In Some Men, Taking Testosterone While Dieting May Help Lose Fat, Not Muscle

Newswise, April 5, 2016— In obese middle-aged men, losing weight while dieting normally depletes both fat and muscle. But adding testosterone treatment may help them lose only fat and retain their muscle, new research suggests.

Overall, 40 percent of obese men have a low testosterone. Weight loss due to calorie restriction is associated with increased circulating testosterone, and testosterone treatment reduces fat. However, researchers don’t know whether adding testosterone treatment to calorie restriction reduces fat mass more than calorie restriction alone.

“There is an epidemic of obesity and related functional hypogonadism, yet testosterone treatment remains controversial,” said principal investigator Mathis Grossmann, MD, PhD, FRACP, associate professor in the Department of Medicine at the University of Melbourne in Victoria, Australia.

“This study shows for the first time that, among obese men with lowered testosterone, testosterone treatment augmented the diet-induced loss of total and visceral fat mass and prevented the diet-induced loss of lean mass.”

Dr. Grossman and colleagues conducted a clinical trial of 100 fairly healthy obese men from the local community between 20 and 70 years of age who had low testosterone levels. Overall, 20 percent of them had diabetes and 10 percent had heart disease.

For the first 10 weeks, all participants were placed on a strict 600 kcal per day very-low calorie diet. They were also encouraged to abstain from alcohol and perform at least 30 minutes a day of moderate exercise. From the 11th through the 56th week, participants in both groups used a weight-maintenance diet based on the Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) Total Wellbeing Diet comprising of normal foods.

Every 10 weeks over the 56-week-long study, 49 men also received injections of 1,000mg of intramuscular testosterone undecanoate, and 51 took placebo.

At the end of 56 weeks, both groups lost roughly 11 kg (24.2 lb). But those in the testosterone group lost almost exclusively fat, while those on placebo lost both lean and fat. The men taking testosterone lost 3 kg (6.6 lb) more body fat than those on placebo and maintained their muscle mass, while those on placebo lost 3.5 kg (7.7 lb) of muscle mass.

Australia’s National Health and Medical Research Council supported the study. Bayer Pharma AG provided testosterone, placebo and financial support but was not directly involved in the study

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Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society, which is celebrating its centennial in 2016, has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at http://www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.

Few Patients Use Weight Loss Medications Despite FDA Approval

Newswise, April 5, 2016— Despite guidelines that advocate the use of weight loss medications to treat obesity, and the availability of FDA approved medications, very few patients use this treatment option, a new study suggests.

More than a third of adults in the U.S. have obesity. Lifestyle changes produce modest weight loss and are appropriate for everyone with a weight problem. Surgery is an effective treatment but it is costly, carries risk and is only appropriate for a limited number of people. Weight loss medications can be effective, and guidelines suggest obese patients and their doctors should consider their use for selected patients.

“We looked at how commonly weight loss medications were prescribed to patients for whom guidelines suggest this treatment would be appropriate,” said lead author Daniel Bessesen, MD, Professor of Medicine and Chief of Endocrinology at the University of Colorado and Denver Health Medical Center. “It seems that despite the broad realization that obesity is a problem and that there are available FDA approved medications, few patients use this treatment option.”

In this study, researchers used electronic medical records from nine sites from 2009-2013. They discovered that out of more than 2 million eligible patients, only 1.02 percent received a weight loss medication. The most commonly prescribed medication was phentermine, which is generic and inexpensive, but only FDA approved for three months of use.

Researchers also found that a small number of providers write a vast majority of the prescriptions for weigh loss medications.

“In many other diseases like hypertension and diabetes, treatment with medications is common and considered standard practice,” Bessesen said. “There remain many questions about why so few patients use weight loss medications.”

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Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society, which is celebrating its centennial in 2016, has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at http://www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.

New Study Finds Testosterone Supplementation Reduces Heart Attack and Stroke Risk in Men with Heart Disease

Newswise,  April 5, 2016 — A new multi-year study from the Intermountain Medical Center Heart Institute in Salt Lake City shows that testosterone therapy helped elderly men with low testosterone levels and pre-existing coronary artery disease reduce their risks of major adverse cardiovascular events — including strokes, heart attacks, and death.

The study showed that patients who received testosterone as part of their follow-up treatment fared much better than patients who didn’t. Non-testosterone-therapy patients were 80 percent more likely to suffer an adverse event.

“The study shows that using testosterone replacement therapy to increase testosterone to normal levels in androgen-deficient men doesn’t increase their risk of a serious heart attack or stroke,” said cardiologist Brent Muhlestein, MD, co-director of cardiovascular research at the Intermountain Medical Center Heart Institute. 

“That was the case even in the highest-risk men — those with known pre-existing heart disease.”

