From Medscape Medical News
Laurie Barclay, MD
Diabetologia. Published online October 22, 2008.
Clinical Context
Good glycemic control can significantly lower morbidity rates related to type 2 diabetes and is therefore a vitally important treatment goal. Lowering and keeping glucose levels as close to the normal range as possible has been shown to reduce microvascular complications of diabetes, including retinopathy, nephropathy, and neuropathy.
In August 2006, the ADA and EASD published a consensus algorithm for the medical management of type 2 diabetes. An update in January 2008 specifically highlighted safety concerns regarding the thiazolidinediones, whereas this current update focuses on new classes of medications for which more clinical data and wider experience are now available.
Study Highlights
In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels of less than 7.0%.
For most patients with type 2 diabetes, the initial treatment approach (tier 1, step 1) with well-validated therapies should include lifestyle intervention and use of metformin, titrated to its maximally effective dose at 1 to 2 months.
Lifestyle changes should aim to improve glucose levels, blood pressure, lipid levels, and weight control.
When tier 1, step 1 fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started.
If target hemoglobin A1c level is not achieved with step 1, or if metformin is contraindicated or poorly tolerated, step 2 is to add another medication, either insulin or a sulfonylurea.
Insulin, typically a basal (intermediate- or long-acting) insulin, is preferred for patients who have a hemoglobin A1c level of more than 8.5% or hyperglycemic symptoms.
Insulin plus metformin is a particularly effective means to lower glycemia while limiting weight gain.
In step 3, insulin therapy is started or intensified by giving additional injections, usually a short- or rapid-acting insulin given before selected meals, to reduce postprandial glucose levels.
Once insulin injections are started, insulin secretagogues (sulfonylurea or glinides) should be discontinued, or tapered and then discontinued.
In selected clinical settings, the tier 2 algorithm, which consists of less well-validated therapies, may be considered.
For patients with hazardous jobs that would make hypoglycemia particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended.
Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%).
If these interventions do not achieve target hemoglobin A1c levels or are not tolerated, tier 2 interventions should be stopped and basal insulin started.
The amylin agonists, alpha-glucosidase inhibitors, glinides, and dipeptidyl peptidase 4 inhibitors may be appropriate for selected patients.
However, they are not included in the 2 tiers of preferred agents because their efficacy to lower glucose is less or equivalent vs the first- and second-tier agents, they are relatively expensive, and clinical data regarding their use are limited.
Selecting individual agents should be based on their efficacy to lower glucose and on other characteristics.
When adding second antihyperglycemic medications, the synergy of particular combinations and other drug interactions should be considered.
Antihyperglycemic drugs with different mechanisms of action typically have the greatest synergy.
Pearls for Practice
In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels less than 7.0%. For most patients, step 1 is lifestyle intervention and metformin. When this fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started. Step 2 is to add another medication, either insulin or a sulfonylurea. In step 3, insulin therapy is started or intensified.
The tier 2 algorithm using less well-validated therapies may be considered in selected patients. For those in whom hypoglycemia would be particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended. Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%),
Sunday, September 27, 2009
Rapid Flu Tests Miss Many Swine Flu Cases: CDC
From Reuters Health Information
By Julie Steenhuysen
CHICAGO (Reuters) Sep 24 - A study of rapid influenza tests found they miss many cases of swine flu and U.S. health experts said on Thursday they are not worth the trouble for this flu season.
A study looking at the effectiveness of a rapid flu test in the first few weeks of the H1N1 pandemic in May found it detected less than half of the cases later confirmed by more sophisticated tests.
The findings, which appeared in the U.S. Centers for Disease Control and Prevention's MMWR, confirm the CDC's current guidelines, which stress that people with flu-like symptoms should get quick treatment, before getting a flu test.
Health and Human Services Secretary Kathleen Sebelius told reporters at a briefing that doctors should simply treat symptoms and not bother with testing.
"The flu is the flu is the flu," she said.
In September, the CDC said doctors should not wait for laboratory confirmation of H1N1 because quick treatment is important, and because a negative rapid test does not rule out the flu.
The latest study, conducted by Dr. James Sabetta and colleagues at the Greenwich Hospital and the Greenwich Department of Health in Connecticut, shows why.
They collected data on patients from two school outbreaks of pandemic H1N1 flu in May. They did rapid flu diagnostic tests on 63 patients using the Xpect Flu A&B test by Remel, a unit of Thermo Fisher Scientific, and more sophisticated lab tests.
They found the rapid flu test detected just 47 percent of the pandemic flu cases later confirmed by the slower, but highly accurate real-time reverse transcription-polymerase chain reaction, or rRT-PCR.
The findings confirm an earlier study by the CDC that found quick flu tests caught just 40 to 69 percent of swine flu cases. That study, released in August, looked at three popular flu tests -- BinaxNow, made by Inverness Medical Innovations, Becton Dickinson's Directigen EZ Flu A+B test and Quidel's QuickVue.
The CDC said the findings confirm their current guidelines, and stress that treating flu -- whether seasonal or pandemic -- is more important than knowing what kind a person has.
"Almost everybody will almost certainly not know what kind of flu they had," Dr. Anne Schuchat of the CDC told the briefing.
Many companies are working on better rapid tests including GlaxoSmithKline and Enigma Diagnostics, Seegene, a company based in South Korea and Maryland, DxNA based in Utah, and Osmetech PLC, based in California.
MMWR September 24, 2009.
By Julie Steenhuysen
CHICAGO (Reuters) Sep 24 - A study of rapid influenza tests found they miss many cases of swine flu and U.S. health experts said on Thursday they are not worth the trouble for this flu season.
A study looking at the effectiveness of a rapid flu test in the first few weeks of the H1N1 pandemic in May found it detected less than half of the cases later confirmed by more sophisticated tests.
