Thursday, January 17, 2013

FDA Reduces Dosage Recommendations Of Sleeping Pills Containing Zolpidem

Manufacturers of sleeping pills with an active ingredient called zolpidem are being forced by the U.S. Food and Drug Administration (FDA) to reduce the current recommended dose of the medications. This measure comes following new evidence showing that the zolpidem blood levels of some people the day after taking the medications can severely impair their alertness and ability to perform tasks, such as driving or handling machinery.
Zolpidem remains in the blood the morning after taking it. By lowering the recommended dose of drugs with the ingredient inside, the blood level of zolpidem the morning after will be reduced. Women take longer than men to flush the ingredient from their system, the FDA has stated that the dosage for women will therefore be less than for men. Patients taking the extended-release forms of these drugs have the highest levels of the ingredient in their blood.

The FDA warns health care professionals of the importance in assuring that patients on these medications are completely aware of the risks associated with zolpidem.

For women, the recommended dosage of zolpidem found in instant release drugs (Edular, Ambien) will be lowered from 10 mg to 5mg, for extended-release drugs it will be lowered from 12.5 mg to 6.25 mg. Although men are able to eliminate the ingredient faster, the FDA still encourages doctors to consider prescribing the same dosages that are recommended to women.

According to Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research:

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia. Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."

Morning drowsiness and impaired alertness is not exclusively associated with zolpidem, the FDA reminded the public that there are many other insomnia drugs that also have the same side effect.

Those who are currently taking 10 mg or 12.5 mg doses of medications with zolpidem should carry on with their prescribed dose before talking to their doctor who will evaluate how to continue with the drug. People on the medication need to talk to their doctors to find an appropriate dose.

The change comes after a laboratory study and driving simulation revealed an increased risk of motor vehicle accident while zolpedim is still in a person's blood, as may occur the morning after taking some insomnia medications.

Dr. Unger. concluded:

"Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people's mental alertness and ability to drive. Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment."

More research will be carried out by the FDA to fully understand the risks of all the other insomnia drugs on the market.

A previous study published in Behavior Therapy revealed that in some instances, taking insomnia medication is not the best form of therapy in the long run, due to it's numerous side effects.

Promising Saliva Gland Test For Detecting Parkinson's

Testing a part of a person's saliva gland may be a way to diagnose Parkinson's disease, according to new research by the Mayo Clinic that will be presented at the American Academy of Neurology's annual meeting in March.
Parkinson's disease is a difficult disease to diagnose. Currently the only way to pinpoint the disease is to do a clinical exam to analyze a person's symptoms. To achieve a definitive answer, an autopsy is performed on the brain after a person has passed away.

Charles Adler, M.D., Ph.D., and main researcher of the study said:

"We have previously shown in autopsies of Parkinson's patients that the abnormal proteins associated with Parkinson's are consistently found in the submandibular saliva glands, found under the lower jaw. This is the first study demonstrating the value of testing a portion of the saliva gland to diagnose a living person with Parkinson's disease. Making a diagnosis in living patients is a big step forward in our effort to understand and better treat patients."

The study consisted of 15 people with a mean age of 68 who had Parkinson's disease for an average of 12 years. The participants chosen had also responded well to Parkinson's medication and did not have any previous saliva gland issues.

Saliva Glands
Diagram of the saliva glands.
1) Parotid Gland. 2) Submandibular Gland. 3) Sublingual Gland.
Two different saliva glands were biopsied: the minor saliva glands in the lower lip and the submandibular gland. The extracted tissues were then analyzed for evidence of the irregular Parkinson's protein.

Researchers suggest that one of the most important potential advantages this test could have is creating more accurate clinical trials. Parkinson's clinical trial participants currently do not always have Parkinson's disease, making it harder to test new therapies.

In nine of the eleven patients who had an adequate amount of tissue to examine, the irregular Parkinson's protein was found. The rate of positive outcomes in the biopsies of the lower lip glands seemed much lower than for the lower jaw gland.

Dr. Alder explained:

"This study provides the first direct evidence for the use of submandibular gland biopsies as a diagnostic test for living patients with Parkinson's disease. This finding may be of great use when needing definitive proof of Parkinson's disease, especially when considering performing invasive procedures such as deep brain stimulation surgery or gene therapy."

Parkinson's, A Progressive Disease

Parkinson's disease is an accelerating disease of the nervous system that affects movement. It starts slowly, sometimes with an unnoticeable hand tremor. Tremors are the hallmark symptoms of Parkinson's - the disease also comes with stiffness and slowing of motor skills.

