FDA OKs First Wireless Pacemaker

Medtronic won approval for Micra Transcatheter Pacing System to treat heart rhythm disorders


April 9, 2016 / Author: Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart.

The Micra Transcatheter Pacing System, manufactured by Medtronic, is a self-contained, one-inch device that is implanted into the right ventricle chamber of the heart and works like other pacemakers to regulate heart rate.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. Nearly 1 million people worldwide are implanted with pacemakers each year, according to the FDA.

The leads in a traditional, single-chamber pacemaker run from the pacemaker — implanted under the skin near the collarbone — through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions.

But Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.

Micra is intended for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

Micra should not be used in patients who are severely obese, who have implanted devices that might interfere with the pacemaker, or who cannot tolerate materials in the device or the blood thinner heparin.

Surgery Might Help Some Heart Patients

Bypass surgery may boost heart failure survival rate, study found


April 10, 2016 / Author: Beth Bolt, RPh 

(RxWiki News) Heart failure patients with clogged arteries had a better chance of surviving 10 years if they had bypass surgery and took medications, as opposed to just taking medications, a new study found.

Unless it’s absolutely necessary, many patients choose to avoid surgery. But this new, long-term study, funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute, found that a larger number of patients with coronary artery disease may benefit from bypass surgery than previously thought.

Study results after five years of research, published in 2011, raised questions about the benefits of bypass versus medicine alone, but researchers said the longer 10-year study clearly favors the surgery.

This study, which involved 1,200 heart failure patients from 22 countries, including the United States, found that patients with reduced heart function and clogged arteries had a better chance of surviving 10 years if they received a combination of bypass surgery and medication.

The results showed that 59 percent of the bypass patients died from any cause — compared to 66 percent of those who received medication only.

Forty-one percent of the patients in the bypass group died from heart disease — compared to 49 percent of those enrolled in the medicine-only group.

An editorial about the current study said the latest results “solidly support” strengthening treatment guidelines to say that coronary artery bypass surgery is “probably beneficial” for these patients.

The study and editorial were published in the New England Journal of Medicine. The authors disclosed no conflicts of interest.

Is a Daily Aspirin Right for You?

Aspirin recommendation for heart attack, stroke and colorectal cancer prevention issued by USPSTF


April 11, 2016 / Author: Beth Bolt, RPh

(RxWiki News) The US Preventive Services Task Force (USPSTF) has issued a recommendation on taking aspirin for heart attack, stroke and colorectal cancer prevention for certain patients.

The USPSTF recommends low-dose aspirin use for the prevention of cardiovascular disease (CVD) and colorectal cancer in adults aged 50 to 59 years who have a 10 percent or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years and are willing to take low-dose aspirin daily for at least 10 years.

Adults aged 60 to 69 years who have a 10 percent or greater 10-year CVD risk may also be candidates for daily low-dose aspirin therapy.

Aspirin — one of the most common and inexpensive over-the-counter drugs — has recently been shown to relieve a great deal more than headaches. The new USPSTF recommendation weighs the evidence from a growing body of research on aspirin and takes into account concerns about its potential harms.

The USPSTF is a panel of experts that makes evidence-based recommendations for clinical care, including cancer screening and preventive medicine use.

This is the first time the USPSTF has issued a recommendation regarding aspirin to prevent both CVD and colorectal cancer. Separate recommendations were made on preventing colorectal cancer and CVD in 2007 and 2009, respectively.

While low-dose aspirin may have cardiovascular and cancer benefits, the medicine isn’t risk-free — it is known to cause digestive system bleeding and may increase stroke risk.

The USPSTF panel said more research is needed to assess whether taking aspirin is beneficial for people younger than 50 or older than 70.

The full recommendation was published in the Annals of Internal Medicine.

What’s Behind the USPSTF’s Aspirin Guidance

Aspirin recommendation from USPSTF was backed by systematic evidence reviews and a modeling paper


April 11, 2016 / Author: / Reviewed by: Beth Bolt, RPh

(RxWiki News) The US Preventive Services Task Force (USPSTF) just released new guidance on daily aspirin to prevent cardiovascular disease (CVD) and colorectal cancer. But what was behind that recommendation?

Three large, systematic evidence reviews and a modeling paper, as it turns out. That means three studies, conducted on behalf of the USPSTF and published in the Annals of Internal Medicine, looked back at other studies on aspirin’s role in CVD and colorectal cancer prevention and found that it could lower those risks for some patients.

