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Hormone replacement therapy (HRT) cuts a woman’s risk of developing colon cancer, new research confirms.

Millions of women stopped taking HRT when a Women’s Health Initiative study showed in 2002 that the hormones raised the risk of stroke, heart disease and breast cancer.

But the Women’s Health Initiative had also found that HRT protected against colon cancer. Some studies have also suggested that oral contraceptives might reduce the risk of the disease, while the fact that women are at lower risk of colon cancer than men also hints at a hormonal role in disease risk.

To investigate ties between HRT and colon cancer further, Dr. Millie D. Long of the University of North Carolina at Chapel Hill and her colleagues matched 443 women diagnosed between 2001 and 2006 with distal large bowel cancer (meaning tumors at the far end of the colon and the rectum) to 405 healthy control women. The average age of the study participants was around 63.

Long’s team found that women who had ever used HRT were at half the risk of this type of colon cancer compared to women who’d never used hormone replacement, and the longer a woman was on HRT, the lower the risk.

For example, women who used hormones for less than four years cut their colon cancer risk by about one-quarter; four to eight years of HRT cut risk by a third; nine to 14 years of use halved risk; and 15 years or more of HRT reduced risk by two-thirds. The effects were the same for African-American women and white women.

However, there was no relationship between oral contraceptive use and colon cancer risk, the study team reports in the American Journal of Gastroenterology.

Long-term hormone therapy is no longer recommended for postmenopausal women, Long and her team note, although it is still sometimes prescribed on a short-term basis to help women with menopausal symptoms such as hot flashes. The major drop off in distal large bowel cancer in recent years could have been related to widespread use of HRT, the researchers say.

More research is needed to determine if HRT’s protective effects persist after women stop taking hormones, the researchers add, or whether there might be a “rebound” effect with more pre-cancerous polyps developing after a woman halts

HRT.

“It may become important in the future to tailor timing of women’s colorectal screening based on cessation of hormonal therapy,” Long and her colleagues conclude.

SOURCE: The American Journal of Gastroenterology

Nicotine withdrawal can create serious problems for smokers who have a medical condition that puts them in intensive care, according to a new study.

Researchers from Caen University Hospital in France found that hospital patients going through nicotine withdrawal can become highly agitated and accidentally remove tubes and catheters, require additional sedation, analgesic or anti-psychotic medicines, or need physical restraints.

Agitation, for example, occurred twice as often among smokers as non-smokers, the researchers found.

Their study, published online April 9 in Critical Care, compared 44 smokers and a control group of 100 non-smokers treated in the hospital’s intensive care unit (ICU).

“These results suggest the need to be aware of nicotine withdrawal syndrome in critically ill patients and support the need for improved strategies to prevent agitation or treat it earlier,” study author Damien du Cheyron said in a news release from the journal’s publisher.

None of the smokers were allowed nicotine replacement therapy (NRT) during the study.

“NRT remains a controversial topic in intensive care and has been associated with mortality,” du Cheyron said. “Due to the serious consequences of withdrawal-induced agitation, including sedation and physical restraint, we suggest the use of nicotine replacement therapy should be tested by a well-designed, randomized controlled clinical trial in the ICU setting.”

SOURCE: BioMed Central

People who are trying to stay trim may want to make sure they get plenty of sleep.

In a study, researchers found that normal-weight young men ate a Big Mac’s-worth of extra calories when they’d gotten four hours of sleep the night before compared to when they slept for eight hours.

Given the findings, and the fact that people have been sleeping less and getting fatter over the past few decades, “sleep restriction could be one of the environmental factors that contribute to the obesity epidemic,” they write in the American Journal of Clinical Nutrition.

A number of studies have linked shorter sleep duration with higher body mass index (BMI) — a measure of weight in relation to height used to gauge whether someone is overweight or obese. But no experimental studies to date have actually looked at what happens to a normal-weight person’s eating patterns when he or she sleeps less.

To investigate, Dr. Laurent Brondel of the European Center for Taste Sciences in Dijon, France, and colleagues looked at sleep, eating, and energy expenditure in 12 healthy young men across two 48-hour sessions.

Two days served as a control period, during which the study participants stuck to their normal routines but kept track of their sleep, eating and activities in a diary. During the second two-day period, the men went to bed at midnight and woke up at 8 a.m. on one day, and on the other day went to bed at 2 a.m. and woke up at 6 a.m. They were allowed to eat as much as they liked.

