The Numbers: Hospital Mortality for Four Key Conditions Continues Downward

Hospital mortality rates for heart failure, pneumonia, myocardial infarction, and stroke continue to trend downward, according to data from the U.S. Agency for Healthcare Research and Quality.

Among the findings:

• Between 1994 and 2007, inpatient mortality rates for heart failure dropped by 60%; for pneumonia, 55%; for MI, 47%; and for stroke, 35%.
• The midwestern states had the greatest decreases in mortality for all four conditions.
• Nationally, in 2000 the poorest communities had lower rates of inpatient mortality for heart failure and pneumonia than the richest communities, but by 2007 the groups had switched their relative rankings.

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FDA Rejects Approval of Another Diet Drug, Qnexa

Qnexa, a combination of phentermine and topiramate, has not been granted approval by the FDA, according to a New York Times report. Earlier this month the FDA refused approval for another diet drug, lorcaserin.

According to the report the agency has asked Vivus, Qnexa's developer, "to provide a thorough evaluation of the drug's potential for causing birth defects and heart problems." In a statement on its website, Vivus said that new studies may be required if the FDA's concerns are not addressed by existing data, which it plans to submit by year's end.

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Heavy Smoking in Midlife Linked to Increased Dementia Risk Decades Later

Heavy smoking in midlife is associated with more than a doubling of risk for dementia in older age, according to an Archives of Internal Medicine study.

An ethnically diverse group of some 21,000 adults aged 50 to 60 were interviewed about their smoking habits between 1978 and 1985. Researchers then assessed the participants' medical records from 1994 to 2008 and found that a quarter had developed dementia, Alzheimer disease, or vascular dementia.

In fully adjusted analyses, the risk for dementia rose as the amount of smoking increased. In particular, participants who smoked more than two packs a day in midlife had more than twice the risk for dementia, AD, or vascular dementia two decades later, compared with those who'd never smoked.

Commenting on the potential reason behind the association, the authors write: "It is well recognized that smoking augments oxidative stress and inflammation, which are also believed to be important pathophysiologic mechanisms in AD."

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Guidelines for Preventing Recurrent Stroke Issued

Updated guidelines on preventing recurrent ischemic stroke have been issued by the American Heart Association and the American Stroke Association.

The document, published in Stroke, offers recommendations in a variety of areas, for example, management of risk factors such as smoking and obesity. The use of antithrombotic therapy after an intracranial hemorrhage also receives much attention.

There are several new strong recommendations, based on high levels of evidence. Among them:

• Although the utility of screening patients for metabolic syndrome has not been established, the dyslipidemic and hypertensive features of the syndrome should be singled out for preventive care.
• In addressing glycemic control and hypertension in diabetes, targets in existing U.S. guidelines should be used.

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Dabigatran Approved for Stroke Prevention in Atrial Fibrillation

Dabigatran Approved for Stroke Prevention in Atrial Fibrillation

The FDA has approved the oral anticoagulant dabigatran (Pradaxa) to prevent stroke and blood clots in patients with atrial fibrillation.

Approval follows the RE-LY trial, in which dabigatran was noninferior to warfarin in terms of a combined endpoint of stroke or systemic embolism. There were also fewer hemorrhagic strokes with dabigatran.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," the director of the FDA's Division of Cardiovascular and Renal Products said in an FDA news release.

The drug, a direct thrombin inhibitor, will come with a medication guide to warn patients of the potential for serious bleeding. Other side effects include gastrointestinal symptoms.

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PS...docs have been waiting for this medication's approval for a long time...if you are on coumadin, you know what I mean...

Botox Approved for Chronic Migraine

Botox Approved for Chronic Migraine

The FDA has approved onabotulinumtoxinA (Botox) for prophylaxis of chronic migraine (more than 14 migraine days monthly).

Treatment involves injections into several areas of the head and neck, about every 12 weeks. Botox was already frequently used off-label for migraine.

In studies, Botox recipients had significantly fewer days with migraine, but not fewer episodes, than placebo recipients, the New York Times reports. It is unclear exactly how the drug prevents migraine. The drug is estimated to cost between $1000 and $2000, analysts tell the Times.

Botox carries a boxed warning, saying that the drug can spread beyond the treatment sites and cause symptoms of botulism, but so far, no serious adverse events have been reported with the regimen used for migraine.