The findings, which appeared in the U.S. Centers for Disease Control and Prevention's MMWR, confirm the CDC's current guidelines, which stress that people with flu-like symptoms should get quick treatment, before getting a flu test.
Health and Human Services Secretary Kathleen Sebelius told reporters at a briefing that doctors should simply treat symptoms and not bother with testing.
"The flu is the flu is the flu," she said.
In September, the CDC said doctors should not wait for laboratory confirmation of H1N1 because quick treatment is important, and because a negative rapid test does not rule out the flu.
The latest study, conducted by Dr. James Sabetta and colleagues at the Greenwich Hospital and the Greenwich Department of Health in Connecticut, shows why.
They collected data on patients from two school outbreaks of pandemic H1N1 flu in May. They did rapid flu diagnostic tests on 63 patients using the Xpect Flu A&B test by Remel, a unit of Thermo Fisher Scientific, and more sophisticated lab tests.
They found the rapid flu test detected just 47 percent of the pandemic flu cases later confirmed by the slower, but highly accurate real-time reverse transcription-polymerase chain reaction, or rRT-PCR.
The findings confirm an earlier study by the CDC that found quick flu tests caught just 40 to 69 percent of swine flu cases. That study, released in August, looked at three popular flu tests -- BinaxNow, made by Inverness Medical Innovations, Becton Dickinson's Directigen EZ Flu A+B test and Quidel's QuickVue.
The CDC said the findings confirm their current guidelines, and stress that treating flu -- whether seasonal or pandemic -- is more important than knowing what kind a person has.
"Almost everybody will almost certainly not know what kind of flu they had," Dr. Anne Schuchat of the CDC told the briefing.
Many companies are working on better rapid tests including GlaxoSmithKline and Enigma Diagnostics, Seegene, a company based in South Korea and Maryland, DxNA based in Utah, and Osmetech PLC, based in California.
MMWR September 24, 2009.
Friday, September 25, 2009
Extended Physiotherapy, High-Dose Vitamin D Reduces Post-Hip Fracture Falls
From Medscape Medical News
Nancy A. Melville
September 22, 2009 (Denver, Colorado) — Extended physiotherapy, along with high-dose supplementation of vitamin D, after hip fracture can significantly improve the rate of falls and hospital readmissions for the elderly, according to a study presented here at the American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting.
High rates of post-hip-fracture morbidity and mortality are a heavy socioeconomic burden, yet there are no well-established guidelines for postfracture care among the elderly, said lead author Heike A. Bischoff-Ferrari, MD, professor of medicine at the University of Zurich in Switzerland. "Guidelines for postfracture care of elderly hip-fracture patients are not established, despite the fact that in the first 12 months after hip fracture, 5% to 10% of patients fracture their other hip, 30% are readmitted to acute care, 50% are left with permanent functional decline, 25% require long-term care, and 10% to 25% die," Dr. Bischoff-Ferrari said in an interview with Medscape Ob/Gyn & Women's Health.
To determine whether a strategy combining a home-based physiotherapy program and a vitamin D regimen could reduce some of the sequelae of hip fracture, the researchers enrolled 173 acute hip-fracture patients in their study; 79% were women with a mean age of 84 years and 77% were living in the community.
The researchers compared the effects of extended physiotherapy, which consisted of 1 hour of supervised physiotherapy per day during acute care plus an unsupervised home physiotherapy program, with those of standard physiotherapy, which consisted of 30 minutes of supervised physiotherapy per day during acute care and no home program.
The home-based physiotherapy involved basic exercises, such as getting in and out of a chair, balancing on 1 leg, walking up and down stairs, and a simple rubber-band exercise for upper-arm strength, Dr. Bischoff-Ferrari said.
The researchers also assessed the effects of 2000 IU of vitamin D3 per day, compared with 800 IU units per day, and the effect that the combined physiotherapy and vitamin D3 components had on the rate of falls and readmissions to the hospital.
Over the course of a 12-month follow-up, the researchers documented a total of 212 falls, with a rate of 1.43 falls per observed patient-year, and 74 hospital readmissions, with a rate of 0.5 per observed patient-year.
Falls among patients in the extended physiotherapy group were significantly reduced by 25%. Patients taking 2000 IU of vitamin D had a rate of hospital readmission that was 39% lower than those taking 800 IU of vitamin D per day.
The lower readmission rate could be explained by the 60% reduction in fall-related injuries and the 90% reduction in infections leading to inpatient care seen among the higher-dose vitamin D group, Dr. Bischoff-Ferrari said.
"Our study demonstrated that an extended physiotherapy program, together with 2000 IU of vitamin D, has complementary benefits for post-hip-fracture care, including a significant 25% reduction in falls and a 39% reduction in hospital readmission," she said. "This regimen could have an exceptional benefit on improving post-hip-fracture care for the elderly."
Jonathan D. Adachi, MD, professor of medicine at McMaster University in Hamilton, Ontario, said the study is particularly notable, not just for the improvements seen with the extended physiotherapy, but for the role of vitamin D.
"The study is very important because it demonstrates the benefit of both vitamin D and physiotherapy," said Dr. Adachi, who was not involved in the study.
"What is particularly important is the dose of vitamin D; most guidelines do not recommend this high a dose of vitamin D and many doctors do not recommend this dose of 2000 IU."
American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting: Abstract 1097. Presented September 12, 2009.
Nancy A. Melville
September 22, 2009 (Denver, Colorado) — Extended physiotherapy, along with high-dose supplementation of vitamin D, after hip fracture can significantly improve the rate of falls and hospital readmissions for the elderly, according to a study presented here at the American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting.
