Diabetes Mellitus

Metformin Holds Promise for Cancer Treatment, Prevention

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Use of Metformin – commonly used as the front-line treatment for type 2 diabetes – improves survival for some breast cancer patients, and shows promise as a treatment for patients diagnosed with endometrial hyperplasia, according to the results of two new studies presented by researchers from the Perelman School of Medicine at the University of Pennsylvania at the American Society of Clinical Oncology (ASCO) Annual Meeting.

In one study (abstract 1569), the first to examine the effect of metformin on survival rates for breast cancer patients, researchers examined clinical outcomes for 1,215 patients who were diagnosed and underwent surgical treatment for breast cancer between 1997 and 2013. Ninety-seven patients examined reported using metformin before their diagnosis, and 97 reported use of the drug after diagnosis.

Results of the study showed that patients who used metformin before being diagnosed with breast cancer were more than twice as likely to die than patients who never used the drug, while patients who began using metformin after their cancer diagnosis were almost 50 percent more likely to survive than non-users.

“Using metformin as a cancer prevention strategy has been controversial and results have been inconsistent, but our analysis reveals that use of the drug is time-dependent, which may explain the disparity. While use of the drug may have a survival benefit for some breast cancer patients, those who developed breast cancer while already using Metformin may have more aggressive cancer subtypes,” said lead author Yun Rose Li, MD, PhD, a clinical research fellow in the division of Endocrine and Oncologic Surgery at the Perelman School of Medicine at the University of Pennsylvania, who will present the results. “Our study also illustrates the complex interaction between underlying metabolic risks and breast cancer outcomes, and underscore the importance of a multi-system approach to cancer treatment.”

Additional results of the study showed that patients who used metformin were more likely to be over the age of 50 at diagnosis and to be African-American. While tumor size and disease progression were similar across all groups, the patients who began using the drug after their diagnosis were more likely to have ER/PR positive tumors while the patients who used it prior to their diagnosis had higher rates of Her2+ and Triple Negative tumors.

Since this work is among the first to examine the effects of long-standing metformin use in the context of when patients start using it as it relates to breast cancer diagnosis, the authors say that further investigations are necessary to examine the impact of metformin use on cancer recurrence. Nonetheless, the authors say there is compelling biological evidence suggesting that the differences observed in breast cancer tumor markers may be due to mechanistic differences in cancer initiation in patients who develop cancer while taking metformin.

In the second study (abstract 5592), researchers examined the effectiveness of using metformin as a treatment for women newly diagnosed with endometrial hyperplasia, a condition that occurs when there is a hormonally related unbalanced overgrowth of the uterine lining. If left untreated, patients are at a significantly higher risk of developing uterine cancer.

Eighteen participants were enrolled in a multi-institutional trial and treated with metformin for three months. Results showed 56 percent of patients responded to treatment, defined as complete resolution of the hyperplasia. The effect was seen especially in women with simple hyperplasia without additional complications or irregularities.

Typically, women with endometrial hyperplasia are treated with progesterone-based therapies via depot injections, intrauterine devices, or oral medications. Progesterone works by counteracting the effects of estrogen and thinning the uterine lining. While effective in up to 80 percent of cases, progesterone therapies have been shown to cause significant side effects such as weight gain, mood changes, and gastrointestinal distress. Hysterectomy (surgical removal of the uterus) is also an alternative therapy for women who are post-menopausal, or have completed child-bearing.

“The results of our study may present an alternative treatment for particular forms of endometrial hyperplasia, in contrast to standard progesterone-based therapies or hysterectomy,” said Emily Ko, MD, MSCR, an assistant professor of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania, and lead author of the study. “Future prospective studies may better identify women for which metformin may be most beneficial, as well as the most effective dosing regimens.”

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India, US to begin bilateral collaborative research partnerships on diabetes

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Both India and the US will soon begin bilateral collaborative research partnerships (CRPs) on diabetes research to advance science and technology important to understanding, preventing, and treating diabetes and its complications through the collaborative efforts of Indian and US investigators and their institutions.

The collaboration of India and the US on diabetes is significant as in both the nations, diabetes is striking increasingly in younger age groups, with potentially devastating implications for the health, well-being, and productivity of future generations. To reduce both the human toll and the societal burden of diabetes in both countries, affordable, practical, and effective approaches and technologies for preventing and managing diabetes and its complications are urgently needed.

Specific areas of interest for this programme include studies that may address or be focused within one or more of the broad research areas such as prevention and management of diabetes or its complications; pathogenesis and pathophysiology of diabetes and its complications; diabetes in youth; innovative technologies for management and prevention of diabetes and/or its complications; and gestational diabetes.

The CRP must be based on interactive relationships that maximise the expertise of the individual Indian and US research teams and interactions between their parent institutions and granting agencies. It is expected that the unique opportunity available through the India-US collaborative research programme will foster collaborative partnerships that may subsequently mature and expand beyond the scope of the work proposed in current application. It is anticipated that some of these partnerships will also be relevant to translation into public health activities in India and/or the United States.

Indian and US collaborating investigators should work together to develop and submit corresponding applications to ICMR and NIH. Indian investigators will respond to this announcement from ICMR and US investigators will respond in parallel to a separate funding announcement from the NIH.

Indian and US investigators seeking support for a collaborative research partnership under this programme are instructed to submit their proposals to the respective agencies not later than 18th September 2014.

Source: PharmaBiz

Coffee Tied to Lower Diabetes Risk

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Drinking more coffee may decrease your risk of Type 2 diabetes, while cutting down may increase your risk, a new study has found.

Over a 20-year period, researchers periodically collected detailed information on diet, lifestyle and medical conditions in more than 120,000 participants. They found 7,269 cases of Type 2 diabetes.

