Hundreds of thousands of babies around the world are born each year with HIV–more than half a million in 2006 alone. Caring for these children is complicated by the fact that their immune systems are not fully developed in the first year of life, which makes them especially susceptible to rapid HIV disease progression and death. The current standard of HIV care in many parts of the world is to treat infants with antiretroviral therapy–but only after they show signs of illness or a weakened immune system.

Now the initial results of an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), suggests that more HIV-infected infants survive if they are given therapy early on, regardless of their apparent state of health.

This trial, called the “Children with HIV Early Antiretroviral Therapy” (CHER) study, is a phase III, randomized clinical trial led by Avy Violari, M.D., FCPaed (SA), of the University of the Witwatersrand in Johannesburg, South Africa, and Mark Cotton, MBChB, MMed, of the University of Stellenbosch in Cape Town, South Africa. Dr. Violari presented these findings on at the 2007 International AIDS Society Conference in Sydney, Australia.

“Children with HIV infection frequently show rapid disease progression within the first year of life due to their developing immune systems and susceptibility to other serious infections,” says NIH Director Elias A. Zerhouni, M.D. “This is the first randomized clinical trial that shows that infants treated before three months of age will do better than infants who have their treatment delayed.”

“The results of this trial could have significant public health implications worldwide,” says NIAID Director Anthony S. Fauci, M.D. “Because these findings will cause experts to consider changes in standards of care in many parts of the world, NIAID has released details of the interim results to the World Health Organization, local ethics committees, regulatory authorities and other key stakeholders for their consideration and evaluation for possible implementation.”

“These initial results also highlight the importance of diagnosing HIV infections early–within the first six to twelve weeks of life,” says Edward Handelsman, M.D., chief of the Pediatric Medicine Branch in NIAID’s Division of AIDS, which is overseeing the CHER study. Dr. Handelsman stresses, however, that the study results cannot necessarily be generalized to asymptomatic adults or older children because young infants are very different in immune function, time since HIV infection and susceptibility to other serious illnesses.

The evidence came to light last month after a routine review by the trial’s data and safety monitoring board (DSMB), an independent committee composed of clinical research experts, statisticians, ethicists and community representatives from Africa, Europe and the United States that regularly reviews interim data from the CHER study to ensure the safety of study participants.

CHER had begun two years earlier to evaluate whether early antiretroviral therapy given over a limited period of time would delay disease progression. The idea was that this approach might allow the immune system to develop and possibly allow the child to stop treatment for a period of time and therefore avoid continuous therapy from an early age.

Starting in July 2005, HIV-infected infants between 6 and 12 weeks old without immune suppression or severe symptoms of clinical disease were enrolled at the Perinatal HIV Research Unit in Soweto and Tygerberg Children’s Hospital in Cape Town. By early 2007, 377 babies were enrolled in one of three groups–those receiving immediate antiretroviral therapy for 40 weeks, those receiving immediate antiretroviral therapy for 96 weeks, and a control group whose treatment was initiated after doctors observed signs of clinical or immunological progression toward the development of AIDS (the current standard of HIV care in many parts of the world).

The trial is designed to continue through 2011, but after reviewing early trial data on June 20, 2007, the DSMB found a significant increase in survival among infants who received immediate antiretroviral therapy. At the time of the DSMB review, 96 percent of these children were alive, compared to only 84 percent of the children in the control group. Based on this finding, the DSMB concluded that providing early antiretroviral therapy to infants is more effective in preventing early death than delaying treatment until clinical or immunological disease triggers are observed.

The DSMB recommended that no additional infants be placed in the deferred-treatment arm of the study and infants previously enrolled in this arm be evaluated for potential initiation of antiretroviral therapy. NIAID accepted these recommendations and informed the study investigators at each site. The doctors at those sites have been contacting the parents and legal guardians of the infants involved in the study to inform them of the interim findings and call them in for evaluation. The DSMB also recommended that all infants enrolled in the study be followed for the planned duration of approximately 3.5 years and those in the 40- and 96-week treatment groups continue with the study.

For more information about CHER, see www3.niaid.nih/news/QA/cher_qa.htm.

