Published on 15 de May de 2024 | http://doi.org/10.5867/medwave.2024.04.2790

Key factors in the choice of appropriate outcomes for clinical trials

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Examples of dissociation between surrogate and clinically relevant outcomes.
Therapeutic interventionDisease or health conditionSurrogate outcomeClinically relevant outcome
CerivastatinDislipidemiaImprovement in lipid profile.Increased mortality due to rhabdomyolysis.
RosiglitazoneDiabetes mellitusDecrease in HbA1c.Increased cardiovascular mortality.
TorcetrapibDislipidemiaIncrease in plasma levels of HDL cholesterol.Increased all-cause mortality.
FluorideOsteoporosisIncrease in bone mineral densitometry.Increased risk of fractures.

HDL, high-density lipoprotein; HbA1c, glycosylated hemoglobin A1c.

Source: Adapted from [15][18][19][20].