High rates of post-hip-fracture morbidity and mortality are a heavy socioeconomic burden, yet there are no well-established guidelines for postfracture care among the elderly, said lead author Heike A. Bischoff-Ferrari, MD, professor of medicine at the University of Zurich in Switzerland. "Guidelines for postfracture care of elderly hip-fracture patients are not established, despite the fact that in the first 12 months after hip fracture, 5% to 10% of patients fracture their other hip, 30% are readmitted to acute care, 50% are left with permanent functional decline, 25% require long-term care, and 10% to 25% die," Dr. Bischoff-Ferrari said in an interview with Medscape Ob/Gyn & Women's Health.
To determine whether a strategy combining a home-based physiotherapy program and a vitamin D regimen could reduce some of the sequelae of hip fracture, the researchers enrolled 173 acute hip-fracture patients in their study; 79% were women with a mean age of 84 years and 77% were living in the community.
The researchers compared the effects of extended physiotherapy, which consisted of 1 hour of supervised physiotherapy per day during acute care plus an unsupervised home physiotherapy program, with those of standard physiotherapy, which consisted of 30 minutes of supervised physiotherapy per day during acute care and no home program.
The home-based physiotherapy involved basic exercises, such as getting in and out of a chair, balancing on 1 leg, walking up and down stairs, and a simple rubber-band exercise for upper-arm strength, Dr. Bischoff-Ferrari said.
The researchers also assessed the effects of 2000 IU of vitamin D3 per day, compared with 800 IU units per day, and the effect that the combined physiotherapy and vitamin D3 components had on the rate of falls and readmissions to the hospital.
Over the course of a 12-month follow-up, the researchers documented a total of 212 falls, with a rate of 1.43 falls per observed patient-year, and 74 hospital readmissions, with a rate of 0.5 per observed patient-year.
Falls among patients in the extended physiotherapy group were significantly reduced by 25%. Patients taking 2000 IU of vitamin D had a rate of hospital readmission that was 39% lower than those taking 800 IU of vitamin D per day.
The lower readmission rate could be explained by the 60% reduction in fall-related injuries and the 90% reduction in infections leading to inpatient care seen among the higher-dose vitamin D group, Dr. Bischoff-Ferrari said.
"Our study demonstrated that an extended physiotherapy program, together with 2000 IU of vitamin D, has complementary benefits for post-hip-fracture care, including a significant 25% reduction in falls and a 39% reduction in hospital readmission," she said. "This regimen could have an exceptional benefit on improving post-hip-fracture care for the elderly."
Jonathan D. Adachi, MD, professor of medicine at McMaster University in Hamilton, Ontario, said the study is particularly notable, not just for the improvements seen with the extended physiotherapy, but for the role of vitamin D.
"The study is very important because it demonstrates the benefit of both vitamin D and physiotherapy," said Dr. Adachi, who was not involved in the study.
"What is particularly important is the dose of vitamin D; most guidelines do not recommend this high a dose of vitamin D and many doctors do not recommend this dose of 2000 IU."
American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting: Abstract 1097. Presented September 12, 2009.
Monday, September 14, 2009
Depression Affects Survival in Cancer Patients
From Medscape Medical News
Roxanne Nelson
September 14, 2009 — The presence of depression might adversely affect outcomes in cancer patients. According to the findings of a meta-analysis, published online September 14 in Cancer, depression is a small but significant predictor of mortality in cancer patients.
Among patients experiencing depressive symptoms, mortality rates were up to 26% higher (unadjusted risk ratio [RR], 1.25; 95% confidence interval [CI], 1.12 - 1.40; P < .001) and among patients diagnosed with major or minor depression were up to 39% higher (unadjusted RR, 1.39; 95% CI, 1.10 - 1.89; P =.03) than those without these symptoms.
Conversely, depressive symptoms did not appear to significantly predict disease progression.
"Our meta-analysis did show an increased risk of risk of death in patients who report more depressive symptoms than others, and also in patients who have been diagnosed with a depressive disorder, compared with patients who have not," said first author Jillian R. Satin, MA, a doctoral student in clinical psychology at the University of British Columbia in Vancouver.
However, she emphasized that this study only shows that a link exists. "We cannot prove with this evidence that depression actually causes the increase in mortality," she told Medscape Oncology. "More research will be needed in order to potentially conclude this."
It is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues.
A certain level of distress is expected after the diagnosis of cancer, Ms. Satin explained. "In our study, we restricted our analysis to studies that measure depression at least 1 month after diagnosis," she said. "Therefore, this is the time frame that our study makes conclusions about."
It can be difficult to define what a "normal" response to a cancer diagnosis looks like, Ms. Satin added, "but it is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues."
Inconclusive Evidence Prompts Meta-Analysis
Depression has been widely studied in cancer patients, and is the most commonly studied psychological variable with respect to cancer progression and mortality in this population, the authors report. Depression is also the only psychological condition that is more commonly found in cancer patients than in the general population, and is the psychological problem most likely to persist throughout the illness trajectory.
The authors also point out that "a plausible model exists to link depression with cancer progression and mortality through both behavioral and biological pathways." An example is chronic activation of the hypothalamo-pituitary–adrenal axis, which has been implicated as a possible mediator of the effect of depression on disease progression in cancer. Depression has also been associated with inflammation, as previously reported by Medscape Oncology.
Although cancer patients and oncologists believe that psychological variables can influence the course of cancer, the evidence remains inconclusive. For this reason, Ms. Satin and colleagues conducted a meta-analysis to evaluate the extent to which depressive symptoms and major depressive disorder predict disease progression and mortality in cancer patients.
Depression Linked to Mortality but Not Progression
To examine the effects of depression on survival, the researchers identified 27 observational studies (n = 9417), conducted from 1990 to 2009, which met all of their inclusion criteria. Of this group, 25 independent studies were based on measures of depressive symptoms, 3 were based on major or minor depression, 16 evaluated survival at less than 5 years postdiagnosis, and 11 examined survival at 5 years postdiagnosis or more.
