In July of 2012, a provision in the newly ratified Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA), paved the way for the FDA to further assist drug manufacturers in expediting the development and introduction of new drugs demonstrating early signs of advancement in the treatment of key conditions. Known as the “breakthrough therapy” designation, this new tool is seen by many as yet another positive sign that the FDA is committed to ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions, desperately in need of new therapeutic options.
Read More
It is well known that type 2 diabetes mellitus is associated with increased risk of cardiovascular disease. A recent epidemiologic study conducted in the United Kingdom assessed the time to first major cardiovascular event in patients with type 2 diabetes mellitus in a large real-world population.
Read More
Once weekly exenatide is an alternative treatment to daily basal insulin
August 9th 2013Typically, basal insulin is chosen as the add-on treatment in patients with severe hyperglycemia. However, it has been questioned whether it is the best option, according to research presented in June at American Diabetes Association 73rd Scientific Sessions, in Chicago.
Read More
Concomitant control of BP, cholesterol is difficult
August 9th 2013Many patients suffer from both hypertension and high cholesterol, putting them at greater risk of coronary heart disease (CHD). Controlling the hypertension and high cholesterol would reduce CHD risk by 50% or more, but less than a third of patients have achieved adequate control of both, according to an online study in Circulation.
Read More
Study finds that dapagliflozin produces similar glycemic efficacy to glipizide
August 9th 2013When metformin cannot maintain glycemic control, sulfonylureas are often used as add-on therapy in type 2 diabetes; however, risks include weight gain and hypoglycemia. Dapagliflozin is an SGLT2 inhibitor and increases urinary glucose excretion and reduces hyperglycemia independently of insulin secretion or action.
Read More
International study finds that dapagliflozin has metabolic benefits
August 9th 2013An international study has found that dapagliflozin has sustained metabolic benefits compared with glipizide. Benefits included stable weight loss and low rates of hypoglycemia. Additionally, therapy was well-tolerated by patients.
Read More
Lower risk of heart failure and stroke with exenatide than with insulin
August 9th 2013In patients with type 2 diabetes, treatment with exenatide has shown beneficial effects on cardiovascular risk factors. A recent study used the GE Healthcare database to evaluate the risk of heart failure, myocardial infarction, and stroke in 2,795 patients taking exenatide twice daily and in 51,547 patients taking insulin in routine clinical practice.
Read More
Triptans widely prescribed for migraine but contraindicated in patients with CV conditions
August 9th 2013Almost 5 million Americans with episodic migraine (EM) should not be prescribed a triptan, the only class of acute medications FDA approved and developed for migraine, because of the presence of cardiovascular contraindications, according to results from the American Migraine Prevalence and Prevention (AMPP) Study.
Read More
Guideline adds aromatase inhibitor for breast cancer prevention
August 9th 2013The new update to the 2009 American Society of Clinical Oncology (ASCO) guideline on the pharmacologic interventions for breast cancer risk reduction now lists aromatase inhibitor exemestane (Aromasin, Pfizer) as an option for postmenopausal women for primary risk reduction that are at an increased risk of developing invasive breast cancer.
Read More
Unauthorized prescribers bill Part D $5 million
August 9th 2013Estimates of the cost of fraud in the Medicare system range broadly from $17 billion to $90 billion. However, there are no estimates of-or methods to detect-how much of the wasted money is attributable to old-fashioned human error rather than blatant crime.
Read More
Blood pressure response to dietary sodium is reproducible over long term
August 9th 2013Blood pressure (BP) response to changes in dietary sodium and potassium is reproducible over the long term and may help identify potential candidates at risk for hypertension and cardiovascular disease, according to a study published in the journal Hypertension.
Read More
Long-term use of CCBs may increase risk of breast cancer
August 9th 2013Long-term use of calcium-channel blockers (CCBs) may increase the risk of breast cancer in postmenopausal women, but additional research is needed to confirm, according to a study in JAMA Internal Medicine, published online August 5.
Read More
Kidney disease: Early diagnosis and analytics are key
August 5th 2013Approximately 90,000 Americans die every year as a result of kidney disease. This disease produces no symptoms until it is in the advanced stages, so people in the early stages are not likely to know they have it unless they are tested.
Read More
Rise in mortality risk seen in hysterectomized women aged 50 to 59 not using estrogen therapy
August 5th 2013A severe decline in the use of estrogen therapy (ET) due to misunderstanding the findings of the Women’s Health Initiative (WHI) Estrogen Plus Progestin Trial has particularly affected hysterectomized women in their 50s, leading to excess mortality, according to a study published online in the American Journal of Public Health.
Read More