A specialist in clinical hypertension critiques the TROPHY trial.

T he stated purpose of the Trophy trial was “to examine whether early pharmacologic treatment of patients with “high normal” blood pressure would prevent or delay the development of clinical hypertension.” To this end 809 study subjects from 71 different study centers were randomized to receive either 16 mgms. of candesartan or a placebo for two years. After that, all patients were observed on placebo for an additional two years. The only primary end-point was the diagnosis of clinical hypertension. The authors concluded (changing their wording) that “treatment of prehypertension appears to be feasible.” The results of this trial deserve careful scrutiny because they may be used to greatly expand the number of people labeled and targeted for long term drug treatment. There are three key issues compromising the trial’s validity: 1. The way the primary endpoint was determined, including the omission of vital data they claim to have collected. 2. The misuse of the terms “prehypertension” and “feasibility.” 3. The author’s failure to even mention their own predetermined analysis of possible outcomes which, if adhered to, could only have led to their own predefined conclusion, “treatment (with candesartan) not feasible.”