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| Long-term Data Show Insomnia Treatment Is Effective |
A new study finds that zolpidem extended-release 12.5 mg, taken three to seven nights per week for up to six months, provided sustained and significant improvements in sleep onset and maintenance, and also improved next-day concentration and morning sleepiness in people with insomnia.
The study focused on 1,018 patients between 18 and 64 years of age with chronic primary insomnia, who had difficulty initiating or maintaining sleep or experiencing non-restorative sleep for three months or greater. The subjects took either a single dose of zolpidem extended-release or a placebo from three to seven nights per week.
According to the results, there was a statistically significantly greater benefit in the zolpidem group than in the placebo group on patient global ratings of improvement, with no reduction in clinical efficacy over the course of the study and no evidence of rebound insomnia upon drug discontinuation. At the 12-week end point, 89.7 percent of zolpidem extended-release patients reported that the medication helped them sleep, compared with 51.4 percent of placebo patients.
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| Some Antipsychotic Drugs May Be Missing Their Mark |
Drugs that treat depression, schizophrenia and other psychotic conditions and that target a particular protein on brain cells might not be triggering the most appropriate response in those cells, new research suggests.
The study by researchers at The Ohio State University Medical Center examined the serotonin 2A receptor, a protein on brain cells sensitive to the neurotransmitter serotonin.
This study examined the early chemical events that happen inside neurons when the 2A receptor is stimulated by serotonin and by a synthetic hallucinogenic agent that is thought to mimic serotonin.
The findings, published online in the early edition of the Proceedings of the National Academy of Sciences with an accompanying editorial, show that although both compounds combine with and activate this receptor, they trigger different chemical pathways inside the neuron.
Researchers say that the work could have important implications for the development of drugs that affect the serotonin 2A receptor, a key target in the treatment of schizophrenia, depression and other mental disorders.
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| Study Finds Most TV Prescription Drug Ads Minimize Risk Information |
Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.
A team led by Wendy Macias, associate professor in the UGA Grady College of Journalism and Mass Communication, analyzed a week's worth of direct-to-consumer ads on broadcast and cable television. The found that the average 60-second ad contained less than 8 seconds (13 percent of total ad time) of side effect disclaimers, while the average 30-second ad has less than 4.4 seconds (15 percent of total ad time) of disclaimers. Most of the 15-second ads studied devoted no time at all to disclaimers.
"These ads clearly don't devote enough time to information about risk," said Macias, whose results appear in the November/December issue of the journal Health Communication. "Adding to the problem is that the information is often presented in a way that people aren't likely to comprehend or even pay attention to."
Macias and her team, which includes Kartik Pashupati at Southern Methodist University and Liza Lewis at The University of Texas at Austin, found that almost all of the ads disclosed side effects solely in a voice-over portion of the ad. Only 2.2 percent of ads had the disclosure in voice-over as well as in text form.
The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required the companies to "present a fair balance between information about effectiveness and information about risk."
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| Cholesterol-Lowering Drugs and the Risk of Hemorrhagic Stroke |
People taking cholesterol-lowering drugs such as atorvastatin after a stroke may be at an increased risk of hemorrhagic stroke, or bleeding in the brain, a risk not found in patients taking statins who have never had a stroke. But researchers caution the risk must be balanced against the much larger overall benefit of the statin in reducing the total risk of a second stroke and other cardiovascular events when making treatment decisions. The research is published in the December 12, 2007, online issue of Neurology®, the medical journal of the American Academy of Neurology.
For the study, researchers conducted a secondary analysis of the results of the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) clinical trial. The trial enrolled 4,731 people who were within one to six months of having had a stroke or transient ischemic attack, or mini-stroke, and with no history of heart disease. Half of the participants received atorvastatin and half received a placebo. The participants were then followed for an average of four and a half years.
Overall, treatment was associated with a 16-percent reduction in total stroke, the study's primary endpoint, as well as significant reductions in coronary heart events. However, secondary analysis found that the overall reduction in stroke included an increase in the risk of brain hemorrhage. Of those people randomized to atorvastatin, the study found 2.3 percent experienced a hemorrhagic stroke during the study compared to 1.4 percent of those taking placebo. The study also found there was a 21-percent reduction in ischemic stroke, a more common type of stroke involving a block in the blood supply to the brain, among people taking atorvastatin.
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Lack of Deep Sleep May Increase Risk of Type 2 Diabetes
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Suppression of slow-wave sleep in healthy young adults significantly decreases their ability to regulate blood-sugar levels and increases the risk of type 2 diabetes, report researchers at the University of Chicago Medical Center in the "Early Edition" of the Proceedings of the National Academy of Science, available online as soon as December 31, 2007.
Deep sleep, also called "slow-wave sleep," is thought to be the most restorative sleep stage, but its significance for physical well-being has not been demonstrated. This study found that after only three nights of selective slow-wave sleep suppression, young healthy subjects became less sensitive to insulin. Although they needed more insulin to dispose of the same amount of glucose, their insulin secretion did not increase to compensate for the reduced sensitivity, resulting in reduced tolerance to glucose and increased risk for type 2 diabetes. The decrease in insulin sensitivity was comparable to that caused by gaining 20 to 30 pounds.
