ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.
Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.
underwriting
Safety Alerts – Eszopiclone Containing Sleep Aids Can Cause Next-Day Impairment
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
Dr. Eric J. Lee
Alpert Medical School News | Alpert Medical School.
Underwriting Solutions LLC has several physicians available for part-time consulting work. Email or call for more information.
Diabetes and the Heart: Risk Greater in Women
Diabetes and the Heart: Risk Greater in Women.
Data from 64 studies with both male and female participants yielded a 44% greater multiple-adjusted relative risk ratio (RRR) for incident coronary heart disease (CHD) in women compared with men (RRR 1.44, 95% CI 1.27-1.63), Rachel Huxley, DPhil, of the University of Queensland in Sydney, Australia, and colleagues found.
Pooled data from 52 studies indicated that women also had a 44% greater chance than men of dying from fatal CHD associated with diabetes, Huxley and colleagues reported online in the journal Diabetologia.
PodMed – A Medical News Roundup From Johns Hopkins 05.23.14
e-cigarettes and quitting smoking, diabetes and cardiovascular disease in women, lung cancer genetics and treatment, antibiotic prescribing for bronchitis.
Falls and Fall Injuries Among Adults with Arthritis – United States, 2012
Falls and Fall Injuries Among Adults with Arthritis — United States, 2012.
Falls are the leading cause of injury-related morbidity and mortality among older adults, with more than one in three older adults falling each year,* resulting in direct medical costs of nearly $30 billion (1). Some of the major consequences of falls among older adults are hip fractures, brain injuries, decline in functional abilities, and reductions in social and physical activities (2).
One in Three Patients Not Filling Prescriptions, Study Finds – AAFP News
OK boys and girls, listen up. When you see the terms non-adherence or non-compliance in that APS you’re reading does this mean the risk is better or worse?
One in Three Patients Not Filling Prescriptions, Study Finds — AAFP News — AAFP.
For the study, Canadian researchers evaluated the electronic health records of 15,961 patients in a primary care network that included 131 physicians to estimate the incidence of primary nonadherence (failure to fill a first-time prescription) and to ferret out which drug, patient and physician characteristics might be associated with nonadherence. Patients’ health records were linked to insurer data on drugs dispensed by community-based pharmacies in relation to specific office visits.
The researchers found that slightly more than 31 percent of all initial drug prescriptions were not filled within nine months. Nonadherence was highest for expensive drugs and preventive therapies for chronic conditions such as ischemic heart disease and depression. In addition, patients with higher copayments, recent hospitalization and more severe comorbid conditions were at increased risk for nonadherence.
RA Patients Living a Decade Longer
RA Patients Living a Decade Longer.
The average age at death for RA patients in a cohort that enrolled patients between 1986 and 1998 was 76.7 years (95% CI 75-78.1), while for a cohort that enrolled patients between 2002 and 2012, the average age of death was 86.7 (95% CI 84.1-89.5), according toSam Norton, PhD, of King’s College in London.
Daily Aspirin – Yes or No?
Aspirin: FDA Says ‘No’ Others Say ‘Yes’.
I found this article quite helpful in my own decision regarding whether or not to continue my daily aspirin 81 mg dose.
The bump I gave myself on the shin a few weeks ago that bled profusely and took hours to clot was also quite helpful in my decision regarding whether or not to continue my daily aspirin 81 mg dose.
Update 06.06.14
Check out the following link. If you’re an older male you might find this of interest.
http://www.webmd.com/erectile-dysfunction/news/20110303/regular-use-of-painkillers-linked-to-ed
Update 07.26.14
This link takes you to the 2012 Circulation article.
Update 08.04.14
More links for your reading and research pleasure.
Aspirin May Not Protect Against Cardiovascular Disease – Prevention.com.
Benefits of aspirin more modest than previously believed — St George’s, University of London.
Researchers from Professor Kausik Ray’s group at St George’s, University of London investigated the drug’s effectiveness in primary prevention and the prevalence of side effects. They also assessed if aspirin had any impact on the risk of death from cancer among people considered at risk of cardiovascular disease.
They analysed data from nine clinical trials involving over 100,000 participants without a history of cardiovascular disease. Half of the participants took aspirin and half took a placebo. The average participant in the aspirin arm of these trials took aspirin for about six years.
The researchers found that although aspirin in conventional daily or alternate day doses reduced the risk of total cardiovascular disease events by 10 per cent, this was largely due to a reduction in non-fatal heart attacks. It did not include a reduction in other cardiovascular disease events including death from heart attack, or fatal or non-fatal stroke.
The study also showed that this benefit was almost entirely offset by a 30 per cent increase in risk of life-threatening or debilitating internal bleeding events. This means that while one cardiovascular disease event was averted for every 120 people treated with aspirin for about six years, one in 73 people suffered from potentially significant bleeding during the same period.
lifeunderwriter.net 
You must be logged in to post a comment.