#1 ST. FRANCIS―authors state “study was underpowered and undertreated”. |
#2 IDEAL―not blinded and better adherence to control than atorvastatin intervention. |
#3 FIELD―More placebo subjects added confounding statin therapy (p < 0.001). |
#4 4D―Atorvastatin reduced the rate of all cardiovascular events combined (p < 0.03). |
#5 ASPEN―Protocol changed at 2 years from secondary to primary intervention. |
#6 WHI―Only 8.6% of the participants had lipid profiles measured. |
#7 ILLUMINATE―Trial terminated early due adverse effects of the CETP inhibitor. |
#8 CDRONA―Heart failure only patients, usually excluded from CVD trials. |
#9 SEAS―Simvastatin plus ezetimibe reduced all ischemic CVD events (p < 0.02). |
#10 GISSI-HF―Study examined death from heart failure, irrespective of cause. |
#11 AURORA―The extremely high CRP indicating inflammation was never reduced. |
#12 SEARCH―Excessive myopathy in the simvastatin arm vs. control (53 vs. 2). |
#13 AIM-HIGH―In a niacin trial, all patients also received simvastatin plus ezetimibe. |
#14 SDHS―Critical data lost, no LDLc data reported. Protocol out of date. |
#15 HPS2-THRIVE―Niacin caused a significant increase in diabetes, bleeding, etc. |
#16 ACCELERATE―The CETP inhibitor raised blood pressure & C-reactive protein. |
#17 HIJ-PROPER―Ezetimibe significantly reduced CVD events in hyper-absorbers. |
#18 EMPATHY―Japanese study which lost patients and data during an earth quake. |
Most of the above unanticipated flaws occurred in the execution and follow-up of the study and were not included in the initial design of the study protocol. |