Diagnosis is based on medical history, an assessment of symptoms and signs, a physical and neurological analysis, and eliminating possibilities of other disorders. Close to 30 percent of patients may be misdiagnosed early on in the disease.

Even though Parkinson's cannot be cured, medications can greatly reduce symptoms

Growing Hearing Hairs May Reverse Deafness In Mice

Small hairs inside the ear that recognize sounds have been regenerated to reverse deafness for the first time, according to a new study in the journal Neuron.
A group of researchers from Massachusetts Eye and Ear Harvard Medical School have shown that hair cells can be regenerated by a using a drug to provoke cells that live inside the ear to become new hair cells. This brings about partial hearing recovery in mice with previously damaged ears.

This discovery holds great promise for future use in possibly reversing deafness in humans.

Senior author, Dr. Albert Edge, of Harvard Medical School and Mass. Eye and Ear explains:

"Hair cells are the primary receptor cells for sound and are responsible for the sense of hearing. We show that hair cells can be generated in a damaged cochlea and that hair cell replacement leads to an improvement in hearing."

Hearing loss is a public health issue that affects nearly 50 million people just in the U.S. The most common condition is known as sensorineural hearing loss which is created by the loss of sensory hair cells in the cochlea.

In 2008 a report stated that the incidence of hearing loss in adults in the U.S. is higher than originally documented. The researchers recommended that screening begin in young adulthood.

Hearing loss can be the result of the following circumstances:
  • aging
  • certain antibiotics and anti-cancer drugs
  • toxins
  • noise exposure
  • infections
In order to hear, sound waves must be changed into electrical signals which the brain can interpret. The initial step of this activity happens inside the inner ear where vibrations move little hairs - the movement produces an electrical signal.

Hearing loss is normally caused by damage to these hairs. There are no known treatments to completely bring back hearing. However, there are hearing aids and cochlear implants that can reduce the symptoms slightly.

Hearing loss can never be reversed completely because auditory hair cells in mammals do not regenerate once they are gone, unlike those of birds or fish. The findings from this study could be a stepping stone for treatment that could bring back hearing after loss of hair cells.

During the experiment, the investigators used a drug that generates hair cells when combined with stem cells outside of the ear. They administered this drug to the cochlea of deaf mice.

The drug was aimed at cells which normally give support to individual hairs. It then changed the path of the cells by changing which genes were being used in the cells, to alter them into hair cells.

Dr. Edge explained:

"The missing hair cells had been replaced by new hair cells after the drug treatment, and analysis of their location allowed us to correlate the improvement in hearing to the areas where the hair cells were replaced."

The results of this study demonstrate the first hair cell regeneration in an adult mammal. The researchers are excited about the outcomes and their future implications in the possible treatment of deafness in humans.

Lung Cancer Screening For Heavy Smokers Recommended

People who have smoked at least a pack-a-day for thirty years should undergo lung cancer screening, the American Cancer Society announced today in its lung cancer screening guidelines.
The American Cancer Society says that doctors with access to high-tech lung cancer screening equipment, as well as treatment centers, should talk to their healthy patients who have been smoking heavily for at least three decades about having their lungs checked.

The Society added that even ex-smokers who gave up less than 15 years ago and smoked heavily for over thirty years should be advised to undergo screening.

According to the guidelines, doctors should tell their patients what the benefits and known harms linked to lung cancer screening are.

The American Cancer Society says that it came to this conclusion after a panel of experts reviewed a number of cancer screening studies that were published in academic journals over the last few decades.

Guidelines published in JAMA in May 2012 recommended that older, current and former heavy smokers should receive annual low-dose CT screening of their lungs.

What are the benefits and harms of lung cancer screening?

The authors of the latest guidelines say that the NLST (National Lung Screening Trial), which was published last year, strongly influenced their conclusions. The NLST involved 53,454 healthy males and females aged at least 55 years who were deemed at high risk of lung cancer because of their smoking history.

Half of them were assigned to the test group of low-dose spiral CT scan, while the other half, the "control group", underwent the standard single view chest X-ray. They were screened three times over a 24-month period. The researchers then checked to see how many were alive five to seven years later and assessed them.

Among those who had undergone the CT scans there were 356 lung cancer deaths, versus 443 deaths in the X-ray control group. The difference of 87 lives saved is a "statistically significant" number - a 20% drop in lung cancer death risk for those in the CT scan group.