"There is no evidence that the effect weakens when adjustments are made for other known risk factors, suggesting that depression may be an independent risk factor in cancer mortality, rather than merely correlating with biological factors associated with a poor prognosis," they write.
Only 3 studies were available for an analysis of the risk for depression on cancer progression, and depressive symptoms did not significantly predict disease progression (unadjusted RR,= 1.23; 95% CI, 0.85 - 1.77; P = .28).
The authors found it "surprising" that depression appeared to predict mortality but not disease recurrence, and postulated that the difference was primarily due to the limited number of studies in their analysis and the corresponding low power.
Roxanne Nelson
September 14, 2009 — The presence of depression might adversely affect outcomes in cancer patients. According to the findings of a meta-analysis, published online September 14 in Cancer, depression is a small but significant predictor of mortality in cancer patients.
Among patients experiencing depressive symptoms, mortality rates were up to 26% higher (unadjusted risk ratio [RR], 1.25; 95% confidence interval [CI], 1.12 - 1.40; P < .001) and among patients diagnosed with major or minor depression were up to 39% higher (unadjusted RR, 1.39; 95% CI, 1.10 - 1.89; P =.03) than those without these symptoms.
Conversely, depressive symptoms did not appear to significantly predict disease progression.
"Our meta-analysis did show an increased risk of risk of death in patients who report more depressive symptoms than others, and also in patients who have been diagnosed with a depressive disorder, compared with patients who have not," said first author Jillian R. Satin, MA, a doctoral student in clinical psychology at the University of British Columbia in Vancouver.
However, she emphasized that this study only shows that a link exists. "We cannot prove with this evidence that depression actually causes the increase in mortality," she told Medscape Oncology. "More research will be needed in order to potentially conclude this."
It is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues.
A certain level of distress is expected after the diagnosis of cancer, Ms. Satin explained. "In our study, we restricted our analysis to studies that measure depression at least 1 month after diagnosis," she said. "Therefore, this is the time frame that our study makes conclusions about."
It can be difficult to define what a "normal" response to a cancer diagnosis looks like, Ms. Satin added, "but it is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues."
Inconclusive Evidence Prompts Meta-Analysis
Depression has been widely studied in cancer patients, and is the most commonly studied psychological variable with respect to cancer progression and mortality in this population, the authors report. Depression is also the only psychological condition that is more commonly found in cancer patients than in the general population, and is the psychological problem most likely to persist throughout the illness trajectory.
The authors also point out that "a plausible model exists to link depression with cancer progression and mortality through both behavioral and biological pathways." An example is chronic activation of the hypothalamo-pituitary–adrenal axis, which has been implicated as a possible mediator of the effect of depression on disease progression in cancer. Depression has also been associated with inflammation, as previously reported by Medscape Oncology.
Although cancer patients and oncologists believe that psychological variables can influence the course of cancer, the evidence remains inconclusive. For this reason, Ms. Satin and colleagues conducted a meta-analysis to evaluate the extent to which depressive symptoms and major depressive disorder predict disease progression and mortality in cancer patients.
Depression Linked to Mortality but Not Progression
To examine the effects of depression on survival, the researchers identified 27 observational studies (n = 9417), conducted from 1990 to 2009, which met all of their inclusion criteria. Of this group, 25 independent studies were based on measures of depressive symptoms, 3 were based on major or minor depression, 16 evaluated survival at less than 5 years postdiagnosis, and 11 examined survival at 5 years postdiagnosis or more.
"There is no evidence that the effect weakens when adjustments are made for other known risk factors, suggesting that depression may be an independent risk factor in cancer mortality, rather than merely correlating with biological factors associated with a poor prognosis," they write.
Only 3 studies were available for an analysis of the risk for depression on cancer progression, and depressive symptoms did not significantly predict disease progression (unadjusted RR,= 1.23; 95% CI, 0.85 - 1.77; P = .28).
The authors found it "surprising" that depression appeared to predict mortality but not disease recurrence, and postulated that the difference was primarily due to the limited number of studies in their analysis and the corresponding low power.
What Are the Latest Childhood Vaccine Recommendations?
From Medscape Nurses > Ask the Experts
Wendy L. Wright
Pediatric
All children aged 6 months to 18 years should be immunized against influenza. In the past, only high-risk children were immunized against seasonal influenza. Now, all children, regardless of risk, should receive this immunization. It is estimated that this recommendation means that approximately 50 million children will need the influenza vaccination this year. It is important, particularly in 2009, that clinicians begin to immunize against influenza as soon as the vaccines are received in the office. This will make way for the receipt of the H1N1 vaccine, which is anticipated in October or November of this year. Clinicians can be assured that although we will begin the immunization campaign in early September, much earlier than in the past, it will protect children throughout flu season.[1]
Patients aged 6 months to 24 years as well as those at high risk as a result of pulmonary or cardiac conditions should receive the H1N1 vaccination when it becomes available. At the time of this writing, this vaccination will probably be a series of 2 vaccinations, separated by 3 weeks. The first injection may be administered at the same time as the seasonal influenza vaccine, if it has not already been given. The vaccine will be purchased by the federal government and shipped to the states for distribution and administration. Each state is in charge of implementing the distribution and administration of the vaccine. While we are anticipating release of the vaccine in October, clinical trials for efficacy and safety are still under way.[1,2]
A combination vaccine named Pentacel is now available for infants. This combination vaccine provides protection against diphtheria, tetanus, and pertussis; polio; and Haemophilus influenzae type B. Depending on the state in which you practice and the vaccines to which you have access, this series may decrease the number of injections given to children by up to 7 shots. It consists of 4 injections administered at 2, 4, 6, and 15-18 months.[1]
The restrictions on H. influenzae type B vaccination have now been relaxed. Healthcare providers should attempt to "catch up" the children who missed dose number 4 of the series due to a lengthy shortage of the vaccine.[1]
There are currently 2 rotavirus vaccines available. RotaTeq is a series of 3 oral vaccinations given at 2, 4, and 6 months and Rotarix is a series of 2 oral vaccinations administered at 2 and 4 months. Providers must be aware of which vaccine product they are using to make certain that the correct schedule is followed
Adolescents
All adolescents age 11-18 years should receive the meningococcal (MCV4 or Menactra) vaccine. In the past, this vaccine was often recommended to be given just before a student went to college. However, the Advisory Committee on Immunization Practices now recommends that all children be immunized with MCV4 to provide protection against 4 strains of Neisseria meningitidis beginning at 11 years. It should be noted that children at high risk due to travel or immunosuppressive conditions may receive the vaccine as early as 2 years of age and may have it repeated, if high risk, 5 years after the initial vaccination.[1]
HPV (human papillomavirus) vaccine is recommended for all young women age 9-26 years as a 3-part series. The series is frequently initiated at 11 years of age but may be given as early as 9 years of age. It is administered according to the following schedule: day 0, 2 months after day 0, and 6 months after day 0. Healthcare providers should observe the recipient for 15 minutes following administration of the vaccine. In addition, the vaccinator may wish to place the child in a semirecumbent position during administration due to reports of syncope after vaccine administration.[1]
Tdap (combined tetanus, diphtheria, and pertussis) should be administered to all adolescents age 11 years and older. This additional pertussis protection should be given once to all adolescents and adults who have not received a pertussis booster.
