prostaglandins and skin flushing. ( Kameda, K; Kihara, S; Kubo, M; Matsuzawa, Y; Nozaki, S; Tarui, S, 1987)
"Niacin is an effective lipid-modifying therapy whose use has been limited by suboptimal tolerability."2.74Effects of aspirin when added to the prostaglandin D2 receptor antagonist laropiprant on niacin-induced flushing symptoms. ( Atiee, GJ; Dishy, V; Ebel, DL; Lai, E; Liu, F; Paolini, JF; Reilley, S; Royalty, J; Wagner, JA, 2009)
"Facial flushing was markedly reduced in the flushing group, but was slightly increased in the non-flushing Occidentals."1.27Aspirin attenuation of alcohol-induced flushing and intoxication in Oriental and Occidental subjects. ( Gaynor, CR; Mehl, DL; Truitt, EB, 1987)

Research

Studies (25)

TimeframeStudies, this research(%)All Research%
pre-19904 (16.00)18.7374
1990's4 (16.00)18.2507
2000's10 (40.00)29.6817
2010's7 (28.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Banka, SS1
Thachil, R1
Levine, A1
Lin, H1
Kaafarani, H1
Lee, J1
Sheikh, SI1
Nestorov, I1
Russell, H1
O'Gorman, J2
Huang, R1
Milne, GL1
Scannevin, RH1
Novas, M1
Dawson, KT1
Drexler, I1
Traenka, C1
von Hessling, A1
Gensicke, H1
Rowe, E1
Russell, HK1
Li, J1
Phillips, G1
Kurukulasuriya, NC1
Viglietta, V1
Alves, JD1
Steinhagen-Thiessen, E1
Darioli, R1
Hostalek, U1
Vogt, A1
Kamal-Bahl, S1
Watson, DJ1
Ambegaonkar, BM1
Dishy, V1
Liu, F1
Ebel, DL1
Atiee, GJ1
Royalty, J1
Reilley, S1
Paolini, JF1
Wagner, JA1
Lai, E2
Thakkar, RB1
Kashyap, ML2
Lewin, AJ1
Krause, SL1
Jiang, P1
Padley, RJ1
Jacobson, TA1
Langley, G1
Smith, W1
Nick, A1
Rhodes, H1
HAINING, CG1
Cheng, K1
Wu, TJ1
Wu, KK1
Sturino, C1
Metters, K1
Gottesdiener, K1
Wright, SD1
Wang, Z1
O'Neill, G1
Waters, MG1
Oberwittler, H1
Baccara-Dinet, M1
Meyers, CD1
Liu, P1
Kamanna, VS1
Cefali, EA1
Simmons, PD1
Stanek, EJ1
McGovern, ME1
Kissling, CJ1
Papaliodis, D1
Boucher, W1
Kempuraj, D1
Theoharides, TC1
Brommer, EJ1
Derkx, FH1
Barrett-Bergshoeff, MM1
Schalekamp, MA1
Jungnickel, PW1
Maloley, PA1
Vander Tuin, EL1
Peddicord, TE1
Campbell, JR1
Worobec, AS1
Hoffer, A1
Whelan, AM1
Price, SO1
Fowler, SF1
Hainer, BL1
Jay, RH1
Dickson, AC1
Betteridge, DJ1
Truitt, EB1
Gaynor, CR1
Mehl, DL1
Nozaki, S1
Kihara, S1
Kubo, M1
Kameda, K1
Matsuzawa, Y1
Tarui, S1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers[NCT01281111]Phase 156 participants (Actual)Interventional2011-02-01Completed
A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID[NCT01568112]Phase 3173 participants (Actual)Interventional2012-04-30Completed
Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia[NCT00626392]Phase 3277 participants (Actual)Interventional2008-02-29Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Duration of Flushing Events During the Overall Treatment Period, Based on MFSS

For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Day 1 to Week 8

Interventionminutes (Mean)
Placebo98.4
BG0001263.2
BG00012 + ASA69.8
BG00012 Slow Titration68.9

Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS

For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Week 1 to Week 4

Interventionminutes (Mean)
Placebo117.6
BG0001267.6
BG00012 + ASA89.8
BG00012 Slow Titration69.2

Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS

For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Week 5 to Week 8

Interventionminutes (Mean)
Placebo113.2
BG0001255.7
BG00012 + ASA73.2
BG00012 Slow Titration56.0

Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)

The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 8

Interventionpercentage of participants (Number)
Placebo73
BG0001281
BG00012 + ASA81
BG00012 Slow Titration86

Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Day 1 to Week 8

Interventionpercentage of participants (Number)
Placebo59
BG0001270
BG00012 + ASA79
BG00012 Slow Titration79

Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Week 1 to Week 4

Interventionpercentage of participants (Number)
Placebo57
BG0001265
BG00012 + ASA67
BG00012 Slow Titration71

Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 4

Interventionpercentage of participants (Number)
Placebo66
BG0001281
BG00012 + ASA79
BG00012 Slow Titration79

Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)

The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Week 5 to Week 8

Interventionpercentage of participants (Number)
Placebo34
BG0001259
BG00012 + ASA50
BG00012 Slow Titration58

Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Week 5 to Week 8

Interventionpercentage of participants (Number)
Placebo41
BG0001259
BG00012 + ASA53
BG00012 Slow Titration61

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)

Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 8

Interventionpercentage of participants (Number)
Placebo43
BG0001286
BG00012 + ASA74
BG00012 Slow Titration93

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 4

Interventionpercentage of participants (Number)
Placebo41
BG0001284
BG00012 + ASA62
BG00012 Slow Titration90

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS

Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score. (NCT01568112)
Timeframe: Week 5 to Week 8

Interventionpercentage of participants (Number)
Placebo24
BG0001286
BG00012 + ASA67
BG00012 Slow Titration85

Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry

Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionparticipants (Number)
ALP: shift to high; n=44, 42, 43, 42ALT: shift to high; n=44, 42, 43, 42AST: shift to high; n=44, 43, 43, 41GGT: shift to high; n=44, 41, 43, 42LDH: shift to low; n=44, 43, 43, 42LDH: shift to high; n=44, 43, 43, 42Total bilirubin: shift to high; n=44, 42, 42, 40BUN: shift to low; n=44, 43, 43, 42BUN: shift to high; n=44, 43, 41, 42Creatinine: shift to low; n=44, 43, 43, 42Creatinine: shift to high; n=44, 43, 43, 42Uric Acid: shift to low; n=44, 43, 43, 42Uric Acid: shift to high; n=44, 43, 43, 42Sodium: shift to low; n=44, 43, 43, 42Sodium: shift to high; n=44, 43, 43, 42Potassium: shift to low: n=44, 43, 43, 42Potassium: shift to high: n=44, 42, 42, 41Chloride: shift to low; n=44, 43, 43, 42Chloride: shift to high; n=44, 43, 43, 42Bicarbonate: shift to low; n=44, 43, 43, 42Bicarbonate: shift to high; n=44, 43, 43, 42Calcium: shift to low; n=44, 42, 43, 42Calcium: shift to high; n=44, 43, 43, 42Glucose: shift to low; n=43, 43, 41, 41Glucose: shift to high; n=44, 43, 43, 42Magnesium: shift to low; n=44, 43, 43, 42Magnesium: shift to high; n=44, 43, 43, 42Phosphorus: shift to low; n=44, 43, 43, 41Phosphorus: shift to high; n=44, 43, 43, 42Albumin: shift to low; n=44, 43, 43, 42Albumin: shift to high; n=44, 43, 43, 42Direct bilirubin: shift to high; n=44, 43, 43, 40Total protein: shift to low; n=44, 41, 43, 41Total protein: shift to high; n=44, 43, 43, 42
BG000120230001001000000100100010001000000
BG00012 + ASA0542010010000010100101010000000010
BG00012 Slow Titration0210001010000000000000020100100000
Placebo0120001010000100110100031100000000

