Antidepressants may not help fight bipolar disorder

Patients with bipolar disorder will gain no treatment benefit by adding an antidepressant to a standard mood stabilizer such as lithium, a new study finds.

The results suggest that treating with a mood stabilizer alone is preferable, a recommendation that goes against common practice.

"We really think that at the beginning of your treatment, it is very reasonable to have this 'mood-stabilizer-optimized' kind of approach, and what we've learned from this study is it makes sense to give that some time to work," said Dr. Gary Sachs, lead author of the study, director of the bipolar clinic and research program at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School in Boston.

"The patient loses nothing from that," Sachs added. "We did not show that any group benefited from having antidepressants added."

On the other hand, doubling up the medications did not confer any risk, Sachs's team reported in the March 29 issue of the New England Journal of Medicine.

Treating bipolar disorder is never a one-size-fits-all proposition, however.
"It's hard to judge at the individual level because of individual variation," said Dr. Christopher Colenda, dean of the Texas A&M Health Science Center College of Medicine in College Station. "As a treating clinician, you may try single therapy for a while and, if it doesn't work, add the antidepressant. This study gives us a rational place to start and to make clinically relevant decisions."

Bipolar disorder is characterized by alternating swings of very high and very low -- or depressed -- moods, along with changes in energy and the ability to function. About 5.7 million American adults, or about 2.6 percent of the population 18 and older, may have bipolar disorder, according to the National Institute of Mental Health.

The standard of care for bipolar disorder is treatment with a mood stabilizer such as lithium, valproate, carbamazepine or other medications that reduce mania.

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Drug provides short-term relief of heart failure symptoms

The drug tolvaptan may improve some symptoms and signs of heart failure during hospitalization, but the drug doesn't reduce the risk of re-hospitalization or death, two new studies conclude.

The studies, published in the March 28 issue of the Journal of the American Medical Association, are also being presented at the American College of Cardiology's annual meeting, in New Orleans.

The first study looked at 4,133 hospitalized heart failure patients in Europe, North America and South America who took part in the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan (EVEREST) trial.

The patients received either 30 milligrams of tolvaptan or a placebo once a day for a minimum of 60 days. After 9.9 months, 25.9 percent of the patients taking tolvaptan had died, compared with 26.3 percent of those in the placebo group.

The combined outcome of cardiovascular death or re-hospitalization occurred in 42 percent of the patients taking the drug and in 40.2 percent of the patients who received the placebo. Both groups had similar rates of clinical worsening of heart failure symptoms and of major adverse events.

"Long-term tolvaptan treatment had no effect, either favorable or unfavorable, on all-cause mortality or the combined endpoint of cardiovascular mortality or subsequent hospitalization for worsening HF [heart failure]," the study authors wrote.

The second study of EVEREST trial patients found that the use of tolvaptan in addition to standard therapy provided short-term (up to seven days) relief of some symptoms and signs of heart failure (such as congestion and breathing difficulty) without causing major side effects. The patients received the drug or placebo within 48 hours of admission to hospital.

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Medication errors common for transplant patients

Medication errors are common and often difficult to detect in patients receiving outpatient care after an organ transplant, U.S. researchers find.

Reporting in the March issue of the journal Archives of Surgery, a team at the Yale University School of Medicine identified 149 medication errors in 93 liver, kidney and pancreas transplant patients who were taking an average of about 11 medications each.

Patient error was the most common type of medication error (56 percent), followed by: prescription errors and delivery errors (both 13 percent); availability errors -- patients did not have at least a 24-hour supply of medication (10 percent); and reporting errors -- the patient could not give researchers enough information to identify the type, dosage or frequency of a medication (8 percent).

The study also found that 48 (32 percent) of the errors resulted in adverse events, including 17 hospitalizations, three outpatient procedures, nine episodes of rejection, and six failed transplants.

The root causes of the medication errors were the patient (68 percent); health care providers (27 percent, including 10 percent by transplant team); and financial issues (five percent).
The study authors noted that medication errors are often the result of communication breakdowns.

"We should strive to continue to eliminate health care system-based errors through centralized records and other streamlining methods to improve processes. In doing so, it seems likely that our patients will gain confidence in us and our ability to help them navigate a complex and confusing system," the study authors wrote.

This would improve patient safety and promote a shift from a culture of blame to a culture of prevention, they noted.

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Unique blood disorder drug, Eculizumab

Soliris (eculizumab), an Orphan Drug, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a very rare blood disorder, has been approved by the US Food and Drug Administration. PNH can lead to disability and premature death. Solaris is a new molecular entity containing an active ingredient never previously marketed in the USA.

Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research, FDA, said "This product is important in that it offers a treatment other than blood transfusion that may help this small population of patients who are often very ill. This approval is one of multiple examples of how the orphan products program can benefit the public health with urgently needed products that would otherwise not be commercially available."