NIAID is sponsoring the CHER trial through the Comprehensive International Program of Research on AIDS (CIPRA) program, which supports research and development efforts in resource-limited areas to create practical, affordable and acceptable ways to prevent and treat HIV/AIDS in adults and children The trial is part of the CIPRA-SA collaborative research program, led by James McIntyre, MBChB, FRCOG, of the Perinatal HIV Research Unit, with additional support provided by the MRC Clinical Trials Unit in London Departments of Health of the Western Cape and Gauteng, South Africa, and GlaxoSmithKline.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)–The Nation’s Medical Research Agency–includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at niaid.nih/.

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Nearly 1.6 million older Americans live in nursing homes in the United States. While many are receiving quality care, the move to a nursing home can still be difficult for older adults and their family members alike.

To help caregivers who are considering moving a loved one to a nursing home ensure that he or she will get the best possible care, the American Geriatrics Society Foundation for Health in Aging (FHA) has published a comprehensive, easily understood “tip sheet” — “Finding Quality Nursing Home Care”.

“Family caregivers may feel guilty, depressed, and upset when they are unable to meet the complex care needs of their older loved one,” says Gregg Warshaw, MD, AGSF, Professor of Family Medicine at the University of Cincinnati in Cincinnati, Ohio. “Caregivers may also fear that their loved one won’t receive adequate care at a nursing home. The Foundation’s tip sheet can help family caregivers find nursing homes offering quality care, and follow through to ensure that care continues to meet their loved one’s needs.”

Among other things, the tip sheet offers advice on what to look for when touring a nursing home. It also explains what to do, once you’ve placed a loved one in a nursing home, to make sure he or she continues to get quality care.

About The FHA

In 1999, the American Geriatrics Society reached beyond its traditional role as a professional medical society and launched the AGS Foundation for Health in Aging (FHA). The FHA aims to build a bridge between geriatrics health care professionals and the public, and advocate on behalf of older adults and their special needs: wellness and preventive care, self-responsibility and independence, and connections to family and community. The FHA champions initiatives in public education, clinical research, and public policy that advance the principles and practice of geriatrics medicine; educate policy makers and the public on the health care needs and concerns of older adults; support aging research that reduces disability and frailty, and improves quality of life and health outcomes; encourage older adults to be effective advocates for their own health care; and help family members and caregivers take better care of their older loved ones and themselves.

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Heart disease and diabetes are among the most common conditions plaguing Americans today, and they are related to a host of other diseases. Research presented today at Digestive Disease Week® 2006 (DDW) now also demonstrates that these conditions can be warning signs for some types of digestive cancers, and may lead to early screening and interventions that may help prevent the onset of cancer or lead to earlier detection and treatment. Furthermore, certain treatments for these diseases may actually reduce digestive cancer risk. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

“The presence of diabetes or heart disease can be a signal for clinicians to evaluate patients’ risk for digestive cancers,” said Randall W. Burt, M.D., professor of medicine, University of Utah School of Medicine and Interim Executive Director, Huntsman Cancer Institute at the University of Utah. “The associations between these two diseases and cancer, as shown in these studies, provide a critical tool to diagnose cancer early when patients might benefit most from treatment. These studies also suggest that certain treatments for heart disease, in particular ACE inhibitors, may reduce the risk of colon, pancreatic and esophageal cancers.”

Resectability of Pre-Symptomatic Pancreatic Cancer and its Relationship to Onset of Diabetes: A Retrospective Review of CT Scans and Fasting Glucose Values Prior to Diagnosis [Abstract 952]

Pancreatic cancer is one of the deadliest forms of cancer, claiming the lives of nearly 32,000 people in the United States each year. With few visible symptoms, pancreatic cancer is often difficult to catch early and many patients are not diagnosed until the cancer is too advanced for surgery.

Up to 80 percent of pancreatic cancer patients are diabetic and research now suggests that a recent diagnosis of diabetes may be a marker of early pancreatic cancer. This study looked at CT scans of pancreatic cancer patients who were also diabetic to determine if a new diabetes diagnosis indeed signals early pancreatic cancer, hoping that it would help with asymptomatic detection and a better chance of successful treatment with surgery.

Mario Pelaez-Luna, M.D., and study partners at the Mayo Clinic in Rochester, Minn. examined the CT scans of 20 patients who had at least one abdominal scan prior to being diagnosed with pancreatic cancer. These initial scans were reviewed to determine the condition of the patient’s pancreas – no changes, some pancreatic duct narrowing or blockage, early, small tumors, or advanced tumors.

