Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Hypertension Experts Clash over TROPHY Study Results

06.03.2007
When the results of a major long-term, multicenter study, the Trial of Preventing Hypertension (TROPHY), were called into question in two editorials published in the November 2006 issue of the American Journal of Hypertension (AJH), it was inevitable that an exchange of views between the study's supporters and detractors would occur.

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.

Yvonne Raiford | alfa
Further information:
http://www.elsevier.com

More articles from Health and Medicine:

nachricht A promising target for kidney fibrosis
21.04.2017 | Brigham and Women's Hospital

nachricht Stem cell transplants: activating signal paths may protect from graft-versus-host disease
20.04.2017 | Technische Universität München

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

Im Focus: Quantum-physical Model System

Computer-assisted methods aid Heidelberg physicists in reproducing experiment with ultracold atoms

Two researchers at Heidelberg University have developed a model system that enables a better understanding of the processes in a quantum-physical experiment...

Im Focus: Glacier bacteria’s contribution to carbon cycling

Glaciers might seem rather inhospitable environments. However, they are home to a diverse and vibrant microbial community. It’s becoming increasingly clear that they play a bigger role in the carbon cycle than previously thought.

A new study, now published in the journal Nature Geoscience, shows how microbial communities in melting glaciers contribute to the Earth’s carbon cycle, a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

7th International Conference on Crystalline Silicon Photovoltaics in Freiburg on April 3-5, 2017

03.04.2017 | Event News

 
Latest News

New quantum liquid crystals may play role in future of computers

21.04.2017 | Physics and Astronomy

A promising target for kidney fibrosis

21.04.2017 | Health and Medicine

Light rays from a supernova bent by the curvature of space-time around a galaxy

21.04.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>