Drugs and Disease – Page 20

November 20, 2015

Yoga May Boost Quality of Life for Prostate Cancer Patients

Yoga may benefit men who are undergoing radiation therapy for prostate cancer, according to a small study.

Many such patients experience side effects, including fatigue, erectile dysfunction, urinary incontinence and a decline in their quality of life, the researchers said.

The new study included 27 men who attended 75-minute yoga classes twice a week. These patients saw their quality of life and side effects remain stable throughout their radiation treatment.

“Data have consistently shown declines in these important measures among prostate cancer patients undergoing cancer therapy without any structured fitness interventions, so the stable scores seen with our yoga program are really good news,” Dr. Neha Vapiwala, an associate professor in the radiation oncology department of the Perelman School of Medicine at the University of Pennsylvania, said in a university news release.

Yoga may help reduce cancer- and treatment-related fatigue, the study authors suggested. It may also strengthen pelvic floor muscles and increase blood flow, which could improve erectile dysfunction and urinary incontinence

“There may also be a psychosocial benefit that derives from participation in a group fitness activity that incorporates meditation and promotes overall healthiness. And all of this ultimately improves general quality of life,” Vapiwala added.

The study was presented this week at the Society of Integrative Oncology’s international conference in Boston. Research presented at meetings should be viewed as preliminary until published in a peer-reviewed journal.

Previous research has suggested that yoga may benefit cancer patients, but those studies have focused mainly on breast cancer.

Nearly 240,000 American men are diagnosed with prostate cancer each year, according to the American Cancer Society, which funded the study.

November 18, 2015

study suggests ,Falls,Fights Cause Most Serious Eye Injuries

Falls and fights are the leading causes of eye injuries that land people in the hospital, a new study finds.

Also, the cost of treating such injuries is going up. The analysis of data from nearly 47,000 people hospitalized for eye injuries between 2002 and 2011 showed that treatment costs rose 62 percent during that time and is now more than $20,000 per injury.

“While we have some clues, we still can’t be certain why it’s more expensive to get treated for an eye injury now than before,” wrote lead researcher Dr. Christina Prescott, an ophthalmology professor at Johns Hopkins University in Baltimore.

“It could be related to drug prices or administrative costs. Either way, it’s clear we need more targeted interventions to help reduce these types of injuries, many of which are preventable,” she added.

Overall, fighting and assaults caused the second highest number of eye injuries, accounting for nearly 8,000 hospitalizations. However, this was the most common cause of eye injuries among those aged 10 to 59.

Among children aged 10 and younger, the leading cause of eye injury was accidentally being hit by a person or object, followed by car crashes and accidentally being hit, pierced or cut by sharp objects such as scissors.

Research presented at meetings is considered preliminary until published in a peer-reviewed medical journal.

November 18, 2015

Breast-Feeding may Reduce Risk of retinopathy of prematurity

Breast-feeding a premature infant may help reduce the risk of a serious eye problem known as retinopathy of prematurity (ROP), new research suggests.

The researchers said that when babies were exclusively fed breast milk, the risk of any-stage ROP appeared to drop by about 75 percent. And the risk of severe ROP seemed to be reduced by 90 percent, the researchers added.

“Human milk feeding potentially plays a strong role in protecting very preterm newborns from any-stage ROP and severe ROP,” the international team of study authors wrote.

Retinopathy of prematurity causes blood vessels to grow in the retina, the light-sensitive tissue in the back of the eye. When the vessels grow, they can cause the retina to detach, destroying vision, according to the U.S. National Eye Institute.

For the study, researchers from China, Canada and the United Kingdom reanalyzed the results of five published studies on ROP. The studies included more than 2,200 preterm infants, comparing how often babies had been fed human milk or formula, and whether or not they developed ROP.

However, the new analysis only showed an association between breast milk and a reduced risk of ROP. It did not prove a cause-and-effect relationship due to the study’s design.

Results of the study were published online Nov. 16 in Pediatrics.

Extremely preterm babies are most at risk of ROP. In the United States, 59 percent of babies born at 22 to 28 weeks have the disorder, said study researcher Dr. Chao Chen, a neonatologist at Children’s Hospital of Fudan University, in Shanghai. He added that in China, a previous study showed the incidence of ROP was 50 percent in infants with a birth weight under 1,000 grams (2.2 pounds).