Previous studies have demonstrated that reduced sleep quantity can impair glucose metabolism and appetite regulation resulting in increased risk of obesity and diabetes. This current study provides the first evidence linking poor sleep quality to increased diabetes risk.
"These findings demonstrate a clear role for slow-wave sleep in maintaining normal glucose control," said the study's lead author, Esra Tasali, MD, assistant professor of medicine at the University of Chicago Medical Center. "A profound decrease in slow-wave sleep had an immediate and significant adverse effect on insulin sensitivity and glucose tolerance."
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| New Drug Targets May Fight Tuberculosis and Other Bacterial Infections in Novel Way |
Over the course of the 20th Century, doctors waged war against infectious bacterial illness with the best new weapon they had: antibiotics.
But the emergence of dangerous, multi-drug resistant strains of tuberculosis and other killer infections means that in the 21st century antibiotics are losing ground against bacterial disease.
Now, researchers from Weill Cornell Medical College in New York City say exciting new molecular targets-so-called "virulence factors" that bacteria use to thrive once they are in the host-present an alternative, potent means of stopping TB, leprosy and other bacterial illness.
"We have developed the first inhibitor of a key small molecule from Mycobacterium tuberculosis and Mycobacterium leprae (which causes leprosy) utilized to subvert human host's defenses and damage and invade human host's cells during infection," explains study senior author Dr. Luis Quadri, Associate Professor of Microbiology and Immunology at Weill Cornell.
"With this work, we now have proof of principle for the inhibition of this virulence factor in bacteria cultured in the lab. Our next step is to explore whether this inhibitor can stop these pathogens from multiplying in a mouse host, curtailing infection," Dr. Quadri says.
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| Biomedical Engineering Study Demonstrates the Healing Value of Magnets |
Magnets have been touted for their healing properties since ancient Greece. Magnetic therapy is still widely used today as an alternative method for treating a number of conditions, from arthritis to depression, but there hasn't been scientific proof that magnets can heal.
Lack of regulation and widespread public acceptance have turned magnetic therapy into a $5 billion world market. Hopeful consumers buy bracelets, knee braces, shoe inserts, mattresses, and other products that are embedded with magnets based on anecdotal evidence, hoping for a non-invasive and drug-free cure to what ails them.
"The FDA regulates specific claims of medical efficacy, but in general static magnetic fields are viewed as safe," notes Thomas Skalak, professor and chair of biomedical engineering at U.Va.
Skalak has been carefully studying magnets for a number of years in order to develop real scientific evidence about the effectiveness of magnetic therapy.
Skalak's lab leads the field in the area of microcirculation research-the study of blood flow through the body's tiniest blood vessels. With a five-year, $875,000 grant from the National Institutes of Health's National Center for Complementary and Alternative Medicine, Skalak and Cassandra Morris, former Ph.D. student in biomedical engineering, set out to investigate the effect of magnetic therapy on microcirculation. Initially, they sought to examine a major claim made by companies that sell magnets: that magnets increase blood flow.
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Believe it or not
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Pharmacy burglar foiled by fog alarm
When a burglar broke into a Medford pharmacy this week, looking to snatch some drug, he was foiled by fog. The dense fog, a new technology offered by alarm companies, made it impossible for the robber to find the sought-after narcotics.
Pharmacy break-ins are prevalent throughout Oregon. And now drugstore owners are stepping up efforts to protect their businesses, using everything from grates over windows and doors to alarms and surveillance cameras.
The fog protection is the latest twist. It adapts fog machine technology used in entertainment to create an extremely fast-spreading, long-lasting, dense fog that is triggered by motion detectors or other sensors.
The fog, made by combining water and glycol, has a "soft mint smell," can fill a room in three to five seconds, and blocks visibility for at least 10 minutes. It can last up to an hour or be removed in about 15 minutes with ventilation and doesn't leave a residue, according to manufacturers.
In the Medford case, police arrived two minutes after the alarm was triggered to find the shop filled with fog and no suspects around.
When the fog cleared and a pharmacist checked the inventory, only "a few bottles of cough syrup were gone," said Detective Sgt. Mike Budreau said.
That's a far cry from the thousands of prescription painkillers that have been stolen in past pharmacy burglaries.
Highly physically addictive pain medication such as oxycodone and hydrocodone are often targeted in the crimes, authorities said.
State law requires controlled substances at pharmacies be secure, but doesn't list specific security requirements.
However, Gary Miner, compliance director at the state Board of Pharmacy, said his inspectors increasingly see sophisticated security measures at pharmacies.
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News From MedWatch |
| Keep up-to-date on all of the recent
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medical products regulated by the U.S. Food and Drug Administration by CLICKING HERE
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Recently Approved Drugs/Indications |
| Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE
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FDA Recalls and Safety Alerts in the Past 60 Days: |
| To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE
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Drug Shortages: |
| As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE
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