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(Hypertension. 2004;44:125.)
© 2004 American Heart Association, Inc.
Editorial Commentaries |
From the University of Texas Southwestern Medical Center, Dallas.
Correspondence to Norman Kaplan, University of Texas Southwestern, Department of Internal Medicine, Hypertension Division, 5323 Harry Hines Blvd., Dallas TX. E-mail norman.kaplan@utsouthwestern.edu
An extract of the first 250 words of the full text is provided, because this article has no abstract. |
The article "Trial of Preventing Hypertension (TROPHY): Design and 2-Year Progress Report" by Stevo Julius et al in this issue of Hypertension1 provides assurance that this ground-breaking trial will likely be successful in providing the first evidence in humans of the ability to delay, if not stop, the development of hypertension by the use of an antihypertensive drug.
To their credit, the investigators obtained financial support from the pharmaceutical marketer of an angiotensin II-receptor blocker, an appropriate choice in view of the cited animal data on the particular ability of angiotensin-converting enzyme (ACE) inhibitors to prevent hypertension in susceptible rats. They carefully selected 809 middle-aged subjects at 71 study centers. The subjects had "high-normal" BP (ie, 130 to 139 systolic or 85 to 89 diastolic) and were, as expected, moderately overweight (body mass index=29.9±5.3).
The protocol randomly allocated the subjects to take either active therapy with candesartan 16 mg/day or placebo for 2 years, followed by another 2 years of only placebo for both groups. The end point is the development of clinical hypertension (ie, BP above 140/90 mm|Hg anytime during the entire 4 years). As they explain, this prolonged placebo-follow-up should obviate problems of interpretation of changes during or immediately after active therapy. The study was able to enroll fewer patients than projected for adequate statistical power, but the likelihood for a successful conclusion is buttressed by a lower rate of dropout and a higher rate of clinical hypertension in those who were enrolled.
The authors shrewdly propose a
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