After the night of short sleep, the researchers found, the men took in 22 percent more calories, on average, than when they were allowed to sleep for eight hours. They ate more at breakfast and dinner, but not at lunch. The average calorie increase was about 560.

It’s possible that people might eat more after a short sleep because mammals have evolved to store up calories in the summer, when nights are short and food is plentiful, Brondel and his colleague Dr. Damien Davenne of the University de Caen in Caen, France noted in an email to Reuters Health.

The findings make it clear that people need to do their best to get an adequate amount of sleep so their bodies can function properly, Brondel and Davenne add. “It is time to understand that sleep is not just losing time, besides the recovery processes that occur, there are many other functions (energy conservation, memory and so on) which are going on.”

SOURCE: American Journal of Clinical Nutrition

Once-a-year screening for chlamydia isn’t likely to protect women from developing pelvic inflammatory disease, researchers say.

A new study has found that most cases of pelvic inflammatory disease occur in women who didn’t have chlamydia infection when they were screened, which suggests they may have become infected later.

Chlamydia is the most common sexually transmitted infection in Europe and the United States. An estimated 3 million new infections are diagnosed annually, and because there are often no symptoms, many cases remain undiagnosed, according to background information provided in a news release about the study. Undiagnosed chlamydia infection may lead to pelvic inflammatory disease.

The study included 2,529 sexually active females, aged 16 to 27, who completed questionnaires and provided vaginal swabs to check for chlamydia. Some of the swabs (1,254) were tested immediately while others (1,265) were tested after a year.

Chlamydia was found in 68 (5.4 percent) of the women who were screened at the start of the study and in 75 (5.9 percent) of those screened a year later. During the study period, pelvic inflammatory disease developed in 15 (1.3 percent) of the women who were screened immediately and in 23 (1.9 percent) of those who were screened after one year.

The majority of cases of pelvic inflammatory disease (79 percent) were among women who tested negative for chlamydia at their initial screening, the study authors found. This suggests that, among high-risk people, frequent testing for chlamydia may be more effective at preventing pelvic inflammatory disease than annual screening, said Dr. Pippa Oakeshott, of the University of London, and colleagues.

Public campaigns should emphasize the need for screening whenever a woman has a new sexual partner, the study authors recommended in the report published online April 9 in BMJ.

“It is disappointing but not surprising that this study could not provide a clear answer as to whether screening is effective in reducing the incidence of pelvic inflammatory disease,” Jessica Sheringham, of University College London, wrote in an editorial accompanying the study.

SOURCE: BMJ

Older men and women who break a hip are five to eight times more likely to die in the first three months after the fracture, a new study by Belgian researchers has found.

And, while the death rate after a hip fracture diminishes substantially during the first two years after the break, it never returns to the death rate seen in similar people who did not fracture a hip, the study authors said.

“A hip fracture is a major blow to the body,” said Dr. Elton Strauss, an associate professor and chief of orthopedic trauma and adult reconstruction at Mount Sinai School of Medicine in New York City, who was not involved in the study.

Strauss said the main problem is not repairing the fracture itself but the toll it takes on older people.

“It’s actually the problem with the elderly skeleton as well as the co-morbidities [other health problems] these patients have,” he said. “There’s also the mental shock.”

For the study, a team led by Dr. Patrick Haentjens, of the Centre for Outcomes Research and the Laboratory for Experimental Surgery at the University Hospital in Brussels, examined 22 studies that included more than 578,000 women and 17 studies that included more than 154,000 men with hip fractures. All study participants were 50 or older.

The researchers found that older women who had a hip fracture had a slightly more than 50 percent greater risk of dying in the first three months after the break, and men had a nearly 80 percent increased risk of dying during that time.

The risk increased with the person’s age. For 80-year-old women with hip fractures, the increased risk of dying was 8 percent at one year, rising to 22 percent at 10 years, compared with women without hip fractures.

For 80-year-old men, the increased risk of death at one year was 18 percent, and 26 percent at five years, compared with men who did not break a hip, the study found.

“These findings may be helpful when performing cost-effectiveness analyses of hip fracture prevention strategies or designing treatment strategies in patients with hip fracture,” the researchers concluded.

The findings were published in the March 16 issue of Annals of Internal Medicine.

Strauss said that one key to surviving and recovering from a hip fracture is to have a good family or other support system when the person leaves the hospital.

“Most of these patients are discharged from hospitals before they can be optimized to the very best condition,” he said. “Most Medicare patients stay in hospitals three days after [a] hip fracture, and three days is just not enough to get these patients back on their feet.”

