Heidi Splete

Hospital mortality rates were 55% lower in 2009 influenza A(H1N1) patients with severe acute respiratory distress syndrome who received extracorporeal membrane oxygenation compared with non-ECMO controls, based on data from a cohort study of 80 patients.

Data from a recent randomized trial showed that patients with acute respiratory distress syndrome (ARDS) who were transferred to an ECMO center were more likely to survive without severe disability compared with non-ECMO patients, but the role of the treatment remains controversial because of the increased costs associated with its use, said Dr. Moronke Noah of Glenfield Hospital in Leicester, England, and colleagues.

In this study, the researchers used data from the Swine Flu Triage study (SwiFT) to compare mortality rates in patients with ARDS resulting from the 2009 H1N1 flu who received ECMO with non-ECMO controls. SwiFT was a prospective study of patients with suspected or confirmed 2009 H1N1 flu who were referred for critical care.

The findings were simultaneously presented at the European Society of Intensive Care Medicine and published online Oct. 5 in JAMA (Epub doi:10.1001/jama.2011.1471).

The researchers reviewed data from 80 patients who were referred for ECMO. They used three different matching techniques: individual matching, propensity scoring, and GenMatch matching. A total of 59 patients were matched with non-ECMO controls using individual matching, 75 were matched with non-ECMO controls using propensity scoring, and 75 were matched with non-ECMO controls using GenMatch matching. GenMatch "combines propensity score matching with multivariate matching," the authors explained.

The hospital mortality rates were significantly lower among ECMO patients than among non-ECMO patients in each of the three matching techniques. Hospital mortality rates were 24% in ECMO patients and 53% in non-ECMO patients when individual matching was used; 24% and 47%, respectively, when propensity scoring was used; and 24% and 51%, respectively, when GenMatch was used.

The findings were limited by the possible role of unobserved confounding variables, and by the lack of data on the exact treatment protocols of non-ECMO patients, the researchers noted.

However, "the unique value of this study lies in the homogeneity of the patients with H1N1-related ARDS and the matching methods used," they said. The consistency of the results across all three matching methods strengthens the role of ECMO in reducing hospital mortality in these patients, they said.

The SwiFT study was supported by the U.K. National Institute for Health Research. Dr. Noah had no financial conflicts to disclose, but many of the study coauthors have received reimbursement or grant support from multiple pharmaceutical companies and institutions.

Hospital mortality rates were 55% lower in 2009 influenza A(H1N1) patients with severe acute respiratory distress syndrome who received extracorporeal membrane oxygenation compared with non-ECMO controls, based on data from a cohort study of 80 patients.

Data from a recent randomized trial showed that patients with acute respiratory distress syndrome (ARDS) who were transferred to an ECMO center were more likely to survive without severe disability compared with non-ECMO patients, but the role of the treatment remains controversial because of the increased costs associated with its use, said Dr. Moronke Noah of Glenfield Hospital in Leicester, England, and colleagues.

In this study, the researchers used data from the Swine Flu Triage study (SwiFT) to compare mortality rates in patients with ARDS resulting from the 2009 H1N1 flu who received ECMO with non-ECMO controls. SwiFT was a prospective study of patients with suspected or confirmed 2009 H1N1 flu who were referred for critical care.

The findings were simultaneously presented at the European Society of Intensive Care Medicine and published online Oct. 5 in JAMA (Epub doi:10.1001/jama.2011.1471).

The researchers reviewed data from 80 patients who were referred for ECMO. They used three different matching techniques: individual matching, propensity scoring, and GenMatch matching. A total of 59 patients were matched with non-ECMO controls using individual matching, 75 were matched with non-ECMO controls using propensity scoring, and 75 were matched with non-ECMO controls using GenMatch matching. GenMatch "combines propensity score matching with multivariate matching," the authors explained.

The hospital mortality rates were significantly lower among ECMO patients than among non-ECMO patients in each of the three matching techniques. Hospital mortality rates were 24% in ECMO patients and 53% in non-ECMO patients when individual matching was used; 24% and 47%, respectively, when propensity scoring was used; and 24% and 51%, respectively, when GenMatch was used.

The findings were limited by the possible role of unobserved confounding variables, and by the lack of data on the exact treatment protocols of non-ECMO patients, the researchers noted.

However, "the unique value of this study lies in the homogeneity of the patients with H1N1-related ARDS and the matching methods used," they said. The consistency of the results across all three matching methods strengthens the role of ECMO in reducing hospital mortality in these patients, they said.

The SwiFT study was supported by the U.K. National Institute for Health Research. Dr. Noah had no financial conflicts to disclose, but many of the study coauthors have received reimbursement or grant support from multiple pharmaceutical companies and institutions.

Hospital mortality rates were 55% lower in 2009 influenza A(H1N1) patients with severe acute respiratory distress syndrome who received extracorporeal membrane oxygenation compared with non-ECMO controls, based on data from a cohort study of 80 patients.

Data from a recent randomized trial showed that patients with acute respiratory distress syndrome (ARDS) who were transferred to an ECMO center were more likely to survive without severe disability compared with non-ECMO patients, but the role of the treatment remains controversial because of the increased costs associated with its use, said Dr. Moronke Noah of Glenfield Hospital in Leicester, England, and colleagues.

In this study, the researchers used data from the Swine Flu Triage study (SwiFT) to compare mortality rates in patients with ARDS resulting from the 2009 H1N1 flu who received ECMO with non-ECMO controls. SwiFT was a prospective study of patients with suspected or confirmed 2009 H1N1 flu who were referred for critical care.

The findings were simultaneously presented at the European Society of Intensive Care Medicine and published online Oct. 5 in JAMA (Epub doi:10.1001/jama.2011.1471).

The researchers reviewed data from 80 patients who were referred for ECMO. They used three different matching techniques: individual matching, propensity scoring, and GenMatch matching. A total of 59 patients were matched with non-ECMO controls using individual matching, 75 were matched with non-ECMO controls using propensity scoring, and 75 were matched with non-ECMO controls using GenMatch matching. GenMatch "combines propensity score matching with multivariate matching," the authors explained.

The hospital mortality rates were significantly lower among ECMO patients than among non-ECMO patients in each of the three matching techniques. Hospital mortality rates were 24% in ECMO patients and 53% in non-ECMO patients when individual matching was used; 24% and 47%, respectively, when propensity scoring was used; and 24% and 51%, respectively, when GenMatch was used.

The findings were limited by the possible role of unobserved confounding variables, and by the lack of data on the exact treatment protocols of non-ECMO patients, the researchers noted.

However, "the unique value of this study lies in the homogeneity of the patients with H1N1-related ARDS and the matching methods used," they said. The consistency of the results across all three matching methods strengthens the role of ECMO in reducing hospital mortality in these patients, they said.

The SwiFT study was supported by the U.K. National Institute for Health Research. Dr. Noah had no financial conflicts to disclose, but many of the study coauthors have received reimbursement or grant support from multiple pharmaceutical companies and institutions.

Overall, the American health care system improved its palliative care grade from a "C" to a "B," according to the study America’s Care of Serious Illness: a State-by-State Report Card on Access to Palliative Care in Our Nation’s Hospitals.

However, location impacts access to palliative care. The District of Columbia and seven other states – Maryland, Minnesota, Nebraska, Oregon, Rhode Island, Vermont, and Washington – earned "A" grades, while Delaware and Mississippi received "F" grades. Hospitals with palliative care programs are currently less common in the South as well as in hospitals with fewer than 50 beds.

The findings were based on data collected by the Center to Advance Palliative Care (CAPC) and the National Palliative Care Research Center (NPCRC).

The data showed that 85% of hospitals with 300 or more beds had palliative care teams, compared with 54% of public hospitals, 37% of sole community provider hospitals, and 26% of for-profit hospitals. Hospitals with 50 or more beds are more likely to be not-for-profit, and thus are more likely to offer palliative care.