The 20 patients had undergone a total of 23 CT scans six or more months prior to their diagnosis of pancreatic cancer. All scans done more than six months prior to diagnosis showed no definite evidence of cancer. At the time of cancer diagnosis, 80 percent of the cancers were too advanced to be treated with surgery. With regard to the relationship to diabetes, all scans prior to the onset of diabetes were found normal. When patients first showed high blood sugar levels suggestive of diabetes, 85 percent still had a normal-appearing pancreas or showed early cancer; only 15 percent of cancers were advanced. The cancer was diagnosed, on average, five months after the diabetes first developed.

The research suggests that the number of pancreatic cancers amenable to surgical treatment can be greatly increased if the diagnosis is made even six months earlier. Diabetes associated with pancreatic cancer occurs at a time when the tumor is still treatable by surgery. Thus, a new diabetes diagnosis can be a warning sign that pancreatic cancer may be present, leading to an early cancer diagnosis with potentially better outcomes.

“Pancreatic cancer is difficult to treat. By the time patients develop symptoms, the cancer is already at an advanced stage” said Mario Pelaez-Luna, M.D., lead author of the study. “However, discovering new links between pancreatic cancer and other conditions such as diabetes is helping us identify clues to early diagnosis. The only hope of offering surgical treatment to more patients with pancreatic cancer is diagnosing the disease before symptoms develop.”

Type 2 Diabetes Mellitus: The Impact on Colorectal Adenoma Risk in Women [Abstract S1245]

Having Type 2 Diabetes Mellitus raises a person’s risk for developing colorectal cancer, and while there have been several studies linking insulin resistance to colorectal cancer risk, there is little data on whether women with diabetes are more at risk for colorectal adenomas, or polyps, which can become cancerous.

In this study, researchers from Washington University in St. Louis, MO., selected 600 women undergoing screening colonoscopies – 100 had Type 2 (adult onset) diabetes and 500 were non-diabetic. Both groups were similar in terms of age, race, having a first-degree relative with colorectal cancer and body mass index.

Results showed that diabetics had increased rates of adenoma than non-diabetics (37 percent versus 24 percent) and advanced adenoma, larger adenomas and/or with more abnormal cells (14 percent versus 6 percent). Researchers compared 245 obese women with 321 non-obese women and found that the obese women had a higher rate of adenoma (32 percent versus 22 percent). Obese diabetics compared with non-obese, non-diabetics had increased rates of any adenoma (42 percent versus 23 percent) and advanced adenoma (19 percent versus 7 percent). A multivariate analysis that took into account age, race, diabetes, hypertension, cholesterol levels, body mass index, and NSAID use showed that diabetes was a risk factor for both adenomas and advanced adenomas and increased age was a risk factor for adenomas.

“This study took a careful look at women with diabetes to determine how gender might impact the diabetes-colorectal cancer connection, and results show colon cancer is indeed a concern for diabetic women,” said Jill E. Elwing, M.D., of Washington University and lead study author. “Colorectal cancer screening is critical for this population, as their diabetic condition raises their risk of colorectal cancer.”

Patients With Coronary Artery Disease Are At High Risk For Developing Colorectal Cancer and Adenoma: An Interim Analysis of a Prospective Study [Abstract 208]

Colorectal cancer is one of the most common but curable cancers, when caught early. This underscores the importance of identifying high risk patients and screening them to ensure early detection and treatment. Investigators from the University of Hong Kong conducted a prospective study to evaluate potential risk factors for colorectal cancer and found that patients with coronary artery disease (CAD) were also prone to colorectal cancer and adenoma, most likely as a result of common risk factors for both diseases. Both conditions share risk factors including male sex, old age, diabetes, smoking, high fat diet, sedentary life style and high body mass index (BMI).

Researchers administered coronary exams in 307 patients, diagnosing coronary artery disease (CAD) in those who had at least 50 percent blockage in one of the main heart arteries. The group of patients with CAD (46.3 percent) showed a higher incidence of adenomas and cancer than the patients who did not have CAD (30.3 percent versus 19.4 percent), including having larger adenomas with abnormal cells (16.9 percent versus 6.7 percent). Five cases of colorectal cancers were detected in the CAD group (3.5 percent) and none were detected in the group that did not have CAD. Analysis of the data showed a strong association between colorectal cancer and adenomas and CAD, with male smokers most at risk to have both diseases.