ROP “has become a leading cause of childhood blindness in recent time,” Chen said. “In general, there are more ROP cases in developed countries, but more severe cases and higher rates of blindness in developing countries.”

The greater incidence of ROP is likely due to the increasing survival rate of very preterm babies in developed countries, according to Chen. In developing countries, preterm babies are less likely to survive. When they do, the screening and treatments are not as good, Chen said, so blindness may be more likely.

Babies in the studies had a range of gestational ages, from 26 to about 30 weeks. Their weights ranged from about 1.7 pounds to about 3 pounds. No information was given about how long the breast-feeding continued.

In re-evaluating the studies, Chen’s team found that breast-feeding in any amount appeared to reduce the risk of ROP. And it appeared that the more breast milk, the better. Exclusive breast-feeding seemed to drop the odds of ROP by 75 percent compared to exclusive formula use. And any breast-feeding appeared to reduce the odds of the serious eye disease by 46 percent, the research showed.

How might human milk offer protection from the eye disorder? The antioxidants in human milk may help, Chen said. Human milk also has immune-protective properties, the researchers said. Breast-feeding also seems to help prevent two conditions known as sepsis and necrotizing enterocolitis that may require oxygen therapy, which has also been linked to a higher risk of ROP, the study authors said.

Dr. Adolfo Llanos, a neonatologist at Nicklaus Children’s Hospital in Miami, who was not involved with the new study, said the “quality of this analysis is very good. It’s reassuring to see the benefit we see with breast milk.”

He said breast milk may help by reducing inflammation in the body. “Preemies don’t regulate inflammation in their bodies well,” he said.

The takeaway from this study, Llanos said, is to breast-feed as long as possible, if possible.

November 18, 2015

FDA Approves Narcan Nasal Spray

Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”

Until this approval, naloxone was only approved in injectable forms(most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.

Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary. However, it is important to note that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient’s behalf.

The FDA granted fast-track designation and priority review for Narcan nasal spray. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. The agency’s priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Narcan nasal spray is being approved in less than four months, significantly ahead of the product’s prescription drug user fee goal date of January 20, 2016.

In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The National Institute on Drug Abuse played a critical role in the development of Narcan nasal spray as well, forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.

“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, M.D., director, National Institute on Drug Abuse at the National Institutes of Health. “While prevention is the ultimate goal, the drug’s successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now.”

Increasing access to and the use of naloxone is part of the targeted strategy that Health and Human Services Secretary Sylvia M. Burwell put forward in March to address the opioid epidemic and save lives. In July, addiction and advocacy groups called for expanded availability of naloxone during an FDA-sponsored public workshop exploring the uptake and use of the drug.

The use of Narcan nasal spray in patients who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

November 17, 2015

Brain Differences May Explain Why hallucination occurs in Schizophrenia

Researchers believe they’ve identified brain structure differences that increase the risk of hallucinations in people with schizophrenia.

“Hallucinations are very complex phenomena that are a hallmark of mental illness and, in different forms, are also quite common across the general population,” said study first author Jane Garrison, from the University of Cambridge in England. “There is likely to be more than one explanation for why they arise, but this finding seems to help explain why some people experience things that are not actually real,” she said in a university news release.

The researchers analyzed brain scans of schizophrenia patients and people without the mental illness. They found that schizophrenia patients with hallucinations had structural differences in a certain part of the brain compared to patients who did not hallucinate and people without the disease.

Specifically, schizophrenia patients with hallucinations had a shorter paracingulate sulcus (PCS), a fold near the front of the brain. A 1-centimeter (0.4-inch) reduction in the fold’s length was associated with a nearly 20 percent increased risk of hallucinations. The effect held for both auditory and visual hallucinations.

The paracingulate sulcus is one of the last structural folds to develop in the brain before birth, and varies in size between people, according to background information with the study, published Nov. 17 in the journal Nature Communications.

Study leader Jon Simons, a neuroscientist from Cambridge’s psychology department, said, “Schizophrenia is a complex spectrum of conditions that is associated with many differences throughout the brain, so it can be difficult to make specific links between brain areas and the symptoms that are often observed.