The number of states earning an "A" grade improved from only three states in 2008 to seven states plus the District of Columbia in 2011. But the lack of palliative medicine physicians remains a major barrier to the continued improvement of palliative care in the U.S., where there is currently one palliative care physician for every 1,200 individuals living with a serious or life-threatening condition, the researchers noted.

"Focused efforts by hospital administration, the health care community, and policymakers are required to promote the development of quality palliative care programs in all hospitals, with special attention needed in small, rural, public, and for-profit hospitals," the CAPC said in a press release accompanying the report.

Overall, the American health care system improved its palliative care grade from a "C" to a "B," according to the study America’s Care of Serious Illness: a State-by-State Report Card on Access to Palliative Care in Our Nation’s Hospitals.

However, location impacts access to palliative care. The District of Columbia and seven other states – Maryland, Minnesota, Nebraska, Oregon, Rhode Island, Vermont, and Washington – earned "A" grades, while Delaware and Mississippi received "F" grades. Hospitals with palliative care programs are currently less common in the South as well as in hospitals with fewer than 50 beds.

The findings were based on data collected by the Center to Advance Palliative Care (CAPC) and the National Palliative Care Research Center (NPCRC).

The data showed that 85% of hospitals with 300 or more beds had palliative care teams, compared with 54% of public hospitals, 37% of sole community provider hospitals, and 26% of for-profit hospitals. Hospitals with 50 or more beds are more likely to be not-for-profit, and thus are more likely to offer palliative care.

The number of states earning an "A" grade improved from only three states in 2008 to seven states plus the District of Columbia in 2011. But the lack of palliative medicine physicians remains a major barrier to the continued improvement of palliative care in the U.S., where there is currently one palliative care physician for every 1,200 individuals living with a serious or life-threatening condition, the researchers noted.

"Focused efforts by hospital administration, the health care community, and policymakers are required to promote the development of quality palliative care programs in all hospitals, with special attention needed in small, rural, public, and for-profit hospitals," the CAPC said in a press release accompanying the report.

Overall, the American health care system improved its palliative care grade from a "C" to a "B," according to the study America’s Care of Serious Illness: a State-by-State Report Card on Access to Palliative Care in Our Nation’s Hospitals.

However, location impacts access to palliative care. The District of Columbia and seven other states – Maryland, Minnesota, Nebraska, Oregon, Rhode Island, Vermont, and Washington – earned "A" grades, while Delaware and Mississippi received "F" grades. Hospitals with palliative care programs are currently less common in the South as well as in hospitals with fewer than 50 beds.

The findings were based on data collected by the Center to Advance Palliative Care (CAPC) and the National Palliative Care Research Center (NPCRC).

The data showed that 85% of hospitals with 300 or more beds had palliative care teams, compared with 54% of public hospitals, 37% of sole community provider hospitals, and 26% of for-profit hospitals. Hospitals with 50 or more beds are more likely to be not-for-profit, and thus are more likely to offer palliative care.

The number of states earning an "A" grade improved from only three states in 2008 to seven states plus the District of Columbia in 2011. But the lack of palliative medicine physicians remains a major barrier to the continued improvement of palliative care in the U.S., where there is currently one palliative care physician for every 1,200 individuals living with a serious or life-threatening condition, the researchers noted.

"Focused efforts by hospital administration, the health care community, and policymakers are required to promote the development of quality palliative care programs in all hospitals, with special attention needed in small, rural, public, and for-profit hospitals," the CAPC said in a press release accompanying the report.

PARIS – Patients recovering from opioid dependence who received monthly injections of 380 mg of extended-release naltrexone reported significant improvements in weeks of abstinence, cravings, and opioid-free days, compared with a placebo group. The findings were published in the Lancet (2011; 377:1506-13) and subsequently presented at the annual meeting of the European Congress of Neuropsychopharmacology.

Naltrexone, an opioid receptor antagonist, has been used to support recovery in opioid-addicted patients, but adherence to the oral medication tends to be poor, which limits effectiveness, said Dr. Evgeny M. Krupitsky of St. Petersburg State Pavlov Medical University, Russia, and his colleagues.

A once-monthly, extended-release naltrexone (XR-NTX) injection has been approved in Russia and in the United States to treat alcohol dependence. Dr. Krupitsky and his colleagues conducted a randomized, placebo-controlled trial to test the safety and effectiveness of the injectable drug in patients with opioid dependence.

The study population included 250 patients aged 18 years and older who were within 30 days or less of completing an inpatient opioid detoxification program. The majority of the patients were young, white men who had been suffering from heroin addiction for about 10 years. Patients were excluded if they were on parole or probation, were pregnant or breastfeeding, or had significant medical conditions such as renal failure, hepatic failure, or histories of AIDS-indicator disease.

Patients were randomized to 380 mg XR-NTX or placebo starting within 1 week after completing detoxification and continuing with one injection every 4 weeks, for a total of six injections over a 24-week period. Patients also were offered counseling sessions.

"XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion."

After 24 weeks, the median proportion of weeks of confirmed abstinence (the primary end point, based on urine tests) was significantly higher in the treatment group, compared with the placebo group (90% vs. 35%). This translated to 45 patients with confirmed abstinence in the treatment group, compared with 28 patients in the placebo group.

The median retention rate was more than 168 days in the treatment group, compared with 96 days in the placebo group. Relapses were confirmed in 17 placebo patients and 1 XR-NTX patient using a naloxone challenge.

In addition, the mean change in cravings, compared with baseline, was significantly greater in the XR-NTX group, compared with the placebo group (–10.1 vs. 0.7) and significantly more patients in the XR-NTX group reported opioid-free days, compared with the placebo group (99% vs. 60%).

Overall, 63 of the XR-NTX patients (50%) and 40 of the placebo patients (32%) experienced at least one adverse event, the most common of which were nasopharyngitis and insomnia.

Two patients in each group discontinued the study because of adverse events, but none of the XR-NTX patients died, overdosed, or discontinued treatment because of severe adverse events. Three patients in the XR-NTX group reported four serious adverse events, including infectious processes such as AIDS or HIV. Four patients in the placebo group reported five serious adverse events, including infections, psychotic disorder, and a peptic ulcer.

The study was limited by a lack of comparison with oral naltrexone, but other studies comparing oral naltrexone with placebo have failed to show an effect on craving reduction or relapse prevention, the researchers noted.

"The extent of patient interest in XR-NTX when opioid substitution treatments are available remains a topic for future health services research," the investigators said. However, "XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion," and the injectable treatment approach might improve acceptance of pharmacotherapy for opioid addiction, they said.

The study was funded by Alkermes. Dr. Krupitsky had no financial conflicts to disclose.

PARIS – Patients recovering from opioid dependence who received monthly injections of 380 mg of extended-release naltrexone reported significant improvements in weeks of abstinence, cravings, and opioid-free days, compared with a placebo group. The findings were published in the Lancet (2011; 377:1506-13) and subsequently presented at the annual meeting of the European Congress of Neuropsychopharmacology.

Naltrexone, an opioid receptor antagonist, has been used to support recovery in opioid-addicted patients, but adherence to the oral medication tends to be poor, which limits effectiveness, said Dr. Evgeny M. Krupitsky of St. Petersburg State Pavlov Medical University, Russia, and his colleagues.

A once-monthly, extended-release naltrexone (XR-NTX) injection has been approved in Russia and in the United States to treat alcohol dependence. Dr. Krupitsky and his colleagues conducted a randomized, placebo-controlled trial to test the safety and effectiveness of the injectable drug in patients with opioid dependence.

The study population included 250 patients aged 18 years and older who were within 30 days or less of completing an inpatient opioid detoxification program. The majority of the patients were young, white men who had been suffering from heroin addiction for about 10 years. Patients were excluded if they were on parole or probation, were pregnant or breastfeeding, or had significant medical conditions such as renal failure, hepatic failure, or histories of AIDS-indicator disease.

