The essential issue is whether the TROPHY data support the conclusions reported in the New England Journal of Medicine. The March issue of the American Journal of Hypertension publishes a response from TROPHY study investigators Stevo Julius, MD, ScD, Brent M. Egan, MD, and M. Anthony Schork, PhD, defending the work, while authors of the original AJH editorials, Dr. Stephen Persell, Dr. David W. Baker and Dr. Jay I. Meltzer provide further information to support their earlier observations and indicate that their original criticisms remain unaddressed.
In a letter to the editor entitled "From TROPHY with Pride" Dr. Julius, Dr. Egan and Dr. Schork write, "Both editorials directly or obliquely express suspicion about our motivation in designing TROPHY….About eight years ago, we designed a protocol which used a definition of hypertension acceptable to practicing physicians. Furthermore, we stipulated that there should be an active treatment period followed by a period of withdrawal of treatment, and that both periods should be equally long. We also requested that at the study end the raw data be transferred to TROPHY investigators for independent analysis. We spent several years contacting various sponsors. To our delight the then Astra Merck US, now AstraZeneca LTD, accepted the protocol and funded the study. Thus, TROPHY was designed by a group of experts and arose from an abiding interest in the topic rather than from a suspicious relationship with industry."
The letter goes on to address Dr. Meltzer's criticisms of a change of terminology from “high normal blood pressure” to “prehypertension" and the fact that the home blood pressure measurements data was not published in the primary paper. It continues with a discussion of Dr. Persell's and Dr. Baker's concerns about how TROPHY participants were classified as hypertensive and how time-related blood pressure trends were presented in TROPHY.
"Drs. Persell-Baker suggested formation of a national consensus panel for design of future trials," the letter concludes. "Debates without new data are not useful. Hopefully Dr. Meltzer, as well as Drs. Persell and Baker, will design improved studies, and in due course materially contribute to our knowledge. Generally our study has been very well received and new studies are planned. We are proud to have opened novel avenues for clinical research in hypertension."
Stephen Persell, MD, MPH, and co-author David W. Baker, MD, MPH, both of the Feinberg School of Medicine at Northwestern University, argue that “We appreciate that Drs. Julius, Egan and Schork responded to our editorial but disagree with their statement that debates without new data are not useful. We live in a country with a healthcare system that has not been able to meet the needs of the public, even for the most well proven therapies and the costs of healthcare continue to rise. It is appropriate for us to critically appraise studies that could influence which treatments are offered to patients.”
Jay I. Meltzer MD, Clinical Specialist in Hypertension in the Nephrology Division of the Columbia College of Physicians and Surgeons, was not convinced by Dr. Julius’ reply. He remains skeptical of the study design, of changes in terminology and in interpretation of data. Most importantly, he includes figures drawn from the original publication of Julius et al (Trial of preventing hypertension, Design and 2-year progress report. Hypertension. 44:146-151, August 2004), as well as the critical figure from the TROPHY final report to permit readers the chance to judge for themselves whether the data supports the contention that hypertension was prevented. He believes that the data confirm his view “that TROPHY did not prove, as claimed, that treatment of high normal blood pressure, or prehypertension, with candesartan for two years prevented the subsequent development of hypertension, but, paradoxically, probably proved the converse, that it did not.”
The reply to the editorials is “From TROPHY with Pride” by Stevo Julius, MD, ScD, Brent M. Egan, MD, and M. Anthony Schork, PhD. The rejoinders are “Response to ‘From TROPHY with Pride’” by Stephen D. Persell, MD, MPH and David W. Baker, MD, MPH; and “Rebuttal of ‘From TROPHY with Pride’” by Jay I. Meltzer MD. All appear in the American Journal of Hypertension, Volume 20/Issue 3 (March 2007), published by Elsevier.
The original editorials are “Studying Interventions to Prevent the Progression from Prehypertension to Hypertension: Does TROPHY Win the Prize?” by Stephen D. Persell, MD, MPH, and David W. Baker, MD, MPH, and “A Specialist in Clinical Hypertension Critiques the TROPHY Trial” by Jay I. Meltzer MD. Both were published in the November 2006 issue of the American Journal of Hypertension, Volume 19/Issue 11.
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