The research team studied 755 male patients at Intermountain Healthcare hospitals. The men were between the ages of 58 and 78, and all had severe coronary artery disease. They were split into three different groups, which received varied doses of testosterone administered either by injection or gel.

The conclusions:

• After one year, 64 patients who weren’t taking testosterone supplements suffered major adverse cardiovascular events, while only 12 who were taking medium doses of testosterone and nine who were taking high doses did.

• After three years, 125 non-testosterone-therapy patients suffered major adverse cardiovascular events, while only 38 medium-dose and 22 high-dose patients did.

“Although this study indicates that hypo-androgenic men with coronary artery disease might actually be protected by testosterone replacement, this is an observational study that doesn’t provide enough evidence to justify changing treatment recommendations,” Dr. Muhlestein said. 

“It does, however, substantiate the need for a randomized clinical trial that can confirm or refute the results of this study.”

The new Intermountain Medical Center Heart Institute study corroborates the findings of a 2015 Intermountain study, which found that taking supplemental testosterone didn’t increase the risk of experiencing a heart attack or stroke for men who had low testosterone levels and no prior history of heart disease.

Both Intermountain Healthcare studies address a recent mandate by the U.S. Food and Drug Administration. Last year, the FDA required manufacturers of all approved testosterone products to add labels outlining the coronary risks of the testosterone supplementation.

“The FDA’s warning was based on the best clinical information available at the time,” Dr. Muhlestein said. “As further information, like our research, becomes available — and especially after a large randomized clinical outcomes trial can be accomplished — hopefully the FDA will be able to change its warning.”

In addition to Muhlestein, other researchers involved in the study were Tami L. Bair, RN; Heidi L. May, PhD; Viet Le, PA; Donald L. Lappé, MD; and Jeffrey L. Anderson, MD.

The Intermountain Medical Center Heart Institute is made up of clinical and research professionals who aim to advance cardiovascular treatment. Intermountain Medical Center is the flagship facility for the Intermountain Healthcare system, which is based in Salt Lake City.

Improving Symptoms of Depression Can Reduce Risk of Major Cardiovascular Problems

Newswise, April 5, 2016 — Depression is a known risk factor for cardiovascular disease, but as a person’s depression improves — or grows worse — their risk for heart disease has remained largely unknown.

But now, a new study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City found that effectively treating depression can reduce a patient’s chance of having a stroke, heart failure, a heart attack or death.

In fact, effective treatment for depression can reduce a patient’s heart risks to the same level as those who never had short-term depression, the study found.

“Our study shows that prompt, effective treatment of depression appears to improve the risk of poor heart health,” said Heidi May, PhD, a cardiovascular epidemiologist with the Intermountain Medical Center Heart Institute.

“With the help of past research, we know depression affects long-term cardiovascular risks, but knowing that alleviating the symptoms of depression reduces a person’s risk of heart disease in the short term, too, can help care providers and patients commit more fully to treating the symptoms of depression,” she said. “The key conclusion of our study is: If depression isn’t treated, the risk of cardiovascular complications increases significantly.”

Dr. May presented her findings at the 2016 American College of Cardiology Scientific Sessions in Chicago on April 2.

Researchers haven’t completely understood whether a short-term encounter with depression affects a person’s cardiovascular risk forever, or how changes in the symptoms of depression over time affect cardiovascular risk.

Dr. May and her team found answers to these questions by studying data compiled in Intermountain Healthcare’s depression registry, a database of more than 100,000 patients.

“There’s little publically-available data about this question,” Dr. May said.

“But now with the help of Intermountain’s depression registry, we have the ability to start answering some of these difficult questions.”

The Intermountain Medical Center Heart research team compiled information from 7,550 patients who completed at least two depression questionnaires over the course of one to two years.

Patients were categorized based on the results of their survey as never depressed, no longer depressed, remained depressed, or became depressed. Following each patient’s completion of the last questionnaire, patients were followed to see if they had any major cardiovascular problems such as a stroke, heart failure, heart attack or death.

At the conclusion of the study, 4.6 percent of patients who were no longer depressed had a similar occurrence of major cardiovascular complications as those who had no depression at all (4.8 percent).

Those who remained depressed, however, and those who became depressed throughout the study, had increased occurrences of major cardiovascular problems — their rates were 6 and 6.4 percent, respectively. Treatment for depression resulted in a decreased risk of cardiovascular risk that was similar to someone who didn’t have depression.

As for the practical application of this study, Dr. May said the research indicates that effective treatment for depression decreases the risk of having cardiovascular problems in the short term, but further study is needed to identify exactly what that treatment should include.

“What we’ve done thus far is simply observe data that has previously been collected,” Dr. May said. “In order to dig deeper, we need do a full clinical trial to fully evaluate what we’ve observed.”