It takes time to fully heal, especially for people who are old and suffering from other medical conditions, Strauss said.

“These fractures are major assaults on people that are getting older,” he said. “Their systems are not as efficient as they were, and they often don’t have the ability to obtain the necessary support once the fracture has been treated.”

“If the patient does not have a family unit, if the patient doesn’t have finances to pay for a nurse or a homemaker or somebody to drive them to the doctor’s office, somebody to help them shop — the resources out there are minimal,” he added. “Most patients get three to four hours of home health aid a day, and that’s not enough.”

SOURCES: Elton Strauss, M.D., associate professor, chief of orthopedic trauma and adult reconstruction, Mount Sinai School of Medicine, New York City.

People who take certain drugs for depression known as selective serotonin reuptake inhibitors (SSRIs) may have a higher-than-average risk of developing cataracts, a study from Canada hints.

Among about 18,700 Quebec residents aged 65 and older with cataracts and 187,000 age-matched Quebec residents without cataracts, study chief Dr. Mahyar Etminan, of Vancouver Coastal Health Research Institute and University of British Columbia, and colleagues found that people taking SSRIs were 15 percent more likely to be diagnosed with cataracts than those not taking these drugs.

While the study does not allow for calculating a person’s actual risk of developing cataracts with SSRI use, Etminan noted that the average lifetime risk of developing cataracts for someone in North America above the age of 50 is approximately 20 percent.

In general, SSRIs roughly increase the risk to 23 percent, the researcher noted.

However, “SSRI therapy should not be stopped for fear of cataracts, which are treatable and relatively benign,” Etminan told Reuters Health.

“The benefits of treating depression, which can be life-threatening, still outweigh the risk of developing cataracts,” the researcher emphasized.

Different SSRIs may pose different risks. For example, current users of fluvoxamine (Luvox) had a 39 percent higher chance of being diagnosed with cataracts and a 51 percent higher chance of having cataract surgery. With venlafaxine (Effexor), one’s risk may be roughly 26 percent higher than average and with fluvoxamine, it may be 30 percent higher.

Current venlafaxine (Effexor) users had a 33 percent higher likelihood of cataracts and a 34 percent higher likelihood of cataract surgery, while taking paroxetine (Paxil) carried a 23 percent higher risk of cataract surgery.

In the current study, current use of fluoxetine (Prozac), citalopram (Celexa), and sertraline (Zoloft) did not seem to raise the odds of cataracts or cataract surgery. And past use of any SSRI also did not appear to pose a risk.

“We found different risks with different agents. However, we don’t want to dwell on this with just one study and think whether the risk is different with different agents should be validated in future studies,” Etminan said.

Smoking is a key risk factor for cataracts and “the main limitation of the study,” Etminan told Reuters Health, “is not being able to control for smoking as this information was not available.”

Still, this is the first study to find a link between SSRI antidepressants and cataracts in humans, while earlier studies have suggested that was true in animals.

Nonetheless, the study does not prove that taking SSRIs can cause cataracts; it only reveals an association between the two. Clearly, more study is needed, the researchers conclude.

SSRIs are one of the most frequently prescribed class of drugs in the US and the third most prescribed class globally.

SOURCE: Ophthalmology.

Heart patients who took a stomach acid-suppressing proton-pump inhibitor along with clopidogrel—a drug that prevents blood clots—were only half as likely to be hospitalized for upper digestive tract bleeding than those who used clopidogrel alone, according to a new study supported by Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) and the National Heart, Lung, and Blood Institute at the National Institutes of Health.

The study also suggested that combining the drugs did not increase the risk of serious heart problems. Clopidogrel (sold as Plavix, Clopilet, and Ceruvin) is usually prescribed for heart patients to reduce the risk of a heart attack or stroke and can also cause bleeding stomach ulcers. Proton-pump inhibitors, which include pantoprazole (Protonix), omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium) and rabeprazole (Aciphex), are used to prevent or treat ulcers, acid reflux disease and other stomach acid-related problems.

Although proton-pump inhibitors are commonly prescribed with clopidogrel to reduce the risk of upper digestive tract bleeding, clinicians worry that this practice may decrease the antiplatelet drug’s ability to prevent blood clots. Until now, there has been limited research on the impact of proton-pump inhibitors on either the effectiveness of clopidogrel or on the ability of the proton-pump inhibitors to reduce digestive tract bleeding and which populations of patients may benefit the most from taking the drugs in combination.