The American Cancer Society wrote "One way of looking at this is: among about 27,000 people screened with a CT scan, 87 lung cancer deaths were prevented, but 356 lung cancer deaths still occurred."

Well designed clinical trials, such as the NLST one, help experts decide whether the benefits of screening outweigh the harms. The authors of the latest guidelines say that among healthy long-term heavy smokers or ex-smokers, the benefits of CT screening definitely outweigh the possible harms.

The experts wrote "A screening recommendation should only be made when the benefit clearly justifies the risk of harm."

What are the harms of screening? - despite the obvious benefits, the harms of screening must not be overlooked. Nearly 27,000 people underwent the 3-CT scans, of whom 40% had abnormal findings. They consequently had additional diagnostic tests, ranging from further CT scans to more invasive bronchoscopy, where a tube is placed down their throat into the lungs (via the mouth). Some of them underwent biopsies of the lung, an even more invasive procedure. The vast majority of the additional tests - 95% of them - did not result in a cancer diagnosis.

Sixteen patients who had received CT screening died within two months after an invasive diagnostic procedure that was carried out after their abnormal finding. Six of these 16 patients who died did not have lung cancer.

Even though nobody knows whether their deaths might have been caused by their invasive diagnostic procedures, the authors say that it reminds us that abnormal screening results can sometimes lead to dangerous diagnostic tests.

The NLST appears to show that for every five to six lives saved from CT-scan lung screening, one was lost because of the additional diagnostic procedures that an abnormal result caused.

Lung cancer screenings should be carried out in centers of excellence with experienced and well trained staff, so that the number of false positive screenings and extra invasive diagnostic tests are kept to a minimum, the Society added.

Lung cancer screening benefit for highest risk people

Lung cancer screening has the most benefit for healthy people at highest risk - those aged 55+ years with a long-term history of heavy smoking.

Lifetime non-smokers, or people with a history of light smoking do have a lung cancer risk, but the risk is not high enough to benefit from routine screening after the age of 55 - for them, the risk of harms from lung cancer screening is greater than the benefits.

The patient needs to make an informed decision

The American Cancer Society says that patients and health care professionals need to know about the benefits, limitations and harms associated with a screening test. Screening tests have limitations and may be linked to possible harms.

Examples of limitations include anxiety, worry, the inconvenience involved in further testing, and the complications and potentially life-threatening risks linked to some diagnostic tests that occur after a false-positive result.

There is concern that modern technology can detect small tumors that are no threat to the patient, even though they are technically cancerous tumors.

"Overdiagnosing" tumors can result in unnecessary procedures and treatments, which themselves raise the risk of complications and pointless discomfort and pain for the patient. In some cases patients' lives may be put at risk.

For doctors and people in the medical profession, keeping these "overdiagnosis" numbers down to a minimum is crucial.

In an online communiqué, the American Cancer Society wrote:

"Still, for the group of people at high risk, the benefit of screening may outweigh the potential risks. If you fall into that group, tell your health care professional about your smoking history so he or she can begin a conversation with you about lung cancer screening."

New Flu Shot Approved By FDA

A new flu shot, Flublok, made using new technology, has just been approved by the U.S. FDA (Food and Drug Administration).
Flublok is the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

Currently, the flu is quickly spreading across the United States. Public health officials have said the flu is now at "epidemic levels". The CDC (Centers for Disease Control and Prevention) advises everyone to receive a flu shot before the upcoming flu season.

The new vaccine has received approval for the prevention of seasonal influenza in people between the ages of 18 and 49. Flublok is made with a process that does not need the virus to be grown in chicken eggs, as current vaccines are currently made. This means that in case of a pandemic, the vaccine could be ready much earlier.

Large quantities of hemagglutinin (HA), the influenza virus protein, are produced by the Flublok's original manufacturing technology. HA is the active ingredient in all inactivated flu shots that is crucial for entry of the virus into the body's cells.

Most of the antibodies that stop the infection of the influenza virus are targeted against HA. Although the technology is new to flu vaccine production, it is used to make vaccines that have received approval from the FDA to prevent other spreadable illnesses.

Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said:

"This approval represents a technological advance in the manufacturing of an influenza vaccine. The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus."

In order to recognize strains that may be the source of most sicknesses in the approaching season, the World Health Organization (WHO), the FDA, the CDC, and other public health specialists work together each year to analyze influenza disease surveillance and laboratory data gathered worldwide.

