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Critique of Re‐Analysis of the TROPHY Study

To the Editor: Two recent letters to the editor of The Journal of Clinical Hypertension suggested reevaluation of the Trial of Preventing Hypertension (TROPHY). Six years after publication, despite extensive valid criticism, it still holds interest for some hypertension specialists. Both letters suggest that the only problem with TROPHY was the artefact in measuring office blood pressure (BP) to diagnose clinical hypertension, and that reassessment of the visit-to-visit BP variation would solve it. As I pointed out in my critique, the problems are much deeper. The most serious was even highlighted by Dr Julius himself in a manuscript published midway into the study. His prospective analysis of the data predicted 5 possible scenarios “to guide analysis” and “ensure a priori objectivity of conclusions.” Each scenario was represented by a Kaplan-Meier graph of patient BPs after stopping 2 years of daily candesartan therapy. They were “Masking Hypertension,” “Eliminating Hypertension,” two forms of “Delaying Hypertension,” and “Slow Unmasking of Hypertension. As I previously concluded in, with the editors of the American Journal of Hypertension in agreement, only “Slow Unmasking” fitted the actual Kaplan-Meier curve of TROPHY. It is unfortunate that Dr Julius and coauthors never addressed the issues they raised in TROPHY, apparently wishing to forget their a priori analysis, performed only 2 years before. Independently, the basic BP data of TROPHY showed a return to control values within 9 months of stopping candesartan, leading Norman Kaplan in Uptodate to conclude “there is no evidence that transient antihypertensive therapy changes the course of prehypertension or hypertension.” Finally, the conclusions of TROPHY have no standing for two additional reasons: there were no events, and the gold standard for BP measurement, ambulatory BP monitoring, was not used. Both should be required before recommending new therapeutic ideas. Since the prevalence of “prehypertension” is 37% in US adults, any suggestion of drug treatment that could result in the medicalization of multi-millions of asymptomatic people should be done on solid evidence. Unfortunately, that is lacking in TROPHY.