Individuals 65 years of age and older should be given Td only, as the pertussis component has not been deemed safe or efficacious for this age cohort.
Wendy L. Wright
Pediatric
All children aged 6 months to 18 years should be immunized against influenza. In the past, only high-risk children were immunized against seasonal influenza. Now, all children, regardless of risk, should receive this immunization. It is estimated that this recommendation means that approximately 50 million children will need the influenza vaccination this year. It is important, particularly in 2009, that clinicians begin to immunize against influenza as soon as the vaccines are received in the office. This will make way for the receipt of the H1N1 vaccine, which is anticipated in October or November of this year. Clinicians can be assured that although we will begin the immunization campaign in early September, much earlier than in the past, it will protect children throughout flu season.[1]
Patients aged 6 months to 24 years as well as those at high risk as a result of pulmonary or cardiac conditions should receive the H1N1 vaccination when it becomes available. At the time of this writing, this vaccination will probably be a series of 2 vaccinations, separated by 3 weeks. The first injection may be administered at the same time as the seasonal influenza vaccine, if it has not already been given. The vaccine will be purchased by the federal government and shipped to the states for distribution and administration. Each state is in charge of implementing the distribution and administration of the vaccine. While we are anticipating release of the vaccine in October, clinical trials for efficacy and safety are still under way.[1,2]
A combination vaccine named Pentacel is now available for infants. This combination vaccine provides protection against diphtheria, tetanus, and pertussis; polio; and Haemophilus influenzae type B. Depending on the state in which you practice and the vaccines to which you have access, this series may decrease the number of injections given to children by up to 7 shots. It consists of 4 injections administered at 2, 4, 6, and 15-18 months.[1]
The restrictions on H. influenzae type B vaccination have now been relaxed. Healthcare providers should attempt to "catch up" the children who missed dose number 4 of the series due to a lengthy shortage of the vaccine.[1]
There are currently 2 rotavirus vaccines available. RotaTeq is a series of 3 oral vaccinations given at 2, 4, and 6 months and Rotarix is a series of 2 oral vaccinations administered at 2 and 4 months. Providers must be aware of which vaccine product they are using to make certain that the correct schedule is followed
Adolescents
All adolescents age 11-18 years should receive the meningococcal (MCV4 or Menactra) vaccine. In the past, this vaccine was often recommended to be given just before a student went to college. However, the Advisory Committee on Immunization Practices now recommends that all children be immunized with MCV4 to provide protection against 4 strains of Neisseria meningitidis beginning at 11 years. It should be noted that children at high risk due to travel or immunosuppressive conditions may receive the vaccine as early as 2 years of age and may have it repeated, if high risk, 5 years after the initial vaccination.[1]
HPV (human papillomavirus) vaccine is recommended for all young women age 9-26 years as a 3-part series. The series is frequently initiated at 11 years of age but may be given as early as 9 years of age. It is administered according to the following schedule: day 0, 2 months after day 0, and 6 months after day 0. Healthcare providers should observe the recipient for 15 minutes following administration of the vaccine. In addition, the vaccinator may wish to place the child in a semirecumbent position during administration due to reports of syncope after vaccine administration.[1]
Tdap (combined tetanus, diphtheria, and pertussis) should be administered to all adolescents age 11 years and older. This additional pertussis protection should be given once to all adolescents and adults who have not received a pertussis booster.
Individuals 65 years of age and older should be given Td only, as the pertussis component has not been deemed safe or efficacious for this age cohort.
Saturday, September 12, 2009
New Review Endorses Cardiovascular Benefits of Fish Oil
From Heartwire
Lisa Nainggolan
August 10, 2009— A new review concludes that there is extensive evidence from three decades of research that fish oils, or more specifically the omega-3 polyunsaturated fatty acids (PUFAs) contained in them, are beneficial for everyone.
This includes healthy people as well as those with heart disease — including postmyocardial infarction (MI) patients and those with heart failure, atherosclerosis, or atrial fibrillation — say Dr Carl J Lavie (Ochsner Medical Center, New Orleans, LA) and colleagues in their paper published online August 3, 2009, in the Journal of the American College of Cardiology.
"We reviewed everything that was published on omega-3 that was clinically important, and the major finding is that there are a tremendous amount of data to support the benefits of omega-3, not just as a nutritional supplement — people have known that for years — but evidence that it prevents and treats many aspects of cardiovascular disease," Lavie told heartwire .
