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eDigest Spring 2013


Fighting Fatty Liver with Vitamin E

Patients at risk for progressive liver disease could get a healthy boost by taking vitamin E. In a randomized study at Cleveland Clinic sponsored by the National Institutes of Health (NIH), patients with advanced fatty liver disease—known as non-alcoholic steatosis hepatitis (NASH)—were given Vitamin E, the diabetes drug pioglitazone (Actos®), or a placebo for about two years.

Liver biopsies before and after treatment showed that liver function in patients taking vitamin E improved by 44 percent compared with a 19 percent improvement in the placebo group.

“This was the first trial to actually look at what type of treatments might be effective for people with NASH,” says Arthur McCullough, MD, gastroenterologist at Cleveland Clinic’s Digestive Disease Institute. He served as the principal investigator at the Cleveland site for the vitamin E study and is Co-chair of the Ancillary Studies Committee of the NIH-funded Clinical Research Network of Fatty Liver Disease. Cleveland Clinic is one of eight centers participating in a long-term NIH study of NASH.

Vitamin E is known for its antioxidant properties and role in decreasing inflammation and enhancing the immune system. But this study presents the vitamin in a new, exciting light. Study participants taking Actos (which is no longer used to treat diabetes because of concerns over increased risk of bladder cancer) improved to some extent, but gained an average of 10 pounds during the study period.

Meanwhile, in a later study at Cleveland Clinic using the drug pentoxifylline (Trental®), patients with fatty liver disease, some of whom were diabetes patients, also benefited from using the drug. (None of the patients in the vitamin E trial were previously diagnosed with diabetes.)

“We showed that vitamin E worked, and Trental worked,” Dr. McCullough says. This is important because of the limited treatment options for NASH. Dr. McCullough says NASH affects about one-third of the U.S. adult population and 15 percent of children and adolescents under 18. It is the third most common cause for liver transplant, “and it’s on track to be the most common cause in eight years or so,” he says.

Continuing this research, Cleveland Clinic recently completed a study in which NASH patients were given fish oil or a placebo. “Through our research, we are testing various treatments that will prevent these patients from developing complications from NASH—basically, progressive liver injury, cirrhosis, and the need for liver transplantation,” Dr. McCullough says.

The next phase of fatty liver research will include investigating its link to heart disease. “We are recognizing that people with fatty liver disease have an independent risk factor for developing heart disease,” Dr. McCullough says, noting that Cleveland Clinic is in the early stages of developing a study.


Cleveland Clinic Florida Adds HIPEC for GI Cancers

Since introducing hyperthermic intraperitoneal chemotherapy (HIPEC) at Cleveland Clinic in 2009, the Digestive Disease Institute has performed nearly 100 procedures to date using this alternative and innovative method of delivering chemotherapy. Now, Cleveland Clinic Florida has established a HIPEC program to expand access to this potentially lifesaving procedure.

The first Florida patient was treated in February 2013 as a result of collaboration between clinicians in the Section of Surgical Oncology at Cleveland Clinic’s main campus in Ohio and colleagues at Cleveland Clinic Florida in Weston.

Sricharan Chalikonda, MD, a general surgeon who pioneered use of HIPEC at Cleveland Clinic main campus, is working closely with Conrad Simpfendorfer, MD, a hepato-pancreato-biliary and transplant surgeon at Cleveland Clinic Florida. Dr. Chalikonda is helping to establish the Florida HIPEC program and advising on the first and most complex cases.

HIPEC is a powerful tool that utilizes regional infusion of heated chemotherapy to fight cancer directly in the abdomen in combination with cytoreductive surgery, Dr. Chalikonda explains. Lower exposure to systemic chemotherapy side effects and prolonged survival (for some patients, according to early data) are among the advantages.

“The partnership with Cleveland Clinic main campus will allow patients and physicians to be confident that complex patients in Florida are going to get the exact same level of care they get at our main campus,” Dr. Chalikonda says.

Since HIPEC isn’t widely available in Florida, Dr. Simpfendorfer notes, many patients were opting to go up to Cleveland Clinic main campus, which was the first FDA-approved program in Ohio and remains one of few programs in the country offering the technology.