Clinical Laboratory Shifts From Baseline in Reported Values: Hematology

Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionparticipants (Number)
White blood cells: shift to low; n=43, 43, 43, 41White blood cells: shift to high; n=44, 43, 43, 42Neutrophils abs: shift to low; n=42, 42, 42, 41Neutrophils abs: shift to high; n=44, 43, 43, 42Lymphocytes abs: shift to low; n=43, 43, 43, 41Lymphocytes abs: shift to high; n=44, 43, 42, 42Monocytes abs: shift to low; n=44, 43, 43, 42Monocytes abs: shift to high; n=44, 43, 43, 42Eosinophils abs: shift to low; n=44, 43, 43, 42Eosinophils abs: shift to high; n=44, 43, 43, 42Basophils abs: shift to high; n=44, 43, 43, 42Red blood cells: shift to low; n=44, 43, 43, 40Red blood cells: shift to high; n=44, 43, 43, 42Hemoglobin: shift to low; n=43, 41, 43, 42Hemoglobin: shift to high; n=44, 43, 43, 42Hematocrit: shift to low; n=44, 43, 43, 42Hematocrit: shift to high; n=43, 43, 43, 42Platelets: shift to low; n=44, 43, 43, 42Platelets: shift to high; n=44, 41, 43, 42
BG000122060500005120302000
BG00012 + ASA0120200006100100001
BG00012 Slow Titration0021300006000000101
Placebo0030100000000100000

Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis

Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionparticipants (Number)
Specific gravity: shift to low; n=44, 43, 43, 42Specific gravity: shift to high; n=44, 42, 43, 42pH: shift to low; n=44, 43, 43, 42pH: shift to high; n=44, 43, 43, 42Blood: shift to positive; n=42, 39, 39, 42Color: shift to positive; n=41, 43, 41, 39Glucose: shift to positive; n=44, 43, 43, 41Ketones: shift to positive; n=44, 43, 43, 42Protein: shift to positive; n=44, 41, 43, 41Microscopic RBC; n=44, 40, 40, 41Microscopic WBC; n=43, 40, 41, 42
BG0001200006127149
BG00012 + ASA02001419113
BG00012 Slow Titration00002506123
Placebo00003201034

Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS

Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionhours (Mean)
Nausea; n=12, 21, 21, 22Diarrhea; n=20, 20 17, 15Upper abdominal pain; n=17, 14, 19, 19Lower abdominal pain; n=12, 19, 17, 16Vomiting; n=3, 3, 3, 2Indigestion; n=12, 13, 12, 12Constipation; n=6, 8, 13, 11Bloating; n=14, 14, 21, 12Flatulence; n=23, 20, 22, 20
BG000127.052.926.6713.9310.0816.4928.2016.919.06
BG00012 + ASA10.0114.6615.8810.841.883.8014.269.6868.93
BG00012 Slow Titration2.984.973.837.750.754.9120.9077.2463.84
Placebo9.745.5719.086.655.874.7620.499.5016.41

Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS

Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Week 1 to Week 4

,,,
Interventionhours (Mean)
Nausea; n=10, 18, 18, 20Diarrhea; n=13, 20, 14, 14Upper abdominal pain; n=14, 14, 17, 15Lower abdominal pain; n=9, 18, 14, 13Vomiting; n=2, 2, 2, 2Indigestion; n=11, 11, 9, 11Constipation; n=4, 8, 11, 11Bloating; n=9, 14, 19, 11Flatulence; n=21, 17, 22, 19
BG000127.232.536.8114.205.6329.0027.6113.819.34
BG00012 + ASA11.1816.0417.6512.512.533.9315.1211.0735.86
BG00012 Slow Titration2.864.974.316.300.755.0521.2895.6961.13
Placebo10.475.2021.375.404.315.0817.056.7012.83

Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS

Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Week 5 to Week 8

,,,
Interventionhours (Mean)
Nausea; n=4, 9, 6, 9Diarrhea; n=12, 13, 6, 8Upper abdominal pain; n=6, 5, 5, 5Lower abdominal pain; n=7, 5, 5, 9Vomiting; n=1, 1, 1, 0Indigestion; n=6, 7, 7, 5Constipation; n=5, 2, 4, 4Bloating; n=7, 8, 7, 8Flatulence; n=9, 13, 7, 10
BG000124.346.621.123.9819.002.5715.4718.527.21
BG00012 + ASA2.667.051.862.840.585.0221.304.16105.86
BG00012 Slow Titration2.342.141.7322.54NA1.6318.2485.6418.48
Placebo3.964.505.296.639.002.4323.3512.4944.67

