‘Silent strokes’ linked to kidney failure in diabetics
WASHINGTON Tiny areas of brain damage caused by injury to small blood vessels can signal an increased risk of kidney disease and kidney failure, according to a new study by Japanese researchers.
Publishing in the Journal of the American Society of Nephrology, researchers led by Takashi Uzu of the Shiga University School of Medicine in Otsu, Japan, included 608 patients with Type 2 diabetes, all initially free of symptomatic stroke, heart disease or kidney disease.
Using magnetic resonance imaging scans of the brain, the researchers found that 29% of the patients had the small areas of brain damage, known as silent cerebral infarction or “silent stroke.” A long-term follow-up of the patients found that those with SCI had higher risks of progressive kidney disease, and compared with those who had normal MRI scans, patients with SCI were about 2.5 times more likely to die or develop end-stage kidney disease.
“Silent cerebral infarction may be a new marker to identify patients who are at risk for declining kidney function,” Uzu said in a statement.
Uzu said that small amounts of the protein albumin present in the urine – a condition known as microalbuminuria – are the most important market to predict the progression of kidney disease in diabetics, but decreased kidney function without microalbuminuria is common in those with Type 2 diabetes. According to the new study, diabetics with SCI were more likely to develop serious kidney disease regardless of the protein condition.
Watson to become commercial partner for emergency contraceptive
MORRISTOWN, N.J. Watson Pharmaceuticals and HRA Pharma have signed a deal whereby Watson will become the commercial partner for an emergency contraceptive undergoing regulatory review by the Food and Drug Administration, Watson announced Monday.
Watson and HRA signed the agreement for ulipristal acetate, also known as UPA, which HRA has marketed in Europe under the EllaOne brand since October 2009. According to data published in a recent issue of medical journal The Lancet comparing the drug with levonorgestrel in 1,696 women in the United States, Ireland and the United Kingdom, UPA provides emergency contraception effectively for up to five days after unprotected sex. Duramed Pharmaceuticals markets levonorgestrel under the Plan B brand, and Watson markets a generic version.
Under the terms of the agreement, Watson will make milestone payments to HRA and royalties on U.S. sales while taking responsibility for commercialization and marketing expenses.
“The opportunity to collaborate with HRA Pharma on the U.S. commercialization of UPA fits nicely within our broader strategy to expand our emerging position in women’s health care and to provide women with a vast array of safe, effective treatment options in contraception as well as other important therapeutic areas,” Watson EVP global brands Fred Wilkinson said. “The published clinical results are significant, and we are optimistic about the prospects of providing U.S. women with a new emergency contraceptive option.”
FDA approves expanded use of breast cancer drug
PHILADELPHIA The Food and Drug Administration has given an additional approval to a breast cancer drug made by GlaxoSmithKline, GSK announced Friday.
The FDA approved Tykerb (lapatinib) combined with Novartis’ Femara (letrozole) as an all-oral, first-line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 protein. HER2 is involved in normal cell growth, but can contribute to cancer when found on cancer cells, and between 25% and 30% of breast cancers overexpress the protein; 60% to 70% of breast cancer cases in the United States and Europe are hormone receptor-positive.
“This combination of Tykerb plus Femara is an example of advancing science and improving patient care,” GSK Oncology research and development SVP Paolo Paoletti said. “This regimen attacks two specific receptors that drive cancer growth. Women battling this disease now have the opportunity to delay the use of traditional cytotoxic chemotherapy, which is an exciting possibility for them.”
Tykerb already had approval as a combination with Roche’s Xeloda (capecitabine) chemotherapy in patients with HER2 advanced or metastatic breast cancer who had received prior therapy with anthracycline chemotherapy and Genentech’s Herceptin (trastuzumab). So far, however, Tykerb combined with Femara — or any other drug belonging to Femara’s class, known as aromatase inhibitors — has not been compared with a treatment regimen based on Herceptin and chemotherapy.