“We need to make sure that the medicines we give patients help and don’t harm” said AHRQ Director Carolyn M. Clancy, M.D. “This evidence on benefits and risks helps inform the combined use of these two drugs.”

The study, published in the March 16 issue of the Annals of Internal Medicine, was based on data from nearly 21,000 patients in the Tennessee Medicaid program between 1999 and 2005. Researchers divided those patients into two groups—those who were prescribed clopidogrel by itself and those who took clopidogrel in combination with a proton-pump inhibitor. The researchers from Vanderbilt University Medical Center in Nashville then determined how many patients in each group had been hospitalized for gastrodoudenal ulcers—raw tissue in the upper part of the small intestine, or duodendum, where it connects to the stomach. The Vanderbilt research team is one of 14 AHRQ-supported Centers for Education & Research on Therapeutics (CERTs).

The researchers found that concurrent use of a proton-pump inhibitor and clopidogrel did not increase patients’ risk of heart attack, sudden cardiac death, stroke or other cardiovascular problems. The same was true for patients who had a procedure called percutaneous coronary intervention, also known as angioplasty with stents.

However, the researchers noted that even though they did not find an elevated cardiovascular risk, they cannot rule it out. They noted data from additional studies, including randomized clinical trials, will clarify how combining clopidogrel and proton-pump inhibitors affects heart and vascular health.

The CERTs research program, established in 1999, is administered by AHRQ in consultation with HHS’ Food and Drug Administration. Its goal is to serve as a trusted national resource for people seeking to improve health through the best use of medical therapies. The CERTs program includes partnerships of public and private organizations, a national steering committee involving multiple sectors and the CERTs investigators, a coordinating center and 14 research centers.

Men suffering from both cardiovascular disease and erectile dysfunction are at greater risk for heart attack, stroke, heart failure and death, a new study finds.

Moreover, treatments for cardiovascular disease had no effect on erectile dysfunction, so the German researchers concluded that erectile dysfunction is an independent risk factor for cardiovascular disease.

“This is an important study that adds to a growing body of literature, which clearly demonstrates that erectile dysfunction is a potent risk factor for death and future cardiovascular events,” said Dr. R. Parker Ward, an associate professor of medicine at the University of Chicago Medical Center. “Presence of erectile dysfunction is a potent risk factor for future heart disease independent of other risk factors or prior cardiovascular disease.”

In fact, the researchers found that men with cardiovascular disease along with erectile dysfunction were 1.9 times more likely to die from cardiovascular disease, twice as likely to have a heart attack, 1.2 times more likely to be hospitalized for heart failure and 1.1 times more likely to have a stroke.

The report was released online March 15 in advance of publication in the March 30 print edition of Circulation.

For the study, a team led by Dr. Michael Bohm, chairman of internal medicine in the Department of Cardiology and Intensive Care at the University of Saarland in Germany, collected data on 1,519 men from around the world who took part in one of two heart disease trials: ONTARGET or TRANSCEND.

These men were classified as having mild, mild-to-moderate, moderate or severe erectile dysfunction. In addition, they were given questionnaires to complete at the start of each study and again about five years later. In both trials, in addition to cardiovascular disease, 55 percent of the men also had erectile dysfunction.

In the ONTARGET study, men were randomly selected to take blood pressure-lowering drugs — either the ACE inhibitor ramipril (Altace) or the angiotensin II receptor antagonist telmisartan (Micardis) or a combination of both. In the TRANSCEND trial, ACE inhibitor-intolerant patients were treated with Micardis or a placebo.

The researchers found men suffering from erectile dysfunction were more likely to have high blood pressure, stroke, diabetes and lower urinary tract surgery, compared to men without erectile dysfunction.

Among those with erectile dysfunction, 11.3 percent died from any cause, compared with 5.6 percent of men with mild or no erectile dysfunction. In addition, 16.2 percent of the men with erectile dysfunction died from a cardiovascular problem, heart attack, stroke or were hospitalized for heart failure, compared with 10.3 percent of men with no or mild erectile dysfunction, the researchers reported.

Erectile dysfunction is linked to the endothelial dysfunction (problems with the cells that line the blood vessels) that occurs in atherosclerosis and the vascular disturbances such as the build-up of plaque that happens before heart attack and stroke, the study authors explained.