The FDA chooses the various flu strains each year that U.S. manufacturers should include in their vaccines for the upcoming flu season by using the data analyzed, as well as the suggestions made by the FDA's Vaccines and Related Biological Products Advisory Committee.

When the strains in the vaccines match the flu virus strains in circulation, people are much better protected from getting the flu.

Flublok protects againsts two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain, because it consists of three, full-length recombinant HA proteins.

The vaccine will be assessed each year by the FDA, as it does with all other flu shots, before the public receives it each flu season.

The FDA will evaluate the recombinant HA proteins that are produced in the baculovirus expression system and included in the new vaccine.

Research conducted at different locations in the United States analyzed the effectiveness of Flublok. Approximately 4,600 people participated in the study, half received Flulbok and the other half were given a placebo.

Results showed that Flublok not only protected against the 3 matched strains that were contained in the shot, but was also found to be 44.6% effective against all circulating influenza strains.

The vaccine's safety was assessed in a study consisting of an estimated 2,500 people who received the shot.

The adverse reactions that were reported most frequently included:
  • headache
  • pain at the injection-site
  • fatigue
  • muscle aches
Those events are also common for traditional egg-based, inactivated flu shots.

Physicians need to check the expiration date before administering Flublok to patients. From the date of manufacture, it has a shelf life of 16 weeks.

The vaccine is manufactured by Protein Sciences Corp., of Meriden, Connecticut.

More Funding Needed For Tropical Diseases, WHO Says

Tropical diseases that were once overlooked, are now receiving more attention from pharmaceutical companies and the government, but also require more funding and innovation.
Diseases that are uncommon in the U.S. such as:
  • lymphatic filariasis (elephantiasis)
  • onchocerciasis (river blindness)
  • schistosomiasis (a parasite)
  • soil-transmitted helminthiasis (intestinal worms)
...can cause many deaths and complicate lives in underdeveloped nations.

In a new report, the WHO (World Health Organization) announces that they have seen groundbreaking progress in regards to these tropical disease, thanks to an international strategy that includes a regular supply of inexpensive, quality-assured medicines, and support from international partners.

The new strategies have brought us closer to the complete removal of many of these illnesses that are particularly devastating in the world's poorest regions.

Reports Show Progress As Well As New Goals

The report reveals significant progress in combating, terminating and eradicating these neglected tropical diseases. Specifically, dracunculiasis (guinea worm disease) and yaws, are due for global eradication in 2015 and 2020 respectively.

In addition, there are six goals set for the removal of five diseases in 2015 and 10 more goals for nine diseases for 2020, either internationally, or in specific geographical regions.

Dr Margaret Chan, Director-General of WHO commented:

"With this new phase in the control of these diseases, we are moving ahead towards achieving universal health coverage with essential interventions. The challenge now is to strengthen capacity of national disease programs in endemic countries and streamline supply chains to get the drugs to the people who need them, when they need them."

Medicine donations and extra funding by several global partners have aided in swift action and measures that are now having a considerable impact in affected countries with a broader scale of precautionary chemotherapy interventions. Of note is the universal delivery of single-dose, safe, quality medications as preventive treatments against five helminthiases and trachoma (chlamydial infection).

In 2010, 711 million people had treatment for at least one of the four diseases covered by preventive chemotherapy.

Coverage Planned to Increase

The WHO believes that treatment for schistosomiasis (bilharzia) will expand to 235 million people over the next five years. This will be achieved through better availability of treatments with donated medicines, as well as organized distribution on regional levels.

Dr. Chan adds:

"The prospects for success have never been so strong. "Many millions of people are being freed from the misery and disability that have kept populations mired in poverty, generation after generation, for centuries."

Other report highlights include:
  • Elimination of guinea worm. There has been a decrease in the number cases, with just 521 between January and September 2012, compared to 1006 for the same time period in 2011. Also human African trypanosomiasis (sleeping sickness) is down to fewer than 7,000 in 2011, from a high of 30,000 cases at the beginning of this century.
  • Rabies has been removed from many countries and the WHO believes this disease will be eradicated on a regional basis by 2020. Antibiotics are now available for buruli ulcer, a chronic and severely disabling skin condition.r
  • In 2012, dengue was the fastest spreading vector-bone viral disease, with the potential to become an epidemic. The WHO suggested an immediate change in approach and put into effect sustainable preventive care.
The report also touches on some challenges that are still present at country levels. It stresses the need for national disease control plans to implement organization, integration, and coordination. It also recommends the use of other sectors like education, agriculture and veterinary public health, as well as strengthening human resources.

