FDA approves new treatment for Type 2 diabetes

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.

People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “It is effective when used alone or when added to existing treatment regimens.”

Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.

Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.

Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

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FDA approves new treatment for large brain aneurysms

The U.S. Food and Drug Administration has approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.

An aneurysm is a bulge in the wall of a blood vessel, which can rupture as it increases in size, causing hemorrhage or death. Brain aneurysms often produce no symptoms until they grow and press on nerves in the brain, or until they begin to leak blood or rupture.

Aneurysms can be repaired in two ways: surgeons can close the base of the aneurysm with a surgical clip, or use a technique commonly known as coiling, in which surgeons use a catheter to thread metallic coils through a blood vessel in the groin and into the blood vessel in the brain that contains the aneurysm. Surgeons then fill the aneurysm with the detachable coils, which block it from circulation and cause blood to clot, effectively destroying the aneurysm.

Aneurysms larger than 10millimeters are difficult to treat with clipping or coiling. The cPAX Aneurysm Treatment System is indicated for use in those brain aneurysms.

“Like coiling, the cPAX Aneurysm Treatment System is a form of endovascular repair,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “But instead of tiny metallic coils, it uses a special polymer material to fill the space within the aneurysm.”

The cPAX polymeric filler material can be secured in the aneurysm in one of two ways, either by insertion through openings in a permanent stent, which is a tiny metal scaffold placed along the vessel wall, or by using a temporary balloon catheter to block off the opening to the aneurysm and keep the filler material from coming out of the aneurysm as it is being delivered.

By filling the bulging space within the aneurysm with implant material, the blood flow through the aneurysm is stopped and any remaining space around the implant material clots. When filled with implant material and blood clot, and the risk of rupture of the aneurysm decreases.

The cPAX Aneurysm Treatment System was approved on April 1, 2011, under a Humanitarian Device Exemption (HDE). The HDE makes medical devices available to patients with rare medical conditions that affect fewer than 4,000 people a year. The approval for this HDE was based on safety data from two studies of 43 subjects.

The cPAX device system is indicated for use in adults ages 22 and older and should not be used in patients with an active infection or in those in whom anticoagulation and antiplatelet therapy is contraindicated.

The cPAX Aneurysm Treatment System is manufactured by Neurovasx Inc., Maple Grove, Min.

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American Heart Association Meeting Report- Metabolic Abnormalities in Obese Teens May Relate to Poor Diets

/PRNewswire/ -- Obese teens may feel healthy, but blood tests show they have inflammation, insulin resistance, and high homocysteine levels, researchers report at the American Heart Association's Nutrition, Physical Activity and Metabolism/Cardiovascular Disease Epidemiology and Prevention 2011 Scientific Sessions.

"The metabolic abnormalities suggest that the process of developing heart disease has already started in these children, making it critical for them to make definitive lifestyle and diet changes," said Ashutosh Lal, M.D., senior author of the study and a pediatric hematologist at the Children's Hospital and Research Center Oakland in California.

Researchers compared the diets and blood test results of 33 obese youths (ages 11 to 19) with 19 age-matched youths of normal weight. Obesity in youths is a body mass index (BMI) higher than the 95th percentile of children the same age. Normal weight youths had a BMI below the 85th percentile. Body mass index is a measure of weight related to height. Two thirds of the participants in both groups were girls. All of the participants were receiving regular health maintenance care at an inner city clinic in Oakland.

Blood tests revealed that the obese teens had:

* C-reactive protein levels almost ten times higher than controls, indicating more inflammation in the body.
* Insulin resistance, a precursor to type 2 diabetes, with greater amounts of insulin needed to keep blood sugar levels normal.
* Homocysteine levels 62 percent higher than controls. High levels of the amino acid homocysteine are related to greater heart disease risk.
* Total glutathione levels 27.9 percent lower than controls, with oxidized glutathione levels 125 percent higher. A higher ratio of oxidized to non-oxidized glutathione indicates oxidative stress, an imbalance in the production of cell-damaging free radicals and the body's ability to neutralize them. Oxidative stress leads to more inflammation and an increase in blood vessel damage and stiffening.


"Looking at the numbers you would think these children might feel sick, but they did not," Lal said. "They are apparently feeling well, but there is a lot going on beneath the surface."