Patients were randomized to 380 mg XR-NTX or placebo starting within 1 week after completing detoxification and continuing with one injection every 4 weeks, for a total of six injections over a 24-week period. Patients also were offered counseling sessions.

"XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion."

After 24 weeks, the median proportion of weeks of confirmed abstinence (the primary end point, based on urine tests) was significantly higher in the treatment group, compared with the placebo group (90% vs. 35%). This translated to 45 patients with confirmed abstinence in the treatment group, compared with 28 patients in the placebo group.

The median retention rate was more than 168 days in the treatment group, compared with 96 days in the placebo group. Relapses were confirmed in 17 placebo patients and 1 XR-NTX patient using a naloxone challenge.

In addition, the mean change in cravings, compared with baseline, was significantly greater in the XR-NTX group, compared with the placebo group (–10.1 vs. 0.7) and significantly more patients in the XR-NTX group reported opioid-free days, compared with the placebo group (99% vs. 60%).

Overall, 63 of the XR-NTX patients (50%) and 40 of the placebo patients (32%) experienced at least one adverse event, the most common of which were nasopharyngitis and insomnia.

Two patients in each group discontinued the study because of adverse events, but none of the XR-NTX patients died, overdosed, or discontinued treatment because of severe adverse events. Three patients in the XR-NTX group reported four serious adverse events, including infectious processes such as AIDS or HIV. Four patients in the placebo group reported five serious adverse events, including infections, psychotic disorder, and a peptic ulcer.

The study was limited by a lack of comparison with oral naltrexone, but other studies comparing oral naltrexone with placebo have failed to show an effect on craving reduction or relapse prevention, the researchers noted.

"The extent of patient interest in XR-NTX when opioid substitution treatments are available remains a topic for future health services research," the investigators said. However, "XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion," and the injectable treatment approach might improve acceptance of pharmacotherapy for opioid addiction, they said.

The study was funded by Alkermes. Dr. Krupitsky had no financial conflicts to disclose.

PARIS – Patients recovering from opioid dependence who received monthly injections of 380 mg of extended-release naltrexone reported significant improvements in weeks of abstinence, cravings, and opioid-free days, compared with a placebo group. The findings were published in the Lancet (2011; 377:1506-13) and subsequently presented at the annual meeting of the European Congress of Neuropsychopharmacology.

Naltrexone, an opioid receptor antagonist, has been used to support recovery in opioid-addicted patients, but adherence to the oral medication tends to be poor, which limits effectiveness, said Dr. Evgeny M. Krupitsky of St. Petersburg State Pavlov Medical University, Russia, and his colleagues.

A once-monthly, extended-release naltrexone (XR-NTX) injection has been approved in Russia and in the United States to treat alcohol dependence. Dr. Krupitsky and his colleagues conducted a randomized, placebo-controlled trial to test the safety and effectiveness of the injectable drug in patients with opioid dependence.

The study population included 250 patients aged 18 years and older who were within 30 days or less of completing an inpatient opioid detoxification program. The majority of the patients were young, white men who had been suffering from heroin addiction for about 10 years. Patients were excluded if they were on parole or probation, were pregnant or breastfeeding, or had significant medical conditions such as renal failure, hepatic failure, or histories of AIDS-indicator disease.

Patients were randomized to 380 mg XR-NTX or placebo starting within 1 week after completing detoxification and continuing with one injection every 4 weeks, for a total of six injections over a 24-week period. Patients also were offered counseling sessions.

"XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion."

After 24 weeks, the median proportion of weeks of confirmed abstinence (the primary end point, based on urine tests) was significantly higher in the treatment group, compared with the placebo group (90% vs. 35%). This translated to 45 patients with confirmed abstinence in the treatment group, compared with 28 patients in the placebo group.

The median retention rate was more than 168 days in the treatment group, compared with 96 days in the placebo group. Relapses were confirmed in 17 placebo patients and 1 XR-NTX patient using a naloxone challenge.

In addition, the mean change in cravings, compared with baseline, was significantly greater in the XR-NTX group, compared with the placebo group (–10.1 vs. 0.7) and significantly more patients in the XR-NTX group reported opioid-free days, compared with the placebo group (99% vs. 60%).

Overall, 63 of the XR-NTX patients (50%) and 40 of the placebo patients (32%) experienced at least one adverse event, the most common of which were nasopharyngitis and insomnia.

Two patients in each group discontinued the study because of adverse events, but none of the XR-NTX patients died, overdosed, or discontinued treatment because of severe adverse events. Three patients in the XR-NTX group reported four serious adverse events, including infectious processes such as AIDS or HIV. Four patients in the placebo group reported five serious adverse events, including infections, psychotic disorder, and a peptic ulcer.

The study was limited by a lack of comparison with oral naltrexone, but other studies comparing oral naltrexone with placebo have failed to show an effect on craving reduction or relapse prevention, the researchers noted.

"The extent of patient interest in XR-NTX when opioid substitution treatments are available remains a topic for future health services research," the investigators said. However, "XR-NTX offers a new treatment option without the risk of physical dependence or illegal diversion," and the injectable treatment approach might improve acceptance of pharmacotherapy for opioid addiction, they said.

The study was funded by Alkermes. Dr. Krupitsky had no financial conflicts to disclose.

Dr. Danesh Modi, and his wife, Dr. Valerie Bonica, participated in a month-long global health rotation that sent them to the Andes Mountains of Ecuador in January 2011. Dr. Modi primarily worked at two hospitals in the city of Riobamba, while Dr. Bonica saw patients in their homes or in several small clinics located in villages throughout a rural region known as Cacha.

"We had wanted to do this for a while," before graduating residency and entering the world of medical practice in the United States, Dr. Modi said in an interview. Both graduates of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine, Stratford, they were able to complete their last months of residency during their time in Ecuador, where they put their Spanish fluency to the test. Here, Dr. Modi shares their experiences.

Photos courtesy Dr. Danesh Modi

Describe the medical settings in Ecuador.

Riobamba is a small city, built in Spanish colonial times, while Cacha is an indigenous community, where the people work generally in subsistence agriculture and rarely visit the town. Very few have cars, and they live in mud or adobe houses in very small communities.

There are a handful of hospitals in Riobamba. We worked at two of them. One was a social security hospital (El Instituto Ecuatoriano de Seguridad Social) and the other was a free hospital, where anyone could walk in and receive free medical care.

The social security hospital is fully privatized, and one cannot receive care there unless you have a social security card. Individuals who have these cards pay for them on a monthly basis. There are no set benefits, but they pay about a third of their salary every month, which gives them the right to be seen at this hospital.

Were there substantial differences between the hospitals?

There was a big dichotomy, as you might expect. The social security hospital has both inpatient and outpatient care. The people who are able to obtain social security cards, in general, are those who are more affluent.

In the free hospital – called the Hospital General Docente – there were six beds to a room, with no curtains, so there was really no privacy for these patients.

How was medicine practiced differently in Ecuador?

Overall, there was a much greater reliance on the clinical exam. The Ecuadorian physicians, from what we saw, performed a more-thorough physical exam than we do in the U.S. For example, in the U.S., an echocardiogram is a relatively common diagnostic study, but in Riobamba, a cardiac ultrasound is not available, even in the social security hospital. In fact, if deemed necessary, patients must be referred to one of the big cities to have an echocardiogram and it’s also very expensive.

Even a plain radiograph required explicit indications and was not often performed. We had to decide whether we really needed a chest x-ray and if it would really change our management. When radiographs were performed, we had to hold the films up to the window to read them, which made it difficult to compare them to prior studies.

What types of conditions did the patients have?

Many of the conditions among the people in the rural villages of Cacha stemmed from poverty and were related to poor sanitation, the lack of clean drinking water, poor diet, and poor personal hygiene. The people live at a high altitude in a relatively cold climate, yet we were surprised to see that many did not wear shoes. We were told that this was part of their culture and not necessarily because people could not afford to buy shoes. The indigenous peoples’ culture and values date back thousands of years, and their beliefs are often incongruous with the beliefs and knowledge of Western medicine.