“By comparing brain structure in a large number of people diagnosed with schizophrenia with and without the experience of hallucinations, we have been able to identify a particular brain region that seems to be associated with a key symptom of the disorder,” he explained in the news release.

Garrison, also a member of the psychology department, said the investigators think “PCS is involved in brain networks that help us recognize information that has been generated ourselves.” People with a shorter paracingulate sulcus “seem less able to distinguish the origin of such information, and appear more likely to experience it as having been generated externally,” she said.

November 16, 2015

Lowering Body Temperature May Help Cardiac Arrest Patients

Lowering the body temperature after someone’s heart has stopped beating may improve the odds of surviving with good brain function, a new study suggests

In fact, patients whose body temperatures were lowered (therapeutic hypothermia) were nearly three times more likely to survive cardiac arrest, the study found. Those treated with the cold therapy were also 3.5 times more likely to have better mental function than those who didn’t receive the therapy, the researchers said.

“Our findings provide support for the idea that all unconscious post-arrest patients should receive aggressive care with therapeutic hypothermia,” said lead researcher Dr. David Gaieski, an associate professor of emergency medicine at the School of Medicine at Thomas Jefferson University in Philadelphia.

“Withholding [this treatment] does not make sense given these data and other data from other studies at many institutions around the world,” he said.

The report was published Nov. 16 online in the journal Circulation.

The body gets too little blood when the heart stops beating, or when blood flow is blocked by a blood clot or stroke, Gaieski said. In these situations, lowering the body’s temperature can help protect it, he explained.

Earlier studies have shown that the cold treatment can improve survival and brain function in people with “shockable” rhythms, such as ventricular fibrillation, the study said. Ventricular fibrillation is a condition where the lower chambers quiver, preventing the heart from pumping blood and causing cardiac arrest, the American Heart Association notes. In many of these cases the heart can be “shocked” into a normal rhythm, Gaieski said.

But there are cases of patients in cardiac arrest with “nonshockable” rhythms. This is when there is no electrical activity in the heart, or when there is electrical activity, the heart isn’t contracting and blood isn’t flowing, he explained. Currently, there aren’t a lot of hospitals using temperature-lowering therapy for patients who have a nonshockable rhythm, the researchers said.

For the study, Gaieski’s team looked at data from more than 500 patients whose hearts stopped beating between 2000 and 2013. All had nonshockable rhythms. Lowering the body’s temperature increased survival rates and brain function in these patients, the study said.

Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City and a spokesman for the American College of Emergency Physicians, said, “This important trial demonstrates that cooling should be tried in all patients with cardiac arrest, regardless of the initial heart rhythm.”

Glatter noted that the actual number of patients who survive mentally intact remains low. But, he added, reducing the body temperature has been shown to have a positive effect on improving outcomes.

“There has been a slow adoption of this treatment from lack of understanding the benefits of this easily implemented therapy,” he said.

Glatter added that lowering body temperature doesn’t require special equipment. It can be accomplished using equipment already in every hospital, he said.

November 13, 2015

Study suggests vitamin D deficiency may cause erectile dysfunction

Low levels of vitamin D may be associated with erectile dysfunction, a new study suggests.

Researchers analyzed data from more than 3,400 American men, age 20 and older, who did not have heart disease. Thirty percent were vitamin D deficient, which means their levels of the “sunshine vitamin” were below 20 nanograms per milliliter of blood. And 16 percent had erectile dysfunction.

Vitamin D deficiency was present in 35 percent of men with erectile dysfunction, compared with 29 percent of those without erectile dysfunction, the study found.

“Vitamin D deficiency is easy to screen for and simple to correct with lifestyle changes that include exercise, dietary changes, vitamin supplementation and modest sunlight exposure,” study lead investigator Dr. Erin Michos, an associate professor of medicine at Johns Hopkins University School of Medicine, said in a university news release.

The researchers concluded that men with vitamin D deficiency were 32 percent more likely to be impotent than those with sufficient vitamin D levels. This association held even after the study authors accounted for other factors associated with erectile dysfunction, such as drinking, smoking, diabetes, higher blood pressure, inflammation and certain medications.

The researchers emphasized that their findings are observational and don’t prove cause and effect. They said more research is needed to determine if there’s a direct link between low vitamin D levels and erectile dysfunction. If that’s the case, they said it could lead to new treatment approaches.

