Studies Flashcards
(17 cards)
Nurse Health Study
Pop: healthy nurses
I: lifestyle choices (physical activity, diet, smoking, alcohol)
O: MACE
R: increase in good lifestyle choices —- reduced RRR of MACE
ASCOT LLA trial
P: HTN pts 40-79yrs w/ at least 3 different CV RF (primary prevention in those with CV risk)
I: atorvastatin 10mg (intermediate)
C: placebo
O: hard clinical outcomes (MI and stroke)
R: decrease in hard composite outcomes by 25% (statin use decreases these by 25%)
Treat to Target
Pop: patients with CAD (secondary prevention)
I: statin therapy with titrating dose to reach LDL target of 1.31.8
C: high intensity statin (R 20mg or A 40mg)
O: composite of death, MI, stroke, or coronary revascularization
R: non-inferior bw fixed dose vs titrating in 2nd prevention
- no differences in SEs/ harms either
- no differences in incidence of DM in 2nd prevention (didn’t increase or decrease incidence)
Jupiter
—- this is the one primary prevention study that used a high dose statin (R 20mg) to see its impact on CV events
- looked at use in pts with high hs-CRP
is there any direct studies that compare different intensities of statins in primary prevention
Nope
Helsinki Heart Study
Pop: men w/out CVD and non HDL > 5.2 (primary prevention)
—- important to note that 35% were smokers (higher than general pop)
I: gemfibrozil
C: placebo
O: incidence of fatal + nonfatal MI and sudden cardiac death
R: RRR of 20-30% (can be used as stain alternative in primary)
—- later studies showed no benefit
Field trial
P : T2Dm
I: fenofibrate + statin
- saw reduction in non fatal MI + coronary revascularization (no impact on fatal events)
Result: combo of statin + fibrates not recommended BUT can be considered in those with high TG
LRC CPPT Trial
pop: men bw 35-59 w/out CVD if total cholesterol > 6.8 (primary prevention)
I: cholestyramine
C: placebo
O: nonfatal MI + CHD death
R: no real impact on mortality but did have a significant impact on composite outcome (CHD death + MI)
no modern studies looking at combo of cholestryamine + statin
IMPROVE It
pop: pts with ACS within past 10 days (2nd prevention)
I: simvastatin 40mg + ezetimibe
C: simvastatin 40mg by itself
** wrong dose — should be high intensity statin bc 2nd
O: non fatal MI or non fatal stroke, CHD
R: decrease in outcome in 2nd prevention ( benefit in combo of the 2 over just the statin)
FOURIER + ODYSSEY
Fourier - evolocumab
Odyssey: alirocumab
P: pt with CVD + on max dose stain already (2nd prevention, looking as add on)
I: E/A + statin vs statin by itself
O: MACE
R: showed decrease in MACE in 2nd prevention
- evidence for use in 2nd prevention in those who are on max dose statin + high risk
- also indicated for homo or hetero FH on max statin
OFF label: primary prevention in super high risk pts on max statins
ORION
trials about inclisiran that are going on right now
— ORION 4: looking at CV outcome trials (clinical outcomes)
- was approved for market based on impact on surrogate markers (50% decrease in LDL)
AIM High
pop: 2nd prevention (pts with CVD)
I: simvastatin 40-80mg + ER niacin (2000mg target a day)
C: simvastatin
O: death from CHD, nonfatal MI, ischemic stroke, hospitalization for an ACS
—- trial ended early due to increase risk of ischemic stroke in treatment group
ELIPSE HoFH
looked at Evinacumab (ANGPTL3 inhibitor): inhibits ANGPTL3 (enzyme that normally inhibits LPL and therefore VLDL + chylo breakdown — increase in TG)
— showed decrease
used as add on therapy for those with homo FH
Reduce It
P: 70% had CVD + 30% DM + other RF
—- all on statins + TG 1.5-5.6
I: add on to statin
C: statin
O: CV death, nonfatal MI, nonfatal stroke, coronary revascularization, unstable angina
R: decrease in primary outcome by 25%
—- can be used in 2nd prevention (add on) or primary prevention (add on if DM, 1+ CV RF) as long as on statins + TG 1.5-5.6
HPS2 THRIVE TRIAL
pop: 50-80 yrs w/ vascular disease (2nd)
I: simvastatin 40mg + niacin ER 2g daily + laropipant
—- laropipant to help with SEs of niacin (prostaglandins D2 R1 antagonist to prevent flushing but also causes platelet aggregation)
O: first major vascular event
R: increased mortality seen in treatment group
Accelerate trial
Pop: 2nd prevention ( those with ACS within past 30-365 days, CAD, PAD, or DM + CAD
I: Evacetrapib
C: placebo
O: death by CV causes, MI, stroke, hospitalization due to unstable angina
result: no impact on clinical outcomes despite decrease in LDL
CLEAR CV trial
pop: pts w/ statin intolerance (little average statin dose daily) and have CVD or are at high risk of CVD (primary + secondary)
—— high risk is Reynolds score >30% or SCORE >7.5% over 10 years, coronary artery calcium score > 400, or T1/T2DM >65(W) or > 60 (M)
I: bempedoic acid
C: placebo
O: CVD death, nonfatal MI, nonfatal stroke , coronary revascularization
R: decrease in LDL by 25% + impact on MACE (no impact on mortality)
— evidence for alternative to statin when meet criteria for increased risk (primary prevention)
—- not approved yet as monotherapy for high risk pts (primary)
can be used as 2nd prevention in combo with statins