“Patients with CAD are at high risk of developing colorectal adenomas,” said Annie On On Chan, M.D., University of Hong Kong and lead study author. “The two diseases share risk factors, and screening by colonoscopy of these patients should be mandatory to help prevent the disease and, if necessary, encourage early treatment.”

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20-25, 2006 in Los Angeles, California. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology

Aimee Frank
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American Gastroenterological Association
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Scientists at the University of Bath, England, and the Unversity of Texas, USA, tested isotretinoin on mice and found a link with depression. The drug, which came onto the market over twenty years ago, has been linked to some suicides and depression in humans.

Isotretinoin is also sold under the brand names: Accytane, Roaccutane, Amnesteem, Claravis and Sotret.

The drug is usually used for teenagers with severe acne. It is very effective and has been used by over 13 million patients globally. The Medicines and Healthcare products Regulatory Agency (MHRA), UK, has received 25 reports of patients committing suicide while being treated with Accutane. It also received 1,588 reports of adverse events.

You can read about this study in the journal Neuropsychopharmacology.

This is the first study to confirm what was already suspected by many patients and health care professionals. There is no warning about a link with depression in the drug’s packaging.

In this study, adolescent mice were given Accutane for six weeks. The researchers observed their behaviour during this period. They noticed that the mice spent a lot more time motionless than they normally would when responding to lab assessment tests – a sign of depression. They did not detect any negative physical side-effects.

Head researcher, Dr. Sarah Bailey, said that further tests are needed to be completely sure their observations could be applied to humans while taking Isotretinoin.

Dr. Bailey added “However, establishing a link between the active molecules within the drug and a change in depression-related behaviour, albeit in mice, is an important step forward in our understanding of the effects of this drug in the wider context of brain function. To date, the only evidence for any link with patients has come from individual case reports and such patient data is complicated by the psychosocial effects of having severe acne. This laboratory evidence provides a useful model for future research into Accutane and understanding how this family of compounds affects the brain.”

The researchers said patients (mostly teenagers) should not suddenly stop taking the drug because of this study. Rather, they should report any signs of depression to their doctors. They also suggested parents be vigilant for any changes in their children’s mood.

Isotretinoin is a retinoid. This means it is a vitamin A-related compound. These compounds can undermine the development of the nervous system. They should never be taken by women who are pregnant.

The makers of Accutane, Roche, said this study is too small to link the same risk for humans.

Chronic Administration of 13-Cis-Retinoic Acid Increases Depression-Related Behavior in Mice
Kally C O’Reilly, Jason Shumake, F Gonzalez-Lima, Michelle A Lane, and Sarah J Bailey
Neuropsychopharmacology (2006) 31, 1919-1927. doi:10.1038/sj.npp.1300998; published online 4 January 2006
Click Here To View Abstract

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A new chemical synthesis method based on a catalyst worth many times the price of gold and providing a far more efficient and economical method than traditional ones for designing and manufacturing extremely novel pharmaceutical compounds is described by its University at Buffalo developers in a review article in the current issue of Nature.

The chemistry, the basis of a new biotech startup company called Dirhodium Technologies, LLC in Buffalo, has the potential to improve dramatically the design and production of new drugs based on small molecule organic compounds, which comprise the great majority of new drug applications.

“If you tend to make things by methods that have been around for 100 years, there’s a decent chance that you’ll make something that’s already known or is very close to something that is,” said Huw M.L. Davies, Ph.D., UB Distinguished Professor in the Department of Chemistry and lead author on the Nature paper. “But if you use an entirely new strategy like the one we developed, virtually every reaction you run will result in a new structural entity. That’s critical to drug development.”

The chemical strategy Davies developed depends on the use of proprietary catalysts his company manufactures.

Minute amounts of the rhodium-based catalyst can have a major impact, he explained, with 1 gram capable of producing 10 kilograms of a pharmaceutical product.

“So it’s like a bit of ‘golden dust’ to get everything going,” said Davies, a researcher at UB’s New York State Center of Excellence in Bioinformatics and Life Sciences and president and chief executive officer of Dirhodium Technologies.

