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April 23/30, 2003

JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

THIS WEEK'S CONTENTS

JAMA NEWS RELEASES

>   CALCIUM CHANNEL BLOCKERS NOT ANY MORE EFFECTIVE THAN DIURETICS OR β-BLOCKERS IN REDUCING RISK FOR ADVERSE CARDIOVASCULAR EVENTS IN HYPERTENSIVE PATIENTS

>   LIFESTYLE CHANGES THAT LOWER BLOOD PRESSURE CAN REDUCE THE RISK OF CARDIOVASCULAR DISEASE

>   SURVEY OF FORENSIC PHYSICIANS IN MEXICO INDICATES TORTURE AND ILL TREATMENT OF DETAINEES

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

>   MAKING DIET AND EXERCISE LIFESTYLE CHANGES CONCURRENTLY CAN DRAMATICALLY IMPROVE BLOOD PRESSURE


CALCIUM CHANNEL BLOCKERS NOT ANY MORE EFFECTIVE THAN DIURETICS OR β-BLOCKERS IN REDUCING RISK FOR ADVERSE CARDIOVASCULAR EVENTS IN HYPERTENSIVE PATIENTS

CHICAGO—The calcium channel blocker verapamil did not show significant increased effectiveness compared to a diuretic and β-blocker in reducing the risk of cardiovascular events in patients with hypertension, according to an article in the April 23/30 issue of the Journal of the American Medical Association (JAMA).

Patients diagnosed as having hypertension are often given a calcium channel blocker to reduce cardiovascular disease risk, but the benefit compared with other drug classes is controversial, according to background information in the article.

Henry R. Black, MD, of Rush-Presbyterian–St Luke's Medical Center, Chicago, Ill, and colleagues conducted a study to determine whether initial therapy with controlled-onset extended release (COER) verapamil is equivalent to atenolol (a β-blocker) or hydrochlorothiazide (a diuretic) in preventing cardiovascular disease. The Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) Trial was a double-blind, randomized clinical trial conducted at 661 centers in 15 countries.

A total of 16 602 participants diagnosed as having hypertension and who had 1 or more additional risk factors for cardiovascular disease (such as diabetes or cigarette smoking) were enrolled between September 1996 and December 1998 and followed up until December 31, 2000. The trial included 8179 participants who received 180 mg of COER verapamil and 8297 who received either 50 mg of atenolol or 12.5 mg of hydrochlorothiazide. The primary endpoints were stroke, heart attack, or cardiovascular disease–related death.

After an average follow-up of 3 years, the sponsor closed the study (2 years early, "for commercial reasons") before unblinding the results, according to the authors.

"Systolic and diastolic blood pressure were reduced by 13.6 mm Hg and 7.8 mm Hg for participants assigned to the COER verapamil group and by 13.5 and 7.1 mm Hg for participants assigned to the atenolol or hydrochlorothiazide group. There were 364 primary cardiovascular disease–related events that occurred in the COER verapamil group vs 365 in atenolol or hydrochlorothiazide group," they write. "The treatment regimens showed some minor and statistically nonsignificant differences in the incidence of each component of the primary end point. The incidence of acute [heart attack] was about 18% lower with COER verapamil than with the atenolol or hydrochlorothiazide group; this benefit was offset by a 15% higher risk of stroke."

The authors conclude, "In summary, CONVINCE was unable to demonstrate equivalence of a COER verapamil-based antihypertensive regimen and a regimen beginning with a diuretic or β-blocker. When considered in the context of other trials of calcium antagonists, including the larger Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), which found that the calcium channel blocker amlodipine was not superior to the diuretic chlorthalidone, in reducing the rate of coronary heart disease or stroke and was associated with a higher rate of heart failure, these data indicate that the effectiveness of calcium channel blocker therapy in reducing cardiovascular disease–related morbidity and mortality is similar but not better than diuretic or β-blocker treatment. These data support the recommendation of the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for low-dose diuretic (or possibly β-blocker) therapy for hypertensive patients who have no specific indication for another antihypertensive drug."
(
JAMA. 2003;289:2073-2082)

Editor's Note: This trial was supported by grants and contracts from G. D. Searle & Co (Skokie, Ill) and Pharmacia (Peapack, NJ). For the financial disclosures of the authors and the role of the sponsor, please see the JAMA article.

EDITORIAL: STOPPING MEDICAL RESEARCH TO SAVE MONEY—A BROKEN PACT WITH RESEARCHERS AND PATIENTS

In an accompanying editorial, Bruce M. Psaty, MD, PhD, of the University of Washington, Seattle, and Drummond Rennie, MD, Deputy Editor, JAMA, Chicago, Ill, address the issue of the CONVINCE trial being stopped 2 years early for commercial reasons by the sponsor. They acknowledge that there are important legitimate reasons to stop a clinical trial early, including evidence of clear harm or benefit or inadequate power. They question the early stoppage of CONVINCE.

