Patient’s Whole Genome Reveals Risk of Diseases and Adverse Drug Responses

Thursday, April 29, 2010
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Patient’s Whole Genome Reveals Risk of Diseases and Adverse Drug Responses

Study demonstrates that whole-genome analysis may play future role in clinical medicine

What: Scientists at Stanford and Harvard Universities collaborated to assess the clinical usefulness of analyzing a patient’s full genome for disease risks and unusual drug responses. The work brings closer to reality the concept that whole-genome sequencing might one day play a clinical role.

The analysis, which was supported by the National Institutes of Health (NIH), appears in the May 1, 2010 issue of Lancet.

The authors evaluated the entire genome of a 40-year old man and compared it to several databases of disease-related gene variants. They also factored in the patient's medical and family history and statistical disease risks. As part of the work, the researchers provided the patient with genetic counseling and clinical tests relevant to his family history.

The genome analysis revealed variants associated with diseases in the man’s family (osteoarthritis, vascular disease and early sudden death). It also uncovered variants linked to conditions not in his family (iron overload and thyroid and parathyroid diseases). Some variants suggested that he might have unusual responses to certain heart medications, which is meaningful in light of his risk for cardiovascular disorders.

The authors view their work as a proof of concept that whole-genome sequencing can yield clinically useful information for individual patients. They acknowledge that many challenges remain, including the effect of the environment, which is difficult to quantify and often changes throughout a person's life. The paper concludes that the transition to genome-informed medical care will require an integrated team including medical and genetics professionals, ethicists and health-care delivery organizations.

Article: Ashley EA, Butte AJ, Wheeler MT, Chen R, Klein TE, Dewey FE, Dudley JT, Ormond KE, Pavlovic A, Morgan AA, Pushkarev D, Neff NR, Hudgins L, Gong L, Hodges LM, Berlin DS, Thorn CF, Sangkuhl K, Hebert JM, Woon M, Sagreiya H, Whaley R, Knowles JW, Chou MF, Thakuria JV, Rosenbaum AM, Zaranek AW, Church GM, Greely HT, Quake SR, Altman RB. Clinical assessment incorporating a personal genome. Lancet, Volume 375:Pages 1525-1535, May 1, 2010.

Who: Jeremy M. Berg, Ph.D., director of the National Institute of General Medical Sciences (NIGMS), which played a leading role in supporting the research, is available to comment on this article.

Contact To schedule interviews, please contact the NIGMS Communications Office at 301-496-7301 or info@nigms.nih.gov.

In addition to NIGMS, the work was supported by the National Heart, Lung, and Blood Institute; the National Human Genome Research Institute; and the National Library of Medicine.

NIGMS is a part of NIH that supports basic research to increase our understanding of life processes and lay the foundation for advances in disease diagnosis, treatment and prevention. For more information on the Institute's research and training programs, see http://www.nigms.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
http://www.nih.gov/news/health/apr2010/nigms-29.htm

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Comparative-Effectiveness Study Confirms New Treatment for Diabetic Macular Edema, April 27, 2010 News Release - National Institutes of Health (NIH)

Tuesday, April 27, 2010
10:30 a.m. EDT Contact:
National Eye Institute, 301-496-5248

Comparative-Effectiveness Study Confirms New Treatment for Diabetic Macular Edema
Ranibizumab Injections Plus Laser Therapy Results in Dramatic Visual Improvement
Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.

Laser treatment alone has been the standard care for the past 25 years. But nearly 50 percent of patients who received this new treatment experienced substantial visual improvement after one year, compared with 28 percent who received the standard laser treatment. The study involved 52 clinical sites within the Diabetic Retinopathy Clinical Research Network (DRCR.net), supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.

"These results indicate a treatment breakthrough for saving the vision of people with diabetic macular edema," said Neil M. Bressler, M.D., chair of the DRCR.net and chief of the Retina Division at the Wilmer Eye Institute, Johns Hopkins University, Md."Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for patients with characteristics similar to those in this clinical trial."

Diabetic retinopathy is the most common cause of vision loss in working-age Americans. This condition damages the small blood vessels in the eye's light-sensitive retinal tissue. When these damaged blood vessels begin to leak fluid near the center of the retina, known as the macula, macular edema occurs. The macula provides detailed central vision used for activities such as reading, driving, and distinguishing faces. In macular edema the retinal tissue swells, which can lead to vision loss if left untreated.

