Table 1 |.

Clinical trials of anti-inflammatory drugs in chronic inflammatory diseases

Trial name	Participants	Design	n	Drug	Dosage	Type of treatment	Outcome	Result	Refs
CANTOS	Patients with previous MI and hsCRP ≥2mg/l	Randomized	10,061	Canakinumab	150 mg every 3 months	Secondary prevention	Cardiovascular events	Beneficial	169,293
CIRT	Patients with previous MI and either T2DM or metabolic syndrome	Randomized	7,000	Methotrexate	15–20 mg weekly	Secondary prevention	Cardiovascular events	Ongoing	170
LoDoCo	Patients with clinically stable CAD	Randomized	532	Colchicine	0.5 mg daily	Primary and Secondary prevention	Cardiovascular events	Beneficial	172
LoDoCo2	Patients with clinically stable CAD	Randomized	3,000	Colchicine	0.5 mg daily	Primary and Secondary prevention	Cardiovascular events	Ongoing	294
COLCOT	Patients with a Documented acute MI in the past 30 days	Randomized	4,500	Colchicine	0.5 mg daily	Secondary prevention	Cardiovascular events	Ongoing	173
ENTRACTE	Patients with moderate- to-severe rheumatoid arthritis	Randomized	3,080	Tocilizumab	8mg/kg every 4 weeks	Prevention	Cardiovascular events	Ongoing	166
PEDRIAN	Patients with T2DM and stage 3–4 CKD	Randomized	169	Pentoxifylline	1,200 mg daily	Prevention	CKD progression	Beneficial	295
NA	Patients aged ≥25 years with T1DM or T2DMa	Randomized	416	Monoclonal anti-TGFβ1 antibody	2, 10, or 50 mg Monthly (subcutaneous)	Prevention	CKD progression	Not beneficial	296
NA	Patients with a recent TIA or minor ischaemic stroke and no contraindication to aspirin	Meta- analysis of two randomized trialsb	5,139+ 2,449	Aspirin	300, 500, or 1,200 mg daily	Primary prevention	Colorectal cancer	Beneficial	297
NA	Patients with a recent TIA or minor ischaemic stroke and no contraindication to aspirin	Meta- analysis of four randomized trialsc	14,033	Aspirin	30, 75, 283, 300, 500, or 1,200 mg daily	Primary prevention	Colorectal cancer	Beneficial	298
CANTOS	Patients with previous MI and hsCRP ≥2mg/l	Randomized	10,061	Canakinumab	150 or 300 mg every 3 months	Primary prevention	Lung cancer	Beneficial	168
NA	Patients with osteoarthritis	Meta- Analysis of five randomized trialsd	1,497	Ibuprofen, naproxen, or celecoxib	800 mg three times daily, 500 mg twice daily, or 200 mg daily	Treatment	Depressive symptoms	Beneficial	299
ADAPT	Individuals aged ≥70 years, cognitively healthy , and with a family history of AD-like dementia	Randomized	2,528	Celecoxib or naproxen	200 mg twice daily or 220 mg twice daily	Treatment	Depressive symptoms	Not beneficial	300
NA	Outpatients with major depression	Randomized	60	Infliximab	5mg/kg (three infusions)	Treatment	Depressive symptoms	Beneficial in patients with high baseline inflammatory blood biomarkers	301
NA	Patients with moderate-to- severe psoriasis	Randomized	96	Adalimumab	40 mg every other week	Treatment	Depressive symptoms	Beneficial	302
NA	Patients with moderate- to-severe psoriasis	Randomized	618	Etanercept	50 mg twice weekly	Treatment	Depressive symptoms	Beneficial	303
NA	Patients with probable AD	Randomized	40	Nimesulide	100 mg twice daily	Treatment	AD	Not beneficial	304
NSAID study	Patients with mild-to-moderate AD	Randomized	351	Rofecoxib or naproxen sodium	25 mg once daily or 220 mg twice daily	Treatment	AD	Not beneficial	305
NA	Patients with mild or moderate AD aged ≥50 years	Randomized	692	Rofecoxib	25 mg daily	Treatment	AD	Not beneficial	306
NA	Patients with mild-to-moderate AD	Randomized	41	Diclofenac	50 mg daily	Treatment	AD	Not beneficial	307
ADAPT	Individuals aged ≥70 years, cognitively healthy , and with a family history of AD	Randomized	2,117	Celecoxib or naproxen	200 mg twice daily or 220 mg twice daily	Primary prevention	AD	Not beneficial	308
TOMORROW	Cognitively healthy participants at high risk of developing MCI	Randomized	3,500	Pioglitazone	0.8 mg daily	Prevention	Onset of MI or MCI owing to AD	Ongoing	309,310
Metformin for Preventing Frailty in High-risk Older Adults	Older adults with impaired glucose tolerance	Randomized	120	Metformin	1,000 mg twice daily	Prevention	Frailty	Ongoing	256
TAME	Individuals aged 65–79 years	Randomized	3,000	Metformin	850 mg twice daily	Prevention	Cardiovascular events, cancer, dementia, and mortality	Ongoing	277

AD, Alzheimer disease; CAD coronary artery disease; CKD, chronic kidney disease; hsCRP, C-reactive protein measured by high-sensitivity assay; MCI, mild cognitive impairment; MI, myocardial infarction; NA, not applicable; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; TGFβ1, transforming growth factor-β1; TIA, transient ischaemic attack.

^aPatients also had a serum creatinine level of 1.3–3.3 mg/dl for women or 1.5–3.5 mg/dl for men (or estimated glomerular filtration rate of 20–60 ml/min/1.73 m2) and a 24-h urine protein: creatinine ratio ≥800 mg/g.

^bBritish Doctors Aspirin Trial and UK-TIA Aspirin Trial.

^cThrombosis Prevention Trial, British Doctors Aspirin Trial, Swedish Aspirin Low Dose Trial, and UK-TIA Aspirin Trial.

^dFive phase IV development trials conducted by Pfizer.