“As rhodium metal costs 10 times the price of gold, the catalyst is a high-value material,” he said.

Available through chemical supply companies, the reagents are being used by pharmaceutical scientists in both industry and academia.

Already, one major pharmaceutical company is using the reagents to synthesize a compound now in clinical trials.

“Demand for our catalysts has gone from gram to kilogram quantities, from fractions of an ounce to multiple pounds,” said Davies.

So far, the new synthesis strategy has generated compounds that have potential activity against a broad range of disease states, from cancer to central nervous system disorders, such as depression, to inflammatory and microbial diseases and medications for treating cocaine addiction.

“This method is like an enabling technology, making available new targets and materials that previously were out of range,” said Davies.

Its ability to result in never-before-seen chemical structures is making Davies’ collaborations with scientists in partner institutions on the Buffalo Niagara Medical Campus especially fruitful.

“We’re using this as a platform for drug discovery, collaborating through the Center of Excellence with biologists at UB, Roswell Park and Hauptman Woodward Medical Research Institute,” said Davies.

Davies’ company is one of 10 life sciences spinoffs based in the Center of Excellence, which has the dual mission of promoting life sciences research while facilitating economic development in Upstate New York.

In addition to helping drug companies design novel leads for new products, the new chemistry also allows pharmaceutical companies to synthesize efficiently and economically large quantities of novel compounds.

Through catalysis, the chemical synthesis method the UB researchers developed allows for highly unusual functionalizations of carbon-hydrogen bonds, Davies explained.

“The method allows you to transform a molecule from a simple structure to a much more elaborate, drug-like material,” he said, “so it goes from a cheap building block to a potential drug-like candidate. Without a catalyst, it won’t happen.”

A major advantage of Davies’ chemical strategy is that the resulting compounds are produced selectively as single mirror images.

Pharmaceutical companies prefer to develop new chiral drugs (chiral meaning “handed”) as a single isomer because opposite mirror images can have different biological effects and may be harmful.

“A small amount of our catalyst can be used to generate large amounts of the active mirror image of the pharmaceutical ingredient,” Davies said.

The UB research has been funded by the National Institutes of Health and the National Science Foundation, both of which were recently renewed for a total of $1.6 million. The work also has been supported by the UB Center for Advanced Biomedical and Bioengineering Technology (UB CAT), located in the Center of Excellence.

The Nature paper was co-authored by James R. Manning, a graduate student in the Department of Chemistry in the UB College of Arts and Sciences.

The New York State Center of Excellence in Bioinformatics and Life Sciences was created in Buffalo in 2002 as part of more than $200 million dollars in investment from state, federal, industrial and philanthropic sources to create a hub of life sciences expertise and innovation in Upstate New York. The COE brings a strong foundation in life sciences research and discovery to its mission and collaborative efforts with industry, government and researchers around the world to improve the health and well-being of the population. The Center of Excellence is a major UB research center; its research partners are Roswell Park Cancer Institute and Hauptman-Woodward Medical Research Institute.

The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York. UB’s more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.

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Botox is well known for its cosmetic uses, but researchers have now found that it can also significantly improve people’s quality of life if they suffer from another problem that increases with age, an overactive bladder (OAB).

A study published in the June issue of BJU International shows that patients who had Botox injections to control bladder problems reported significant improvements in their lives as well as their symptoms for at least 24 weeks.

UK urologists from Guy’s Hospital and King’s College London carried out a randomised, double-blind placebo trial on 34 patients with an average age of 50. Seven men and nine women received the Botox injections while eight men and ten women received the placebo.

“The Botox or placebo injections were administered using a flexible injection needle inside a cystoscope, a long tube that enables urologists to see inside the bladder” explains consultant urological surgeon Prokar Dasgupta from Guy’s Hospital and King’s College London School of Medicine.

“This minimally invasive technique involved 20 injections – five in the midline posterior bladder wall, five in the left lateral wall, five in the right lateral wall and five across the dome of the bladder. In all, 200ml of Botox or placebo was administered.”

Patients in both groups were assessed when they started the study and at four, 12 and 24 weeks after they received the injection. All the patients who took part in the study had failed to tolerate or respond to anticholinergic drugs, which, along with lifestyle modifications and bladder training, are traditionally used to manage OAB.