Laser treatment of the retina has been the standard care for diabetic macular edema since an NEI-supported study in 1985 showed it to be beneficial. However, recent small short-term studies have revealed the visual benefits of eye injections of medications that block a chemical signal that stimulates blood vessel growth, known as vascular endothelial growth factor (VEGF). These studies have indicated that repeated doses of anti-VEGF medications, such as ranibizumab, may prevent blood vessels from leaking fluid and causing macular edema. The DRCR.net study, published online April 27 in Ophthalmology, confirms preliminary results and provides evidence of the treatment's effectiveness in combination with laser therapy through at least one year of follow up.

"This comparative-effectiveness study demonstrated that a new treatment can protect and, in many cases, improve the vision of people with diabetic macular edema," said NEI Director Paul A. Sieving, M.D., Ph.D.

The current study included a total of 854 eyes of 691 people, who had one or both eyes treated. Participants, who were on average in their early 60s, were diagnosed with type 1 or 2 diabetes and macular edema. They were randomly assigned to one of four study groups: sham injections plus prompt laser treatment within one week; ranibizumab injections plus prompt laser treatment; ranibizumab plus deferred laser treatment after six months or more; or injections of corticosteroid medication known as triamcinolone (Trivaris) plus prompt laser treatment.

Ranibizumab injections could be given as often as every four weeks, and triamcinolone injections or laser treatments could be given as often as every 16 weeks. In general, treatment was continued until a participant’s vision or retinal thickness returned to normal, or additional treatment did not improve vision or retinal swelling.

After one year, nearly 50 percent of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. People could read at least two additional lines on an eye chart with the treated eye, or letters that were at least one-third smaller than they could read before the study treatment. Fewer than 5 percent of eyes in these groups experienced a visual loss of two or more lines. The results were similar whether patients received prompt or deferred laser treatment with the ranibizumab injections.

In contrast, about 30 percent of eyes that received laser treatment alone or triamcinolone plus laser showed a visual improvement of two or more lines on an eye chart, while 13 to 14 percent of eyes in these groups had a visual loss of two or more lines.

Although participants in all three injection groups had a greater decrease in retinal thickness after one year than with laser treatment alone, patients who received triamcinolone injections had greater complication rates. About 30 percent of people in the triamcinolone group developed high eye pressure that required medications, and about 60 percent developed cataracts that required surgery.

Few participants who received eye injections of ranibizumab had eye-related complications, such as an infection inside the eye likely caused by the injections, or worsening of a retinal detachment that existed prior to beginning treatment. The study found that eye injections of ranibizumab were not associated with any serious risks such as heart attack or stroke. DRCR.net researchers will continue to monitor the study participants for at least three years to obtain additional information about the safety and effectiveness of these macular edema treatments.

Find more information about this clinical trial (NCT00444600) at www.clinicaltrials.gov.

Soundbites and b-roll, including interview with and footage of study participant, are available to the media by calling the NEI Office of Communication at 301-496-5248.

The National Eye Institute, part of the National Institutes of Health, leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs that result in the development of sight-saving treatments. For more information, visit www.nei.nih.gov.

The National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Comparative-Effectiveness Study Confirms New Treatment for Diabetic Macular Edema, April 27, 2010 News Release - National Institutes of Health (NIH)

FDA Approves New Device for Adults with Severe and Persistent Asthma

FDA NEWS RELEASE
For Immediate Release: April 27, 2010
Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Device for Adults with Severe and Persistent Asthma

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.

For more information:

Medical Device Approvals at FDA1
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

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FDA Approves New Device for Adults with Severe and Persistent Asthma

Alzheimer's Disease and Cognitive Decline: Structured Abstract

Alzheimer's Disease and Cognitive Decline
April 2010

--------------------
Structured Abstract
Objectives: To assess whether previous research on purported risk or protective factors for Alzheimer's disease (AD) and cognitive decline is of sufficient strength to warrant specific recommendations for behavioral, lifestyle, or pharmaceutical interventions/modifications targeted to these endpoints.

Data Sources: MEDLINE® and the Cochrane Database of Systematic Reviews. Additional studies were identified from reference lists and technical experts.

Review Methods: A group of experts in the field developed the list of factors to be evaluated in preparation for an upcoming National Institutes of Health (NIH) Office of Medical Applications of Research (OMAR) State-of-the-Science Conference addressing the prevention of AD and cognitive decline. We grouped the factors into the following categories: nutritional factors, medical conditions and prescription and non-prescription medications, social/economic/behavioral factors, toxic environmental factors, and genetics. Outcomes of interest were a diagnosis of AD or cognitive decline. Both observational and intervention studies were evaluated. Studies were evaluated for eligibility and quality, and data were abstracted on study design, demographics, intervention or predictor factor, and cognitive outcomes.