Dietary quality was poor in all the children – low in fresh produce, fiber, and dairy products. On questionnaires, obese and normal-weight children reported consuming similar amounts of grains, proteins, fats and total calories. However, the obese children reported significantly fewer servings of dairy products and tended towards fewer fruit servings. The obese children's diets were lower in potassium, vitamin C, vitamin D, and vitamin A, found in fortified dairy products and as well as in deeply colored fruits and vegetables.

With such poor dietary quality in both the obese and control groups, clinicians should pay more attention to what their young patients are eating, researchers said.

"Obese teens were consuming too few of the natural sources of anti-oxidants, fruits and vegetables, and may have increased antioxidant needs based on the inflammation associated with their extra adiposity," Lal said. "For their heart health, obese teens need to eat better, not just eat less."

Though the study's participants attended an inner city health clinic, researchers said the metabolic differences between obese and normal-weight teens would be found in all socioeconomic groups.

The children in the study were racially diverse. The obese group was 39 percent African-American, 30 percent non-African-American Hispanic, 18 percent Caucasian and 6 percent Asian and 7 percent other. The control group was 21 percent African-American, 5 percent Hispanic, 42 percent Caucasian, 21 percent Asian and 11 percent other.

This study was funded by the Clinical and Translational Science Institute, University of California, San Francisco, and the Bruce and Giovanna Ames Foundation.

Co-authors are: Michele Mietus-Snyder, M.D.; Jung H. Suh, Ph.D.; Bruce N. Ames, Ph.D.; and Betty Flores, P.N.P. Author disclosures are on the abstract.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding. 

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FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis

The U.S. Food and Drug Administration today (March 4) announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning.

In patients with PAH, Letairis slows the worsening of symptoms and improves the ability to exercise. Approved in 2007, Letairis is in a class of medications called endothelin receptor antagonists, which stop the action of endothelin, a substance that narrows blood vessels and prevents normal blood flow in those with PAH.

“We have concluded that monthly liver enzyme testing for patients taking Letairis, as previously noted in the boxed warning, is not necessary,” said Mary Ross Southworth, Pharm.D., deputy director for safety in the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Health care professionals should still continue to order liver enzyme tests when they consider it clinically indicated.”

Letairis was approved with a Risk Minimization Action Plan (RiskMAP) to manage liver damage and fetal malformation. The RiskMAP called for liver enzyme testing prior to treatment and monthly during treatment for all patients. It also required monthly pregnancy testing for women of childbearing potential because Letairis causes birth defects in animals, like other drugs in this class. The Letairis RiskMAP was converted to a Risk Evaluation and Mitigation Strategy in 2009.

The boxed warning on the risk of serious birth defects and the contraindication for use during pregnancy will remain in the labeling. Letairis will continue to be available only through a restricted distribution program called the Letairis Education and Access Program (LEAP). For women who can become pregnant, monthly pregnancy tests will still be required before Letairis is shipped.

The liver warnings were based on experience with other drugs in Letairis’ drug class, as well as a few observed instances of increased liver enzymes in people treated with Letairis. The FDA’s further evaluation has shown that rates of liver problems in Letairis-treated patients are consistent with rates within the general PAH population. In the controlled clinical trials, the rates of liver problems in Letairis-treated patients are similar to the rates in people receiving an inactive pill (placebo).

For a discussion of the FDA’s rationale and regulatory decisions regarding Letairis, refer to the Drug Safety Communication issued today.

People who take Letairis should not stop taking it without talking to their health care professional. Health care professionals should order and review tests for liver function as necessary based on the patient’s condition and history. Adverse events involving Letairis should be reported to the FDA MedWatch program1.

Letairis is made by Gilead Sciences Inc., Foster City, Calif.

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FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension

/PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved EDARBI (azilsartan medoxomil) for the treatment of hypertension, or high blood pressure, in adults. EDARBI is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. EDARBI is approved as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications.

Takeda Global Research & Development Center, Inc. U.S. submitted a new drug application (NDA) for EDARBI in April 2010. The NDA was supported by seven controlled phase 3 clinical trials involving more than 5,900 patients with hypertension. Pivotal phase 3 studies showed EDARBI (80 mg/day) was statistically superior to placebo and the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40 mg/day) and valsartan (320 mg/day), in lowering both clinic and 24-hour mean blood pressure measurements.

"We are pleased to be able to build upon our global expertise in the cardiovascular therapeutic area with the approval of EDARBI in the U.S.," said Shinji Honda, president and CEO, Takeda Pharmaceuticals North America. "Through the discovery, development and commercialization of new medicines, Takeda is committed to bringing therapies like EDARBI to market. EDARBI is an important new treatment option for patients with hypertension and the health care professionals who treat them."