These communities were fairly isolated, and the people for the most part were self-sufficient, farming their own crops and tending their own livestock. They rarely went down to the town and often by the time they presented to the hospital or to one of the public health clinics, they were quite sick.

We saw many parasitic infections from the lack of clean drinking water, as well as other infectious diseases that you rarely see in the U.S.

The cases we saw included amebiasis, thyroid disease (a common problem because noniodized salt is cheaper), alcoholic cirrhosis, blindness from uncontrolled hypertension and diabetes, GI bleeds, tuberculosis, interstitial lung disease (in miners and agricultural workers), rheumatic heart disease, and influenza.

Vaccinations were available but were infrequently administered. The infection rates would have likely decreased dramatically with improved use of these vaccines as well as continued education regarding personal hygiene. We saw many cases of both influenza and pneumococcal disease.

Because we were working at about 10,500 feet about sea level, many of our patients had secondary polycythemia. At altitudes that high, your body naturally makes more red blood cells, and we frequently saw hemoglobin levels as high as 18 or 19 in hospitalized, acutely ill patients.

Diabetes (mostly type 2 diabetes) is a big problem in Ecuador as well. It is also one of the leading causes of preventable blindness globally. Unfortunately, for both cultural and financial reasons, the diet of many of the people consists almost entirely of carbohydrates. There is fruit available in the market, but few people from the villages buy it because it is too expensive. Bread, noodles, and potatoes are very cheap and taste good, so often that is all they eat, and this predisposes them to diabetes. Interestingly, because of the altitude and resultant polycythemia, the physicians in Riobamba cannot use the hemoglobin A_1c test to screen for diabetes; they use fasting blood sugar instead.

Also, alcohol abuse is a significant problem. There were frequent cultural and religious celebrations in these communities, and we often saw people passed out in the street. Alcoholic liver disease may continue to be a problem even if people are able to quit drinking. We saw many people who were end-stage cirrhotic and needed a liver transplant. But the only hospital in the country that performs liver transplants is several hours away by bus. Patients who need a transplant generally move closer to the hospital and wait until a liver becomes available.

What were the challenges to providing health care in this setting?

A major problem is that the pharmacies are not necessarily run by pharmacists. We were told that anyone can open a pharmacy as long as they have a credentialed pharmacist cosign their papers. After that, the pharmacist need not even set foot in the building, and the pharmacy could be run by just about anybody. These pharmacies dispensed medications at will. On several occasions, we saw pharmacy employees using flashlights to examine customers’ throats and then administering antibiotics or vitamin C tablets depending on what they saw. We walked into a pharmacy in the middle of Riobamba, without a prescription, asked for amoxicillin for a sore throat, and received it easily. As you may imagine, this is a huge public health dilemma.

Patients also do not receive directions about safe dosing. When a patient requests a medication for pain, they routinely are "prescribed" NSAIDs. Basically, they walk out of the pharmacy with a giant bottle of naproxen. Since the patients are seeking pain relief and have not been educated about the risks of NSAIDs, they keep popping the pills like candy. In one month, we saw four cases of NSAID-induced end-stage renal disease that required dialysis. One of the patients was 34-years-old.

The Ecuadorian physicians recognize that this is a big problem, and they have been trying to combat it for decades. These pharmacies are arguably the largest and most dangerous health problem that this population currently faces.

What were the most rewarding aspects of your experience?

It was most rewarding to work with the indigenous community. They were very appreciative of everything we did for them and, despite centuries of relying on traditional or herbal medicines, they were still receptive to foreign doctors, and they allowed us to play a small role in their care.

Also, it was a wonderful experience to work with the public health teams caring for people in their homes and in the Cacha-based clinics. These health care providers crossed an enormous cultural divide themselves as they sought out people in the indigenous communities, many of whom were suspicious of them and occasionally unreceptive to the services being offered. But the Ecuadorian team was always trying to build trust and to let people in the villages know that access to health care existed. We were very inspired by the people who worked tirelessly to meet the health care needs in these communities, day in and day out.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column online or e-mail us.

Dr. Danesh Modi, and his wife, Dr. Valerie Bonica, participated in a month-long global health rotation that sent them to the Andes Mountains of Ecuador in January 2011. Dr. Modi primarily worked at two hospitals in the city of Riobamba, while Dr. Bonica saw patients in their homes or in several small clinics located in villages throughout a rural region known as Cacha.

"We had wanted to do this for a while," before graduating residency and entering the world of medical practice in the United States, Dr. Modi said in an interview. Both graduates of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine, Stratford, they were able to complete their last months of residency during their time in Ecuador, where they put their Spanish fluency to the test. Here, Dr. Modi shares their experiences.

Photos courtesy Dr. Danesh Modi

Describe the medical settings in Ecuador.

Riobamba is a small city, built in Spanish colonial times, while Cacha is an indigenous community, where the people work generally in subsistence agriculture and rarely visit the town. Very few have cars, and they live in mud or adobe houses in very small communities.

There are a handful of hospitals in Riobamba. We worked at two of them. One was a social security hospital (El Instituto Ecuatoriano de Seguridad Social) and the other was a free hospital, where anyone could walk in and receive free medical care.

The social security hospital is fully privatized, and one cannot receive care there unless you have a social security card. Individuals who have these cards pay for them on a monthly basis. There are no set benefits, but they pay about a third of their salary every month, which gives them the right to be seen at this hospital.

Were there substantial differences between the hospitals?

There was a big dichotomy, as you might expect. The social security hospital has both inpatient and outpatient care. The people who are able to obtain social security cards, in general, are those who are more affluent.

In the free hospital – called the Hospital General Docente – there were six beds to a room, with no curtains, so there was really no privacy for these patients.

How was medicine practiced differently in Ecuador?

Overall, there was a much greater reliance on the clinical exam. The Ecuadorian physicians, from what we saw, performed a more-thorough physical exam than we do in the U.S. For example, in the U.S., an echocardiogram is a relatively common diagnostic study, but in Riobamba, a cardiac ultrasound is not available, even in the social security hospital. In fact, if deemed necessary, patients must be referred to one of the big cities to have an echocardiogram and it’s also very expensive.

Even a plain radiograph required explicit indications and was not often performed. We had to decide whether we really needed a chest x-ray and if it would really change our management. When radiographs were performed, we had to hold the films up to the window to read them, which made it difficult to compare them to prior studies.

What types of conditions did the patients have?

Many of the conditions among the people in the rural villages of Cacha stemmed from poverty and were related to poor sanitation, the lack of clean drinking water, poor diet, and poor personal hygiene. The people live at a high altitude in a relatively cold climate, yet we were surprised to see that many did not wear shoes. We were told that this was part of their culture and not necessarily because people could not afford to buy shoes. The indigenous peoples’ culture and values date back thousands of years, and their beliefs are often incongruous with the beliefs and knowledge of Western medicine.

These communities were fairly isolated, and the people for the most part were self-sufficient, farming their own crops and tending their own livestock. They rarely went down to the town and often by the time they presented to the hospital or to one of the public health clinics, they were quite sick.

We saw many parasitic infections from the lack of clean drinking water, as well as other infectious diseases that you rarely see in the U.S.

The cases we saw included amebiasis, thyroid disease (a common problem because noniodized salt is cheaper), alcoholic cirrhosis, blindness from uncontrolled hypertension and diabetes, GI bleeds, tuberculosis, interstitial lung disease (in miners and agricultural workers), rheumatic heart disease, and influenza.

Vaccinations were available but were infrequently administered. The infection rates would have likely decreased dramatically with improved use of these vaccines as well as continued education regarding personal hygiene. We saw many cases of both influenza and pneumococcal disease.