Number of Participants With Abnormalities in Vital Signs

↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionparticipants (Number)
Temperature >38°C + ↑ from BL of ≥1°CPulse >120 bpm or ↑ from BL of >20 bpmPulse <50 bpm or ↓ from BL of >20 bpmSBP >180 mm Hg or ↑ from BL of >40 mm HgSBP <90 mm Hg or ↓ from BL of >30 mm HgDBP >105 mm Hg or ↑ from BL of >30 mm HgDBP <50 mm Hg or ↓ from BL of >20 mm HgRespiration rate >25 b/m or ↑ from BL of ≥50%Respiration rate 10 b/m or ↓ from BL of ≥50%
BG000120104020320
BG00012 + ASA0203010030
BG00012 Slow Titration0174010130
Placebo0811110110

Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results

Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.' (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionparticipants (Number)
Shift to abnormal, not adverse eventShift to abnormal, adverse event
BG0001230
BG00012 + ASA20
BG00012 Slow Titration40
Placebo20

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)

AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened. (NCT01568112)
Timeframe: Day 1 up to end of Safety Follow-up (9 weeks)

,,,
Interventionparticipants (Number)
Any eventModerate or severe eventSevere eventRelated eventSerious eventDiscontinuation of treatment due to an eventWithdrawal from study due to an event
BG000122413417144
BG00012 + ASA2612416066
BG00012 Slow Titration2611118033
Placebo241008022

Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)

Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 8

,,,
Interventionpercentage of participants (Number)
Overall flushing eventsOverall redness eventsOverall warmth eventsOverall tingling eventsOverall itching events
BG000129186938886
BG00012 + ASA8177846772
BG00012 Slow Titration9890988698
Placebo4127412320

Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS

Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 1 to Week 4

,,,
Interventionpercentage of participants (Number)
Overall flushing eventsOverall redness eventsOverall warmth eventsOverall tingling eventsOverall itching events
BG000128681888477
BG00012 + ASA7263675156
BG00012 Slow Titration9888958395
Placebo4125412316

Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS

Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8

,,,
Interventionpercentage of participants (Number)
Overall flushing eventsOverall redness eventsOverall warmth eventsOverall tingling eventsOverall itching events
BG000128678868178
BG00012 + ASA7264756458
BG00012 Slow Titration8579827061
Placebo2415171522

Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS

Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Day 1 to Week 4

,,,
Interventionunits on a scale (Mean)
NauseaDiarrheaUpper abdominal painLower abdominal painVomitingIndigestionConstipationBloatingFlatulence
BG000121.61.81.11.40.30.90.91.11.3
BG00012 + ASA1.61.51.71.30.30.60.61.31.4
BG00012 Slow Titration1.51.01.41.20.20.90.91.01.6
Placebo0.71.00.80.50.20.70.40.51.3

Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS

Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Week 5 to Week 8

,,,
Interventionunits on a scale (Mean)
NauseaDiarrheaUpper abdominal painLower abdominal painVomitingIndigestionConstipationBloatingFlatulence
BG000120.91.40.50.40.10.50.10.71.2
BG00012 + ASA0.80.80.40.50.10.50.60.70.4
BG00012 Slow Titration0.90.70.60.90.00.40.30.80.9
Placebo0.41.00.60.60.20.40.40.50.8

Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 4

,,,
Interventionunits on a scale (Mean)
Overall flushingRednessWarmthTinglingItching
BG000124.43.84.03.43.2
BG00012 + ASA2.41.62.31.61.3
BG00012 Slow Titration5.65.15.24.04.3
Placebo1.20.71.20.50.5

Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS

Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8

,,,
Interventionunits on a scale (Mean)
Overall flushingRednessWarmthTinglingItching
BG000123.83.63.93.33.1
BG00012 + ASA3.32.93.12.32.3
BG00012 Slow Titration3.12.92.92.21.8
Placebo0.90.40.80.30.7

Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe. (NCT00626392)
Timeframe: 4 weeks

InterventionNumber of Events per Subject per Week (Mean)
Any Acetylsalicylic Acid0.3
No Acetylsalicylic Acid0.8

Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily. (NCT00626392)
Timeframe: 4 weeks

InterventionScores on a Scale (Mean)
Any Acetylsalicylic Acid3.1
No Acetylsalicylic Acid5.1

Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment

The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated. (NCT00626392)
Timeframe: From Baseline to end of Week 1

,
InterventionPercentage of Subjects (Number)
NoneMildNone/mildModerateSevereVery severe
Any Acetylsalicylic Acid5728851141
No Acetylsalicylic Acid4824711784

Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment

The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated. (NCT00626392)
Timeframe: 4 weeks

,
InterventionPercentage of Subjects (Number)
NoneMildNone/MildModerateSevereVery severe
Any Acetylsalicylic Acid30285828114
No Acetylsalicylic Acid151430352313

Reviews

3 reviews available for aspirin and Flushing

ArticleYear
A "hot" topic in dyslipidemia management--"how to beat a flush": optimizing niacin tolerability to promote long-term treatment adherence and coronary disease prevention.
    Mayo Clinic proceedings, 2010, Volume: 85, Issue:4

    Topics: Aspirin; Attitude to Health; Coronary Disease; Delayed-Action Preparations; Dose-Response Relationsh

2010
Clinical evidence for use of acetyl salicylic acid in control of flushing related to nicotinic acid treatment.
    International journal of clinical practice, 2006, Volume: 60, Issue:6

    Topics: Aspirin; Dose-Response Relationship, Drug; Dyslipidemias; Flushing; Humans; Hypolipidemic Agents; Ni

2006
Treatment of systemic mast cell disorders.
    Hematology/oncology clinics of North America, 2000, Volume: 14, Issue:3

    Topics: Adrenal Cortex Hormones; Adrenergic beta-Antagonists; Antineoplastic Agents; Aspirin; Cholinergic An

2000

Trials

9 trials available for aspirin and Flushing

ArticleYear
Randomized controlled trial of different aspirin regimens for reduction of niacin-induced flushing.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2017, Jun-15, Volume: 74, Issue:12

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cross-Over Studies; Dose-Response Relations

2017
Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers.
    Clinical therapeutics, 2013, Volume: 35, Issue:10

    Topics: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cyclooxygenase Inhibitors; Dela

2013
Influence of the timing of low-dose aspirin on tolerability of prolonged-release nicotinic acid in patients at elevated cardiovascular risk.
    Current medical research and opinion, 2008, Volume: 24, Issue:10

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aspirin; Cardiovascular Diseases; Cholesterol, HDL; Dela

2008
Effects of aspirin when added to the prostaglandin D2 receptor antagonist laropiprant on niacin-induced flushing symptoms.
    Journal of clinical pharmacology, 2009, Volume: 49, Issue:4

    Topics: Administration, Oral; Adult; Aged; Aspirin; Cross-Over Studies; Cyclooxygenase Inhibitors; Delayed-A

2009
Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia.
    American journal of cardiovascular drugs : drugs, devices, and other interventions, 2009, Volume: 9, Issue:2

    Topics: Administration, Oral; Adult; Aged; Aspirin; Delayed-Action Preparations; Dose-Response Relationship,

2009
Aspirin reduces cutaneous flushing after administration of an optimized extended-release niacin formulation.
    International journal of clinical pharmacology and therapeutics, 2007, Volume: 45, Issue:2

    Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cross-Over Studies; Delayed-

2007
Effect of two aspirin pretreatment regimens on niacin-induced cutaneous reactions.
    Journal of general internal medicine, 1997, Volume: 12, Issue:10

    Topics: Adult; Aged; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cross-Over Stud

1997
The effect of aspirin on niacin-induced cutaneous reactions.
    The Journal of family practice, 1992, Volume: 34, Issue:2

    Topics: Adult; Aspirin; Double-Blind Method; Drug Therapy, Combination; Female; Flushing; Humans; Hyperlipid

1992
Effects of aspirin upon the flushing reaction induced by niceritrol.
    British journal of clinical pharmacology, 1990, Volume: 29, Issue:1

    Topics: Adolescent; Adult; Aspirin; Flushing; Humans; Male; Middle Aged; Niceritrol; Nicotinic Acids; Random

