Weight loss has been noted among patients who’ve had a knee or hip replacement, a new study says.

The research focused on 196 patients, mean age 67 years, who had knee or hip replacement surgery (arthroplasty) at the Mount Sinai Medical Center in New York City between 2005 and 2007.

The researchers found that, after their surgery, nearly 20 percent of the patients had significant weight loss (5 percent or more of body weight) and decreased body mass index (BMI), which is a measurement that takes into account a person’s height and weight. The mean weight of the patients decreased from 175.5 pounds to 172.2 pounds, they noted.

Knee replacement patients were more likely than hip replacement patients to experience a significant decrease in BMI (21.5 percent and 16.9 percent, respectively). Patients with a BMI score greater than 30 before their surgery, and therefore considered obese, were most likely to have significant post-surgery weight loss.

“Total joint arthroplasties are performed with the intent of relieving a patient’s pain and disability. Both total knee patients and total hip patients experienced a statistically significant and clinically significant corrected weight loss following surgery, which indicates a healthier overall lifestyle,” lead author Dr. Michael Bronson, chief of joint replacement surgery at Mount Sinai School of Medicine, said in a Mount Sinai news release.

Further studies of knee and hip replacement patients that also include diet counseling and long-term fitness goals may show even more encouraging weight loss results, the researchers noted.

The study was published in the June issue of the journal Orthopedics.

Technorati Tags: Knee replacement, Weight Loss

Popular wisdom has long held that young children survive traumatic events better than adults do, in part because they suffer less. Being too young to understand fully the nature of what’s happening around them – during war or natural disaster, for instance – they should bounce back with much more resilience.

But new research on child survivors of Hurricane Katrina and witnesses of the 9/11 terrorist attacks suggests otherwise. “There is increasing evidence that kids know what is going on if they are directly exposed and see something like planes crashing into the [World Trade Center] towers,” says child psychologist Claude Chemtob of New York University, lead author of one of several new papers on children and disaster, published in a special section of the July and August issue of Child Development. (See the top 10 scientific discoveries of 2009.)

Together, the new studies show that young children and teens not only exhibit symptoms of posttraumatic stress and depression that are similar to those of adults, but that they may react more strongly to trauma because adults do. They also show that younger children and girls are more likely to develop symptoms of posttraumatic stress disorder (PTSD) than boys and older kids.

In the first two studies, researchers analyzed the long-term effects on children and their parents of the 9/11 attacks. In one analysis, led by Chemtob, researchers followed 116 preschool children and their mothers in Lower Manhattan who had been directly exposed to the World Trade Center attacks. Interviews were conducted with the mothers and with the children’s preschool teachers nearly three years after 9/11. (See pictures of the World Trade Center’s destruction.)

Chemtob found that compared with children whose mothers did not report symptoms of PTSD or depression, those whose mothers were affected were three times more likely to be emotionally reactive – being clingy and quick to become upset – and seven times more likely to exhibit aggressive behavior three years after the traumatic events. “Kids are very attuned to their moms because moms send cues to their kids about what’s safe and what’s not. If Mom is less available and more focused on the fearful aspects of life, then she is not helping,” Chemtob says. (Comment on this story.)

In contrast, a second study on 9/11 that looked at more than 400 children, aged 12 to 20, and their mothers, found that those who were directly exposed to the attacks – those who witnessed the planes hit the towers, for example – were only slightly more likely to suffer PTSD than children who did not directly experience the trauma, but were significantly more likely to be depressed. Only 4% of these children had PTSD 15 months after the attacks, but 12% were depressed.

Notably, this study, led by child-development researcher Elizabeth Gershoff of the University of Texas at Austin, mirrors the findings of a 2008 study that Chemtob conducted with the same group of children involved in his current paper. In the 2008 study, he also found that children who were directly exposed to the events of 9/11 – seeing dead or injured people, watching people jump out of a building or witnessing a tower collapse – were three times more likely to be depressed or anxious than those who were not directly exposed. “We have tended to say that young kids don’t need help, but in fact they are very vulnerable,” says Chemtob. (See pictures of an army town coping with PTSD.)