Because we were working at about 10,500 feet about sea level, many of our patients had secondary polycythemia. At altitudes that high, your body naturally makes more red blood cells, and we frequently saw hemoglobin levels as high as 18 or 19 in hospitalized, acutely ill patients.

Diabetes (mostly type 2 diabetes) is a big problem in Ecuador as well. It is also one of the leading causes of preventable blindness globally. Unfortunately, for both cultural and financial reasons, the diet of many of the people consists almost entirely of carbohydrates. There is fruit available in the market, but few people from the villages buy it because it is too expensive. Bread, noodles, and potatoes are very cheap and taste good, so often that is all they eat, and this predisposes them to diabetes. Interestingly, because of the altitude and resultant polycythemia, the physicians in Riobamba cannot use the hemoglobin A_1c test to screen for diabetes; they use fasting blood sugar instead.

Also, alcohol abuse is a significant problem. There were frequent cultural and religious celebrations in these communities, and we often saw people passed out in the street. Alcoholic liver disease may continue to be a problem even if people are able to quit drinking. We saw many people who were end-stage cirrhotic and needed a liver transplant. But the only hospital in the country that performs liver transplants is several hours away by bus. Patients who need a transplant generally move closer to the hospital and wait until a liver becomes available.

What were the challenges to providing health care in this setting?

A major problem is that the pharmacies are not necessarily run by pharmacists. We were told that anyone can open a pharmacy as long as they have a credentialed pharmacist cosign their papers. After that, the pharmacist need not even set foot in the building, and the pharmacy could be run by just about anybody. These pharmacies dispensed medications at will. On several occasions, we saw pharmacy employees using flashlights to examine customers’ throats and then administering antibiotics or vitamin C tablets depending on what they saw. We walked into a pharmacy in the middle of Riobamba, without a prescription, asked for amoxicillin for a sore throat, and received it easily. As you may imagine, this is a huge public health dilemma.

Patients also do not receive directions about safe dosing. When a patient requests a medication for pain, they routinely are "prescribed" NSAIDs. Basically, they walk out of the pharmacy with a giant bottle of naproxen. Since the patients are seeking pain relief and have not been educated about the risks of NSAIDs, they keep popping the pills like candy. In one month, we saw four cases of NSAID-induced end-stage renal disease that required dialysis. One of the patients was 34-years-old.

The Ecuadorian physicians recognize that this is a big problem, and they have been trying to combat it for decades. These pharmacies are arguably the largest and most dangerous health problem that this population currently faces.

What were the most rewarding aspects of your experience?

It was most rewarding to work with the indigenous community. They were very appreciative of everything we did for them and, despite centuries of relying on traditional or herbal medicines, they were still receptive to foreign doctors, and they allowed us to play a small role in their care.

Also, it was a wonderful experience to work with the public health teams caring for people in their homes and in the Cacha-based clinics. These health care providers crossed an enormous cultural divide themselves as they sought out people in the indigenous communities, many of whom were suspicious of them and occasionally unreceptive to the services being offered. But the Ecuadorian team was always trying to build trust and to let people in the villages know that access to health care existed. We were very inspired by the people who worked tirelessly to meet the health care needs in these communities, day in and day out.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column online or e-mail us.

Dr. Danesh Modi, and his wife, Dr. Valerie Bonica, participated in a month-long global health rotation that sent them to the Andes Mountains of Ecuador in January 2011. Dr. Modi primarily worked at two hospitals in the city of Riobamba, while Dr. Bonica saw patients in their homes or in several small clinics located in villages throughout a rural region known as Cacha.

"We had wanted to do this for a while," before graduating residency and entering the world of medical practice in the United States, Dr. Modi said in an interview. Both graduates of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine, Stratford, they were able to complete their last months of residency during their time in Ecuador, where they put their Spanish fluency to the test. Here, Dr. Modi shares their experiences.

Photos courtesy Dr. Danesh Modi

Describe the medical settings in Ecuador.

Riobamba is a small city, built in Spanish colonial times, while Cacha is an indigenous community, where the people work generally in subsistence agriculture and rarely visit the town. Very few have cars, and they live in mud or adobe houses in very small communities.

There are a handful of hospitals in Riobamba. We worked at two of them. One was a social security hospital (El Instituto Ecuatoriano de Seguridad Social) and the other was a free hospital, where anyone could walk in and receive free medical care.

The social security hospital is fully privatized, and one cannot receive care there unless you have a social security card. Individuals who have these cards pay for them on a monthly basis. There are no set benefits, but they pay about a third of their salary every month, which gives them the right to be seen at this hospital.

Were there substantial differences between the hospitals?

There was a big dichotomy, as you might expect. The social security hospital has both inpatient and outpatient care. The people who are able to obtain social security cards, in general, are those who are more affluent.

In the free hospital – called the Hospital General Docente – there were six beds to a room, with no curtains, so there was really no privacy for these patients.

How was medicine practiced differently in Ecuador?

Overall, there was a much greater reliance on the clinical exam. The Ecuadorian physicians, from what we saw, performed a more-thorough physical exam than we do in the U.S. For example, in the U.S., an echocardiogram is a relatively common diagnostic study, but in Riobamba, a cardiac ultrasound is not available, even in the social security hospital. In fact, if deemed necessary, patients must be referred to one of the big cities to have an echocardiogram and it’s also very expensive.

Even a plain radiograph required explicit indications and was not often performed. We had to decide whether we really needed a chest x-ray and if it would really change our management. When radiographs were performed, we had to hold the films up to the window to read them, which made it difficult to compare them to prior studies.

What types of conditions did the patients have?

Many of the conditions among the people in the rural villages of Cacha stemmed from poverty and were related to poor sanitation, the lack of clean drinking water, poor diet, and poor personal hygiene. The people live at a high altitude in a relatively cold climate, yet we were surprised to see that many did not wear shoes. We were told that this was part of their culture and not necessarily because people could not afford to buy shoes. The indigenous peoples’ culture and values date back thousands of years, and their beliefs are often incongruous with the beliefs and knowledge of Western medicine.

These communities were fairly isolated, and the people for the most part were self-sufficient, farming their own crops and tending their own livestock. They rarely went down to the town and often by the time they presented to the hospital or to one of the public health clinics, they were quite sick.

We saw many parasitic infections from the lack of clean drinking water, as well as other infectious diseases that you rarely see in the U.S.

The cases we saw included amebiasis, thyroid disease (a common problem because noniodized salt is cheaper), alcoholic cirrhosis, blindness from uncontrolled hypertension and diabetes, GI bleeds, tuberculosis, interstitial lung disease (in miners and agricultural workers), rheumatic heart disease, and influenza.

Vaccinations were available but were infrequently administered. The infection rates would have likely decreased dramatically with improved use of these vaccines as well as continued education regarding personal hygiene. We saw many cases of both influenza and pneumococcal disease.

Because we were working at about 10,500 feet about sea level, many of our patients had secondary polycythemia. At altitudes that high, your body naturally makes more red blood cells, and we frequently saw hemoglobin levels as high as 18 or 19 in hospitalized, acutely ill patients.

Diabetes (mostly type 2 diabetes) is a big problem in Ecuador as well. It is also one of the leading causes of preventable blindness globally. Unfortunately, for both cultural and financial reasons, the diet of many of the people consists almost entirely of carbohydrates. There is fruit available in the market, but few people from the villages buy it because it is too expensive. Bread, noodles, and potatoes are very cheap and taste good, so often that is all they eat, and this predisposes them to diabetes. Interestingly, because of the altitude and resultant polycythemia, the physicians in Riobamba cannot use the hemoglobin A_1c test to screen for diabetes; they use fasting blood sugar instead.

Also, alcohol abuse is a significant problem. There were frequent cultural and religious celebrations in these communities, and we often saw people passed out in the street. Alcoholic liver disease may continue to be a problem even if people are able to quit drinking. We saw many people who were end-stage cirrhotic and needed a liver transplant. But the only hospital in the country that performs liver transplants is several hours away by bus. Patients who need a transplant generally move closer to the hospital and wait until a liver becomes available.