“Checking vitamin D levels may turn out to be a useful tool to gauge ED risk,” Michos said. “The most relevant clinical question then becomes whether correcting the deficiency could reduce risk and help restore erectile function.”

About 40 percent of men older than 40 and 70 percent of those older than 70 are unable to attain and maintain an erection, the researchers said. Vitamin D deficiency affects up to 40 percent of adult Americans, according to the U.S. Centers for Disease Control and Prevention.

The study was presented Tuesday at the American Heart Association’s annual meeting in Orlando, Fla. Research presented at meetings should be considered preliminary until it’s published in a peer-reviewed medical journal.

November 13, 2015

Study says Medicines Last as Long in Space as Here on Earth

Medicines don’t degrade faster in space than they do on Earth, a new study finds.

Researchers analyzed nine medications that were stocked on the International Space Station for 550 days and returned unused to Earth, where they were kept under controlled conditions for three to five months.

The medications included pain relievers, sleeping aids, antihistamines/decongestants, an anti-diarrheal and an alertness drug.

The researchers assessed whether the active ingredients and the amount of degradation in the medications met United States Pharmacopeia (USP) guidelines for viability.

One medication met the USP standards five months after its expiration date, four met the standards up to eight months after their expiration dates, and three met the standards when tested three months before their expiration dates. A dietary supplement/sleeping aid did not meet the standards when tested 11 months after its expiration date.

No unusual degradation was found in any of the medications, according to the study published online Nov. 6 in the AAPS Journal.

Until now, there has been little information about how long periods of time in space affect medications.

While the International Space Station is regularly resupplied with medications, this may not be possible on long missions to more distant locations in space, said study leader Virginia Wotring. She’s with the Center for Space Medicine and Department of Pharmacology at Baylor College of Medicine in Houston.

Researchers said further studies in this area are necessary before planning long-term space flights, such as missions to Mars.

November 13, 2015

FDA Approves Adynovate for Hemophilia A

The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.

Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. Adynovate consists of the full-length Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood.

“The approval of Adynovate provides an important therapeutic option for use in the care of patients with Hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. Hemophilia A is an inherited, sex-linked, blood-clotting disorder that primarily affects males, which is caused by defects found in the Factor VIII gene. According to the Centers for Disease Control and Prevention, Hemophilia A affects one in every 5,000 male births in the United States. Patients with hemophilia A may experience repeated episodes of serious bleeding, primarily into the joints, which can be severely damaged as a result. The safety and efficacy of Adynovate were evaluated in a clinical trial of 137 adults and adolescents aged 12 years and older, which compared the recommended routine prophylactic (preventative) treatment regimen to on-demand therapy. The trial demonstrated that Adynovate was effective in reducing the number of bleeding episodes during routine care. Additionally, Adynovate was effective in treating and controlling bleeding episodes. No safety concerns were identified during the trial. Adynovate is manufactured by Baxalta US Inc., based in Westlake Village, California.

November 12, 2015

Kidney transplant may increase the risk for certain types of cancer, a new study suggests.

Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests.

Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues.

For the study, published in the Nov. 12 online edition of the Journal of the American Society of Nephrology, the researchers looked at data from more than 200,000 U.S. kidney transplant candidates and recipients.

Along with finding that these patients are at increased risk for certain types of cancer, the investigators also identified clear patterns of risk associated with different types of treatment. However, the associations seen in the study do not prove cause-and-effect.

The risk of kidney and thyroid cancers was especially high when kidney failure patients were on dialysis. The risk of non-Hodgkin lymphoma, lung cancer, melanoma and certain other types of skin cancers was highest after kidney transplantation. The increased risk after a transplant is probably a result of the drugs that suppress the immune system that patients have to take to prevent rejection of the new kidney, the study authors suggested.

“Our study indicates that the needs of individuals with end-stage renal disease, in terms of cancer prevention and cancer screening, will likely differ over time,” Yanik said in a news release from the American Society of Nephrology.

“Vigilance for kidney cancer and thyroid cancer may be of particular importance while these individuals are on dialysis. Extra consideration for screening for melanoma or lung cancer may be called for while taking immunosuppressant medications following a kidney transplant,” she concluded.

The findings show the need to closely monitor these patients for cancer, Yanik’s team said.