Because of the complex nature of depression, it’s hard to say whether depression leads to risk factors associated with cardiovascular problems, such as high blood pressure, high cholesterol levels, diabetes or a lack of exercise — or if it’s the other way around.

Results from the study indicate that changes in depression symptoms may also cause immediate physiological changes in the body, which in turn cause major cardiovascular problems to occur in the short term, but future studies are needed to further answer these questions.

Other researchers involved in the study include Kimberly Brunisholz, PhD; Benjamin Horne, PhD; Brent J. Muhlestein, MD; Tami Bair, RN; Donald Lappé, MD; Adam B. Wilcox, PhD; and Brenda Reiss-Brennan, PhD, APRN.

Intermountain Medical Center is the flagship facility for the Intermountain Healthcare system, which is based in Salt Lake City. 

Adding Stress Management to Cardiac Rehab Cuts New Incidents in Half

 Newswise, March 28, 2016-- Patients recovering from heart attacks or other heart trouble could cut their risk of another heart incident by half if they incorporate stress management into their treatment, according to research from Duke Health.

 

The findings, published March 21 in the American Heart Association journal Circulation, are the result of a randomized clinical trial of 151 outpatients with coronary heart disease who were enrolled in cardiac rehabilitation due to heart blockages, chest pain, heart attacks or bypass surgery. They ranged in age from 36 to 84 years old.

About half of the patients participated in three months of traditional cardiac rehabilitation, which included exercise, a heart-healthy diet and drugs to manage cholesterol and high blood pressure.

The other half went to cardiac rehab and also attended weekly, 90-minute stress management groups that combined support, cognitive behavior therapy, muscle relaxation and other techniques to reduce stress. Patients were followed for an average of three years after rehab.

Thirty-three percent of patients who received only cardiac rehabilitation had another cardiovascular event such as a heart attack, bypass surgery, stroke, hospitalization for chest pain or death from any cause. By comparison, 18 percent of the patients who participated in stress-management training during their cardiac rehabilitation had subsequent cardiovascular trouble -- about half the rate of the other group.

Both sets of patients who went to rehab fared better still than recovering heart patients who elected not to attend rehab; 47 percent of this group later died or had another cardiovascular incident, according to the article.

Reducing stress may seem like an obvious part of any plan for improving heart health, said lead author James Blumenthal, Ph.D., a clinical psychologist and professor in psychiatry and behavioral sciences at Duke.

“Over the past 20 to 30 years, there has been an accumulation of evidence that stress is associated with worse health outcomes,” Blumenthal said. “If you ask patients what was responsible for their heart attacks, most patients will indicate that stress was a contributing factor.”

 But stress management is typically not part of most cardiac rehabilitation programs, he said.

“I think part of the issue is that stress is hard to define, and there’s no universally accepted way of measuring it or treating it,” Blumenthal said. “The data we provide indicate that by reducing stress, patients can improve clinical outcomes, even beyond the benefits that we know exercise already has on reducing stress and improving cardiovascular health.”

For the trial, patients’ stress levels were measured using five standard instruments on which participants self-reported their levels of depression, anxiety, anger and perceived stress. Overall, those who participated in stress management reported reductions in anxiety, distress and their overall level of perceived stress.

Both groups that participated in cardiac rehabilitation saw similar and significant physical improvements in their cholesterol levels and proteins that indicate heart disease-related inflammation, as well as their exercise capacity.

"We have known for some time that participation in a supervised exercise program is beneficial in patients with coronary heart disease,” said Alan Hinderliter, M.D., cardiologist with UNC Health Care and co-investigator on the trial.

“The results of this study suggest that stress management is also a very important element of a comprehensive cardiac rehabilitation program. The intervention was clearly helpful in reducing stress levels, but we need additional research to confirm the benefits of stress management in improving cardiovascular outcomes.”

Although death rates from heart disease have improved, it remains the No. 1 cause of death in the U.S. and is growing worldwide, according to the American Heart Association.

In addition to Blumenthal and Hinderliter, study authors included Andrew Sherwood, Ph.D.; Patrick J. Smith Ph.D.; Lana Watkins Ph.D.; Stephanie Mabe; William E. Kraus, M.D.; Krista Ingle, Ph.D.; and Paula Miller, M.D.

The National Heart, Lung, and Blood Institute, a component of the National Institutes of Health, supported this study (R01HL093374-01A2). The authors reported no conflicting financial interests.

Financial Burden of Cancer Survivors

Health and quality of life negatively affected

March 28, 2016--An analysis of US data from 2011 indicates that nearly 29 percent of cancer survivors are financially burdened as a result of their cancer diagnosis and/or treatment.

Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the study also reveals that such hardships can have lasting physical and mental effects on cancer survivors.

Few studies have assessed the impact of cancer-related financial burden on cancer survivors' quality of life. To investigate, Hrishikesh Kale, MS, and Norman Carroll, PhD, of Virginia Commonwealth University School of Pharmacy, analyzed 2011 Medical Expenditure Panel Survey data on 19.6 million cancer survivors.