Coffee Drinking Tied To Urinary Incontinence In Men

Men who consume about two cups of coffee a day, or the equivalent amount of caffeine, are significantly more likely to have urinary incontinence or a "leaky bladder" than men who drink less or none at all, according to new research from the US.
Senior author Alayne D. Markland, a professor at the University of Alabama at Birmingham, and colleagues, report their findings in a paper published online 2 January in The Journal of Urology.

In their background information they note while several studies have already established a link between caffeine intake and leaky bladder in women, the evidence for such a link in men is limited.

For their study, the researchers used national survey results from NHANES 2005-06 and 2007-08. This gave them data on over 5,000 American men aged 20 and over, with complete data available on nearly 4,000 of them.

The survey had collected information about food and drink intake which allowed the researchers to work out the men's caffeine consumption, water intake, and the total moisture content of their diet.

The survey data also included Incontinence Severity Index scores, for which a value of 3 and above is rated moderate to urinary incontinence (UI). Moderate to severe UI is more than a few drops of urine leakage in a month.

After adjusting for other potential influencers, the researchers found the men who consumed the most caffeine were more likely to have a leaky bladder than those who consumed the least or none at all.

Their analysis shows men who consumed 234 or more mg per day of caffeine were 72% more likely to have moderate to severe UI than men who consumed the least or none at all.

Men with a daily caffeine intake of 392 mg per day were more than twice as likely to have leaky bladder problems.

In contrast, men's total water intake was not linked to their risk for moderate to severe UI.

The researchers conclude:

"Caffeine consumption equivalent to approximately 2 cups of coffee per day (250mg) is significantly associated with moderate-severe UI in US men."

They call for further studies to look into this link.

Although the researchers did not establish whether coffee drinking causes men's leaky bladder problem, Markland told the press "It's something to consider ..."
People who are having problems with urinary incontinence should modify their caffeine intake and I think that's part of clinical practice," she says, in a statement reported by Reuter's Health

Sunday, January 13, 2013

Special Issue On Disaster Preparedness: Southern Medical Journal

Surveys suggest that while most US physicians are willing to play a role in responding to natural and manmade disasters, most do not feel adequately prepared to fulfill that role. Toward helping physicians and health care systems understand and fulfill their obligation to provide medical care in disasters, the January Southern Medical Journal* is a special issue on disaster medicine and physician preparedness. The official journal of the Southern Medical Association, the SMJ is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The special issue includes 22 reviews and original papers on preparing for the medical response to disasters and catastrophic events. Dr. G. Richard Holt, Editor-in-Chief of the Southern Medical Journal, writes: "I take the position that it is a professional and an ethical responsibility to potential patients and society for physicians to engage in sufficient self-learning that would provide them with at least an acceptable level of clinical preparation to meet the demands of caring for victims of a disaster in their town, city, county, or state."

'Lessons Learned' from Experts in Disaster Preparedness

The articles were prepared by experts in the medical response to disasters - including those with real-life experience with patient care in disaster situations. The special issue is freely available on the journal website.**

Adding authoritative commentary in the special issue is Dr. Harold Timboe, a leading expert in disaster preparedness and medical response. A retired US Army Major General, Dr. Timboe's experience includes coordinating the health response to the September 11 terrorist attack on the Pentagon and leading a team of volunteer physicians and nurses on a US Navy hospital ship responding to the 2004 tsunami in Indonesia. He writes, "Each of us in our own specialty, subcomponent of our local health system, and building to the aggregate capabilities at the community, regional, state, and national levels contribute to a growing sense of confidence in our overall preparedness."

The special issue opens with a section on physician preparedness, emphasizing the need for doctors to play an active role in planning and supporting the response to catastrophic events. By being prepared, physicians can help to mitigate the impact of disasters in their community.

A section on healthcare system preparedness emphasizes measures to plan disaster-response measures on the local and regional level. Contributions include informative experiences with drills and simulations to build and assess preparedness for catastrophic events.

The concluding section on patient care preparedness discusses disaster preparation and response for specific patient populations and types of care - including mental health aspects of disasters and the importance of psychiatric consultation. Professionals involved in responding to Katrina and other recent Gulf Coast hurricanes and to the 2011 tornado in Joplin, Mo., share lessons learned in preparing for future disasters.