Lavie said he believes physicians are not as familiar with the omega-3 studies as they should be: "Clinicians know the findings of many statin trials even if they do not know all the details — they know that there are a ton of statin data. The omega-3 data may not be as impressive or as plentiful as this, but it should be 'promoted' to clinicians."
Omega-3 PUFA, says Lavie, "is a therapy that clinicians should be considering prescribing to their patients. Not just as something healthy but as something that may actually prevent the next event. In HF [heart failure], it may prevent death or hospitalization and the same thing post-MI." He and his colleagues reiterate the advice of the American Heart Association (AHA): that those with known coronary heart disease (CHD) or HF eat four or five oily-fish meals per week or take the equivalent in omega-3 supplements; healthy people should consume around two fatty-fish meals per week or the same in supplements.
Most Data on EPA and DHA
In their review, Lavie and colleagues explain that most of the data on omega-3 have been obtained in trials using docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the long-chain fatty acids in this family. The most compelling evidence for cardiovascular benefits comes from four controlled trials of almost 40,000 participants randomized to receive EPA with or without DHA in studies of primary prevention, after MI, and most recently with HF, they note.
They discuss the results for each specific cardiovascular condition in turn. For CHF, three large randomized trials — the Diet and Reinfarction Trial (DART), the Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico (GISSI)-Prevenzione, and the Japan EPA Lipid Intervention Study (JELIS) — have indicated that omega-3 PUFAs lower CV risk in both the primary- and secondary-prevention settings, they note.
Lavie elaborated to heartwire : "The benefit is different in different studies but can be as much as 30%." The effects are seen on total mortality, sudden death, CHD mortality, and cardiovascular mortality.
But there are some studies that have not shown favorable results, although there are generally methodological reasons for this, they say. However, they do flag the most recent study of post-MI patients, OMEGA, which suggests there may not be additional short-term benefit of omega-3 PUFAs in low-risk patients already receiving optimal modern therapy.
There is also evidence of benefit in atherosclerosis and in a wide range of arrhythmias, with the most significant effect and potential benefit seen in "the current epidemic" of atrial fibrillation (AF), note the researchers. But more studies are needed to explore the effects of various doses of omega-3 PUFAs on the primary and secondary reduction of AF and to determine whether the benefits are caused by antiarrhythmic effects, benefits on autonomic tone, or even anti-inflammatory effects, they observe.
Benefit of Fish Oils Also Extend to HF
Recently, the potential benefits of omega-3 PUFAs "have been extended to the prevention and treatment of HF," say Lavie et al. Although the reduction in events was "only 8% to 9% in the recent GISSI-HF trial, which is not huge," Lavie admits, "when you think of HF, it's a very serious disorder, and in GISSI-HF, those patients were treated vigorously for their HF, so they were on good therapy, and adding just one [omega-3 PUFA] pill a day reduced deaths by between 8% and 9%, which is a pretty nice additional benefit."
But he and his colleagues say further studies are needed to determine the optimal dosing of omega-3 PUFA for different stages of HFand to investigate the underlying mechanisms for the benefits. However, in the meantime, omega-3 PUFA supplements "should join the short list of evidence-based life-prolonging therapies for HF."
They also discuss the data on omega-3 PUFAs in hyperlipidemia, noting that the FDA has approved one such supplement for the treatment of very high triglyceride levels.
And they note that more studies are needed to determine the optimal mix of DHA relative to EPA in various populations.
Finally, they state that this review does not focus on the plant-based precursor of EPA, alpha-linolenic acid (ALA), which is found in abundance in flaxseed and to a lesser extent in other plants. But they observe "the overall evidence is much weaker for ALA than for EPA and DHA."
Recommendations for Omega-3 Consumption
Mirroring recommendations from the AHA, European Society of Cardiology, and the World Health Organization (WHO), Lavie and colleagues recommend that healthy people consume at least 500 mg per day of EPA/DHA — equal to around two fatty-fish meals per week — and that those with known CHD or HF get 800 to 1000 mg per day EPA/DHA.
Asked by heartwire whether people should try to consume more fish or alternatively take supplements, Lavie says: "If somebody really were eating salmon and tuna and mackerel and sardines, and they were doing that several times a week, then they wouldn't need to be taking a supplement. But in the US, at least, very few people are going to eat the therapeutic doses of fatty fish."
Other good reasons to take supplements include the fact that they have usually had impurities, such as mercury, removed, he notes.
If people are trying to improve their consumption of oily fish, they could take supplements only on the days they were not eating such fish or every other day to try to get up to the recommended amount of omega-3 PUFAs, Lavie says.
But he warns that regimens that are too complex might result in underconsumption: "I would tend to think that most people are getting very little omega-3 PUFAs in the diet. There's no harm in taking extra — the only negative of extra is the calories. I don't think anyone thinks now that fish oil is doing any harm."
Lisa Nainggolan
August 10, 2009— A new review concludes that there is extensive evidence from three decades of research that fish oils, or more specifically the omega-3 polyunsaturated fatty acids (PUFAs) contained in them, are beneficial for everyone.
This includes healthy people as well as those with heart disease — including postmyocardial infarction (MI) patients and those with heart failure, atherosclerosis, or atrial fibrillation — say Dr Carl J Lavie (Ochsner Medical Center, New Orleans, LA) and colleagues in their paper published online August 3, 2009, in the Journal of the American College of Cardiology.
"We reviewed everything that was published on omega-3 that was clinically important, and the major finding is that there are a tremendous amount of data to support the benefits of omega-3, not just as a nutritional supplement — people have known that for years — but evidence that it prevents and treats many aspects of cardiovascular disease," Lavie told heartwire .
Lavie said he believes physicians are not as familiar with the omega-3 studies as they should be: "Clinicians know the findings of many statin trials even if they do not know all the details — they know that there are a ton of statin data. The omega-3 data may not be as impressive or as plentiful as this, but it should be 'promoted' to clinicians."