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Chest Compressions Emphasized in New Heart Association Guidelines on CPR

Chest Compressions Emphasized in New Heart Association Guidelines on CPR

The American Heart Association has updated its 2005 guidelines on cardiopulmonary resuscitation and emergency cardiac care. For CPR, the guidelines newly emphasize chest compressions because of their importance for survival. Among the changes, published in Circulation:

• The order of CPR is now C-A-B (compressions, airway, breathing) instead of A-B-C for everyone except newborns. The first cycle should include 30 compressions before rescue breaths.
• "Look, listen, and feel" is no longer recommended.
• Compressions for adults should be at least (instead of up to) 2 inches and performed at a rate of at least 100 per minute.
• Untrained bystanders should perform compression-only CPR (previous guidelines did not address untrained bystanders separately).
• Emergency cardiac treatments no longer recommended include routine atropine for pulseless electrical activity/asystole, cricoid pressure (with CPR), and airway suctioning for all newborns (exception for those with obvious obstruction).
• New sections address post-arrest care, care for children with cardiac arrest and specific congenital heart defects, and follow-up for children or young adults with sudden, unexplained cardiac death.

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FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

In contrast with earlier reassurance that there was no "clear connection" between use of bisphosphonates and atypical femoral fractures, the FDA now says labeling changes are needed.

Changes to the warnings section of all bisphosphonates given for osteoporosis will highlight the potential risk for subtrochanteric and diaphyseal femoral fractures. In addition, manufacturers will need to include a medication guide for use by patients.

The FDA says that the fractures being reported "may be related to use of bisphosphonates for longer than five years." Consequently, physicians are being asked to reevaluate the need for the drugs if their patients have been using them longer than that.

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What's Happening To Your Health Plan?

Employers already are passing on a bigger share of their health-care costs to employees than they have over the previous decade, according to data from the Kaiser Family Foundation. The Menlo Park, Calif.-based nonprofit found this year that family premiums for firms went up 3% in 2010, but workers' share of those costs rose 14%.

This so-called cost-shifting trend appears to be intensifying. When Zurich Insurance Services Inc., a property and casualty firm in Jacksonville, Fla., conducted its open enrollment last month, it asked employees to pay 10% of their premiums for the first time. The company always has paid 100%, but "we reached the breaking point," says Ryan Schwartz, senior vice president of corporate affairs, citing higher costs generated by the new health-law provisions.

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Weight Loss Medication Pulled from Market

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

[Posted 10/08/2010]

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

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Iphone to Launch on Verizon

http://online.wsj.com/article/SB10001424052748703735804575536191649347572.html?mod=WSJ_hp_mostpop_read

AT&T Inc. is about to lose its lock on the iPhone.

Apple Inc. is making a version of its iPhone that Verizon Wireless will sell early next year, according to people familiar with the matter, ending an exclusive deal with AT&T and sharpening the competition with Google Inc.-based phones.

While Apple is on track to sell 40 million iPhones across the globe this year, the touchscreen handset is facing pressure in the U.S. from phones running Google's Android software, which have been heavily promoted by Verizon Wireless, the biggest U.S. carrier by subscribers.

Apple plans to begin mass producing the new iPhone by the end of the year, and it would be released in the first quarter of 2011, these people said. The phone would resemble the iPhone 4 currently sold by AT&T, but would be based on an alternative wireless technology used by Verizon, these people said.

Data on Clopidogrel and Omeprazole Offer 'Reassurance' on Cardiovascular Risk, Researchers Say

Patients on dual antiplatelet therapy showed no increase in cardiovascular events while receiving omeprazole to lower risks for gastrointestinal bleeding, according to a New England Journal of Medicine study.

In a double-blind trial, 3700 patients were randomized to receive the proton-pump inhibitor (PPI) omeprazole or placebo, while taking both aspirin and clopidogrel. The study had two primary endpoints: gastrointestinal bleeding or pain, and cardiovascular events, such as cardiovascular death, MI, or ischemic stroke. (Cogentus Pharmaceuticals, the manufacturer of the clopidogrel-omeprazole combination pill, designed and sponsored the trial, but the company is now defunct.)

Over the course of a median follow-up of 106 days, gastrointestinal events were significantly less frequent with clopidogrel-omeprazole. Cardiovascular event rates were also less frequent, but not significantly so (4.9% vs. 5.7%).

The authors say the outcome "provides reassurance that there is no clinically significant cardiovascular interaction between PPIs and clopidogrel."

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Compression-Only CPR by Bystanders Raises Rates of Survival

Compression-only CPR by lay rescuers modestly increases survival over conventional resuscitation, a JAMA study finds.

Researchers prospectively studied rates of survival to hospital discharge in some 4400 adult victims of out-of-hospital cardiac arrest not witnessed by emergency medical personnel. All episodes occurred over a 5-year period in Arizona during a public campaign to encourage bystander intervention with compression-only CPR.

Among the principal findings:

• The overall annual rate of bystander CPR increased during the 5-year period, from 28% to 40%.
• Compression-only CPR increased from 20% to 76%.
• Overall survival increased from 4% to 10%; survival was 13% in the compression-only group.
• Good neurological status at discharge, however, did not differ significantly between those getting compression-only versus conventional CPR.

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