ibuprofen and Coronary Artery Disease studies

Coronary Artery Disease: Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Research Excerpts

Excerpt	Relevance	Reference
"In this double-blind, randomized, multicentre non-inferiority CV-safety trial, 444 patients (mean age 62 ± 10 years, 54% female) with osteoarthritis (92%) or rheumatoid arthritis (8%) and evidence of or at increased risk for coronary artery disease received celecoxib (100-200 mg bid), ibuprofen (600-800 mg tid), or naproxen (375-500 mg bid) with matching placebos in a 1: 1: 1 allocation, to assess the effect on 24-h ambulatory BP after 4 months."	5.24	Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) ( Beckerman, B; Borer, JS; Davey, DA; Fayyad, R; Flammer, AJ; Graham, DY; Husni, ME; Iorga, D; Krum, H; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Ruschitzka, F; Solomon, DH; Wisniewski, LM; Yeomans, ND, 2017)
"This was a post hoc analysis from the INternational VErapamil Trandolapril STudy (INVEST), which enrolled patients with hypertension and coronary artery disease."	3.77	Harmful effects of NSAIDs among patients with hypertension and coronary artery disease. ( Bavry, AA; Cooper-Dehoff, RM; Gong, Y; Handberg, EM; Khaliq, A; Pepine, CJ, 2011)
" Naproxen users had the lowest adjusted rates of serious coronary heart disease (myocardial infarction, coronary heart disease death) and serious cardiovascular disease (myocardial infarction, stroke)/death from any cause, with respective incidence rate ratios (relative to NSAID nonusers) of 0."	3.75	Cardiovascular risks of nonsteroidal antiinflammatory drugs in patients after hospitalization for serious coronary heart disease. ( Arbogast, PG; Castellsague, J; Chung, CP; Daugherty, JR; García-Rodríguez, LA; Murray, KT; Ray, WA; Stein, CM; Varas-Lorenzo, C, 2009)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (33.33)	29.6817
2010's	2 (66.67)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Ruschitzka, F	1
Borer, JS	1
Krum, H	1
Flammer, AJ	1
Yeomans, ND	1
Libby, P	1
Lüscher, TF	1
Solomon, DH	1
Husni, ME	1
Graham, DY	1
Davey, DA	1
Wisniewski, LM	1
Menon, V	1
Fayyad, R	1
Beckerman, B	1
Iorga, D	1
Lincoff, AM	1
Nissen, SE	1
Ray, WA	1
Varas-Lorenzo, C	1
Chung, CP	1
Castellsague, J	1
Murray, KT	1
Stein, CM	1
Daugherty, JR	1
Arbogast, PG	1
García-Rodríguez, LA	1
Bavry, AA	1
Khaliq, A	1
Gong, Y	1
Handberg, EM	1
Cooper-Dehoff, RM	1
Pepine, CJ	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen[NCT00346216]	Phase 4	24,081 participants (Actual)	Interventional	2006-10-04	Completed
A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerability of Topically Administered ProF-001[NCT03115073]	Phase 2/Phase 3	84 participants (Actual)	Interventional	2017-04-04	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"VAS question How much pain do you have was graded on a scale from 0 to 100 with 0 indicating No pain and 100 indicating Worst possible pain." (NCT00346216)
Timeframe: ITT and MITT Population - Baseline to 42 months

The First Occurrence of a Major Adverse Cardiovascular Events (MACE)

Intervention	Number of participants (Mean)
	Baseline (ITT) N= 8014, 8001, 7928	Change-Baseline to Mon1 (ITT) N=7382, 7379, 7325	Change-Baseline to Mon2 (ITT) N=7180, 7090, 7149	Change-Baseline to Mon4 (ITT) N=6777, 6696, 6740	Change-Baseline to Mon8 (ITT) N=6230, 6137, 6159	Change-Baseline to Mon12 (ITT) N=5792, 5696, 5846	Change-Baseline to Mon18 (ITT) N=5310, 5181. 5246	Change-Baseline to Mon24 (ITT) N=4818, 4776, 4785	Change-Baseline to Mon30 (ITT) N=4140, 4069, 4086	Change-Baseline to Mon36 (ITT) N=3692, 3627, 3635	Change-Baseline to Mon42 (ITT) N=3469, 3406, 3439	Baseline (MITT) N=7974, 7954, 7894	Change-Baseline to Mon1 MITT N=7372, 7367, 7321	Change-Baseline to Mon2 MITT N=7170, 7078, 7142	Change-Baseline to Mon4 MITT N=6772, 6686, 6732	Change-Baseline to Mon8 MITT N=6224, 6128, 6155	Change-Baseline to Mon12 MITT N=5787, 5689, 5844	Change-Baseline to Mon18 MITT N=5305, 5175, 5242	Change-Baseline to Mon24 MITT N=4815, 4769, 4782	Change-Baseline to Mon30 MITT N=4139, 4067, 4085	Change-Baseline to Mon36 MITT N=3691, 3623, 3635	Change-Baseline to Mon42 MITT N=3468, 3404, 3438
Celecoxib	54.0	-8.2	-10.5	-11.4	-11.7	-11.0	-11.3	-11.3	-10.5	-10.1	-11.4	54.0	-8.2	-10.5	-11.4	-11.7	-11.0	-11.3	-11.4	-10.5	-10.2	-11.4
Ibuprofen	54.1	-9.0	-10.6	-11.7	-12.1	-11.6	-11.3	-11.5	-11.2	-10.7	-11.1	54.1	-9.0	-10.6	-11.7	-12.1	-11.6	-11.3	-11.5	-11.2	-10.7	-11.1
Naproxen	54.1	-9.9	-11.1	-12.3	-12.1	-11.9	-11.7	-11.4	-11.3	-11.6	-12.1	54.1	-9.9	-11.1	-12.3	-12.1	-11.9	-11.7	-11.3	-11.3	-11.6	-12.1

MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA (NCT00346216)
Timeframe: ITT Population - 30 months; MITT Population - 42 months

The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).

Intervention	Percentage of Participants (Number)
	ITT (N = 8072, 8040, 7969)	MITT (N = 8030, 7990, 7933)
Celecoxib	4.2	3.1
Ibuprofen	4.8	3.6
Naproxen	4.3	3.2

APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology). (NCT00346216)
Timeframe: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)

Intervention	Percentage of Partcipants (Number)
	ITT (N = 8072, 8040, 7969)	MITT (N = 8030, 7990, 7933)
Celecoxib	2.3	1.7
Ibuprofen	2.7	1.9
Naproxen	2.5	1.8

CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer (NCT00346216)
Timeframe: ITT Population - 30 months; MITT Population - 42 months

Article	Year
Cardiovascular risks of nonsteroidal antiinflammatory drugs in patients after hospitalization for serious coronary heart disease. Circulation. Cardiovascular quality and outcomes, 2009, Volume: 2, Issue:3 Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseases; Celecoxib; Cohort Studies; C	2009
Harmful effects of NSAIDs among patients with hypertension and coronary artery disease. The American journal of medicine, 2011, Volume: 124, Issue:7 Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Blood Pressure; Celec	2011

ibuprofen and Coronary Artery Disease