What were the challenges to providing health care in this setting?

A major problem is that the pharmacies are not necessarily run by pharmacists. We were told that anyone can open a pharmacy as long as they have a credentialed pharmacist cosign their papers. After that, the pharmacist need not even set foot in the building, and the pharmacy could be run by just about anybody. These pharmacies dispensed medications at will. On several occasions, we saw pharmacy employees using flashlights to examine customers’ throats and then administering antibiotics or vitamin C tablets depending on what they saw. We walked into a pharmacy in the middle of Riobamba, without a prescription, asked for amoxicillin for a sore throat, and received it easily. As you may imagine, this is a huge public health dilemma.

Patients also do not receive directions about safe dosing. When a patient requests a medication for pain, they routinely are "prescribed" NSAIDs. Basically, they walk out of the pharmacy with a giant bottle of naproxen. Since the patients are seeking pain relief and have not been educated about the risks of NSAIDs, they keep popping the pills like candy. In one month, we saw four cases of NSAID-induced end-stage renal disease that required dialysis. One of the patients was 34-years-old.

The Ecuadorian physicians recognize that this is a big problem, and they have been trying to combat it for decades. These pharmacies are arguably the largest and most dangerous health problem that this population currently faces.

What were the most rewarding aspects of your experience?

It was most rewarding to work with the indigenous community. They were very appreciative of everything we did for them and, despite centuries of relying on traditional or herbal medicines, they were still receptive to foreign doctors, and they allowed us to play a small role in their care.

Also, it was a wonderful experience to work with the public health teams caring for people in their homes and in the Cacha-based clinics. These health care providers crossed an enormous cultural divide themselves as they sought out people in the indigenous communities, many of whom were suspicious of them and occasionally unreceptive to the services being offered. But the Ecuadorian team was always trying to build trust and to let people in the villages know that access to health care existed. We were very inspired by the people who worked tirelessly to meet the health care needs in these communities, day in and day out.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column online or e-mail us.

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

"Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue," said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville. The findings were presented at the annual meeting of the North American Menopause Society.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms, Dr. Pinkerton said. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo.

The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was –0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, –0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, –0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and –0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate.

In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year, Dr. Pinkerton noted.

Four abnormal mammograms were seen in the 20 mg BZA/0.45 mg conjugated estrogens group, two in the 20 mg BZA/0.625 conjugated estrogens group, one in the 20 mg BZA alone group, three in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20 mg BZA/0.45 mg conjugated estrogens group, compared to one case in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups.

Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

"The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy," for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

"Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue," said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville. The findings were presented at the annual meeting of the North American Menopause Society.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms, Dr. Pinkerton said. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo.

The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was –0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, –0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, –0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and –0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate.

In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year, Dr. Pinkerton noted.

Four abnormal mammograms were seen in the 20 mg BZA/0.45 mg conjugated estrogens group, two in the 20 mg BZA/0.625 conjugated estrogens group, one in the 20 mg BZA alone group, three in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20 mg BZA/0.45 mg conjugated estrogens group, compared to one case in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups.

Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

"The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy," for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

NATIONAL HARBOR, MD. – Use of a combination of bazedoxifene and conjugated estrogens had no significant impact on breast density (a potential risk factor for breast cancer) in postmenopausal women, based on data from the SMART-5 trial.

"Preclinical studies have suggested that the selective estrogen receptor modulator (SERM) bazedoxifene (BZA) prevents estrogen-induced stimulation of breast tissue," said Dr. JoAnn V. Pinkerton of the University of Virginia, Charlottesville. The findings were presented at the annual meeting of the North American Menopause Society.

The Selective Estrogens, Menopause, and Response to Therapy (SMART)-5 study was a 1-year, randomized, double-blind, placebo-controlled, phase III study of healthy postmenopausal women with a uterus who sought treatment for vasomotor symptoms, Dr. Pinkerton said. A subset of 940 women from this study took part in a breast density substudy to assess changes in breast density after a year of treatment with BZA/conjugated estrogens, compared to other treatment or a placebo.

The women underwent mammograms at baseline and again after 1 year of treatment. Changes in breast density were assessed using an analysis of covariance (ANCOVA) model.

After 1 year, the mean adjusted change in breast density from baseline was –0.38% in the women who were received 20 mg BZA/0.45 mg conjugated estrogens, –0.44 in the women who received 20 mg BZA/0.625 conjugated estrogens, –0.24% in the women who received 20 mg BZA alone, 1.60% in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate, and –0.32% in the women who received a placebo.

The only significant difference in breast density either within group or versus placebo occurred in the women who received 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate.

In addition, BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg showed noninferiority to placebo for breast density at 1 year, Dr. Pinkerton noted.

Four abnormal mammograms were seen in the 20 mg BZA/0.45 mg conjugated estrogens group, two in the 20 mg BZA/0.625 conjugated estrogens group, one in the 20 mg BZA alone group, three in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, and one in the placebo group.

Two cases of breast cancer were reported in the 20 mg BZA/0.45 mg conjugated estrogens group, compared to one case in the 0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate group, one case in the placebo group, and none in the other groups.

The mean age of the women was 54 years, and they were menopausal from 4 to 5 years. Approximately 90% were white. The demographics were similar among all five groups.

Overall, there was no significant difference in the incidence of breast-related adverse events among the groups.

The findings are consistent with those from a previous retrospective study of the SMART-5 data, said Dr. Pinkerton.

"The favorable breast effects seen with BZA 20 mg/CE 0.45 mg and 0.625 mg in this prospective evaluation are a potential advantage of BZA/CE over conventional estrogen/progestin therapy," for postmenopausal women with a uterus, she said.

The study was sponsored by Wyeth Research, now a division of Pfizer, and several of the study coinvestigators are Pfizer employees. Dr. Pinkerton has received fees given to the University of Virginia. She has served as a consultant to Pfizer, Teva, Depomed, and Novo Nordisk, received grants or research support from Pfizer, Depomed, and EndoCeutics, and served on the data safety monitoring board for Boehringer Ingelheim.

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference on Sept. 21.

The annual flu vaccine is never perfect, but "we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot," Dr. Frieden said.

Approximately 90 million doses of vaccine are currently available, and 170 million doses are expected this year, Dr. Frieden said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, approximately 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations for flu vaccination remain the same as last year: "Everyone aged 6 months and older should get the flu vaccine, this year and every year," Dr. Frieden said. He emphasized that flu shots are necessary each year, even though the strains of flu in this year’s vaccine and the viruses seen so far this year are the same as for the 2010-2011 season.

"You need this year’s flu shot to protect you against this year’s flu," he said. One shot should protect against the flu for the duration of the season, but protection does wane and can’t be expected to carry over year to year, he explained.

This year, there are four types of flu vaccine available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine featuring a barely noticeable needle. The intradermal vaccine is only approved for use in individuals aged 18-64 years.

Approximately 51% of children in the United States received a flu vaccine last year, Dr. Frieden noted, which represents a 7% increase over the previous year. Although the news on vaccination rates is encouraging, "it is critical to continue to make progress; there are too many illnesses and deaths from influenza each year," he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

"Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider," said Dr. Burton. "Every child needs an influenza vaccine if they are 6 months of age or older," he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, and children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said.

Young children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. Approximately 60% of adults who were vaccinated last year said that they did so because a health care professional specifically recommended it.

Vaccination rates in health care professionals themselves were approximately 63% last year, Dr. Schaffner said, but there is room for improvement.* "There are a lot of health care professionals who still don’t understand that it’s a patient safety issue," he noted. "And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect," he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, "a strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients," which means that flu vaccination is expected, "is essential for increasing flu vaccination among health care professionals," he said.