They considered financial burden to be present if one of the following problems was reported: borrowed money/declared bankruptcy, worried about paying large medical bills, unable to cover the cost of medical care visits, or other financial sacrifices.

The researchers found that nearly 29 percent of US cancer survivors reported at least one financial problem resulting from cancer diagnosis, treatment, or lasting effects of that treatment.

Of all cancer survivors in the analysis, 21 percent worried about paying large medical bills, 11.5 percent were unable to cover the cost of medical care visits, 7.6 percent reported borrowing money or going into debt, 1.5 percent declared bankruptcy, and 8.6 percent reported other financial sacrifices.

Cancer survivors who faced such financial difficulties had lower physical and mental health-related quality of life, higher risk for depressed mood and psychological distress, and were more likely to worry about cancer recurrence compared with cancer survivors who did not face financial problems.

Also, as the number of financial problems reported by cancer survivors increased, their quality of life continued to decrease and their risk for depressed mood, psychological distress, and worries about cancer recurrence continued to increase.

The investigators also identified the effects of different types of financial problems on quality of life: declaring bankruptcy was associated with a 20 percent to 25 percent reduction in quality of life, while worrying about paying large medical bills was associated with a reduction of 6 percent to 8 percent.

"Our results suggest that policies and practices that minimize cancer patients' out-of-pocket costs can improve survivors' health-related quality of life and psychological health," said Dr. Carroll.

"Reducing the financial burden of cancer care requires integrated efforts, and the study findings are useful for survivorship care programs, oncologists, payers, pharmaceutical companies, and patients and their family members."

Mr. Kale noted that oncologists should consider selecting treatments that are less expensive but similar in effectiveness, discuss treatment costs with patients, and involve patients in making decisions about their therapy.

"Also, cancer patients and family members should educate themselves regarding survivorship issues, coverage and benefit design of their health plans, and organizations that provide financial assistance. Cancer survivorship care programs can identify survivors with the greatest financial burden and focus on helping them cope with psychological stress, anxiety, and depression throughout their journey with cancer."

Conservative Care May Be a Reasonable Option for Elderly Kidney Failure Patients

Dialysis may not prolong patients’ survival

Among kidney failure patients aged ≥80 years, there was no statistically significant survival advantage for those who chose dialysis over conservative management.'

Half or more of all patients on dialysis are aged ≥65 years in some countries.

Newswise, March 18, 2016— A new study found no significant survival advantage among elderly kidney failure patients who chose dialysis over conservative management. The findings, which appear in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN), indicate that conservative care may be a reasonable choice for selected older patients.

Worldwide, increasing numbers of older patients are developing kidney failure, or end-stage renal disease (ESRD), that can be treated with renal replacement therapy such as kidney transplantation or dialysis.

Some experts have questioned whether older patients, who often have other medical conditions, are likely to benefit from these treatment options and should instead opt to be treated conservatively, with care that includes control of fluid and electrolyte balance, correcting anemia, and providing appropriate palliative and end of life care.

To look at the issue, a team in the country where hemodialysis was originally invented compared survival in older patients with ESRD who chose either dialysis (204 patients) or conservative management (107 patients) between 2004 and 2014. In this single-center observational study, investigators led by Wouter Verberne, MD and Willem Jan Bos, MD,PhD (St. Antonius Hospital, Nieuwegein, in The Netherlands) found no statistically significant survival advantage among patients aged ≥80 years old who chose dialysis over conservative management. In general, patients with additional medical illnesses died sooner than patients without comorbidities.

“We do not conclude that dialysis treatment should not be given to anybody ≥80 years or with severe comorbidity, but we show that the treatment is on average of little advantage regarding survival,” said Dr. Verberne.

“Our next task is to predict who benefits and who does not. Until we are able to give a better prediction of the results of dialysis treatment at high age, we can merely suggest that conservative management is an option which should honestly be discussed when ESRD is approaching.” Dr. Verberne added that more research is needed to determine how different treatment options affect patients’ other outcomes, such as quality of life and severity of symptoms.

In an accompanying editorial, Helen Tam-Tham, MSc and Chandra Thomas, MSc, MD (University of Calgary, in Canada) noted that conservative management programs can vary considerably from place to place. “Further research is necessary for enhancing and evaluating the multiple components necessary for a comprehensive conservative management program,” they wrote.

Study co-authors include A.B.M. Tom Geers, MD, PhD, Wilbert Jellema, MD, PhD, Hieronymus Vincent, MD, PhD, and Johannes van Delden, MD, PhD.

Disclosures: This research was made possible thanks to an unrestricted grant from Roche (Woerden, The Netherlands) to the St. Antonius Research Fund.