Men need to realize that erectile dysfunction is a risk factor for cardiovascular disease just as high blood pressure and cholesterol are, Bohm said in a statement: “If a man has erectile dysfunction, then he needs to ask his physician to check for other risk factors of cardiovascular disease.”

This study provides further evidence that all physicians should include questions about erectile function as part of their office-based assessment of a patient’s risk of future cardiovascular disease, Ward said.

“It is important that we make patients aware of implications of erectile dysfunction on their heart health so they freely discuss these sensitive issues with their physicians,” he said. “While the best strategies to reduce this additional risk in patients with erectile dysfunction have not been proven, it is reasonable for physicians to intensify traditional strategies aimed at lowering cardiac risk in patients with erectile dysfunction.”

Another expert, Dr. Gregg Fonarow, a professor of cardiovascular medicine at the University of California, Los Angeles, said that “erectile dysfunction is observed more frequently in men with cardiovascular risk factors and those with established cardiovascular disease, and recent studies have suggested men with erectile dysfunction may be at increased risk for heart attack and stroke.”

He added that “erectile dysfunction may be an important indicator of more advanced atherosclerotic vascular disease and endothelial dysfunction.”

SOURCES: Gregg Fonarow, M.D., professor, cardiovascular medicine, University of California, Los Angeles; R. Parker Ward, M.D., associate professor, medicine, University of Chicago Medical Center;  Circulation, online

Review of data indicating life-threatening heart abnormality underway

The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

When used together, the drugs may cause prolongation of the QT and PR intervals on an electrocardiogram. Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With torsades de pointes or with heart block, patients may experience lightheadedness, fainting, or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation.

Review of the data is ongoing. Preliminary findings suggest that some patients using Invirase and Norvir may be at an increased risk for heart abnormalities leading to irregular heart rhythms. For example, the risk for torsades de pointes may be increased in patients who are also using medications known to cause a heart disturbance called QT interval prolongation. The risk may also be increased in patients who have a history of QT interval prolongation.

Patients using Invirase should talk to their health care professional about any questions or concerns they have about Invirase. Patients and health care professionals should report any side effects from the use of Invirase to the FDA’s MedWatch program:
http://www.fda.gov/safety/MedWatch/default.htm

Invirase is an antiretroviral medication that was first approved in 1995. Invirase is used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent you from developing HIV-related illnesses, and may not prevent you from spreading HIV to other people.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as the review is complete.

Invirase is marketed by San Francisco-based Genentech, a subsidiary of the Roche Group. Norvir is marketed by Abbott Park, Ill.-based Abbott Laboratories.

For more information: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201221.htm

How quickly an HIV patient’s immune system deteriorates may not affect the outcome of the illness, a study has found, and this could help change current guidelines for treatment of the disease.

There is no cure for the human immunodeficiency virus (HIV) that causes AIDS, but combinations of drugs can keep the virus from replicating and damaging the immune system.

Doctors normally do not start treatment until there is some evidence of damage to this system, measured by counting the number of immune cells, called CD4 T-cells.

In developed countries, HIV treatment usually begins when CD4 numbers drop below 350 cells per microlitre of blood.

Some treatment guidelines also recommend that therapy be started more quickly for people whose CD4 counts decline rapidly.

But the study, involving an international team of researchers, found that the pace of decline did not result in any substantial differences to the outcome of the illness.

“What we looked at was whether it matters how a person reached his current CD4 cell count, whether the CD4 count declined very quickly, or very slowly, and we found that the CD4 cell dynamics don’t provide additional information about the patient’s prognosis on top of the current CD4 cell count,” said Marcel Wolbers of the Hospital for Tropical Diseases in Ho Chi Minh City in Vietnam.

Wolbers, a biostatistician and one of the principal investigators of the study, and his colleagues examined records of 2,820 HIV patients from Australia, Canada and Europe with varying rates of CD4 declines.

They found no significant differences in their progression to AIDS or the number of deaths.

“The current rate of CD4 cell decline is neither a strong predictor of whether a person is progressing to AIDS or dies, nor does it predict future CD4 cell decline,” he said. “Therefore, it shouldn’t guide clinical decisions, in particular the decision whether to initiate (drug) therapy or not.

“A further implication of our study is that the patient’s CD4 cell count should be monitored regularly regardless of the prior rate of CD4 decline and that should be done according to current guidelines, i.e. every three to six months.”

The study, published in the latest issue of PLoS Medicine, is available for free at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000239.

(Reporting by Tan Ee Lyn, Editing by Ron Popeski)