To help encourage vaccination this year, the NFID introduced a "leading by example" initiative that calls on health care professionals as well as community and business leaders to get vaccinated themselves as an example to their employees and colleagues.

Dr. Frieden set an example by getting his flu shot live during the press conference. "It didn’t hurt a bit," he said.

The press conference was sponsored by the National Foundation for Infectious Diseases. For the latest information on the 2011-2012 flu season, visit the CDC website.

* Correction, 9/29/2011: The original version of this article incorrectly stated that healthcare worker vaccinations increased by 63%. Instead, 63.5% of healthcare workers were vaccinated last year.

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference on Sept. 21.

The annual flu vaccine is never perfect, but "we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot," Dr. Frieden said.

Approximately 90 million doses of vaccine are currently available, and 170 million doses are expected this year, Dr. Frieden said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, approximately 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations for flu vaccination remain the same as last year: "Everyone aged 6 months and older should get the flu vaccine, this year and every year," Dr. Frieden said. He emphasized that flu shots are necessary each year, even though the strains of flu in this year’s vaccine and the viruses seen so far this year are the same as for the 2010-2011 season.

"You need this year’s flu shot to protect you against this year’s flu," he said. One shot should protect against the flu for the duration of the season, but protection does wane and can’t be expected to carry over year to year, he explained.

This year, there are four types of flu vaccine available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine featuring a barely noticeable needle. The intradermal vaccine is only approved for use in individuals aged 18-64 years.

Approximately 51% of children in the United States received a flu vaccine last year, Dr. Frieden noted, which represents a 7% increase over the previous year. Although the news on vaccination rates is encouraging, "it is critical to continue to make progress; there are too many illnesses and deaths from influenza each year," he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

"Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider," said Dr. Burton. "Every child needs an influenza vaccine if they are 6 months of age or older," he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, and children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said.

Young children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. Approximately 60% of adults who were vaccinated last year said that they did so because a health care professional specifically recommended it.

Vaccination rates in health care professionals themselves were approximately 63% last year, Dr. Schaffner said, but there is room for improvement.* "There are a lot of health care professionals who still don’t understand that it’s a patient safety issue," he noted. "And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect," he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, "a strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients," which means that flu vaccination is expected, "is essential for increasing flu vaccination among health care professionals," he said.

To help encourage vaccination this year, the NFID introduced a "leading by example" initiative that calls on health care professionals as well as community and business leaders to get vaccinated themselves as an example to their employees and colleagues.

Dr. Frieden set an example by getting his flu shot live during the press conference. "It didn’t hurt a bit," he said.

The press conference was sponsored by the National Foundation for Infectious Diseases. For the latest information on the 2011-2012 flu season, visit the CDC website.

* Correction, 9/29/2011: The original version of this article incorrectly stated that healthcare worker vaccinations increased by 63%. Instead, 63.5% of healthcare workers were vaccinated last year.

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference on Sept. 21.

The annual flu vaccine is never perfect, but "we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot," Dr. Frieden said.

Approximately 90 million doses of vaccine are currently available, and 170 million doses are expected this year, Dr. Frieden said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, approximately 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations for flu vaccination remain the same as last year: "Everyone aged 6 months and older should get the flu vaccine, this year and every year," Dr. Frieden said. He emphasized that flu shots are necessary each year, even though the strains of flu in this year’s vaccine and the viruses seen so far this year are the same as for the 2010-2011 season.

"You need this year’s flu shot to protect you against this year’s flu," he said. One shot should protect against the flu for the duration of the season, but protection does wane and can’t be expected to carry over year to year, he explained.

This year, there are four types of flu vaccine available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine featuring a barely noticeable needle. The intradermal vaccine is only approved for use in individuals aged 18-64 years.

Approximately 51% of children in the United States received a flu vaccine last year, Dr. Frieden noted, which represents a 7% increase over the previous year. Although the news on vaccination rates is encouraging, "it is critical to continue to make progress; there are too many illnesses and deaths from influenza each year," he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

"Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider," said Dr. Burton. "Every child needs an influenza vaccine if they are 6 months of age or older," he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, and children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said.

Young children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. Approximately 60% of adults who were vaccinated last year said that they did so because a health care professional specifically recommended it.

Vaccination rates in health care professionals themselves were approximately 63% last year, Dr. Schaffner said, but there is room for improvement.* "There are a lot of health care professionals who still don’t understand that it’s a patient safety issue," he noted. "And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect," he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, "a strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients," which means that flu vaccination is expected, "is essential for increasing flu vaccination among health care professionals," he said.

To help encourage vaccination this year, the NFID introduced a "leading by example" initiative that calls on health care professionals as well as community and business leaders to get vaccinated themselves as an example to their employees and colleagues.

Dr. Frieden set an example by getting his flu shot live during the press conference. "It didn’t hurt a bit," he said.

The press conference was sponsored by the National Foundation for Infectious Diseases. For the latest information on the 2011-2012 flu season, visit the CDC website.

* Correction, 9/29/2011: The original version of this article incorrectly stated that healthcare worker vaccinations increased by 63%. Instead, 63.5% of healthcare workers were vaccinated last year.

QUEBEC CITY – Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis peak at different ages, based on data from 386 young women.

Age-specific incidence rates of these three sexually transmitted infections (STIs) in young women have not been well studied, said Wanzhu Tu, Ph.D., of Indiana University, Indianapolis, and colleagues.

In a longitudinal cohort study, the researchers recruited young women aged 14-17 years from three adolescent medicine clinics. The participants completed questionnaires and face-to-face interviews to determine lifetime and recent sexual activity; cervical and vaginal specimens were collected and tested.

Participants were interviewed and tested for STIs every 3 months. The average length of follow-up was 3.5 years. Any participants with positive tests received treatment, according to the findings presented in a poster session at a congress of the International Society for Sexually Transmitted Diseases Research.

The separate baseline prevalence rates for chlamydia, gonorrhea, and trichomoniasis were 11%, 4%, and 6%, respectively.

The combined peak incidence of any of the three infections was approximately 15% at age 20 years.

When the separate incidence of the three infections was examined as a function of age, chlamydia incidence rose gradually from 7% at age 14 years, peaked at approximately 18 years (11%), and then steadily declined to almost 1% at age 24 years. Gonorrhea rose from 1% at age 14 years, peaked at approximately 19 years (4%), and declined gradually to almost 0% until age 24 years. By contrast, the incidence of trichomoniasis infections started slightly above 1% at age 14 years, peaked at approximately 21 years (6%), and remained steady through age 24 years.

The average age of the participants was 15 years, the average age at the time of sexual debut was 14 years, and the average number of sexual partners at study enrollment was three. A total of 89% of the participants were black.

"The estimated STI incidence rates clearly differ by organism, not only in magnitude but also in peak age," the researchers noted.

"Prevalences of the respective organisms in the partner population are likely contributors to the differential risk of STI acquisition," they added. However, the fact that the differences were seen within the same group of young women with relatively few sexual partners suggests that biologically determined differences in age-related susceptibility may play a large role in STI infections, they said.

The researchers said they had no relevant financial disclosures.

For more information about STIs in teens, check out the latest statistics at the Centers for Disease Control and Prevention website.

QUEBEC CITY – Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis peak at different ages, based on data from 386 young women.

Age-specific incidence rates of these three sexually transmitted infections (STIs) in young women have not been well studied, said Wanzhu Tu, Ph.D., of Indiana University, Indianapolis, and colleagues.

In a longitudinal cohort study, the researchers recruited young women aged 14-17 years from three adolescent medicine clinics. The participants completed questionnaires and face-to-face interviews to determine lifetime and recent sexual activity; cervical and vaginal specimens were collected and tested.

Participants were interviewed and tested for STIs every 3 months. The average length of follow-up was 3.5 years. Any participants with positive tests received treatment, according to the findings presented in a poster session at a congress of the International Society for Sexually Transmitted Diseases Research.

