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HDL increasing drugs in cardiovascular prevention for all type of patients, clinical trials results

anacetrapib versus placebo
DEFINE, 2010
NCT00685776
anacetrapib 100mg fr 18 months
versus
placebo
patients with coronary heart disease or at high risk for coronary heart diseasedouble-blind
20 countries
REVEAL HPS-3 TIMI-55, 2017
NCT01252953
anacetrapib 100mg daily
versus
placebo
high risk patients already taking statinsdouble-blind
Follow-up duration: median 4 years
REALIZE, 2015
NCT01524289
oral anacetrapib 100 mg for 52 weeks
versus
placebo
patients aged 18-80 years with a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolaemia, on optimum lipid-lowering treatment for at least 6 weeks, and with an LDL-C concentration of 2·59 mmol/L or higher without cardiovascular disease or 1·81 mmol/L or higher with cardiovascular diseasedouble-blind
Follow-up duration: 52 weeks
bezafibrate versus placebo
BECAIT, 1996
bezafibrate 200 mg three times daily
versus
placebo
dyslipidaemic male survivors of myocardial infarction who were younger than 45 years at the time of the eventdouble blind
Follow-up duration: 5.0 years
Sweden
BIP, 2000
bezafibrate 400 mg/d
versus
placebo
patients with a previous myocardial infarction or stable angina, total cholesterol of 180 to 250 mg/dL, HDL-C < or =45 mg/dL, triglycerides < or =300 mg/dL, and low-density lipoprotein cholesterol < or =180 mg/dL double blind
Follow-up duration: 6.2 y
Israel
LEADER, 2002
bezafibrate 400 mg daily
versus
placebo
men with lower extremity arterial diseasedouble-blind
Follow-up duration: 4.6y
UK
SENDCAP, 1998
bezafibrate 400 mg daily
versus
placebo
type 2 diabetic subjects without a history of clinical cardiovascular double blind
Follow-up duration: 3.0 years
UK
clofibrate versus placebo
Acheson, 1972
clofibrate
versus
placebo
cerebral vascular disease NA
Follow-up duration: 6 years
UK
Begg, 1971
clofibrate
versus
placebo
peripheral arteriopathy
Follow-up duration: 3.5 y
CDP Clofibrate, 1975
clofibrate 1.8 mg/d
versus
placebo
men, 30-64 ydouble blind
Follow-up duration: 6.2 years
USA
Cullen, 1974
clofibrate
versus
placebo