Chemtob’s and Gershoff’s conclusions are further supported by two other studies appearing in the current issue of Child Development on the child survivors of Hurricane Katrina. In the first study, a team of researchers from Louisiana State University (LSU) interviewed 387 public schoolchildren in St. Bernard Parish, one of the areas most devastated by Katrina, and found that young children were more profoundly affected than adolescents. Three years after the hurricane, children between the ages of 9 and 11 were four times more likely to show symptoms of PTSD than were teenagers between the ages of 15 and 18.

Although the study reported that behavioral problems among the study sample had decreased overall over time – with nearly half of the children showing no lasting signs of stress – more than 25% of the younger kids were still exhibiting significant symptoms of PTSD and depression, such as feeling sad or nervous and having trouble sleeping or concentrating.

It may be that older children had more emotional resources to call on, which made it easier for them to bounce back. “Whereas younger children are more dependent on their caretakers, adolescents can turn to their friends or others in the community,” says Joy Osofsky, a child psychologist at LSU who co-authored the study. Indeed, the children who fared best post-Katrina were those whose schools were quickly rebuilt and who had supportive relationships, both at home and at school. (Read “Study Points at a Clear-Cut Way to Diagnose PTSD.”)

Despite the age advantage, girls of any age were twice as likely as boys to have problems adapting after the disaster – an effect reported by both Osofsky’s current research as well as several prior studies. One explanation, put forth by the second Katrina study in Child Development, is that girls may simply be more expressive of their feelings of stress than boys are, even if boys have the same emotions. In the study, which analyzed saliva samples from 62 boys and girls between the ages of 12 and 19 who had been relocated to camps after the hurricane, researchers found no significant difference in levels of salivary cortisol, a hormone associated with stress, between the genders.

Jacob Vigil, a psychologist at the University of New Mexico and lead author of the study, hypothesizes that the differences in the way boys and girls react to trauma may be due to social conditioning rather than actual physiological effects. It may also be possible that similar levels of stress hormones affect males and females differently.

Past studies have shown that PTSD is more likely to manifest itself in boys as concentration and behavioral problems, while girls tend to exhibit emotional reactions like guilt and anxiety. “Girls tend to internalize their problems, whereas boys are more likely to act out,” says Gershoff. Other common symptoms of the disorder may include nightmares, upsetting thoughts about the past trauma, avoidance of reminders of the event and persistent worrying about more bad things happening.

Although there was no significant difference in the levels of cortisol in boys and girls in Vigil’s study, he did note that cortisol levels in the traumatized population of kids living in relocation camps were lower on average than those of a control group. That suggests the Katrina survivors had lived with constant stress for so long that they had become almost inured to its effect – they became less reactive to relatively minor, day-to-day stressors. “It’s like a rubber band that gets stretched too much. Folks who are not reactive to stress seem to have more stress in their life,” notes Vigil. Low cortisol levels have been associated with depression in adults, and while depression is a separate condition from PTSD, they share many of the same symptoms such as trouble sleeping and concentrating.

Child advocates say that one way to minimize long-term PTSD in kids is to provide them with the same level of psychological support that is regularly offered to adults. “It is important that kids have access to mental-health services right after a disaster,” says Gershoff. “We can’t just assume that kids are going to get over it. They need someone who can help them cope,” especially when their parents can’t.

Technorati Tags: posttraumatic depression, posttraumatic stress

Eisai Co and Pfizer Inc said they won U.S. regulatory approval for a higher dose once-daily version of Aricept, a drug that treats Alzheimer disease.

Eisai, Japan’s No. 4 drugmaker, said in March it expected annual U.S. sales of the drug, its flagship product, to fall 60 percent to $800 million from $2 billion between 2011 and 2013 with the expiration of its patent for the drug looming.

The U.S. Federal Drug Administration approved a 23 mg tablet version of the drug, which treats moderate-to-severe Alzheimer’s. About 3.5 million Americans over the age of 65 suffer from the disease.

(Reporting by Phil Wahba; editing by Carol Bishopric)

Technorati Tags: Alzheimer disease, Aricept, Eisai Co, Pfizer Inc

The cancer drug Avastin, when used in combination with standard chemotherapy, is safe and can effectively treat an advanced form of one of the most common lung cancers, researchers report.

Previously it had been thought that this combination might have serious adverse side effects, including life-threatening bleeding, for patients with non-squamous non-small-cell lung tumors. However, this phase 4 trial, which used Avastin (bevacizumab) plus chemotherapy in a large population found these problems were minimal.

