XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
  Hypertension
   Pulmonary Hypertension
  CAD
  Myocardial Infarction
  CHF
  Clinical Trials
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Oct 27th, 2006 - 16:45:19

American Journal of Hypertension

Hypertension Channel
subscribe to Hypertension newsletter

Latest Research : Cardiology : Hypertension

   DISCUSS   |   EMAIL   |   PRINT
Is TROPHY misleading?
Oct 27, 2006, 16:39, Reviewed by: Dr. Rashmi Yadav

"Further straining the question of applicability is the confusion between what the authors said they would do and what they actually did. They renamed TROPHY a 'feasibility' study, without specifically defining the term."

 
There may be as many as 70 million Americans with prehypertension. If these people can be treated pharmacologically to avoid or delay progression to clinical hypertension, there would be significant benefits to them and the overall health of the population. The recent TROPHY study seems to lead to that conclusion. However, two editorials published in the November issue of the American Journal of Hypertension emphatically argue that the study is flawed and the conclusions reached are misleading.

Persons with prehypertension, generally defined as having a systolic blood pressure in the range of 120-139 mm Hg or a diastolic blood pressure of 80-89, will usually develop hypertension at the rate of about 10% per year. The recent Trial of Preventing Hypertension (TROPHY) examined whether treating patients with candesartan for two years resulted in a sustained reduction in the incidence of high blood pressure after the drug was discontinued. The TROPHY study concluded that the treatment significantly reduced the risk of incident hypertension over the four year study.

According to Stephen Persell, MD, MPH, TROPHY results are likely invalid. He and co-author David W. Baker, MD, MPH, both of the Feinberg School of Medicine at Northwestern University, argue that the study used an unusual definition of incident hypertension which could not accurately discriminate whether the drug had a sustained effect. They demonstrate that because blood pressure readings taken during active treatment were combined with readings taken after treatment had ended, a difference between treatment and placebo could appear even if blood pressures were identical after the treatment had ended. They also analyze how the results could be misleading due to the methods used to calculate the mean blood pressures.

In the second editorial, Jay I. Meltzer MD, Clinical Specialist in Hypertension in the Nephrology Division of the Columbia College of Physicians and Surgeons, also zeros in on the study endpoint. He argues that clinical practitioners would require a more realistic, classical definition of incident hypertension than was used in TROPHY.

Dr. Meltzer also identifies two other issues in the study. He explains, "Further straining the question of applicability is the confusion between what the authors said they would do and what they actually did. They renamed TROPHY a 'feasibility' study, without specifically defining the term. It usually means a pilot study, but TROPHY was not designed as a pilot�Clinicians rightly suspect bias when the trial language is changed post hoc to allow more accommodation to the data." Finally, he argues that the major conclusion that the drug did prevent the development of hypertension was compromised by the choice of an arbitrary endpoint.

Persell and Baker caution that "the consequences of drawing erroneous conclusions from studies of treatments to prevent progression from pre-hypertension to hypertension are enormous. An expert panel of statisticians and trial methodologists without ties to pharmaceutical companies should be convened to provide consensus recommendations for how future studies addressing the prevention of hypertension should be conducted and reported. Computer models should also be used to confirm that the study methodology would not make it appear that a treatment for prehypertension had sustained benefits when, in fact, none existed."

Dr. Meltzer is equally direct. "What conclusions might actually be appropriate? TROPHY proved that two years of candesartan treatment of patients with 'high normal' or 'prehypertension' did not prevent or delay the development of hypertension, but instead caused a 'slow unmasking.' Reasonable acceptance of the author's own predetermined guidelines for the interpretation of 'slow unmasking' would have necessitated publishing a negative study, which, paradoxically, could have been a great benefit to the hypertension literature. Instead, TROPHY was presented in a way that enables those who want to believe in the original idea despite the evidence against it, still can and still do. Even as the authors trumpet candesartan's success in the paper's conclusions and in public presentations, the conclusion section of TROPHY paradoxically states that they do not advocate treating the 25 million people with prehypertension, but don't explain why."
 

- The editorials are published in the November issue of the American Journal of Hypertension
 

http://www.elsevierhealth.com/

 
Subscribe to Hypertension Newsletter
E-mail Address:

 

The 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 appear in the November issue of the American Journal of Hypertension, Volume 19/Issue 11, published by Elsevier.



Related Hypertension News

Uric acid levels closely related to hypertension in Blacks
Is TROPHY misleading?
High blood pressure induces low fat metabolism in heart muscle
Beta Blockers No More First Choice for Hypertension
Job stress does not raise blood pressure
Blood Pressure Readings Lower when Patients Slow Down
Promising evidence of new drug therapies in Pulmonary arterial hypertension (PAH)
Fewer hours of sleep could lead to hypertension
Loneliness linked to high blood pressure in aging adults
Grape seed extract may be effective in reducing blood pressure


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us