Department of Medicine

Case Western Reserve University School of Medicine & UH Case Medical Center

New England Journal of Medicine editorial :: James Fang, MD

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A substudy of a randomized comparison of medical therapy with or without bypass surgery for ischemic heart disease in patients with LV systolic dysfunction found that overall, substantial viable myocardium evident at baseline imaging studies had no independent bearing on all-cause mortality over five years; and such viability didn’t influence the relative effectiveness of the two treatment strategies, either for all-cause mortality or the secondary end points of CV mortality and CV hospitalization.

The findings, from the Surgical Treatment for Ischemic Heart Failure trial, based on a selected cohort of about half the total trial population, don’t necessarily mean myocardial viability doesn’t have functional implications, observe the substudy authors…

After pointing out the abundant and longstanding but primarily observational support for revascularization guided by viability testing, Dr James C Fang, University Hospitals and Case Medical Center, Cleveland, OH writes in an accompanying editorial that it was “perhaps surprising” that viability didn’t predict a survival benefit from revascularization. The findings, however, “should be interpreted cautiously,” given the substudy’s limitations; for example, patients were selected for viability testing individually at the physicians’ discretion. “However, the substudy’s findings do raise reasonable questions about the most appropriate method to assess myocardial viability,” Fang writes. “The analysis is a strong reminder that in this era of cost-effectiveness, the role of expensive technologies should be accountable to a rigorous study of incremental benefit.”

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BMJ Editorial :: Cystic fibrosis & survival in patients with advanced lung disease

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Elliott Dasenbrook, MD, Assistant Professor of Medicine and Pediatrics, LeRoy W Matthews Cystic Fibrosis Center, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine wrote the following editorial for BMJ.

Cystic fibrosis and survival in patients with advanced lung disease ::
rhDNase slows progression, and is strongly recommended in treatment guidelines”

1st deployment of transcather aortic valve inplantation – TAVI

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The Division of Cardiovascular Medicine successfully deployed the first transcatheter aortic valve implantation [TAVI].

University Hospitals Case Medical Center is one of only forty sites in the U.S. and the only one in Northeast Ohio – to participate in this clinical trial.

TAVI is a state of the art, minimally invasive technique that benefits high-risk elderly patients who develop aortic stenosis.

Novel Clinical Trial Aims to Reduce Recurrence of Aggressive Breast Cancer

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Tuesday, March 08

In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center are exploring a new method to potentially prevent recurrence of an early stage, aggressive type of breast cancer.  The pilot study, conducted by Joe Baar, MD, Director of Breast Cancer Research at UH Case Medical Center’s Seidman Cancer Center, is recruiting patients with HER-2 neu+ breast cancer.

Patients with this form of breast cancer typically have a higher recurrence rate of nearly 25% following initial treatment. This novel study aims to improve outcomes through performing bone barrow biopsies to identify if patients’ cancer has spread and adding an additional cancer-targeting drug to standard therapy.

“This study has the potential to change the standard of care for women with this type of breast cancer, which tends to spread very quickly,” says Dr. Baar, who is also Associate Professor of Medicine at Case Western Reserve University School of Medicine. “A small number of HER-2 neu+ breast cancer patients do not do well following standard therapy. We are hoping to identify these high-risk patients and stop the cancer before it progresses to other parts of the body.”

Case Western Reserve/University Hospitals join nationwide HIV vaccine clinical trial

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The Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit is now screening potential participants for a nationwide HIV vaccine clinical trial (HVTN505) being conducted by the HIV Vaccine Trials Network. The HIV vaccine trial is the first of its kind in Cleveland since 2003.

The trial is testing the safety and effectiveness of a combination of two HIV vaccines to see if they will stimulate an immune response to HIV or decrease the amount of virus in the blood if a person later becomes infected. Neither vaccine can cause HIV infection. The trial, which also is open in 15 other U.S. cities, is looking to enroll 1,350 gay men and transgender women. Participants must be 18-50 years old and HIV-uninfected (negative).

“Historically, vaccines have been key to ending viral epidemics,” said Benigno Rodriguez, MD, an infectious disease physician at University Hospitals (UH) Case Medical Center and assistant professor of medicine at Case Western Reserve School of Medicine. “Even with good antiretroviral therapy, millions of people become newly infected each year. We cannot treat our way out of this epidemic.”

“Throughout the AIDS epidemic, Greater Cleveland’s gay community has consistently supported AIDS-related clinical trials. We believe that the men of Cleveland will want to stand up and learn more about HIV vaccine research. We anticipate that many will be willing to participate in this study,” continued Dr. Rodriguez.

The vaccine trial comes to Cleveland after a year of promising developments in the worldwide search for effective new tools to help stem the AIDS epidemic, now entering its third decade. Last year, clinical trials proved some level of effectiveness for two HIV prevention strategies. The CAPRISA004 study demonstrated for the first time that a microbicide – a gel used by a woman prior to sexual activity, could reduce a woman’s risk of acquiring HIV. Another clinical trial showed that antiretroviral drugs – used to treat people living with HIV – can reduce a person’s risk of acquiring HIV if used consistently prior to sexual contact.

Dr. Gerard Isenberg discusses how antibiotic may become long-awaited treatment for IBS sufferers

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cleveland.com
Featured Physician :: Dr. Gerard Isenberg
Division of Gastroenterology and Liver Disease

An antibiotic may become the first new treatment in a decade for an extremely common, and sometimes debilitating, digestive disorder. The treatment provided long-lasting relief to patients with diarrhea-predominant irritable bowel syndrome (IBS) in a large clinical trial completed at Cedars Sinai Medical Center in Los Angeles.