" ... the recruitment and involvement of human research participants places clinical trials in a category decidedly distinct from the customary swapping and trading of traditional goods and services. When patients or other research participants are recruited for scientific investigations, they agree willingly to expose themselves to risk. Individuals often participate out of a sense of altruism, and counted among the most important reasons for joining trials are the improvements in their own health, the contributions to science, and the improvement of the health of others," they write. "If CONVINCE had been continued to the originally planned completion, the improved blood pressure control associated with trial participation might well have produced substantial health benefits."

"The participants in CONVINCE were not only deprived of personal benefit from the completed trial, but also the social benefit of genuine scientific contributions from an adequately powered study. If the conduct of a seriously underpowered study is unethical, the willful creation of an underpowered study by the early stopping of CONVINCE seems unethical as well. What the company apparently treated as a simple commercial matter rendered the original promise to participate in research that contributes substantively to medical knowledge impotent, useless, or fraudulent."

"Medical research, even if it is conducted by the pharmaceutical industry, is not solely a commercial enterprise designed to maximize personal gain or company profits. The responsible conduct of medical research involves a social duty and a moral responsibility that transcends quarterly business plans or the changing of chief executive officers," they write. "The findings of CONVINCE have been hobbled by the early stopping of this trial. Not only is power inadequate, but the investigators were placed in the difficult position of closing out the trial safely and on short notice."

They add that in its current form, CONVINCE adds little new information to the other recent comparative trials.

They conclude: "In light of ALLHAT, switching appropriate patients to low-dose diuretic therapy would at once improve health outcomes for patients and, one prescription change at a time, whisper an evidence-based reminder to the pharmaceutical industry about the social value and the public health importance of large long-term trials that are successfully brought to completion."
(JAMA. 2003;289:2128-2130)

Editor's Note: Dr Psaty is supported in part by grants from the National Heart, Lung, and Blood Institute, Bethesda, Md; from the National Institute on Aging, Bethesda; and from the AHA (American Heart Association) Pharmaceutical Roundtable Outcomes Research Program, Dallas, Tex.

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LIFESTYLE CHANGES THAT LOWER BLOOD PRESSURE CAN REDUCE THE RISK OF CARDIOVASCULAR DISEASE

CHICAGO—Patients with high blood pressure and stage 1 hypertension who make lifestyle changes to lower their blood pressure also reduce the risk of developing cardiovascular disease (CVD), according to an article in the April 23/30 issue of the Journal of the American Medical Association (JAMA).

According to information in the article, high blood pressure (BP) is a risk factor for CVD. Almost 50 million US adults (approximately 25% of the US adult population) have hypertension, defined as a BP of 140/90 millimeters of mercury (mm/Hg) or higher and/or currently use antihypertensive (BP-lowering) medication. Hypertension risk increases with age, and approximately half of all people 60 years or older have hypertension, and the estimated lifetime risk for developing hypertension is 90%. Lifestyle modifications that lower BP are weight loss, reduced salt intake, increased physical activity, limited alcohol consumption, and a balanced diet, especially the Dietary Approaches to Stop Hypertension or DASH diet, which emphasizes eating fruits, vegetables, low-fat dairy products, whole grains, poultry, fish, and nuts and is reduced in fats, red meats, and sweets.

Lawrence J. Appel, MD, MPH, of the John Hopkins Medical Institutions, Baltimore, Md, and colleagues investigated the effectiveness of lifestyle changes on BP.

The researchers studied 810 adults (average age, 50 years; 62% women; 34% African American) with above-optimal BP, including stage 1 hypertension (120-159 mm Hg systolic and 80-95 mm/Hg diastolic) and who were not taking antihypertensive medications. Patients who participated in this randomized trial were enrolled at 4 clinical centers from January 2000 to June 2001, and were randomly assigned to 1 of 3 groups: "established," a behavioral intervention that used established recommendations for lifestyle changes for lowering BP (n=268); "established plus DASH," which also used the DASH diet (n=269); and an "advice-only" comparison group (n=273).

The researchers found that both of the behavioral interventions significantly reduced weight, increased fitness levels, and lowered sodium intake. The established plus DASH intervention also increased fruit, vegetable and dairy intake. From baseline to 6 months, the mean reduction in systolic BP (the top number in blood pressure) were 6.6 mm Hg in the advice-only group, 10.5 mm Hg in the established group, and 11.1 mm Hg in the established plus DASH diet group.