Results: A total of 25 systematic reviews and 250 primary research studies were included. Only a few factors showed a consistent association with AD or cognitive decline across multiple studies, including both observational studies and randomized controlled trials (when available). Such factors associated with increased risk of AD and cognitive decline were: diabetes, epsilon 4 allele of the apolipoprotein E gene (APOE e4), smoking, and depression. Factors showing a fairly consistent association with decreased risk of AD and cognitive decline were: cognitive engagement and physical activities. A consistent association does not imply that findings were robust, as the data were often limited, and the quality of evidence was typically low. In addition, the risk modification effect of reported associations was typically small to moderate for AD, and small for cognitive decline. Some of the factors that did not show an association with AD or cognitive decline in this review may still play an influential role in late-life cognition, but there was not sufficient evidence to draw this conclusion. Many of the factors evaluated are not amenable to randomization, so rigorous observational studies are required to assess their effect on AD and cognitive decline.

Conclusions: The current research on the list of putative risk or protective factors is largely inadequate to confidently assess their association with AD or cognitive decline. Further research that addresses the limitations of existing studies is needed prior to be able to make recommendations on interventions.



-------------------
Download Report
Alzheimer's Disease and Cognitive Decline

•Evidence Report (Publication No. 10-E005) (PDF File, 6.8 MB, 727 pages) PDF Help.
http://www.ahrq.gov/downloads/pub/evidence/pdf/alzheimers/alzcog.pdf
Persons with disabilities experiencing problems accessing portions of the PDF file for this report should contact Janet Howard at (301) 427-1882.

Evidence-based Practice Center: Duke University

Current as of April 2010


------------------
Internet Citation:

Alzheimer's Disease and Cognitive Decline, Structured Abstract. April 2010. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/tp/alzcogtp.htm

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Alzheimer's Disease and Cognitive Decline: Structured Abstract

Adding Coronary Calcium Score to Traditional Risk Factors Improves Risk Assessment for Heart Disease, April 27, 2010 News Release - National Institutes of Health (NIH)

Tuesday, April 27, 2010
4 p.m. EDT Contact:
NHLBI Communications Office
301-496-4236
Adding Coronary Calcium Score to Traditional Risk Factors Improves Risk Assessment for Heart Disease
Including a coronary artery calcium score in a risk assessment for future heart disease events, such as heart attacks, provides a better estimate in some populations than a standard coronary risk factors assessment, according to research supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

A coronary artery calcium score was most helpful for people considered to be at intermediate risk of a heart disease — defined as those with a 3 to 10 percent chance of developing heart disease over the next five years — according to the report in the April 28 issue of the Journal of the American Medical Association.

In the Multi-Ethnic Study of Atherosclerosis (MESA), researchers used cardiac CT scans, which detect specks of calcium in the walls of the coronary arteries. These specks, indicating calcifications, are an early sign of coronary artery disease, or heart disease. Heart disease is the leading cause of heart attacks, angina (chest pain) and death in the United States.

"This study adds to our knowledge about the possible use of a coronary calcification scan to improve prediction of a patient's risk of heart disease, especially in individuals considered at intermediate, or moderate, risk of heart disease," said NHLBI Acting Director Susan B. Shurin, M.D. "However, further evidence is needed to know whether using this test will actually change the course of heart disease and improve patient outcomes."

The study drew from 5,878 MESA participants, ages 45 to 84, who initially did not have known cardiovascular disease, and included both men and women who were white, African-American, Hispanic, or of Chinese heritage. Interviewers telephoned participants or a family member at intervals of nine to 12 months to inquire about interim hospital admissions, diagnoses of cardiovascular disease, and deaths.

Participants were followed for almost six years. Over the follow-up period, 209 participants experienced a heart disease event, such as heart attack, death from heart disease, or cardiac arrest.

Using the coronary artery calcium score in addition to standard risk factors accurately placed 77 percent of the overall population into the highest or lowest risk categories, compared to only 69 percent assessed with traditional risk factors alone.

The risk assessment with the coronary calcium score reclassified a notable proportion of participants to a more accurate risk classification. An additional 23 percent of those who experienced events were reclassified to high risk, and an additional 13 percent who did not experience an event were appropriately reclassified to low risk.

Risk classifications were created using risk factors from the Framingham Heart Study Risk Score and based upon the risk of having a heart attack or dying from heart disease within five years. Risk factors considered were age, gender, tobacco use, systolic blood pressure (the top number in a blood pressure reading), blood pressure medication use, blood cholesterol levels, and ethnicity. Individuals with less than a 3 percent chance of heart disease in the next five years were considered to be low-risk; those with a 3 to 10 percent chance to be intermediate-risk; and those with more than a 10 percent chance to be high-risk.