But these reviews also confirmed some past findings on daily aspirin’s role in gastrointestinal bleeding risk, a potentially deadly complication.

To clarify these findings, the USPSTF conducted a study that modeled the risks and benefits of daily aspirin use. Here’s what the task force found:

  • Aspirin’s positive effects would likely be maximized, and the negative effects minimized, in patients who begin taking it daily between the ages of 40 and 69 and who have a raised CVD risk.
  • For patients without a raised CVD risk, the benefits did not appear to outweigh the harms in the modeling study.

In the end, though, even the USPSTF says the decision on whether to take a daily aspirin should come down to individual doctor and patient preferences.

For Cardiac Arrest, Rx May Save the Day

Amiodarone, lidocaine in cardiac arrest patients helped improve survival to hospital


April 12, 2016 / Author: / Reviewed by: Beth Bolt, RPh

(RxWiki News) When patients enter cardiac arrest outside of a hospital, certain heart rhythm medications could help patients survive the ambulance trip to the hospital.

When paramedics administered amiodarone (brand name Cordarone) or lidocaine(Xylocaine) to cardiac arrest patients who hadn’t responded to electrical shocks, those patients were more likely to make it to the hospital alive, a new study found.

The medications didn’t appear to raise overall survival by much, but the University of Washington Medical Center researchers behind this study said they still helped a little — particularly if the patient’s cardiac arrest had initially been witnessed by a bystander.

Around 10 percent of patients who have cardiac arrest outside of a hospital survive, according to the National Institutes of Health. Cardiac arrest occurs when the heart’s rhythm stops or changes.

Emergency medical personnel often give medications like amiodarone and lidocaine to cardiac arrest patients who are not responding to defibrillation. But little research has shown whether this strategy is effective.

This three-year study of 3,026 patients, published recently in the New England Journal of Medicine, suggests that it may be.

This study was funded by the National Heart, Lung and Blood Institute and others. Authors disclosed various potential conflicts of interest.

A Warning About Infant Rice Cereal

Infant rice cereal and arsenic exposure may be linked.


April 8, 2016 / Author: Anyssa Garza, PharmD

(RxWiki News) The US Food and Drug Administration (FDA) is taking steps to lower the amount of inorganic arsenic in infant rice cereal.

The FDA is requiring manufacturers of infant rice cereal to lower inorganic arsenic levels in their products.

FDA officials are concerned about arsenic exposure in infants and pregnant women. This concern is based on evidence that inorganic arsenic exposure in infants and pregnant women may result in lower scores in certain developmental tests measuring a child’s learning.

The FDA recommends eating a well-balanced diet and avoiding eating or drinking any item in excess.

When it comes to common “starter” foods for infants, infant rice cereal is near the top of the list. With this being said, it’s OK to feed a baby iron-fortified cereals because they are a good source of nutrients, according to the FDA. However, the FDA does note that iron-fortified cereals should not be the only source of nutrition and do not need to be the first source.

The FDA goes on to recommend giving infants other cereals like oat, barley and multigrain.

When it comes to toddlers, the agency recommends a well-balanced diet rich in grains. For expecting mothers, the FDA also recommends eating a well-balanced diet. Pregnant women should try to eat a variety of foods, including a variety of grains.

Speak to your doctor or pediatrician about the best nutrition for you and your baby.

Muscle Trouble? There May Be an Alternative to Statins

Evolocumab may help lower cholesterol in patients who cannot tolerate statins


April 9, 2016 / Author: / Reviewed by: Beth Bolt, RPh

(RxWiki News) Some patients who need to take statins to lower cholesterol report related muscle pain or weakness that keeps them from taking the drugs, but statins may not be at fault.

In a two-phase study of 511 patients with high cholesterol, researchers found that muscle-related adverse effects were not always tied to statin use, and that a non-statin treatment,evolocumab (brand name Repatha), may help lower cholesterol.

In the first phase, patients were given either a statin or a placebo. Some patients discontinued their use of the statin due to muscle problems, but some also reported the same muscle problems with the placebo, suggesting that statins may not always be to blame for muscle-related adverse effects in patients with high cholesterol.

Meanwhile, in phase two of this study, which was conducted by Cleveland Clinic researchers, study patients received one of two non-statin medications to see whether they could effectively lower cholesterol. Thirty percent of patients receiving evolocumab reached a significantly lowered cholesterol goal.