Compared with the 38% prevalence of hypertension at the beginning of the study, the prevalence at 6 months was 26% in the advice only group, 17% in the established group, and 12% in the established plus DASH group. The prevalence of optimal BP (<120 mm/Hg systolic, and <80 mm/Hg diastolic) was 19% in the advice-only group, 30% in the established group, and 35% in the established plus DASH group.

"In summary, our trial results demonstrate the feasibility of comprehensive behavioral interventions and their beneficial effects on BP and hypertension control," write the authors. "Benefits extend to both nonhypertensive individuals at risk for developing hypertension and hypertensive individuals who are not receiving medication therapy."

"Ultimately, population-wide adoption of healthy lifestyles as promoted in the PREMIER [the current study] interventions should substantially reduce the societal burden of CVD and other chronic diseases."
(
JAMA. 2003;289:2083-2093)

Editor's Note: This work was supported by grants from the National Institutes of Health, Bethesda, Md.

EDITORIAL: LIFESTYLE MODIFICATION AND BLOOD PRESSURE CONTROL

In an accompanying editorial, Thomas G. Pickering, MD, DPhil, of Mount Sinai Medical Center, New York, NY, writes, "Perhaps the most important issue is how these new findings should be interpreted and put into practice. While it is often stated that nondrug treatment is less expensive and has fewer adverse effects than drug treatment, this is not necessarily the case."

"Interventions such as those studied in the PREMIER trial require numerous counseling sessions to achieve their results and are not feasible in everyday practice. Nevertheless, for whatever reason, the advice-only group in the PREMIER trial did have a substantial decrease in blood pressure," writes Dr Pickering. "Physicians should certainly continue to counsel patients using the type of advice provided to the advice-only group of the PREMIER study ... "

"Beyond this, it is worth focusing on weight, the risk factor most likely contributing most to the patient's level of risk. Weight loss has many benefits for obese and overweight individuals other than lowering blood pressure. For normal-weight individuals with hypertension, the DASH diet also may be beneficial," Dr Pickering concludes.
(JAMA. 2003;289:2131-2132)

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SURVEY OF FORENSIC PHYSICIANS IN MEXICO INDICATES TORTURE AND ILL TREATMENT OF DETAINEES

CHICAGO—A survey of forensic physicians in Mexico indicates that detainees experience torture and ill treatment, according to an article in the April 23/30 issue of the Journal of the American Medical Association (JAMA).

According to background information in the article, torture and ill treatment of detainees commonly occur in more than half of the world's countries and have devastating physical, psychological, and social health consequences. In response to this problem, physicians and other health professionals worldwide are playing crucial roles in efforts to investigate and document medical evidence, treat torture survivors, prevent torture, and oppose any form of physician involvement in torture. International and Mexican human rights organizations have documented torture of detainees (ie, those held and indicted but not sentenced) in all 31 states and the Federal District of Mexico, but little is known about the attitudes and experiences of forensic physicians who examine detainees.

Michele Heisler, MD, MPA, of the Physicians for Human Rights, Boston, Mass, and colleagues assessed forensic physicians' experiences with and attitudes toward torture and ill treatment of detainees in Mexico examined in the previous year. With the support of the Mexican Office of the Federal Attorney General, as part of a larger initiative to implement governmental reforms to eradicate torture in Mexico, an anonymous survey designed to assess correspondence of physician practices and attitudes with international standards on forensic investigation and documentation of torture was distributed to all federal forensic physicians (n=115) and a convenience sample of state forensic physicians (n=99) in Mexico in 2002.

The researchers wanted to determine estimates of the numbers of federal detainees medically evaluated and numbers of cases of suspected, alleged, and documented torture or ill treatment among federal detainees; factors interfering with documentation of forensic evidence; physicians' attitudes toward torture; measures that would help them document torture; and recommendations for reform.

Survey responses were received from 93 (81%) federal and 91 (92%) state forensic physicians. "Forty-nine percent of federal physicians and 58% of state physicians reported that torture is a severe problem for detainees in Mexico. Federal physicians estimated that they had conducted 26 445 to 30 650 or more medical evaluations of the 13 000 federal detainees in the past year and that between 1658 and 4850 of these detainees had alleged torture; these physicians also estimated that they had documented evidence of torture in a range of 285 to 1090 cases," they write.

Among the federal forensic physicians responding to this survey, 40% "had suspected torture and/or ill treatment of detainees examined during the previous year, 64% had examined detainees who alleged these practices had occurred, and 49% had documented forensic evidence of torture among these detainees. Respondents reported that lack of photographic equipment and services (58%), inadequate monitoring and accuracy of medical examinations (36%), inadequate documentation of torture (29%), limitations in their training (28%), fear of reprisals for documenting torture (23%), and fear of coercion by police officials (18%) are factors that interfere with documentation of torture and ill treatment of detainees. Respondents further reported the need for additional training (98%), standardized protocols and documentation procedures for use in cases of alleged or suspected torture and/or ill treatment (81%), and monitoring to ensure the quality and accuracy of medical evaluations (95%)," the researchers add.