PNH is a disease which generally develops during adulthood. The red blood cells develop abnormally. Once these abnormal cells are present in the bloodstream, naturally occurring proteins designed to destroy bacteria and other organisms break these cells down. This leads to darkened urine and causes anemia. Depending on how serious a patient's disorder is, they can experience varying degrees of pain, fatigue and debilitating weakness - they may require frequent blood transfusions, experience blood clots, strokes, heart failure and intestinal disease. Soliris treats the breakdown of red blood cells.

The FDA based its approval on a randomized, double-blind, placebo-controlled clinical study of 87 patients with PNH, as well as some other clinical studies. Half of the 87 patients receiving Soliris had stabilization of blood hemoglobin concentrations, compared with no stabilization among the placebo (control) group - this was over a 26-week period. The trial also found that the patients receiving Soliris required significantly fewer blood transfusions.

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FDA says pills can cause sleep-driving

All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy (news, bio, voting record) crashed his car after taking Ambien.

It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive — with no memory of doing so.

The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports — and is worried that more are going uncounted.

Given the millions of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous — and there are precautions that patients can take — the FDA ordered a series of strict new steps Wednesday.
First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:

_sleep-driving, along with other less dangerous "complex sleep-related behaviors" — like making phone calls, fixing and eating food, and having sex while still asleep.

_and life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.

Next, doctors this week will begin getting letters notifying them of the new warnings.
Later this year, all prescription sleeping pills will begin coming with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.

Sleep-driving made headlines last May when Kennedy, D-R.I., crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a sedative. Kennedy has said he had no memory of the event. He pleaded guilty to driving under the influence of prescription drugs, and was sentenced to court-ordered drug treatment and a year's probation.

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Beta carotene pills may not save vision

Carrots, rich in beta carotene, long have been thought to sharpen eyesight, but a new study suggests that beta carotene pills are powerless against a common type of vision loss among older people. Age-related macular degeneration is the leading cause of blindness in people 65 and older. The condition blurs the center of the field of vision, making it difficult to read, drive, thread a needle and even recognize faces. It affects more than 10 million Americans and there is no cure.

An earlier large study had shown that beta carotene — when taken with certain vitamins and zinc — could slow or prevent vision loss in people with age-related macular degeneration. Commercial formulations of the eye-protecting combination vitamins are sold over the counter.
But the new study found no benefit for beta carotene supplements alone against the disease.
That may be a comfort for smokers with signs of macular degeneration. Smoking is a risk factor for the condition, but beta carotene has been shown in other research to raise the risk of lung cancer in smokers. So eye doctors have advised smokers concerned about macular degeneration to find a vitamin regimen without beta carotene.

"This study at least suggests that beta carotene might not be an important component of that (vitamin) formulation," said Dr. Stuart Fine of the University of Pennsylvania's Scheie Eye Institute, who was not involved in the new study.

The finding is based on data from more than 21,000 male doctors who were followed for an average of 12 years. The doctors were randomly assigned to take either 50 milligrams of beta carotene every other day or a dummy pill. The doctors didn't know whether the pills they took contained beta carotene.

Roughly the same number of doctors in both groups developed the eye condition, suggesting beta carotene didn't help or hurt. After 12 years, there were 162 cases of macular disease in the beta carotene group and 170 cases in the group taking the dummy pills. The difference in the numbers was not statistically significant, meaning it could have occurred by chance.
Study co-author Dr. William Christen at Harvard-affiliated Brigham and Women's Hospital in Boston said it's possible that beta carotene might be helpful only in combination with the other vitamins and zinc, but he said that's unlikely.

Christen said it's unclear whether the latest findings would apply to women since the experiment only involved men; he said he'd like to see a similar study among women. The research, appearing in the March issue of the Archives of Ophthalmology, also says nothing about carrots and eyesight.

"Currently the best advice might be something you've heard before: Eat five or more servings of fruits and vegetables a day because it's the combination of nutrients that seems to be the important factor," Christen said.

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Breast cancer prevention drugs show additional health benefits

The result from the Study of Tamoxifen and Raloxifene (STAR) trial, one of the largest breast cancer prevention clinical trials ever conducted, provide a good opportunity to look back at the obstacles and successes in the development of these two drugs, according to a commentary by V. Craig Jordan, Ph.D., D.Sc., of Fox Chase Cancer Center in Philadelphia. He discusses the discovery and development of these two drugs, their benefits outside breast cancer prevention, such as treating osteoporosis, and a glimpse into future research.

Both tamoxifen and raloxifene belong to a class of drugs known as selective estrogen receptor modulators (SERMs), which have been shown in clinical trials to successfully prevent breast cancer. These drugs act by occupying estrogen receptors in breast and other tissue, and therefore block estrogen's message to the cell to divide and spread.

While the STAR trial demonstrated that development of new chemoprevention drugs is a slow, often unpredictable, process, chemoprevention must remain a priority, Jordan says. Both tamoxifen and raloxifene have been highly effective at reducing the incidence of breast cancer and in the case of tamoxifen, the death rates when used to treat breast cancer. Nevertheless, it's important that research continue in order to develop new prevention options, specifically cost-effective treatments that are intended for premenopausal women.