1990

Other Studies

13 other studies available for aspirin and Flushing

ArticleYear
Internal carotid artery dissection and asymmetrical facial flushing: the Harlequin sign.
    Stroke, 2014, Volume: 45, Issue:5

    Topics: Aspirin; Autonomic Nervous System Diseases; Carotid Artery, Internal, Dissection; Female; Flushing;

2014
[Psoriasis therapy. Dose regulation or aspirin to control flush].
    MMW Fortschritte der Medizin, 2014, Nov-06, Volume: 156, Issue:19

    Topics: Aspirin; Flushing; Fumarates; Germany; Guideline Adherence; Humans; Psoriasis

2014
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate.
    Clinical therapeutics, 2015, Jul-01, Volume: 37, Issue:7

    Topics: Abdominal Pain; Adult; Aspirin; Constipation; Delayed-Action Preparations; Diarrhea; Dimethyl Fumara

2015
Patients' experiences of niacin-induced flushing in clinical practice: a structured telephone interview.
    Clinical therapeutics, 2009, Volume: 31, Issue:1

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Data Collection; Female; Flushing; Hu

2009
Tramadol-induced flushing managed with aspirin premedication.
    Journal of pain and symptom management, 2010, Volume: 40, Issue:6

    Topics: Analgesics, Opioid; Antipyretics; Aspirin; Female; Flushing; Humans; Premedication; Tramadol

2010
EFFECTS OF ANTI-RHEUMATIC COMPOUNDS AND PYRIDINE DERIVATIVES ON THE CUTANEOUS RESPONSE TO THURFYL NICOTINATE IN THE GUINEA-PIG.
    British journal of pharmacology and chemotherapy, 1963, Volume: 21

    Topics: Animals; Antirheumatic Agents; Aspirin; Flushing; Furans; Guinea Pigs; Niacin; Nicotinic Acids; Phar

1963
Antagonism of the prostaglandin D2 receptor 1 suppresses nicotinic acid-induced vasodilation in mice and humans.
    Proceedings of the National Academy of Sciences of the United States of America, 2006, Apr-25, Volume: 103, Issue:17

    Topics: Adolescent; Adult; Animals; Aspirin; Female; Flushing; Humans; Hydantoins; Male; Mice; Mice, Inbred

2006
Nicotinic acid induces secretion of prostaglandin D2 in human macrophages: an in vitro model of the niacin flush.
    Atherosclerosis, 2007, Volume: 192, Issue:2

    Topics: Aspirin; Calcimycin; Calcium; Flushing; Humans; Macrophages; Models, Biological; Niacin; Nicotinic A

2007
The flavonoid luteolin inhibits niacin-induced flush.
    British journal of pharmacology, 2008, Volume: 153, Issue:7

    Topics: Animals; Aspirin; Body Temperature; Disease Models, Animal; Flushing; Hypolipidemic Agents; Luteolin

2008
The inability of propranolol and aspirin to inhibit the response of fibrinolytic activity and factor VIII-antigen to infusion of DDAVP.
    Thrombosis and haemostasis, 1984, Feb-28, Volume: 51, Issue:1

    Topics: Antigens; Arginine Vasopressin; Aspirin; Blood Pressure; Deamino Arginine Vasopressin; Factor VIII;

1984
Niacin reaction.
    The Journal of family practice, 1992, Volume: 34, Issue:6

    Topics: Aspirin; Flushing; Humans; Niacin

1992
Aspirin attenuation of alcohol-induced flushing and intoxication in Oriental and Occidental subjects.
    Alcohol and alcoholism (Oxford, Oxfordshire). Supplement, 1987, Volume: 1

    Topics: Alcoholic Intoxication; Asian People; Aspirin; Blood Pressure; Ethanol; Flushing; Heart Rate; Humans

1987
Increased compliance of niceritrol treatment by addition of aspirin: relationship between changes in prostaglandins and skin flushing.
    International journal of clinical pharmacology, therapy, and toxicology, 1987, Volume: 25, Issue:12

    Topics: 6-Ketoprostaglandin F1 alpha; Adult; Aged; Aspirin; Cholesterol; Dinoprostone; Flushing; Humans; Hyp

1987