"In conclusion, torture and ill treatment of detainees continues to be a significant problem in Mexico and is facilitated by a number of factors. Forensic physicians support measures to improve forensic documentation of torture and ill treatment of detainees, including specialized training, standardized protocols, and documentation procedures, as well as monitoring of the quality and accuracy of medical evaluations in cases of alleged torture and ill treatment. Such measures must be integral components of broader efforts to hold perpetrators accountable and eliminate torture."
(
JAMA. 2003;289:2135-2143)

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JAMA REPORTS

MAKING DIET AND EXERCISE LIFESTYLE CHANGES CONCURRENTLY CAN DRAMATICALLY IMPROVE BLOOD PRESSURE

VIDEO:
NAT SOT UP FULL FOR :03 Health care provider checking Charles' blood pressure


AUDIO:
Sound of blood pressure being taken

VIDEO:
B-ROLL Health care provider checking Charles' blood pressure

Charles on treadmill

Fruit in supermarket

Blood pressure cuff


AUDIO:
CHARLES VALLETTE LOWERED HIS HIGH BLOOD PRESSURE BY MAKING A NUMBER OF LIFESTYLE MODIFICATIONS ... HE EXERCISED MORE, LIMITED PORTION SIZES, ATE MORE DAIRY, ATE 9 TO 10 SERVINGS OF FRUITS AND VEGETABLES A DAY, AND CUT BACK ON THE SALT IN HIS DIET. IN JUST 6 MONTHS HIS BLOOD PRESSURE WENT FROM 150 OVER 90, DOWN TO WHAT DOCTORS CALL OPTIMAL ... 120 OVER 70.

VIDEO:
SOT/FULL @: 23 Super: Charles Vallette (lowered his blood pressure), Runs: 10


AUDIO:
"I'm very pleased with the results. I lost 23 pounds and I feel a lot healthier than I did before the program, and it's a program I can continue for the rest of my life."

VIDEO:
B-ROLL Dr Appel at desk/computer

Women exercising

African American woman getting BP checked

Man eating in restaurant

More exercising

GFX
JAMA cover

AUDIO:
CHARLES WAS PART OF A STUDY LED BY DR LAWRENCE APPEL (apple) OF THE JOHNS HOPKINS MEDICAL INSTITUTIONS. DR APPEL AND HIS COLLEAGUES WANTED TO KNOW 2 THINGS ... COULD PEOPLE WITH HIGH BLOOD PRESSURE MAKE ALL KINDS OF LIFESTYLE CHANGES AT ONCE, INSTEAD OF JUST FOCUSING ON DIET OR EXERCISE? AND, WOULD THESE CHANGES REDUCE HIGH BLOOD PRESSURE? THEY STUDIED 810 PEOPLE, PUTTING THEM IN DIFFERENT GROUPS. SOME TRIED JUST A FEW LIFESTYLE CHANGES, AND OTHERS TRIED MAKING LOTS OF CHANGES. THE RESULTS APPEAR IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL @: 1:02 Super: Lawrence Appel, MD, MPH, Johns Hopkins Medical Institutions, Runs: 12


AUDIO:
"People who were assigned to make all the lifestyle changes achieved the lowest blood pressure, had the best blood pressure control and achieved an optimal blood pressure and that was significantly better than the other groups."

VIDEO:
B-ROLL Blood pressure cuff

People eating


AUDIO:
IN FACT, THE NUMBER OF PEOPLE WITH HIGH BLOOD PRESSURE WAS REDUCED BY TWO THIRDS. DR APPEL ADMITS THAT CHANGING YOUR DIET AND EXERCISING MORE CAN BE TOUGH, BUT THE RESULTS ARE WELL WORTH IT.

VIDEO:
SOT/FULL Lawrence Appel, MD, MPH, Johns Hopkins Medical Institutions, Runs: 12


AUDIO:
"It may actually be a means to control blood pressure and a lot of heart disease and stroke without actually relying on medication".

VIDEO:
Charles on treadmill


AUDIO:
CHARLES VALLETTE SAYS IF HE CAN DO IT, ANYONE CAN.

VIDEO:
SOT/FULL Charles Vallette (lowered his blood pressure), Runs: 09


AUDIO:
I'm sure that others could do what I've done to lower their blood pressure. It just takes a little determination, but the results come quick and they're good results."

VIDEO:
B-ROLL Charles on treadmill


AUDIO:
GOOD RESULTS THAT CAN LITERALLY SAVE YOUR LIFE. THIS IS MAVIS PRALL REPORTING.

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