"For the moment, raloxifene is proving to be an important advance in chemoprevention because it is a multifunctional medicine that can target women at low risk for breast cancer with [low bone mineral density] and healthy women with a high risk of breast cancer. Nevertheless, new SERMs are necessary for clinical testing in postmenopausal women. The SERM concept clearly works, but a long-acting SERM is required to replace raloxifene, a drug that does not appear to perform optimally in a high-estrogen environment," Jordan writes.

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Study may alter current views on drug-resistant TB

Most cases of drug-resistant tuberculosis (TB) in patients being treated for the disease may be caused by new infections, not acquired resistance, a Chinese study suggests.
Acquired resistance occurs when an organism mutates and becomes progressively resistant to standard therapy.

If the finding is confirmed in future studies, it would alter current beliefs about drug-resistant TB and could lead to major change in methods of controlling the respiratory disease, the researchers said.

This study included 38 patients treated for TB in Shanghai hospitals from 1999 to 2004. Samples taken from the patients before and during treatment revealed that in 87 percent of the patients, the strains of TB in the pre-treatment samples were genetically different from strains in samples taken during treatment.

Further research found that re-infection caused five times as many cases of TB as acquired resistance.

"It was surprising to find a high rate of primary drug-resistant strains among treated patients. This overturned the common belief that drug resistance among treated patients is always acquired," researcher Qian Gao said in a prepared statement.

"Our findings highlight the urgency of accelerating efforts to interrupt the transmission of drug-resistant tuberculosis," Gao said.

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New pharmaceutical drug halts progress of metastatic kidney cancer

Research has shown the efficacy of a pharmaceutical drug known as sunitinib which halts progress of metastatic kidney cancer. The work was published recently in the prestigious international medical journal, The New England Journal of Medicine and involved medical co-researchers from the Oncology Department of the University Hospital of Navarra, in collaboration with the Clinical Trials Area of the same Department.

To date the usual treatment for kidney cancer of a metastatic nature has been based solely on immunotherapy. In phase III of the research sunitinib was compared with interferon (a type of immunotherapy) in 750 patients with metastatic kidney cancer and it was shown that sunitinib is more efficient in halting the progress of the disease. 101 medical centres from all over the world took part in the research.

Given the short period of follow-up in the research, the effect of the treatment on survival rates could not be corroborated. Although, in general, the treatment is well tolerated, certain side effects can occur and have to be taken into consideration - hypothyroidism, high blood pressure and fatigue.

Metastatic kidney cancer is one of the cancer pathologies the treatment of which has made least progress in recent years. The usual treatment with immunotherapy had not shown clearly positive results in many patients. Sunitinib is one of the few pharmaceutical drugs that provide clear improvements in this type of cancer. The mechanism of functioning of sunitinib is in blocking the generation of new blood vessels. Tumours, in order to grow, need to develop blood vessels and this pharmaceutical drug impedes their growth, blocking a factor known as VEGF, and other similar ones, which stimulate vascular growth. The use of sunitinib in Spain is to be approved shortly for the treatment of kidney cancer with metastasis although, at the University Hospital, it has been employed with over 40 patients for the last two years, using clinical trials.

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Severe stress harmful to children's brain

Severe stress can affect children's brain development, according to U.S. researchers.
Children with post-traumatic stress disorder and high levels of the stress hormone cortisol were likely to experience a decrease in the size of the hippocampus, a brain structure important in memory processing and emotion, said researchers at the Stanford University School of Medicine and Lucile Packard Children's Hospital

The children in the study were suffering from post-traumatic stress disorder, or PTSD, as a result of undergoing physical, emotional or sexual abuse, witnessing violence or experiencing lasting separation and loss. This type of developmental trauma often impairs the child's ability to reach social, emotional and academic milestones.

The researchers studied 15 children from age 7 to 13 suffering from PTSD. They measured the volume of the hippocampus at the beginning and end of the 12- to 18-month study period.
After correcting for gender and for physiological maturity, they found that kids with more severe PTSD symptoms and higher bedtime cortisol levels (another marker of stress) at the start of the study were more likely to have reductions in their hippocampal volumes at the end of the study than their less-affected, but still traumatized peers.

"We know, for example, that these children are at higher risk of developing depression and/or anxiety as adults," said child psychiatrist Victor Carrion.

Carrion, assistant professor of child and adolescent psychiatry at the medical school and director of Stanford's early life stress research program speculated that cognitive deficits arising from stress hormones interfere with psychiatric therapy and prolong symptoms.

"We'd really like to understand why some children are more resilient than others, and what the long-term effects of extreme stress are," said Carrion.

Children predisposed by genetics or environment to be more anxious than their peers are also more likely to develop PTSD in response to emotional trauma, perhaps because their responses to other life experiences simply left them closer to that threshold than less-anxious children, according to the study to be published in the March issue of Pediatrics.

Although similar effects have been seen in animal studies, this is the first time the findings have been replicated in children.

Source: www.medical-health-care-information.com