After controlling for smoking, age, weight, physical activity, alcohol consumption and a family history of diabetes, they found that people who increased their coffee intake by more than an eight-ounce cup a day in a four-year period had an 11 percent lower risk of diabetes than those whose consumption remained steady. People who decreased their consumption by the same amount had a 17 percent higher risk. The report appears online in Diabetologia.

“It’s not the caffeine,” said the lead author, Shilpa N. Bhupathiraju, a research fellow at Harvard. “We know that. But coffee has a lot of antioxidants and other bioactive compounds” important in glucose metabolism. The effect has been found in previous studies with decaffeinated coffee, she said.

Dr. Bhupathiraju warned that coffee is not a cure-all, and that a healthy diet and lifestyle are still the best protection against diabetes. “If you’re going to eat a doughnut and smoke while having coffee,” she said, “it won’t help.”

Qiagen offers help to India for targeted screening of TB cases

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Qiagen, a world leader in sample and assay technologies, has offered assistance to India for targeted TB screening as the country has a huge burden of latent TB cases, having potential to develop into full-blown TB cases.

“We are working with governments in several countries like China where the authorities showed keen interest. We have already met the senior officials of the Health Ministry and are willing to help the government whichever way possible,” said Dr Masae Kawamura, senior director scientific and medical affairs at Qiagen.

“TB is a silent killer. There are 1.96 million active cases per year. About 40 percent of Indian population has latent TB. About 5-15 per cent of them could develop into active cases. India should go for targeted screening at a massive level, focusing the high risk areas. The question is whether the Government is willing,” she told Pharmabiz, during her recent visit to the country.

Dr Kawamura, a former TB Controller of San Francisco, said the target of the WHO is to reduce the prevalence of TB cases by 50 per cent by 2015. Globally, 2 billion people are having latent TB cases and some countries had gone for universal screening.

“There are advanced tools for screening the latent TB. We are ready to assist the Government in this regard,” she said. A TB clinician for more than 23 years, she was instrumental in making San Francisco to implement interferon gamma release assay (IGRA) as the first jurisdiction in the US.

One out every four TB patients were found to have diabetes. The government should introduce a system to screen all diabetes patients for TB and all TB patients for diabetes if the country wanted to fight TB effectively in the country, pointed out leading diabetologist Dr Anil Kapur, citing diabetes as high risk area for TB.

Pointing out the challenges of massive screening of latent TB in India, DDr Shalabh Malik, head of department of microbiology and clinical pathology at Dr Lal PathLbas, said the high duties on the diagnostic kits and technologies and lack of indigenously-developed tool kits make fight against TB more complex.

Source: PharmaBiz

Merck’s insulin pen, VetPen for use in diabetic dogs and cats receives US FDA nod

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Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck, announced that the US Food and Drug Administration (FDA) has recently approved VetPen, the first insulin pen for use in diabetic dogs and cats. For years, insulin pens have made managing diabetes more convenient for human diabetics. Merck Animal Health, a leader in pet diabetes management, has now brought the same technology to veterinary medicine. VetPen is used with Vetsulin (porcine insulin zinc suspension) insulin cartridges. Vetsulin is the only veterinary insulin product approved for use in both dogs and cats.

“VetPen was developed to make giving insulin injections more convenient for pet owners, and precision dosing makes it easier to consistently deliver an accurate dose of insulin compared to syringes,” said Kathleen Heaney, D.V.M., director of technical services for Merck Animal Health. “VetPen initially will be offered in a number of veterinary clinics throughout the country. This will provide us with the opportunity to work with veterinarians on its use – helping to ensure pet owners are administering Vetsulin safely and effectively.”

Vetsulin is the world’s most trusted veterinary insulin, proven safe and effective for more than 20 years in hundreds of thousands of diabetic pets. Recent advances have made treating diabetes in dogs and cats easier. Today, along with proper diet and exercise, Vetsulin and VetPen play an important role in successfully managing diabetes in both dogs and cats.

“At Merck Animal Health, we are committed to providing veterinarians and pet owners with innovative products to meet the ever changing healthcare needs of animals,” Dr. Heaney said. “VetPen is an exciting breakthrough, which will help in the treatment of pet diabetes – a serious and growing issue in dogs and cats.”

The prevalence of diabetes mellitus in dogs and cats ranges from one in 1001 to one in 5002, and the number of dogs diagnosed with the disease has tripled during the past 30 years. Getting the disease under control is paramount to survival. In a study of dogs treated with Vetsulin, investigators reported adequate glycemic control was achieved an average of 81 per cent of the time during the study period, and in a pivotal US study of diabetic cats, Vetsulin reduced all major diabetes indicators to within normal range by day 60 of treatment.

Today, dogs receiving the proper treatment have the same expected lifespan as a non-diabetic dog of the same age and gender, while only 50 per cent of dogs used to survive the first 60 days following a diagnosis of diabetes. With effective treatment, lifestyle changes and monitoring, a diabetic cat also can have the same expected life span as a non-diabetic cat of the same age.

Merck Animal Health is committed to supporting veterinarians in the ongoing treatment of their patients, including making diabetes professionals available to answer questions.

Vetsulin should not be used in dogs or cats known to have a systemic allergy to pork or pork products. Vetsulin is contraindicated during periods of hypoglycemia. Keep out of reach of children. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia is essential to attain and maintain adequate glycemic control and prevent associated complications. Overdosage can result in profound hypoglycemia and death. The safety and effectiveness of Vetsulin in puppies and kittens, breeding, pregnant, and lactating dogs and cats has not been evaluated. See package insert for full information regarding contraindications, warnings, and precautions.

Source: PharmaBiz

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