Phase 4 trials are done after a drug is on the market, to look for any new problems.

“Today we have a new option to treat non-squamous lung cancer, incorporating Avastin in chemotherapy regimens and in maintenance therapy,” said lead researcher Dr. Lucio Crino, director of medical oncology at S. Maria della Misericordia Hospital in Perugia, Italy.

“The practical implication is the possibility to incorporate Avastin with any chemotherapy regimen in the frontline therapy of metastatic non-squamous lung cancer,” he added.

The report, which is funded by the maker of Avastin, F Hoffman-La Roche Ltd., is published in the July 20 issue of The Lancet Oncology. The funder was involved in study design, coordination of data collection, data analysis, data interpretation, and writing of the report, the journal noted.

Advanced non-small-cell lung cancer is a common cancer that kills 1.18 million people every year worldwide, according to background information in the study. Avastin is a so-called monoclonal antibody that works by blocking vascular endothelial growth factor A, which stimulates the growth of the tumor’s blood supply.

When used as an adjunct to chemotherapy, Avastin had already shown cancer-fighting activity in two phase 3 trials, the researchers noted.

For the study, Crino’s team studied Avastin in more than 2,200 patients with advanced or recurrent non-squamous non-small-cell lung cancer. The patients were treated at centers in 40 countries around the world.

These patients were given the drug every three weeks along with standard chemotherapy, for up to six cycles. Patients were then treated with Avastin alone until the cancer began to progress (“maintenance” therapy).

The researchers reported few clinically significant adverse events, meaning that most were no greater than what one would expect in the general population. One percent of patients experienced bleeding in the lungs and 4 percent had bleeding, Crino’s group found.

Overall, 3 percent of the patients died due to adverse events associated with Avastin. These included 1 percent who had blood clots and 1 percent who suffered bleeding.

Other serious adverse events associated with Avastin were blood clots in the lungs and nosebleeds, low white blood cell counts, fever along with a low white blood cell count and deep vein thrombosis (DVT), all of which occurred in 1 percent of the patients.

Dr. Robert Pirker, from the department of medicine at the Medical University of Vienna in Austria, and author of an accompanying journal editorial, said that Avastin “can be safely given when certain precautions are taken.”

However, several issues remain to be determined, including the optimal dose and the role of maintenance therapy with Avastin, he said.

“In addition, it is unknown whether bevacizumab [Avastin] increases survival when added to cisplatin-based chemotherapy in patients with advanced non-squamous non-small-cell lung cancer,” Pirker said.

Overall, Avastin, like several other targeted agents have led to therapeutic advances in lung cancer, he added. “Hurdles in clinical development do occur but — as shown for bevacizumab — can be overcome,” Pirker said.

Another expert, Dr. Norman H. Edelman, chief medical officer at the American Lung Association, and professor of preventive medicine, internal medicine, physiology & biophysics at Stony Brook University in New York, called the study “very good bread-and-butter clinical research.”

The efficacy of the drug has been proven previously, he noted, but this study provides an in-depth analysis of Avastin’s safety profile under “real life” conditions, he added.

“Too often this step is shortcircuited in the rush to market of a new drug and we have to await the laborious collection of after-market data to find the real dangers of many new drugs,” Edelman said.

“So, the researchers and sponsors are to be congratulated for doing this study. They find that there are real deleterious side effects but that they are manageable, and conclude the drug is worth using under the proper circumstances,” he said.

Avastin is in the spotlight Tuesday for another reason, as well. U.S. regulators could rescind approval of the drug for the treatment of breast cancer, based on follow-up studies reported Friday that failed to show the medication shrank tumors or extended lives, according to published reports.

The Food and Drug Administration on Tuesday will ask a panel of outside experts to review the evidence on the Roche drug, the Associated Press said. It’s possible the FDA will withdraw approval of Avastin as a breast cancer treatment.

The drug is also approved for lung, colon, brain and kidney cancer.

Technorati Tags: Advanced Lung Cancer, Avastin

An experimental obesity drug, taken along with formal counseling on lifestyle changes, may spur greater weight loss than counseling alone, a new study finds.