The extension of HIPEC to Florida was, therefore, natural – as was the collaboration between Drs. Chalikonda and Dr. Simpfendorfer, who trained together as residents.

The initial Cleveland Clinic Florida patient was a man in his early 50s with a pseudomyxoma peritoneal mucinous tumor of the appendix. Its relatively slow progression gave Dr. Simpfendorfer a few months to prepare both the patient and the program. “The patient was interested only in having surgery at Cleveland Clinic. He was willing to wait two to three months. He was young and otherwise healthy – an ideal first case.”

HIPEC, however, is not for everyone. “Patient selection is critical,” Dr. Simpfendorfer says. The cancer needs to be confined to the peritoneal cavity. Patients also need to be strong enough to undergo both cytoreductive surgery and HIPEC.

Drs. Chalikonda will continue to consult regularly with Dr. Simpfendorfer to ensure Florida patients who want Cleveland Clinic’s HIPEC expertise can get the procedure locally. Such a close collaboration also may benefit the so-called “snow birds” who split their time between Florida and Cleveland by offering a previously unavailable continuity of care.

“They can see both of us throughout the year because their care and our shared electronic medical records are seamless,” Dr. Chalikonda says.


Digestive Disease Clinical Trials

Highlights of our featured clinical trials in both Cleveland and Florida:

IRB 12-716 Ursula Szmulowicz, MD
Disease: Fecal Incontinence
A Prospective, Single-Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI).

Summary: For patients who have been diagnosed with fecal incontinence. The purpose of this study is to evaluate the long term safety and efficacy of an injectable gel (Solesta®) for the treatment of fecal incontinence. Solesta is a gel that is injected locally with the aid of an anoscope (a hollow tube with light illumination) into the lining of the wall of the anal canal. The purpose of this treatment is to narrow (bulk up) this area to improve control of leakage of stool. The device is intended to be a permanent implant; once injected, it can only be removed by surgery. There will be up to 8 visits over a 3-year period.

IRB 12-180 Bret Lashner, MD
Disease: Ulcerative Colitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of CP-690,550 for the Induction of Clinical Remission in Subjects with Moderate to Severe Ulcerative Colitis.

Summary: For patients who have moderately to severely active ulcerative colitis (UC). The purpose of this study is to find out if a new investigational drug, called tofacitinib can help people with UC. Tofacitinib blocks a group of enzymes which act like a gate into the cells of the immune system (the body’s defense against infection). By blocking these enzymes, the cells of the immune system are expected to produce fewer chemicals believed to cause bowel inflammation in UC. The study will compare the effects of tofacitinib to a placebo in patients with UC. Participation will last about 15 weeks including at least 7 clinic visits.

IRB 13-371 Mansour Parsi, MD
Disease: Primary Sclerosing Cholangitis (PSC)
Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC).

Summary: For patients age 18-65 who have primary sclerosing cholangitis (PSC), a disease in which fibrosis (scarring) occurs in the liver. The study drug (an injection by you) is designed to help prevent the progression of liver fibrosis in people with PSC. Participation will last about 108 weeks (including a screening period that can last up to eight weeks) with at least 29 clinic visits required. Participants will be randomized to receive one of three treatment groups. Blood samples will be taken approximately 26 times throughout the course of the study, 9 electrocardiograms (ECG) and may have up to 3 liver biopsies and 2 MRCPs (Magnetic Resonance Cholangiopancreatography).

IRB 13-277 Arthur McCullough, MD
Disease: Non-Alcoholic Steatohepatitis (NASH)
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 ( LOXL2) in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH).

Summary: For patients age 18-65 who have advanced fibrosis (scar tissue) of the liver as a result Non-Alcoholic Steatohepatitis (NASH). The study drug (an injection by you) is designed to help reverse the scarring process, and the aim of this study is to see if this can reverse the advanced fibrosis in your liver and prevent cirrhosis. Participation will last about 108 weeks with at least 29 clinic visits required. Participants will be randomized to receive one of three treatment groups. Blood samples will be taken approximately 27 times throughout the course of the study, and up to 3 liver biopsies will be done.

For more information, please call 216.636.5340.

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