FDA approves Novartis drug for high blood pressure treatment
EAST HANOVER, N.J. — The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company.
Amturnide combines the only approved direct rennin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).
The FDA approval was based on data from a double-blind, active-controlled study, which showed that Amturnide provided significantly greater reductions in blood pressure compared with all dual combinations of its components.
Amturnide is approved for patients whose blood pressure is not adequately controlled with any two of its individual components and is not indicated as initial therapy for high blood pressure. Amturnide is only the third high blood pressure treatment to combine three drugs in a single pill.
"Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient," noted Alan Gradman, professor of medicine at Temple University School of Medicine. "The approval of Amturnide provides physicians with an effective treatment option that combines the benefits of the only approved direct renin inhibitor, a calcium channel blocker and a diuretic in one pill, while offering blood pressure reductions greater than two drugs alone."
High blood pressure affects nearly 75 million adults in the United States and about 1 billion adults worldwide. An estimated 31% of adults being treated with antihypertensive medications are not at their blood pressure goal. Large-scale clinical trials suggest that up to 85% of patients may need multiple medicines to achieve target levels of blood pressure control, and hypertensive patients with lower blood pressure goals or with substantially elevated blood pressure may require three or more medications.
FDA approves Merck’s Gardasil for prevention of anal cancer
WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.
According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.
In the United States, an estimated 75% to 80% of males and females will be infected with HPV in their lifetime. For most, HPV will clear on its own. However, for those who don’t clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women.
There is no way to predict who will or won’t clear the virus.
Anal cancer affects both men and women, with approximately 60% of cases occurring in women. According to the American Cancer Society, it is estimated that approximately 2,000 men and more than 3,000 women will have been diagnosed with anal cancer in 2010.
There is no standardized screening recommended for the general population for anal cancer, and many people are diagnosed when the disease is more advanced.
Study: More research needed to improve patient medication adherence
WOONSOCKET, R.I. — The industry has a lot to learn in order to determine how to most effectively use electronic communications to improve patient medication adherence, as few studies show how health information technology can be leveraged to motivate patients to take medications as prescribed, according to research sponsored by CVS Caremark.
A new study that reviews more than four decades of medical journal articles about the impact of HIT and electronic communications on medication adherence concludes that while there is evidence to suggest that simple electronic reminders are an effective and low-cost means to improve adherence, there are few studies that show how HIT can be leveraged to more thoughtfully engage or motivate patients to take medications as prescribed.
The study was published this week in the American Journal of Managed Care and is the result of a research partnership between Harvard University, Brigham and Women’s Hospital and CVS Caremark — a three-year collaboration focused on developing a better understanding of patient behavior, particularly around medication adherence.
According to the researchers, the study findings "highlight the disappointing state of evidence on a topic of substantial health importance." The researchers concluded that as the United States "invests substantially in the broad implementation of HIT, innovative adherence interventions built on the capabilities of HIT are essential and must be rigorously tested to identify applicable best practices."
Researchers reviewed more than 7,000 articles published between 1966 and 2010 that discussed the use of HIT for treating cardiovascular disease and diabetes. After screening out articles that did not address how electronic communications can promote adherence, only 13 articles warranted full review, according to CVS Caremark.
"These findings show that our industry has a lot to learn in order to determine how we can most effectively use electronic communications to improve patient adherence," stated Troyen Brennan, EVP and chief medical officer of CVS Caremark and an author of the study. "As HIT-based interventions are developed and enhanced, we need to focus on how the interventions will help improve patient behavior related to taking their medications and reduce medical costs in order to justify growing technology expenditures."