This study was published in JAMA.

Amgen, a pharmaceutical company, funded this research. Study authors disclosed multiple conflicts of interest, including financial ties to various pharmaceutical companies.

Pregnancy Problems Tied to Bigger Babies

Gestational diabetes, obesity during pregnancy tied to early overgrowth of baby in womb



April 12, 2016 / Author: Reviewed by: Beth Bolt, RPh

(RxWiki News) Obesity during pregnancy and gestational diabetes may be tied to overly large babies at six months’ pregnancy, a new study found.

This finding, according to the authors of this study, may suggest that measures to screen for diabetes during pregnancy may come too late to prevent the problem.

Maternal obesity and gestational diabetes have been tied in past research to health problems like obesity for children later on, as well as overgrowth in the womb.

This study looked at 4,069 women. The study authors found that fetuses of women who were obese during pregnancy or who developed gestational diabetes were more likely to be too large by 28 weeks.

Twenty-eight weeks of pregnancy happens to be a common time when pregnant women in the US are given a full test for gestational diabetes, these researchers noted. This could mean that, by the time some pregnant women are screened for gestational diabetes, their babies could already be overly large.

These researchers called for earlier screening for gestational diabetes.

This study was published in the Journal Diabetes Care.

The National Institute for Health ResearchCambridge Comprehensive Biomedical Research Centre, and Stillbirth and Neonatal Death Charity funded this research. Researchers cited several potential conflicts of interest, including ties to medical device manufacturers.

Fast Food May Mean More Phthalates

Phthalate exposure was higher in those who ate more fast food

April 13, 2016 / Author: / Reviewed by: Anyssa Garza, PharmD  

April 13, 2016 / Author: / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) Fast food may expose diners to potentially harmful chemicals called phthalates, a new study found.

Those who said they ate more fast food in a national survey of 8,877 people had higher concentrations of phthalates in their urine, according to this study.

Phthalates are industrial chemicals used in plastic and similar items such as food packaging.

In this study, researchers from the George Washington University Milken Institute found the more fast food respondents ate, the more they were exposed to phthalates. Furthermore, they found those with the highest fast-food intake had nearly 40 percent higher levels of one phthalate in their urine.

These researchers said more research is needed to confirm the exact health effects of phthalates, but, in the meantime, diners should opt for more fruits and vegetables and fewer fast-food burgers and burritos.

This study was published in Environmental Health Perspectives.

The National Institute of Environmental Health Sciences funded this research. Conflict of interest disclosures were not available at the time of publication.


Vegetable Oils May Not Help You Live Longer

Vegetable oils tied to lower cholesterol but not longer life,

lower heart disease risk



April 15, 2016 / Author: Staff / Reviewed by: Anyssa Garza, PharmD

(RxWiki News) There’s now reason to doubt the heart-health benefits of vegetable oils rich in linoleic acid, according to a new study.

Cutting the saturated fat in your diet and replacing it with vegetable oils rich in linoleic acid may lower your cholesterol, but that may not translate to a longer life or lower heart disease risk, this study found.

(RxWiki News) There’s now reason to doubt the heart-health benefits of vegetable oils rich in linoleic acid, according to a new study.

Cutting the saturated fat in your diet and replacing it with vegetable oils rich in linoleic acid may lower your cholesterol, but that may not translate to a longer life or lower heart disease risk, this study found.

This National Institutes of Health study, published in The BMJ, looked at 9,423 patients from state mental hospitals and a nursing home. One group of patients replaced saturated fat, which is found in animal products like margarine and meat, with corn oil, a vegetable oil rich in linoleic acid, which is thought to improve heart health. The other group ate a diet high in saturated fat.

The group that replaced saturated fats with vegetable oil did have lower cholesterol but did not appear to live longer. The authors of this study even found that patients who had sharper drops in cholesterol had a higher rather than a lower risk of death.

These researchers took the study a step further by analyzing past studies similar to the current one. The evidence didn’t support the idea that lowering cholesterol reduced the risk of death, they found.

More research is needed before any dietary recommendations can be made. In the meantime, eat a healthy, well-balanced diet full of fruits, vegetables and whole grains, recommended the author of an editorial about this study.

The National Institutes of HealthUniversity of North Carolina Program on Integrative Medicine and others funded this research. The authors disclosed no conflicts of interest.