Patients who received the Botox injections reported significant improvements when it came to a number of quality of life factors. These were measured using the King’s Health Questionnaire, a zero to 100 scale, which was developed in the late 1990s to assess women with urinary incontinence. High scores recorded on the scale indicate a lower quality of life.

All the factors the researchers studied showed a reduction.

The median (mid point) improvements from baseline to 12 weeks were:
Incontinence impact – from 100 to 65

Role limitations – from 83 to 50

Physical limitations – from 75 to 42

Social limitations – from 72 to 39

Emotions – from 100 to 65

Severity measures – from 67 to 34

Sleep/energy – from 83 to 58

Personal relationships – from 67 to 50.

Symptom severity in the Botox group fell from 17 to 12 when it was measured on a zero to 30 scale.

The only improvement in the placebo group was role limitations, from a median level of 83 to 66. The rest of the categories showed no improvement.

At 12 weeks the study was unblinded so that both the clinicians and patients knew who was receiving the Botox injections. Further improvements were noted in all categories during this extended period, including sleep and energy and personal relationships, which had not performed as well as the other categories in the first 12 weeks.

Previous research has shown that as many as one in six people over the age of 40 suffer from an overactive bladder and that the condition can have a very adverse affect on people’s quality of life.

“Our study showed a significant relationship between the overall improvement in OAB symptoms and improved quality of life scores” says Mr Dasgupta.

“For example, at four weeks urgency and urge urinary incontinence were statistically correlated with improvements in quality of life and the same was true at 12 weeks for frequency and urgency.

“The overall benefits lasted at least 24 weeks after the injections were administered, with patients reporting both a reduction in bothersome bladder symptoms and an improved quality of life.”

Improvement in quality of life after botulinum toxin-A injections for idiopathic detrusor overactivity: results from a ranzomized double-blind placebo-controlled trial. Sahai et al. BJU International. 103, 1509-1515. (June 2009)

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A nationwide database called the Comprehensive Dialysis Study (CDS) includes detailed information on a wide range of health factors in US dialysis patients and provides a valuable new resource for improving dialysis outcomes, according to a report in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN).

“The primary goal of the CDS is to better understand the interrelations among general health, nutrition, physical function, and health-related quality of life in a representative sample of patients recently starting maintenance hemodialysis,” comments Nancy J. Kutner, PhD, Director of the Rehabilitation/ Quality of Life Special Studies Center of the United States Renal Data System (USRDS) at Emory University in Atlanta, GA. “By linking these data with patient-specific information in USRDS files, researchers will be able to examine the predictive significance of early physical and nutritional status for morbidity and mortality outcomes.”

The CDS includes 1,646 patients from a random sample of 295 dialysis facilities in 48 states and the District of Columbia. The patients range in age from 19 to 94 years, with an average age of 60. At the time they were enrolled in the CDS, the patients had been on dialysis for an average of four months.

In telephone interviews, patients provided detailed information on a broad range of factors that may affect health, functioning, and long-term outcomes on dialysis. “The CDS includes patient employment status and validated measures of health-related quality of life, physical activity level, sleep disturbance, and depression collected from all participants,” says Dr. Kutner. One subgroup of patients gave detailed information on dietary intake; another provided blood samples for assessment of nutrition, inflammation and other key measures.

The CDS provides an unprecedented depth of information on a large group of patients just beginning dialysis. It enables researchers to examine the interrelated factors affecting the health of new dialysis patients. Follow-up of patients enrolled in the CDS will enable researchers to determine which baseline characteristics have the greatest impact on long-term dialysis outcomes.

Because of the relatively low participation rate (less than 20 percent), the CDS falls short of being a nationally representative sample of US dialysis patients. “In addition, while CDS patients were generally similar to the overall population, they were younger on average, had higher educational status, were less likely to have heart failure or stroke, and less likely to be nonambulatory or institutionalized, compared to all incident dialysis patients,” according to Dr. Kutner.

Linking the CDS to the USRDS database will help to identify factors associated with survival, hospitalization, use of medical services, and health care costs. “The CDS therefore provides a unique resource to inform the design of interventions addressing several related conditions affecting longevity and health status in patients on dialysis,” Dr. Kutner concludes.