Other topics of special interest include:
  • A description and evaluation of a one-day, competency-based emergency preparedness curriculum, which effectively enhances trainees' skills and confidence in providing patient care in a disaster
  • An introduction to the concept of "complete self-sufficiency planning," outlining a comprehensive approach to designing and constructing hospitals to withstand and remain functional during disasters
  • Insights into the unique health challenges facing older adults involved in disaster situations, focusing on mobilizing resources to improve health outcomes and recovery
Dr. Timboe encourages all physicians to familiarize themselves with resources on disaster response and responsibilities and to consider which aspects are most relevant to their training and experience. He concludes, "We hope this duty never calls, but if it does, we will demonstrate our readiness - the moral ethics of our profession, duty to the public good, and commitment to serve others require our utmost diligence."

Gilead On Schedule With Hepatitis C Treatments

Various updates have been announced pertaining to Gilead Sciences' late-stage, forthcoming candidates for the treatment of chronic hepatitis C infection (HCV).
The company made public results of an ongoing Phase 2 ELECTRON study analyzing the nucleotide sofosbuvir and the NS5A inhibitor GS-5885, as well as giving a progress report on several Phase 2 and 3 clinical trials assessing a once a day daily, fixed dose pill mixture containing both medicines.

Outcomes from eight other parts of the ELECTRON study were published earlier this month.

Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, said:

"Since the acquisition of Pharmasset only a year ago, we have fully enrolled four Phase 3 studies of sofosbuvir and during the first quarter of this year we will have initiated two Phase 3 studies of the sofosbuvir and GS-5885 fixed-dose combination. We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014."

The results came from a 12 week course of oral treatment with softosbuvir, GS-5885 and ribavirin (RBV) with patients with genotype 1 HCV who have not showed any progress from interferon therapy.

Data presented in November showed that three out of nine participants stayed HCV RNA undetectable four weeks following treatment (SVR4). The most recent announcement verifies that all nine patients in this particular group reached SVR4. The patients will continue to be followed to monitor sustained virologic response rates at 12 and 24 weeks (SVR12 and SVR24).

Progress On A Fixed-Dose Combination Medicine

ION-1: A Phase 3 trial that started in October of 2012 and is measuring sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks. After an analysis of results from the two 12 week parts of an enrollment of 200 patients, ION-1 will recruit more participants and examine sofosbuvir/GS-5885 in 800 people.

ION-2: The 2nd Phase 3 trial for sofosbuvir/GS-5885 is planning on starting to screen patients this month. The study will analyze the fixed-dose combination with RBV for 12 weeks and with and without RBV for 24 weeks of treatment for patients with genotype 1 HCV. Individuals in this study will have not responded to earlier treatment with IFN or IFN with a protease inhibitor.

LONESTAR: Enrollment is taking place for another Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks, for patients with genotype 1 HCV who have not responded to previous treatment. There will be two more parts to this trial that will assess sofosbuvir/GS-5885 with and without RBV for 12 weeks for patients with genotype 1 HCV who had previously had a protease inhibitor-containing regimen. This is the first study to assess the combination of sofosbuvir and GS-5885 for just an 8 week time period for treatment.

Sofosbuvir and GS-5885, as well as the fixed-dose combination, are new exploratory products and their safety and effectiveness have not been proven as of yet

Interferon-Free Therapy For Hepatitis C May Become A Reality

A new exploratory agent has been tested in the treatment of the hepatitis C virus infection (HCV), allowing patients to avoid the current interferon treatment that comes with harsh side effects.
A clinical trial published in the New England Journal of Medicine has defined sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, as successful in the treatment of HCV infection.

The standard treatment for the HCV infection is interferon, given by injection under the fat. Troublesome side effects are also found with interferon, including:
  • flu-like symtoms
  • fatigue
  • decrease in white blood count
  • depression
  • irritability
  • sleep disruptions
  • anxiety
The creation of orally administered medications have helped move forward the possibility of getting rid of interferon treatment and avoiding its harmful side effects and tedious application.

The study was open-label and researchers split 40 patients with untreated HCV, genotype 2 or 3 infection, into four groups. All groups received sofosbuvir (400 mg once a day) as well as ribavirin for the duration of 12 weeks.

Three of the groups were also given peginterferon alfa-2a for 4, 8, or 12 weeks. Another two extra groups who were also untreated previously and had HCV genotype 2 or 3, were given only sofosbuvir for 12 weeks or a combination of sofosbuvir and peginterferon afda-2a for eight weeks.

