Hypothesis
Extended-release niacin with laropiprant, added to statin therapy, would reduce major vascular events by further lowering LDL and raising HDL cholesterol.
What failed
In 25,673 adults with vascular disease over a median 3.9 years, major vascular events occurred in 13.2% on niacin-laropiprant vs 13.7% on placebo (rate ratio 0.96, P=0.29), while serious disturbances of diabetes control rose by 3.7 percentage points.
Broken assumption
Further lowering LDL and raising HDL with niacin reduces vascular events once patients are on an effective statin.
- Target engaged
- Yes
Why
The lipid changes were real but modest on top of effective statin therapy (LDL about 10 mg/dL lower, HDL about 6 mg/dL higher) and did not translate into fewer events — while adverse events increased.
From the published paper: HPS2-THRIVE Collaborative Group. N Engl J Med, 2014. NCT00461630 ↗