The study of nearly 800 obese adults examined the effects of a drug called Contrave — which combines the antidepressant bupropion (Wellbutrin) and naltrexone, a medication used to treat alcohol and drug addiction.

The trial is one of four studies that the drug’s developer, Orexigen Therapeutics, has sponsored in a bid to win approval from the U.S. Food and Drug Administration (FDA).

The other trials have so far shown that Contrave generally outperforms placebo pills in spurring weight loss; in one, for instance, study participants on the drug lost an average of 6 percent of their initial weight over one year, compared with just over 1 percent among placebo users.

The current findings support the previous results, and suggest that combining the medication with counseling on diet and lifestyle would provide further benefits, the researchers report in the journal Obesity.

They found that over one year, participants in the drug-plus-counseling group lost 9 percent of their initial weight, on average — versus an average of 5 percent among those who received behavioral counseling plus a placebo.

Orexigen recently filed for FDA approval of Contrave and has said that it expects the agency to give a ruling early next year.

The drug is one of three experimental weight-loss medications currently under FDA scrutiny. Later this week, an advisory panel to the agency is set to review Qnexa, a weight-loss drug developed by Vivus Inc. The drug combines phentermine, an appetite suppressant, with topiramate, an epilepsy medication that also happens to help control appetite. In documents made public on Tuesday, FDA staff said Onexa appears to help people shed pounds, but concerns remain about its safety.

The third candidate drug — lorcaserin, developed by Arena Pharmaceuticals Inc. — acts on certain receptors in a portion of the brain that regulates appetite and metabolism.

For its part, Contrave is believed to act on brain pathways involved in food craving.

These latest findings are based on 793 obese men and women who were randomly assigned to take either Contrave or a placebo for one year in addition to 28 sessions of group counseling on diet, exercise and behavioral tactics for encouraging weight loss — like eating more slowly and avoiding temptations.

Researchers led by Dr. Thomas A. Wadden, of the University of Pennsylvania in Philadelphia, found that after 56 weeks, the Contrave group shed more pounds overall. Just over 41 percent lost 10 percent or more of their starting weight, versus 20 percent of the placebo group; 29 percent lost at least 15 percent of their initial weight, compared with 11 percent of placebo users.

It remains to be seen what role, if any, Contrave or its would-be competitors might have in battling obesity, which now affects about one-third of U.S. adults.

Weight-loss drugs have had a troubled history, starting in 1997 when the medication known as “fen-phen” was withdrawn from the market after being linked to fatal heart-valve problems.

One component of that medication, fenfluramine, was taken off the market; the other, phentermine (now a component of Qnexa) is generally considered safe at low doses.

There are currently two weight-loss medications FDA-approved for longer-term use: sibutramine (Meridia) and orlistat (Xenical), the latter also being available in a lower-dose, over-the-counter version called Alli.

Those medications have had their problems as well. Meridia carries warnings about high blood pressure and a risk of heart attack and stroke in patients with heart problems, and is no longer sold in Europe. Xenical can cause serious liver problems, uncontrolled bowel movements and gas.

Among the side effects so far seen with Contrave are nausea, constipation, dizziness, abdominal pain and ringing in the ears. In the current study, 34 percent of Contrave users reported nausea, while one-quarter reported constipation — compared with 10 percent and 14 percent, respectively, in the placebo group.

The side effects were reported mainly during the first month of treatment, according to Wadden’s team.

Besides the issue of side effects, experts generally caution people to temper their expectations regarding the effectiveness of any weight-loss drug. They stress that none is considered a “magic pill” that will work without the help of diet changes and regular exercise.

One of the FDA criteria for judging a weight-loss medication effective is that its average weight loss beat a placebo by 5 percentage points, which is a relatively modest benefit.

Still, research indicates that even moderate weight loss — 5 to 10 percent of a person’s starting weight — can have health benefits for someone who is obese.

In the current study, Contrave users saw, along with their greater weight loss, a larger reduction in triglycerides (a type of blood fat) and insulin levels, and a greater gain in “good” HDL cholesterol levels.

SOURCE: http://link.reuters.com/byx37m Obesity, online June 17, 2010.

Technorati Tags: Contrave, naltrexone, obesity drug, Weight Loss, wellbutrin

Clinical trials aimed at pinpointing emerging safety problems with drugs already on the market should only be conducted when other, less invasive research is not possible, a U.S. advisory group said on Friday.