Two other groups of subjects with HCV genotype 1 infection took sofosbuvir and ribavirin for 12 weeks, including 10 people who had no reaction to earlier treatment and 25 people with no earlier treatment.

Conclusions showed that of the 40 patients who were in the randomized groups, 100% who received sofosbuvir plus ribavirin and no interferon had a sustained viral response (six months without RNA of the HCV in the blood).

The group that received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8 or 12 weeks also showed a sustained viral response. Of the volunteers who received sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks, 100% had a sustained viral response, while only 60% of those who received sofobuvir by itself showing a sustained viral response.

Among the participants with HCV genotype 1 infection, 84% of those who were untreated before and 10% of those with no response to prior therapy had a sustained viral response.

Side effects that were present during the study included headache, nausea, anemia, fatigue, insomnia, and rash.

The authors believe these findings are the first step to an oral-based, short time-period treatment regimen that does not include interferon.

The current findings support a previous study conducted by Boehringer Ingelheim that found the interferon-free combination of two investigational compounds, the once-a-day protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, successfully brought patients to a sustained viral response.

Hepatitis C Drug May Cause Fatal Skin Reactions

Current ratings for:
Hepatitis C Drug May Cause Fatal Skin Reactions

The oral hepatitis C drug telaprevir (Incivek) will now come with a boxed warning regarding the potentially fatal severe skin reactions that may occur in patients.

Vertex Pharmaceuticals stated that there have been reports of fatal cases in patients with a continuous rash and systemic symptoms who kept taking INCIVEK combination treatment after recognizing a severe skin reaction.

It has been known that receiving INCIVEK combination treatment may cause a person to develop a rash and serious skin reactions, as the adverse side effects were previously listed in the warnings and precautions section of the drug label.

The alert has been given a greater significance via a boxed warning, due to the reported fatalities that have occurred and the importance of discontinuing INCIVEK combination treatment if any skin conditions are experienced.

Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex, explained:

"The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use INCIVEK properly. We will continue to educate physicians to follow the rash management plan developed while INCIVEK was in clinical trials and the information contained in the updated label."

Less than 1% of the patients who received INCIVEK combination treatment in Phase 3 clinical trials developed a severe skin reaction. A hospital visit was needed to treat the skin reactions, but all of the patients recuperated.

The fatality reports that were linked to skin reactions appeared after post marketing observation. However, the number of deaths was not reported by the company.

Anyone who is receiving INCIVEK combination treatment should stop immediately if any severe skin reactions occur and should seek medical assistance, Vertex Pharmaceuticals said.

Further information was also added onto the label regarding the time period leading to onset of anemia and management of the condition.

Wednesday, January 2, 2013

Robotic-Assisted Radical Bladder Surgery Potentially Benefits Bladder Cancer Patients

About 30 percent of the more than 70,000 bladder cancer cases expected in 2012 are muscle invasive. In such cases, radical cystectomy is the preferred treatment. In a pilot trial, a team of investigators assessed the efficacy of open radical cystectomy (ORC) vs. robotic-assisted laparoscopic radical cystectomy (RARC). While there were no significant differences in treatment outcomes, RARC resulted in decreased estimated blood loss and shorter hospital stay compared to ORC. The results are published in the February 2013 issue of The Journal of Urology.

"In the last decade minimally invasive approaches including robotic-assisted approaches have emerged as viable surgical options for many urological malignancies with the promise of decreased morbidity with shorter hospital stays, faster recovery, and less narcotic analgesic requirements," says lead investigator Dipen J. Parekh, MD, Professor and Chairman of the University of Miami Miller School of Medicine's Department of Urology and Director of robotic surgery; formerly at the University of Texas Health Science Center at San Antonio.

The goal of the clinical trial was to provide preliminary data from a single institution's randomized trial that evaluated the benefits of robotic-assisted vs. open surgery in patients with invasive bladder cancer. The trial, conducted between July 2009 and June 2011, involved 47 patients and was performed at the University of Texas Health Science Center at San Antonio. Primary eligibility was based on candidacy for an open or robotic approach at the discretion of the treating surgeon. Forty patients were randomized individually and equally to either an ORC or RARC group using a computer randomization program. Each of the two study groups was similar in distribution of age, gender, race, body mass index, previous surgeries, operative time, postoperative complications, and final pathological stage.

Investigators evaluated five surgery outcome factors: Estimated blood loss, operative time from incision to closure, transfusion requirements, time to return of bowel function, and length of stay.