Follow-up duration: 2 years
Hanefeld, 1991
clofibric acid 1.6 g/day
versus
placebo
newly diagnosed middle-aged (30- to 55-yr-old) patients with non-insulin-dependent diabetes mellitus double-blind
Follow-up duration: 5 years
Germany
Harrold, 1969
clofibrate
versus
placebo
diabetic retinopathy double-blind
Follow-up duration: 1 years
Newcastle, 1971
clofibrate 1.5-2 g daily
versus
placebo
Hommes et femmes < 65 ans double blind
Follow-up duration: 3.6 y
UK
Scottish, 1971
clofibrate 1.6-2 g daily
versus
placebo
Hommes et femmes, de 40 à 69 ansdouble blind
Follow-up duration: 3.4 years
Scotland
VA Neurology Section, 1974
clofibrate
versus
placebo
treatment of cerebrovascular disease
Follow-up duration: 1.8 years
USA
WHO clofibrate, 1978
clofibrate 1.6 g daily
versus
olive oil
primary prevention, Hommes, de 30 à 59 ans double blind
Follow-up duration: 5.3 years
Scotland, Hungary, Czech Republic
dalcetrapib versus placebo
dal-VESSEL, 2011
dalcetrapib 600 mg daily
versus
placebo
men and women with coronary heart disease or coronary heart disease risk equivalents with HDL-cholesterol levels <50 mg/dLdouble-blind
Follow-up duration: 12 weeks
dal-OUTCOMES, 2012
NCT00658515
dalcetrapib 600 mg daily beginning 4 to 12 weeks after an index ACS event
versus
placebo
patients with recent acute coronary syndromedouble-blind
Follow-up duration: 31 montsh (median)
27 countries
etofibrate versus placebo
Emmerich, 2009
etofibrate 1g/j
versus
placebo
patients with type 2 diabetes mellitus and concomitant diabetic retinopathydouble-blind
Follow-up duration: 12 months
Germany
evacetrapib versus placebo
ACCELERATE, 2017
NCT01687998
evacetrapib at adose of 130 mg
versus
placebo
Patients at a High-Risk for Vascular Outcomes who had at least one of the following conditions: an acutecoronary syndrome within the previous 30 to 365 days, cerebrovascular atheroscleroticdisease, peripheral vascular arterial disease, or diabetes mellitus with coronaryartery diseasedouble-blind
37 countries
fenofibrate versus placebo
DAIS, 2001
fenofibrate 200 mg/day
versus
placebo
men and women with type 2 diabetes and coronary atherosclerosis double-blind
Follow-up duration: 3.3 years
Canada, Finland, France, Sweden
FIELD, 2005
ISRCTN64783481
fenofibrate 200mg/d
versus
Placebo
participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entrydouble blind
Follow-up duration: 5 years
Australia, New Zealand, Finland
fenofibrate versus placebo (on top simvastatine)
ACCORD lipid, 2010
NCT00000620
fenofibrate on top simvastatin
versus
placebo (on top simvastatine)
high-risk patients with type 2 diabetes double-blind
Follow-up duration: 4.7y
United States and Canada
gemfibrozil versus placebo
Helsinki (HHS), 1987
gemfibrozil 1,2 g/d
versus
placebo
asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter [5.2 mmol per liter]double blind
Follow-up duration: 5 years
Finland
HHS (Frick)(secondary prev subgroup), 1993
gemfibrozil 600 mg twice daily
versus
placebo
individuals who exhibited symptoms and signs of possible coronary heart disease double blind
Follow-up duration: 5.0 years
Sweden
LOCAT, 1997
gemfibrozil 1200 mg/d
versus
placebo
post-coronary bypass men, who had an HDL cholesterol concentration < or = 1.1 mmol/L and LDL cholesterol < or = 4.5 mmol/Ldouble blind
Follow-up duration: 32 months
Germany
VA-HIT, 1999
NCT00283335
gemfibrozil 1.2g daily
versus
placebo
men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or lessdouble blind
Follow-up duration: 5.1 years
USA
niacin versus control
VA drugs, 1968
niacin
versus
double blind
Follow-up duration: 3.2 years
niacin versus ezetimibe
ARBITER 6-HALTS (niacin vs ezetimibe), 2009
NCT00397657
extended-release niacin 1 g/d, titrated to max tolerable dose up to 2 g/d (HDL-focused strategy)
versus
ezetimibe 10 mg/d (LDL-focused strategy)
patients with known coronary or vascular disease or coronary risk equivalentsopen
Follow-up duration: 14 months
US
niacin versus placebo
CDP niacin, 1975
niacin 3 mg/d
versus
placebo
Hommes, de 30 à 64 ans double blind
Follow-up duration: 6.2 years
niacin versus placebo (on top statin)
AIM-HIGH, 2011
NCT00120289
high-dose, extended-release niacin in gradually increasing doses up to 2000 mg daily (+ simvastatin)
versus
placebo
patients with a history of cardiovascular disease, high triglycerides, and low levels of HDL cholesteroldouble blind
Follow-up duration: 32 months
US, Canada
HPS 2-Thrive,
NCT00461630
2 g of extended-release niacin and 40 mg of laropiprant
versus
placebo
patients with vascular diseasedouble blind
Follow-up duration: 3.9y (median)
UK, Scandinavia, China
Oxford Niaspan Study, 2009
NCT00232531
niacin 2g daily (added to statin therapy)
versus
placebo (statins alone)
patients with low HDL-C (<40 mg/dl) and either a type 2 diabetes with coronary heart disease or a carotid/peripheral atherosclerosisdouble blind
Follow-up duration: 1 year
USA
ARBITER 2, 2009
long-acting niacin target dose of 1 g/day (added to statin therapy)
versus
placebo
patients with known coronary artery disease and well controlled on statin therapydouble blind
Follow-up duration: 1 y
USA
HATS, 2001
simvastatin plus niacin
versus
placebo
patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol levels double blind
Follow-up duration: 3 y
USA, Canada
torcetrapib versus placebo
RADIANCE 1, 2007
NCT00136981
atorvastatin combined with 60 mg of torcetrapib
versus
atorvastatin monotherapy
patients with heterozygous familial hypercholesterolemia open
Follow-up duration: 24 months
ILLUMINATE, 2007
NCT00134264
torcetrapib 60mg daily plus atorvastatin (at a dose established during the runinperiod)
versus
atorvastatin alone
patients at highcardiovascular riskdouble blind
Follow-up duration: 1.52y
7 countries
RADIANCE 2, 2007
torcetrapib 60mg daily (on top of atorvastatin attitrated dose)
versus
placebo +atorvastatin attitrated dose
patients with mixed dyslipidaemiadouble blind
Follow-up duration: 24 months
North America and Europe
ILLUSTRATE, 2007
NCT00134173
atorvastatin plus 60 mg of torcetrapib daily
versus
atorvastatin monotherapy
patients with coronary diseaseopen
Follow-up duration: 24 months
North America and Europe

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