Omega-3 PUFA, says Lavie, "is a therapy that clinicians should be considering prescribing to their patients. Not just as something healthy but as something that may actually prevent the next event. In HF [heart failure], it may prevent death or hospitalization and the same thing post-MI." He and his colleagues reiterate the advice of the American Heart Association (AHA): that those with known coronary heart disease (CHD) or HF eat four or five oily-fish meals per week or take the equivalent in omega-3 supplements; healthy people should consume around two fatty-fish meals per week or the same in supplements.
Most Data on EPA and DHA
In their review, Lavie and colleagues explain that most of the data on omega-3 have been obtained in trials using docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the long-chain fatty acids in this family. The most compelling evidence for cardiovascular benefits comes from four controlled trials of almost 40,000 participants randomized to receive EPA with or without DHA in studies of primary prevention, after MI, and most recently with HF, they note.
They discuss the results for each specific cardiovascular condition in turn. For CHF, three large randomized trials — the Diet and Reinfarction Trial (DART), the Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico (GISSI)-Prevenzione, and the Japan EPA Lipid Intervention Study (JELIS) — have indicated that omega-3 PUFAs lower CV risk in both the primary- and secondary-prevention settings, they note.
Lavie elaborated to heartwire : "The benefit is different in different studies but can be as much as 30%." The effects are seen on total mortality, sudden death, CHD mortality, and cardiovascular mortality.
But there are some studies that have not shown favorable results, although there are generally methodological reasons for this, they say. However, they do flag the most recent study of post-MI patients, OMEGA, which suggests there may not be additional short-term benefit of omega-3 PUFAs in low-risk patients already receiving optimal modern therapy.
There is also evidence of benefit in atherosclerosis and in a wide range of arrhythmias, with the most significant effect and potential benefit seen in "the current epidemic" of atrial fibrillation (AF), note the researchers. But more studies are needed to explore the effects of various doses of omega-3 PUFAs on the primary and secondary reduction of AF and to determine whether the benefits are caused by antiarrhythmic effects, benefits on autonomic tone, or even anti-inflammatory effects, they observe.
Benefit of Fish Oils Also Extend to HF
Recently, the potential benefits of omega-3 PUFAs "have been extended to the prevention and treatment of HF," say Lavie et al. Although the reduction in events was "only 8% to 9% in the recent GISSI-HF trial, which is not huge," Lavie admits, "when you think of HF, it's a very serious disorder, and in GISSI-HF, those patients were treated vigorously for their HF, so they were on good therapy, and adding just one [omega-3 PUFA] pill a day reduced deaths by between 8% and 9%, which is a pretty nice additional benefit."
But he and his colleagues say further studies are needed to determine the optimal dosing of omega-3 PUFA for different stages of HFand to investigate the underlying mechanisms for the benefits. However, in the meantime, omega-3 PUFA supplements "should join the short list of evidence-based life-prolonging therapies for HF."
They also discuss the data on omega-3 PUFAs in hyperlipidemia, noting that the FDA has approved one such supplement for the treatment of very high triglyceride levels.
And they note that more studies are needed to determine the optimal mix of DHA relative to EPA in various populations.
Finally, they state that this review does not focus on the plant-based precursor of EPA, alpha-linolenic acid (ALA), which is found in abundance in flaxseed and to a lesser extent in other plants. But they observe "the overall evidence is much weaker for ALA than for EPA and DHA."
Recommendations for Omega-3 Consumption
Mirroring recommendations from the AHA, European Society of Cardiology, and the World Health Organization (WHO), Lavie and colleagues recommend that healthy people consume at least 500 mg per day of EPA/DHA — equal to around two fatty-fish meals per week — and that those with known CHD or HF get 800 to 1000 mg per day EPA/DHA.
Asked by heartwire whether people should try to consume more fish or alternatively take supplements, Lavie says: "If somebody really were eating salmon and tuna and mackerel and sardines, and they were doing that several times a week, then they wouldn't need to be taking a supplement. But in the US, at least, very few people are going to eat the therapeutic doses of fatty fish."
Other good reasons to take supplements include the fact that they have usually had impurities, such as mercury, removed, he notes.
If people are trying to improve their consumption of oily fish, they could take supplements only on the days they were not eating such fish or every other day to try to get up to the recommended amount of omega-3 PUFAs, Lavie says.
But he warns that regimens that are too complex might result in underconsumption: "I would tend to think that most people are getting very little omega-3 PUFAs in the diet. There's no harm in taking extra — the only negative of extra is the calories. I don't think anyone thinks now that fish oil is doing any harm."
Thursday, September 10, 2009
Soluble Fiber May Be Effective for Symptoms of IBS
From Medscape Medical News CME
Laurie Barclay, MD & Charles P. Vega, MD
BMJ. 2009;339:b3154. Abstract
Clinical Context
IBS has a population-wide prevalence of approximately 10%, according to the authors of the current study. However, only a minority of individuals with IBS seek medical care for their symptoms. Most patients with IBS are women, and, although most cases of IBS are managed in primary care practices, few primary care clinicians use formal criteria to diagnose IBS.
Dietary advice and fiber supplements are considered mainstays of therapy for IBS. The current study compares a soluble fiber (psyllium) and insoluble fiber (bran) vs placebo in the treatment of IBS.
Study Highlights
Study participants included adults between the ages of 18 and 65 years who had been diagnosed with IBS in the previous 2 years. The study was conducted in primary care practices in the Netherlands. Diagnoses of IBS were identified through billing data, and researchers evaluated whether patients met formal diagnostic criteria for IBS as well.
Patients who had received fiber treatment in the past 4 weeks, who had a psychiatric disorder, or who had another diagnosis of organic bowel disease were excluded from study participation.