The safety and efficacy of EDARBI were studied as a once-daily oral therapy, as well as in combination with chlorthalidone and amlodipine. Results from the phase 3 clinical trials showed EDARBI successfully met the primary endpoint, change in 24-hour mean systolic blood pressure (SBP) as measured by Ambulatory Blood Pressure Monitoring, with statistical significance of lowering blood pressure compared to placebo and head-to-head active comparators. Specifically, results from one study showed EDARBI at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.3 mm Hg and 13.2 mm Hg from baseline, respectively. The blood pressure reductions of EDARBI (80 mg/day) were statistically superior to those of the active comparators valsartan 320 mg/day (-10.0 mm Hg) and olmesartan medoxomil 40 mg/day (-11.7 mm Hg). Similar results were observed in all three comparator studies. The most common adverse reaction in adults was diarrhea (2%).

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

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FDA approves additional medical indication for Sprycel

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells.

In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the treatment’s safety and effectiveness.

Other FDA-approved drugs to treat various forms of CML include Gleevec, approved in May 2001, and Tasigna (nilotinib), approved in October 2007.

The FDA granted Sprycel a priority review for Ph+ CP-CML.

This is the third drug approved for Ph+ CP-CML under accelerated approval, a process allowing the FDA to approve a drug to treat a serious disease with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. A company is required to collect additional long term efficacy and safety information data confirming the drug’s benefit. The accelerated approval program provides earlier patient access to promising new drugs while confirmatory clinical trials are being conducted.

“These drugs have dramatically changed the lives of patients with CML,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease.”

In CML, too many blood stem cells develop into a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. These cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or unexpected bleeding may occur.

One open-label, randomized clinical trial in patients with CP-CML evaluated the safety and effectiveness of Sprycel. The trial measured complete cytogenetic response (CCyR) and cytogenetic response (MCyR), gene-based indicators of how well the malignant cells respond to the treatment. The most commonly reported side effects of Sprycel included decreased bone marrow activity resulting in fewer red and white blood cells and platelets (myelosuppression), fluid retention, diarrhea, headache, musculoskeletal pain, and rash.

Sprycel is marketed by New York City-based Bristol-Myers Squibb. Tasigna and Gleevec are marketed by East Hanover, N.J.-based Novartis Pharmaceuticals.

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FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart's two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.

"People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Stockbridge says.

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating also were reported.

Pradaxa was approved with a Medication Guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.

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House, Senate Put Forth Legislation to Renew Funding, Bolster Nation's Bone Marrow and Umbilical Cord Program

/PRNewswire/ -- The National Marrow Donor Program® (NMDP) today applauded the introduction of the "Stem Cell Therapeutic and Research Reauthorization Act of 2010." Sens. Orrin Hatch (R-UT), Christopher Dodd (D-CT), Richard Burr (R-NC), Jack Reed (D-RI), John Ensign (R-NV), and Al Franken (D-MN) introduced the act in the U.S. Senate as S. 3751 on Thursday, Aug. 5. Last evening, Reps. C.W. Bill Young (R-FL) and Doris Matsui (D-CA) introduced the companion legislation, (H.R. 6081), in the House. This legislation seeks to reauthorize the C.W. Bill Young Cell Transplantation Program (National Program) and the National Cord Blood Inventory (NCBI). These programs must be reauthorized before the NCBI sunsets.

Last year 12,000 patients searched the national registry, publicly known as the Be The Match Registry®, for a marrow donor or umbilical cord blood unit. Congressional support of the National Program and the NCBI is critical to ensure all patients have access to transplant.

"I am pleased with the introduction of this legislation and continued bipartisan support," said Jeffrey W. Chell, M.D., chief executive officer of the NMDP. "The reauthorization will provide us with the opportunity to continue our efforts to increase the number of adult donors and umbilical cord blood units available through the National Program."

Since its inception in the mid-1980s, the NMDP has operated the National Program awarded via a competitive bid process administered by the Health Services Resources Administration (HSRA). Every day, the National Program helps thousands of patients with leukemia, certain lymphomas, and other life-threatening diseases find a matching donor or umbilical cord blood unit. For many of these patients, a transplant may be the best or only hope for a cure. To date, the NMDP has facilitated more than 40,000 transplants. This accomplishment would not have been possible without the ongoing, sustained support of Congress and its efforts to increase unrelated marrow and cord blood transplants in the United States.