The robotic group experienced significantly decreased blood loss, accompanied by a trend toward faster return of bowel function, fewer hospitalizations beyond five days, and fewer transfusions.

"The strength of our study is the prospective randomized nature that eliminates selection biases that may have been present in prior retrospective analyses," says Dr. Parekh. "We also believe that our study demonstrates that a prospective randomized trial comparing traditional open and robotic approaches in bladder cancer is possible."

This investigative team has joined with several institutions nationally to build on its study and has started an advanced randomized clinical trial among multiple institutions to further compare and assess open vs. robotic-assisted radical cystectomy among patients with invasive bladder cancer. It plans to collect intermediate and long-term survival data from these same patients as well as data on quality of life, daily living activities, handgrip strength, and mobility.

How To Start The New Year Healthy

For a lot of people, the start of the New Year also means the start of a healthier lifestyle, which for many has to do with either losing weight or eating healthily. This can seem difficult or out of reach at first, but with a bit of motivation, dedication and discipline it is certainly possible.
The key to losing weight and staying fit is through identifying and changing bad lifestyle habits and behaviors.

Obesity is a serious problem in the United States, with nearly one third of the country's adults with a body mass index (BMI) of 30+ (considered as obese).

The weight-loss industry makes an absolute fortune in selling products to try and help people lose weight, but one of the main problems is discipline and consistency. Only 20 percent of Americans who diet and lose the desired amount of weight actually stay that way for more than a year.

According to Dr. Jessica Bartfield, who specializes in medical weight loss at Gottlieb Memorial Hospital, part of the Loyola University Health System:

"People need a motivation to lose weight and the new year is an opportunity to start fresh. Maybe it was the shock of seeing oneself in recent holiday photos, or not being able to fit into desired party attire that causes a vow to lose weight, and for many more it is a medical event such as a heart attack, the threat of diabetes or high blood pressure."

Bartfield belongs to a team of dedicated doctors who specialize in providing comprehensive surgical and non-surgical programs for weight reduction at The Loyola Center for Metabolic Surgery & Bariatric Care.

Behavioral change is one of the key factors in losing weight, with professional health advice being vital in helping people learn what to do, how to do it and how to maintain their behavior change.

Dr. Bartfield said "Behavior change is the cornerstone of healthy, successful weight loss and it takes about three months to establish a new behavior. Just as you learn to play a musical instrument from a skilled teacher, you need to learn how to lose weight from professionals. You need to practice and make mistakes until you get it right. At Loyola, a team of tried-and-true medical experts can teach you the skills you need to achieve and maintain behavior change."

She compares making behavioral changes to playing a new musical instrument, each time you expect to hit the right note you might accidentally hit the wrong one. You just need to keep trying and trying until you eventually perfect it. With weight loss, you need to have a similar mindset - do not be put off by a few bumps along the way.

Dr. Bartfield and team identified the best weight loss behaviors by gathering and examining data from 4,000 Americans from The National Weight Control Registry (NWCR). They all lost 30 pounds and kept their weight down for at least five years.

What Are Most Effective Weight Loss Behaviors?

  • Eat breakfast within one hour of waking up in the morning. Breakfast is the most important meal of the day and it boosts the body's metabolism by over 20%, which can really help with weight loss.
  • Consistently measure how much you weigh. Try and weigh yourself each week and track how much weight you've either put on or lost, this will allow you to see what behaviors work for you.
  • Try and exercise or do moderate physical activity for at least one hour every day. This does not necessarily mean doing cardio for one hour non-stop; a series of activities, such as vacuuming and going up the stairs can all add up to achieving this.
  • Limit the amount of time you spend idle, watching TV. Try and limit this to a maximum of 10 hours a week. Instead, find activities that are more physically active, more than half of the NWCR members watched TV for fewer than 10 hours a week. Children who have a television in their room are much more likely to become obese, a recent study found.
  • Make sure you are consistent with your diet plan and behavioral changes. It's no good to eat well and exercise for five days and then have a massive splurge afterwards; you will seriously undermine your progress. If you are consistent for at least 25 days per month, you can achieve substantial weight loss.
  • Monitor how much physical activity you do during the day and do your best to make sure you make small changes in your life that increase your amount of physical activity. For example, try walking instead of using transportation whenever you can. A simple way to be more physically active is to spend less time in a car.
Aerobic exercises versus resistance training - if your initial aim is to lose weight, bear in mind that aerobic training is much more effective for burning fat than resistance training.