Participants were randomly assigned to receive 10 g of psyllium, 10 g of bran, or rice flour placebo in 2 daily dosages. Each study treatment was mixed with food, preferably yogurt. The treatment period was 3 months.
The main outcome of the study was adequate symptom relief for at least 2 weeks of the previous month, which was defined as response to treatment. Secondary outcomes included a measurement of IBS symptom severity, the severity of abdominal pain specifically, and disease-specific quality of life.
275 patients underwent randomization. 78% of participants were women, and 94% were white. The mean age of participants was 34.4 years.
Only 39% of participants fulfilled the Rome II diagnostic criteria for IBS. Most subjects had constipation-predominant IBS.
The mean intake of daily fiber before study treatment was 26.9 g/day, which was consistent with national average consumption in the Netherlands.
Only 60% of participants attended the final visit at the end of the 3-month study period. Most patients who left the trial did not provide a reason for discontinuing their participation, but study discontinuation was most common among the bran group in the first study month. Most of these patients complained of a worsening of IBS symptoms.
Among patients who remained in the trial, adherence to study therapy was similar in the psyllium and bran groups, as were the consumption of dietary fiber and total fluids.
57% of participants receiving psyllium experienced a treatment response at 1 month vs 35% of participants receiving placebo. The respective response rates at month 2 were 59% and 41%, and psyllium was significantly superior to placebo in both months. The superiority of psyllium was lost in the third month of the trial.
Subgroup analysis focusing on patients who met Rome II criteria for IBS suggested that psyllium may be even more effective for these patients. Psyllium remained more effective than placebo in an analysis limited to participants with constipation-predominant IBS.
Bran was superior to placebo in the main study outcome only in the third month of the trial.
Psyllium was associated with a significant overall reduction in IBS symptoms vs placebo, whereas bran was not.
Neither psyllium nor bran relieved IBS abdominal pain or improved quality of life vs placebo. The percentages of participants who remained in the study and reported adverse events were 74%, 64%, and 66% in the psyllium, bran, and placebo groups, respectively. Diarrhea and constipation were the most commonly reported adverse events and were common in all treatment groups.
Clinical Implications
The prevalence of IBS is approximately 10%, with a predilection for women. Most patients with IBS do not seek medical care for their symptoms, and most primary care physicians do not use formal criteria to diagnose IBS.
The current study suggests that psyllium may relieve IBS symptoms, whereas bran may worsen symptoms.
Laurie Barclay, MD & Charles P. Vega, MD
BMJ. 2009;339:b3154. Abstract
Clinical Context
IBS has a population-wide prevalence of approximately 10%, according to the authors of the current study. However, only a minority of individuals with IBS seek medical care for their symptoms. Most patients with IBS are women, and, although most cases of IBS are managed in primary care practices, few primary care clinicians use formal criteria to diagnose IBS.
Dietary advice and fiber supplements are considered mainstays of therapy for IBS. The current study compares a soluble fiber (psyllium) and insoluble fiber (bran) vs placebo in the treatment of IBS.
Study Highlights
Study participants included adults between the ages of 18 and 65 years who had been diagnosed with IBS in the previous 2 years. The study was conducted in primary care practices in the Netherlands. Diagnoses of IBS were identified through billing data, and researchers evaluated whether patients met formal diagnostic criteria for IBS as well.
Patients who had received fiber treatment in the past 4 weeks, who had a psychiatric disorder, or who had another diagnosis of organic bowel disease were excluded from study participation.
Participants were randomly assigned to receive 10 g of psyllium, 10 g of bran, or rice flour placebo in 2 daily dosages. Each study treatment was mixed with food, preferably yogurt. The treatment period was 3 months.
The main outcome of the study was adequate symptom relief for at least 2 weeks of the previous month, which was defined as response to treatment. Secondary outcomes included a measurement of IBS symptom severity, the severity of abdominal pain specifically, and disease-specific quality of life.
275 patients underwent randomization. 78% of participants were women, and 94% were white. The mean age of participants was 34.4 years.
Only 39% of participants fulfilled the Rome II diagnostic criteria for IBS. Most subjects had constipation-predominant IBS.
The mean intake of daily fiber before study treatment was 26.9 g/day, which was consistent with national average consumption in the Netherlands.
Only 60% of participants attended the final visit at the end of the 3-month study period. Most patients who left the trial did not provide a reason for discontinuing their participation, but study discontinuation was most common among the bran group in the first study month. Most of these patients complained of a worsening of IBS symptoms.
Among patients who remained in the trial, adherence to study therapy was similar in the psyllium and bran groups, as were the consumption of dietary fiber and total fluids.
57% of participants receiving psyllium experienced a treatment response at 1 month vs 35% of participants receiving placebo. The respective response rates at month 2 were 59% and 41%, and psyllium was significantly superior to placebo in both months. The superiority of psyllium was lost in the third month of the trial.
Subgroup analysis focusing on patients who met Rome II criteria for IBS suggested that psyllium may be even more effective for these patients. Psyllium remained more effective than placebo in an analysis limited to participants with constipation-predominant IBS.
Bran was superior to placebo in the main study outcome only in the third month of the trial.
Psyllium was associated with a significant overall reduction in IBS symptoms vs placebo, whereas bran was not.
Neither psyllium nor bran relieved IBS abdominal pain or improved quality of life vs placebo. The percentages of participants who remained in the study and reported adverse events were 74%, 64%, and 66% in the psyllium, bran, and placebo groups, respectively. Diarrhea and constipation were the most commonly reported adverse events and were common in all treatment groups.
Clinical Implications
The prevalence of IBS is approximately 10%, with a predilection for women. Most patients with IBS do not seek medical care for their symptoms, and most primary care physicians do not use formal criteria to diagnose IBS.
The current study suggests that psyllium may relieve IBS symptoms, whereas bran may worsen symptoms.
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