The results, published Wednesday in the New England Journal of Medicine, provide solid support for the theory that the symptoms of this difficult-to-treat illness are sometimes caused by excess bacteria in the small intestine.

CWRUmedicineIBS is a disorder of the lower intestinal tract that causes pain, bloating, nausea, diarrhea and constipation. It affects up to 20 percent of the population, making it one of the most commonly diagnosed disorders, according to the National Institutes of Health.

The treatment, an oral antibiotic called rifaximin, would be the first medication for patients with diarrhea-predominant IBS in more than 10 years if approved by the FDA. The drug is set for review in IBS patients in March.

It may be a boon for a vast number of patients.

Pimentel’s research has shown that between 30 percent and 80 percent of IBS patients, particularly those who suffer primarily from diarrhea, may have bacterial overgrowth and would benefit from rifaximin.

In the current study, a group of more than 1,200 diarrhea-predominant IBS patients gained significant relief from their symptoms — including bloating, pain and diarrhea — from the antibiotic, compared to a placebo.

Rifaximin is different than other antibiotics because it is minimally absorbed and mainly stays in the intestines, reducing side effects, said Pimentel. Symptom relief continued for 10 weeks of follow-up after the initial two-week dose of medication.

IsenbergDr. Gerard Isenberg, associate chief of the Division of Gastroenterology and Liver Disease at University Hospitals Case Medical Center, has used the therapy on his patients for the past two years as an off-label use. The drug is approved for the treatment of traveler’s diarrhea.

Many have shown dramatic improvement and seen few side effects, he says. “What’s hard about IBS is that it’s usually life-long, and you’re confronted with the question of whether you can repeat treatments of an antibiotic.”

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Treatment with Avastin May be Cut Short

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UH Case Medical Center’s Dr. Joseph Baar explains his hopes for the Avastin, which the FDA will rule on for use in late stage breast cancer patients.

Researcher W. Henry Boom, MD, awarded NIH grant to further study of MTB

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Case Western Reserve University Department of Medicine  is reaping the rewards of funding from the National Institutes of Health (NIH), in the form of grants and contracts.

Researcher W. Henry Boom, MD, Vice Chair of Research, Professor of Medicine and Director of the Tuberculosis Research Unit, is working to tackle the easily transmissible, and often deadly, Mycobacterium tuberculosis (MTB). He received a grant for more than $750,000 from the NIH, with the potential to receive up to $2.8 million over the next four years.

Four steps to reduce diabetes risk

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CNN Health | November 23

Half of all Americans may be diabetic or prediabetic by 2020, a report from an insurance company warned Tuesday. That’s an even bleaker projection than the Centers for Disease Control’s recent estimate that one in three Americans would have diabetes by 2050.

Current rates show that about one in 10 Americans has diabetes, and the risks increase with age. Even children and teenagers are developing type 2 diabetes.

A report released this week by UnitedHealth Group showed that treating diabetes will also take up almost 10 percent of all health care spending. That 10-year price tag: $3.35 trillion.

Despite such gloomy projections, diabetes is not inevitable. Practical health changes can lower risk of type 2 diabetes, which occurs more commonly with aging and sedentary lifestyles. Type 1 diabetes is an autoimmune disease unrelated to aging or lifestyle.

Genetics, race and family history affect a person’s chances of developing diabetes, but you can take steps to lower your risk of type 2 diabetes.

The most important thing: Lose weight

“The heavier we are, the tougher it is for our body,” said Dr. Armand Krikorian, who specializes in endocrinology and diabetes at University Hospitals Case Medical Center in Ohio. “It has to make more insulin to keep the blood sugar under control.”

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Physicians speak out on implications of dabigatran approval

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Cardiology Today | December 1 2010

Expert, Albert Waldo, MD, weigh pros and cons of the first new oral anticoagulant in more than 50 years.

The market for stroke prevention in patients with nonvalvular atrial fibrillation may soon be heading in a new direction with the recent FDA approval of dabigatran etexilate.

This approval came 1 year after data published in The New England Journal of Medicine from the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial reported a reduction in risk for stroke and systemic embolism in patients given dabigatran (Pradaxa, Boehringer Ingelheim) compared with the current standard of care, warfarin (Coumadin, Bristol-Myers Squibb). The 150-mg dose of the newly approved drug was released to pharmacies nationwide on Nov. 3, with the release of the 75-mg dose following shortly afterward.

An economic factor that must be considered, according to Albert L. Waldo, MD, Walter H. Prichard Professor of Cardiology at Case Western Reserve University/University Hospitals Case Medical Center, Cleveland, and Editorial Board member for Cardiology Today’s Arrhythmia Disorders section, is the expected long-term benefits with dabigatran.

“If this drug is significantly better than warfarin, you would hope that there would be fewer complications than from warfarin. So it would be more economical in the long run by keeping people out of hospitals,” Waldo told Cardiology Today. “However, on an individual basis, there is concern about the expense of the pill. So I think it is going to have to filter through our health care system on how drugs get supported by the different insurance plans and see how costly it is going to be for the patient. The hope is that because the drug is better and safer, there will be a lot of cost savings in the long run associated with fewer strokes and less bleeding than in patients taking warfarin.”

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