The researchers reported no financial disclosures.

The article, entitled “The Comprehensive Dialysis Study (CDS): A USRDS Special Study” will appear online at cjasn.asnjournals on Wednesday, March 4, 2009, doi 10.2215/CJN.05721108.

Founded in 1966, the American Society of Nephrology (ASN) is the world’s largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its world-renowned meetings and first-class publications, disseminates information and educational tools that empower physicians.

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Meridia (sibutramine), combined with behavioural therapy, has been shown to be effective in helping obese teenagers lose weight, according to a study carried out by Dr. R Berkowitz and team at Children Hospital of Philadelphia. The researchers found the treatment is effective for obese 12-year-olds as well.

The study involved 498 12-16 year old children at 33 weight-loss clinics – all of the children were obese. The children were divided into two groups, one received Meridia combined with behavioural therapy while the other received a placebo and behavioural therapy. The Meridia group lost an average of 14 pounds over a year, while those on a placebo carried on gaining weight. Those on Meridia also managed to achieve better HDL cholesterol levels and triglycerides (HDL is the good cholesterol).

The study found Meridia is relatively safe and effective for younger teenagers. Meridia is approved in the USA just for people over 16 as a drug for aiding weight loss.

You can read about this study in the Annals of Internal Medicine.

The team said further studies are needed to find out whether this treatment has long-term benefits: Do the teenagers continue to lose weight? Do they keep the weight off after treatment stops? Are there any other health benefits, such as a lower likelihood of developing heart disease or diabetes type 2?

The scientists also stressed that this drug is aimed at patients who are obese. It is not for slightly overweight people who want to shed a few pounds. It is an appetite suppressor that has, in the past, been blamed by some groups for causing fatal heart problems.

In this study, 12.5% of children taking Meridia experienced accelerated heart rates, versus 6.2% of children who were on a placebo. The researchers say it is vital for any patient taking this drug to have his/her blood pressure and heart rate closely monitored.

Adults who have received Meridia tend to lose weight only while they are receiving the drug. Most of them put the weight back on afterwards. Whether or not the same would happen with younger patients remains to be seen.

The makers of Meridia, Abbott Laboratories, funded the study.

Effects of Sibutramine Treatment in Obese Adolescents – A Randomized Trial
Robert I. Berkowitz, MD; Ken Fujioka, MD; Stephen R. Daniels, MD, PhD; Alison G. Hoppin, MD; Stanford Owen, MD; Arlette C. Perry, PhD; Melinda S. Sothern, PhD; Cheryl L. Renz, MD; Mark A. Pirner, MD, PhD; Julia K. Walch, BS; Olga Jasinsky, MBA; Ann C. Hewkin, MSc; Vicky A. Blakesley, MD, PhD, for the Sibutramine Adolescent Study Group
Annals of Internal Medicine
18 July 2006 | Volume 145 Issue 2 | Pages 81-90
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View drug information on MERIDIA.

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Millions of people are taking herbs and other plant-based dietary supplements to improve their health, but they have precious little information on the actual effectiveness or potential ill effects of these products. That’s the topic of an article in the current issue of Chemical & Engineering News (C&EN), ACS’ weekly news magazine.

C&EN Senior Editor Celia Henry Arnaud suggests that consumers are taking a gamble when it comes to the safety and effectiveness of hundreds of pills and potions cluttering store shelves. Such products include black cohosh and red clover, used by menopausal women to reduce hot flashes, and kava, which is used to treat anxiety and insomnia. Scientists are concerned that some supplements may contain high levels of toxic metals, such as lead and mercury, or pesticides. There’s also the possibility that the plant itself might be toxic or that a supplement can cause harm by reacting with conventional drugs.

The U.S. Food & Drug Administration, which regulates supplements as foods rather than drugs, recently took a step toward improving the situation by requiring all supplement manufacturers to test their products for contaminants. But scientists still know little about the ingredients in many supplements and what effect they might have on the body. Ongoing research is providing new information that will help address these concerns in the future, including the long-term safety of these products for consumers, the article indicates.

Article:
“Supplementing Knowledge”

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

The brand product had annual sales of approximately $556 million in the United States, based on IMS sales data.

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Teva Pharmaceutical Industries Ltd.

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