The proposed legislation demonstrates the continued federal commitment to these programs and recognizes the importance of providing patients and physicians with a single point of access to marrow and cord blood units that can be used for transplant. It also addresses the importance of building a diverse registry of marrow donors and cord blood units. Additionally, the legislation includes modifications necessary to continue the successful work of these programs.

The NMDP applauds the hard work and dedication of Congress to produce a bipartisan and fiscally responsible bill that will assist the NMDP in advancing its life-saving mission. The NMDP looks forward to working with Congress, and its network partners in the transplant community including, physicians, cord blood banks, donors, patients, and their families, to gain additional support for continued success of cellular transplantation.

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Drug for Erectile Dysfunction and Pulmonary Hypertension Improves Heart Function in Children and Young Adults With Single Ventricle Heart Disease

/PRNewswire/ -- Heart function significantly improved in children and young adults with single ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

Single ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood. Examples include: tricuspid atresia, pulmonary atresia/intact ventricular septum and hypoplastic left heart syndrome.

The Fontan operation is a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third surgery in a staged palliation for single ventricle heart defects.

Researchers hypothesized that sildenafil may help cardiac performance by directly improving the squeeze of the heart muscle and by allowing for better filling of the heart.

In this study, researchers randomized 28 children and young adults who had undergone the Fontan operation to receive placebo or sildenafil three times a day for 6 weeks. After a 6 week break, subjects were switched to the opposite treatment course. The researchers found significant improvement in heart performance during treatment with sildenafil.

"The enhanced heart performance may improve exercise performance and quality of life in these children and young adults," said David J. Goldberg, M.D., pediatric cardiologist at The Children's Hospital of Philadelphia, who presented the abstract today at the American Heart Association Scientific Sessions in Orlando, Fla.

Grants from The Mark H. and Blanche M. Harrington Foundation and from Big Hearts to Little Hearts provided funding for this study.

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FDA Approves New Treatment for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. Products may receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live longer or with fewer side effects of a disease.

“The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra's effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.

The most serious side effects of Arzerra are increased chance of infections, including progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. Patients at high risk for Hepatitis B should be screened before being treated with Arzerra. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

Arzerra is manufactured by London-based GlaxoSmithKline.

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Mayo Clinic Proceedings: Common Blood Disorder May Not be Linked to as Many Serious Diseases, as Previously Thought

A symptomless blood disorder, monoclonal gammopathy of undetermined significance, known as MGUS, is not linked to as many serious diseases as previously thought. This finding may save patients from undergoing unnecessary workup and treatment according to a study published in the August 2009 issue of Mayo Clinic Proceedings.

MGUS has long been thought to be a precursor of serious disease, such as multiple myeloma, primary amyloidosis and Waldenström macroglobulinemia. However, for years physicians have reported possible association of MGUS with many more diseases. As a result, some patients with MGUS who had these disorders were subjected to investigations and sometimes additional treatments as a precaution.

MGUS is a fairly common disorder, affecting roughly 3 percent of the U.S. population. This study was supported in part by grants from the National Institutes of Health and the U.S. Public Health Service.

In this study, researchers looked at the records of 17,398 patients, all of whom were uniformly tested for the presence or absence of MGUS. Among the 17,398 samples tested, 605 cases of MGUS were identified. The researchers then looked at the incidence of over 16,000 different diagnosis codes in those with MGUS and those without. They identified 14 real disease associations, while 61 disease associations with MGUS were determined to be likely coincidental.

In addition to multiple myeloma, the associations deemed real include vertebral and hip fractures and osteoporosis. "In addition to the article, we have made available on the journal Web site an appendix that has the raw data on all 16,062 hospital diagnosis codes which we think will be valuable to other researchers in the field," says S. Vincent Rajkumar, M.D., of Mayo Clinic's Department of Hematology and senior author on the study.

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com.
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FDA Clears a Test for Ovarian Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

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Piedmont Fayette Hospital Auxiliary Hosts Blood Drive

Piedmont Fayette Hospital's Auxiliary will host an American Red Cross Blood Drive on Thursday, Aug. 13, from noon until 5 p.m. The American Red Cross bloodmobile will be located in the parking area of Piedmont Fayette Hospital’s 1279 Building. The current blood supply has dropped critically low throughout the Southeast according to the American Red Cross. Donors of all blood types are welcome, but there is an urgent need for type O negative, B negative and A negative blood donors. Giving blood is simple and convenient, you must be healthy, at least 17 years old and weigh at least 110 pounds. You must not have donated whole blood in the last 56 days.