The separate baseline prevalence rates for chlamydia, gonorrhea, and trichomoniasis were 11%, 4%, and 6%, respectively.

The combined peak incidence of any of the three infections was approximately 15% at age 20 years.

When the separate incidence of the three infections was examined as a function of age, chlamydia incidence rose gradually from 7% at age 14 years, peaked at approximately 18 years (11%), and then steadily declined to almost 1% at age 24 years. Gonorrhea rose from 1% at age 14 years, peaked at approximately 19 years (4%), and declined gradually to almost 0% until age 24 years. By contrast, the incidence of trichomoniasis infections started slightly above 1% at age 14 years, peaked at approximately 21 years (6%), and remained steady through age 24 years.

The average age of the participants was 15 years, the average age at the time of sexual debut was 14 years, and the average number of sexual partners at study enrollment was three. A total of 89% of the participants were black.

"The estimated STI incidence rates clearly differ by organism, not only in magnitude but also in peak age," the researchers noted.

"Prevalences of the respective organisms in the partner population are likely contributors to the differential risk of STI acquisition," they added. However, the fact that the differences were seen within the same group of young women with relatively few sexual partners suggests that biologically determined differences in age-related susceptibility may play a large role in STI infections, they said.

The researchers said they had no relevant financial disclosures.

For more information about STIs in teens, check out the latest statistics at the Centers for Disease Control and Prevention website.

QUEBEC CITY – Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis peak at different ages, based on data from 386 young women.

Age-specific incidence rates of these three sexually transmitted infections (STIs) in young women have not been well studied, said Wanzhu Tu, Ph.D., of Indiana University, Indianapolis, and colleagues.

In a longitudinal cohort study, the researchers recruited young women aged 14-17 years from three adolescent medicine clinics. The participants completed questionnaires and face-to-face interviews to determine lifetime and recent sexual activity; cervical and vaginal specimens were collected and tested.

Participants were interviewed and tested for STIs every 3 months. The average length of follow-up was 3.5 years. Any participants with positive tests received treatment, according to the findings presented in a poster session at a congress of the International Society for Sexually Transmitted Diseases Research.

The separate baseline prevalence rates for chlamydia, gonorrhea, and trichomoniasis were 11%, 4%, and 6%, respectively.

The combined peak incidence of any of the three infections was approximately 15% at age 20 years.

When the separate incidence of the three infections was examined as a function of age, chlamydia incidence rose gradually from 7% at age 14 years, peaked at approximately 18 years (11%), and then steadily declined to almost 1% at age 24 years. Gonorrhea rose from 1% at age 14 years, peaked at approximately 19 years (4%), and declined gradually to almost 0% until age 24 years. By contrast, the incidence of trichomoniasis infections started slightly above 1% at age 14 years, peaked at approximately 21 years (6%), and remained steady through age 24 years.

The average age of the participants was 15 years, the average age at the time of sexual debut was 14 years, and the average number of sexual partners at study enrollment was three. A total of 89% of the participants were black.

"The estimated STI incidence rates clearly differ by organism, not only in magnitude but also in peak age," the researchers noted.

"Prevalences of the respective organisms in the partner population are likely contributors to the differential risk of STI acquisition," they added. However, the fact that the differences were seen within the same group of young women with relatively few sexual partners suggests that biologically determined differences in age-related susceptibility may play a large role in STI infections, they said.

The researchers said they had no relevant financial disclosures.

For more information about STIs in teens, check out the latest statistics at the Centers for Disease Control and Prevention website.

Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.

The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).

© Yarinca/istockphoto.com

A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.

The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.

Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.

"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.

The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.

The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.

Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.

Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.

The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).

© Yarinca/istockphoto.com

A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.

The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.

Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.

"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.

The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.

The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.

Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.

Nearly half the flu-related deaths in children last year occurred in those younger than 5 years, and only 23% of eligible children had been vaccinated, according to data from the Centers for Disease Control and Prevention.

The CDC released data on influenza-associated pediatric deaths between September 2010 and August 2011 in the Morbidity and Mortality Weekly Report, published online Sept. 16 (MMWR 2011;60:1233-38).

© Yarinca/istockphoto.com

A total of 115 flu-related deaths in children younger than age 18 years were reported to the CDC during the study period. Of these, 56 (49%) had no known high-risk medical conditions as defined by the CDC’s Advisory Committee on Immunization Practices. Only 17 children (23%) had been fully vaccinated, based on data from the 74 children aged 6 months and older for whom vaccination information was available.

The median age of the patients who died was 6 years, and 53 deaths (46%) occurred in children younger than 5 years.

Overall, 71 cases (62%) were associated with influenza A viruses, and 44 (38%) were associated with influenza B viruses.

"Influenza B was identified in a disproportionate number of pediatric influenza-associated deaths," although only 26% of the circulating viruses during the 2010-2011 flu season were influenza B, the researchers noted. In previous seasons, the percentage of influenza B viruses in flu-related pediatric deaths has been equal or greater than the percentage of influenza B circulating virus for that season, they said.

The data are subject to the limitations of the current surveillance system, the researchers noted. But the report emphasizes the need for continued surveillance. The CDC continues to recommend annual flu vaccinations for all children aged 6 months and older.

The MMWR also included a report on flu activity in the United States and worldwide from May 22, 2011 through Sept. 3, 2011 (MMWR 2011;60:1239-41). In the U.S., 122 respiratory specimens were positive for influenza, including 87 cases of influenza A and 35 of influenza B. Flu viruses were reported in 26 states during this period, and they were different from the currently circulating H3N2 virus.

Worldwide, the 2009 H1N1 virus was the dominant circulating virus in Australia, while influenza B viruses dominated New Zealand. The 2009 H1N1 virus also dominated cases in southern Africa, while the influenza A H3N2 was the dominant virus in Asia during this period.

PARIS  – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.

The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.

PARIS  – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.

The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.

PARIS  – The percentage of children and adolescents who developed metabolic syndrome while taking antipsychotics more than doubled from 3% after 3 months of use to 7% after 12 months, according to data from a longitudinal study of 235 children and adolescents, Jessica Merchán-Naranjo reported at the Annual Congress of the European College of Neuropsychopharmacology.

Data from previous studies have shown the development of metabolic adverse effects as a result of antipsychotics, but the nature of the impact on children has not been well studied, said Ms. Merchán-Naranjo of the Hospital General Universitario Gregorio Marañón in Madrid.

At baseline, 116 children had no prior antipsychotic treatment and 119 had fewer than 30 days of exposure to antipsychotics. The patients were assessed at baseline and again after 3, 6, and 12 months of antipsychotic use. The mean age of the children was 14 years, 141 were male, and 89% were white.

The diagnoses were divided into three groups: schizophrenia or other disorders with psychotic symptoms (93 patients), bipolar disorder (38 patients), and other disorders (104 patients). The majority of the children were treated with risperidone (146 patients). The most common additional medications were olanzapine (39 patients), and quetiapine (38 patients). The remaining patients were treated with clozapine, haloperidol, pimozide, or aripiprazole.

The percentage of children who met criteria for metabolic syndrome at 3, 6, and 12 months was 3%, 6%, and 7%, respectively. Metabolic syndrome was defined as at least three of the following conditions: body mass index in the 95th percentile or higher, triglycerides greater than 110 mg/dL, HDL cholesterol less than 40 mg/dL, and glucose of 110 mg/dL or higher.

The percentage of children who were considered at risk for metabolic syndrome at 3, 6, and 12 months was 22%, 24%, and 33%, respectively. The researchers defined "at risk" as either a body mass index in the 95th percentile or higher, or a BMI in the 85th percentile or higher plus the presence of hypertension, dyslipidemia, or hyperglycemia.

The results confirm that adverse events should be monitored in children and adolescents taking antipsychotics throughout the entire treatment period, she added.

The study was funded by Spain’s Ministry of Science and Innovation and by an independent investigator award from the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM). Ms. Merchán-Naranjo reported no conflict of interest.