The Institute of Medicine’s report, requested by U.S. Food and Drug Administration officials, comes ahead of a highly-anticipated meeting next week on GlaxoSmithKline Plc’s diabetes drug Avandia, that has come under fire for potential heart risks.

Glaxo is conducting a randomized, controlled trial called TIDE to compare Avandia to Takeda Pharmaceutical Co’s rival drug, Actos, after safety concerns emerged with Avandia that the FDA and its advisers concluded were unclear.

While the IOM did not target the Avandia trial in particular, FDA Commissioner Margaret Hamburg asked the independent, nonprofit medical group to weigh in with at least an initial finding on general ethical issues involving the safety of studying the risks of drugs already in use.

The FDA called in 2007 for the TIDE study, which aims to enroll 16,000 patients and end in 2015, although some critics say it could take longer.

Analyses of other data since then have convinced some researchers that Avandia’s risks are greater than those of Actos and have repeatedly called for the trial to be halted.

Glaxo has defended its drug, saying data overall shows it does not increase the risk of heart attack, stroke or death.

On Tuesday and Wednesday, FDA’s panel of outside experts will weigh numerous studies and analyses before recommending whether Avandia should remain on the market, be pulled from the market, or various options in between.

They also will be asked to weigh in on the TIDE trial.

In its report, the IOM said randomized controlled trials should only be done when “a responsible policy decision cannot be made based either on the existing evidence or on evidence from new observational studies.”

It also said studies of real world use of a drug — known as observational studies and often done by reviewing insurance claims and other databases — can yield strong data.

In separate FDA documents released on Friday, FDA staff scientists were split over whether the TIDE trial should continue just as they are divided over whether another major Glaxo trial, RECORD, showed excessive heart-attack risks with Avandia.

Some staff also pointed to studies done since 2007, including an FDA analysis of 52 trials on the prescription drug, as well as a review of Medicare data that showed a greater risk of heart attack and other complications with Glaxo’s drug.

“Based on these findings, any proposed head-to-head trial of rosiglitazone vs. pioglitazone is unethical and exploitative,” agency reviewers David Graham and Kate Gelperin wrote.

Rosiglitazone is the generic name for Avandia, and pioglitazone is the generic name for Actos.

Another FDA scientist, clinical reviewer Karen Mahoney, said that the TIDE trial does not have many of the limitations of the earlier RECORD study and could be illuminating.

“This trial, if it continues to completion, has the potential to address the question of the cardiovascular safety of rosiglitazone more definitively,” she wrote in a separate memo.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

Technorati Tags: Actos, Avandia, drug safety trials, pioglitazone, Rosiglitazone

The U.S. House of Representatives has approved a ban on some patent agreements between brand name and generic drug companies, deals which a federal agency says slow the arrival of cheaper generic drugs to market.

The House, voting late on Thursday, approved the measure as part of its approval of money to pay for President Barack Obama’s Afghanistan troop increase.

The measure, backed by the Federal Trade Commission, must now be considered by the Senate. The U.S. House has approved the measure previously but it has died in the Senate.

The Generic Pharmaceutical Association (GPhA) said it was disappointed in the vote.

“As this legislation moves to the Senate, GPhA will expand its efforts to point out that a curb on settlements will not hasten generic market entry, but rather will delay the launch of new and affordable generic medicines,” the group said.

“The unintended consequence of these restrictions on settlements will significantly harm the millions of Americans who rely on generic drugs,” it said in a statement.

But the House move pleased FTC Chairman Jon Leibowitz, who has made stopping the deals a centerpiece of his tenure on the commission. The FTC says the deals break antitrust law in instances where brand name drug companies essentially pay generic companies to delay entering the market.

“Congress has taken a critical step toward ending a practice that is dramatically increasing the cost of prescription drugs,” said Leibowitz.

The FTC has estimated that the deals — which often come as part of settling patent litigation — cost consumers about $3.5 billion a year by delaying access to generics.

(Reporting by Diane Bartz; Editing by Tim Dobbyn)

Technorati Tags: brand name drug, cheaper generic drugs, drug patent, generic drug, generic medicines, prescription drugs