Donating blood is a simple process that helps to save more than five million people in need of blood transfusions each year in the United States, according to the American Red Cross. Blood is needed every two seconds in the United States for emergency medical situations. It is always needed for the treatment of accident victims, cancer patients, hemophiliacs and surgery patients. Please call the Piedmont Fayette Hospital Auxiliary office at (770) 719‑7098 for more information or to schedule your appointment. Walk-ins are welcome; however appointments will be honored first.
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Study Finds Blood Cells Can Be Reprogrammed to Act as Embryonic Stem Cells

/PRNewswire / -- In a recent study, U.S. researchers have reprogrammed cells found in circulating blood into cells that are molecularly and functionally indistinguishable from embryonic stem cells, a revolutionary achievement that provides a readily accessible source of stem cells and an alternative to harvesting embryonic stem cells. The findings were prepublished online in Blood, the official journal of the American Society of Hematology.

Embryonic stem cells have long been coveted for their potential to treat a multitude of diseases as a result of their unique properties of nearly indefinite self-renewal and pluripotency (the ability to develop into any type of cell in the body), but their use has been the subject of political controversy.

"Our findings provide the first proof that cells from human blood can morph into stem cells," said senior study author George Q. Daley, M.D., Ph.D., an investigator for the Howard Hughes Medical Institute at Children's Hospital, Boston. "Making pluripotent stem cells from blood, which is one of the easiest tissues to obtain, provides an easy strategy for generating patient-specific stem cells that are valuable research tools and may one day be used to treat a number of diseases."

To generate induced pluripotent stem cells (dubbed iPS cells), blood was collected from a 26-year-old male donor. From the blood sample, the researchers isolated CD34+ cells, a type of stem cell that produces only blood cells, and cultured them in growth factors for six days to increase their number.

During the culture, the scientists infected the CD34+ cells with viruses carrying reprogramming factors, genes normally expressed in embryonic stem cells that can reset the blood cells to an embryonic state. Colonies of cells exhibiting physical characteristics similar to embryonic stem (ES) cells appeared about two weeks after the procedure. To determine whether these cells were also functionally similar to ES cells, the scientists analyzed the CD34+ iPS cell lines to see if they had acquired stem cell "markers," the unique combination of proteins that coat the cells' surface and distinguish them from other types of cells. Indeed, the iPS cell lines expressed the same markers as ES cells and further shared the capacity to differentiate into a variety of specialized cell types.

In vitro, the iPS cells readily developed into clusters of cells called embryoid bodies from which cells of virtually any type can develop. These differentiated cells expressed genes for all three embryonic germ layers (the tissues from which all other tissue types in the body develop) and also produced myeloid and granulocyte colonies (types of white blood cells).

The group confirmed that the reprogrammed cells had acquired ES cell characteristics by injecting the newly reprogrammed cells into immunodeficient mice. The cells successfully generated well-differentiated teratomas, benign masses containing all three embryonic germ layers, including respiratory, bone, and neural tissue.

"Not only has this work identified a new programmable cell type, but the cells are easy to obtain and analyze in many research laboratories and bone marrow transplantation centers around the world," said Grover C. Bagby, M.D., Professor of Medicine and Molecular and Medical Genetics at Oregon Health and Science University, who is not affiliated with the study. "These findings will immediately enhance the pace of laboratory research in this field and will ultimately help to determine whether iPS cells have a therapeutic potential equivalent to that of embryonic stem cells."

The American Society of Hematology (www.hematology.org) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. In September 2008, ASH launched Blood: The Vital Connection (www.bloodthevitalconnection.org), a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. It provides hematologist-approved information about these common blood conditions including risk factors, preventive measures, and treatment options.

Blood, the official journal of ASH, is the most cited peer-reviewed publication in the field. Blood is issued to Society members and other subscribers weekly and is available in print and online at www.bloodjournal.org.

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FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants

The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.

Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas. Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell.

Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy. G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream.

"Collecting the millions of cells needed for a bone marrow transplant can take hours or days," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy."

In two randomized clinical trials – one in patients with non-Hodgkin’s lymphoma, the other with multiple myeloma – Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with patients receiving G-CSF alone.

The most commonly reported adverse reactions in these trials and other smaller studies were diarrhea, nausea, fatigue, injection site reactions, headaches, joint pain, dizziness and vomiting.

Mozobil is manufactured by Genzyme Corp., Cambridge, Mass.

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