The MESA findings indicate that a coronary artery calcium score may not be an efficient screening tool among low-risk individuals. It is generally accepted that patients who are at high risk should be treated regardless of their coronary artery calcium score, and as a result do not need coronary artery calcium testing for additional risk assessment.

"We found that when we included the coronary artery calcium score to predict risk, we were better able to identify those who developed serious chest pain or heart attacks. The coronary artery calcium score was most helpful in people who would usually be thought of as intermediate risk," explained Tamar Polonsky, M.D., of Northwestern University, the lead author of the paper. "It can sometimes be hard to know whether to do things such as start patients at intermediate risk on cholesterol-lowering medicine, and so it is possible that the coronary artery calcium score may help physicians and patients decide the best way to control their risk factors."

Coronary artery calcium scanning is not generally recommended as a screening test. Whether it would improve outcomes is unknown and the scans entail additional costs and some risks, such as exposure to small amounts of radiation. One recent study provided some indication of an elevated cancer risk if a calcium score is obtained every five years. Some have suggested that a coronary artery calcium score-guided strategy may actually cost more money and prevent fewer events than simply treating all patients at intermediate risk.

"Physicians should first consider and treat major risk factors, such as high cholesterol and high blood pressure, and address smoking in their patients, because modifying these risk factors will improve outcomes,"said Diane Bild, M.D., director of the NHLBI's Prevention and Population Sciences Program, and a coauthor of the paper.

MESA researchers are investigating the early stages of coronary artery disease in various studies. More than 6,000 ethnically diverse men and women from six communities in the United States are participating in MESA. Participants undergo coronary tests such as CT scans, magnetic resonance imaging, ultrasounds, and electrocardiograms.

To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at (301) 496-4236 or email nhlbi_news@nhlbi.nih.gov. To arrange an interview with Dr. Polonsky, please contact the Northwestern University Feinberg School of Medicine Office of Communications at (312) 503-8928 or email marla-paul@northwestern.edu.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.


--------------------------------------------------------------------------------
Resources:
•The Multi-Ethnic Study of Atherosclerosis (MESA): http://www.mesa-nhlbi.org•The Multi-Ethnic Study of Atherosclerosis (MESA) in ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00005487?term=mesa&rank=5•What Is a Coronary Calcium Scan?: What is Atherosclerosis?: http://www.nhlbi.nih.gov/health/dci/Diseases/Atherosclerosis/Atherosclerosis_WhatIs.html

•What Is Coronary Artery Disease?: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html•What Is a Heart Attack?: http://www.nhlbi.nih.gov/health/dci/Diseases/HeartAttack/HeartAttack_WhatIs.html

•What Is Sudden Cardiac Arrest?: http://www.nhlbi.nih.gov/health/dci/Diseases/scda/scda_whatis.html

•What Is Cardiac CT? http://www.nhlbi.nih.gov/health/dci/Diseases/ct/ct_whatis.html

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Adding Coronary Calcium Score to Traditional Risk Factors Improves Risk Assessment for Heart Disease, April 27, 2010 News Release - National Institutes of Health (NIH)

Licensure of a High-Dose Inactivated Influenza Vaccine for Persons Aged ≥65 Years (Fluzone High-Dose) and Guidance for Use --- United States, 2010

Licensure of a High-Dose Inactivated Influenza Vaccine for Persons Aged ≥65 Years (Fluzone High-Dose) and Guidance for Use --- United States, 2010
Weekly
April 30, 2010 / 59(16);485-486


Persons aged ≥65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups (1,2), and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults (3). On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone. Fluzone High-Dose is licensed as a single dose for use among persons aged ≥65 years and will be available beginning with the 2010--11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines (4). This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.

Standard dose inactivated trivalent influenza vaccines contain a total of 45 µg (15 µg of each of the three recommended strains) of influenza virus hemagglutinin antigen per 0.5mL dose (5). In contrast, Fluzone High-Dose is formulated to contain a total of 180 µg (60 µg of each strain) of influenza virus hemagglutinin antigen in each 0.5mL dose. Like other inactivated influenza vaccines, Fluzone High-Dose is administered as an intramuscular injection (6). Fluzone High-Dose is available as a single-dose prefilled syringe formulation and is distinguished from Fluzone by a gray syringe plunger rod. As with other 2010--11 influenza vaccines, Fluzone High-Dose will contain antigens of the three recommended virus strains: A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like (7).

Immunogenicity data from three studies among persons aged ≥65 years indicated that, compared with standard dose Fluzone, preparations of Fluzone High-Dose elicited significantly higher hemagglutination inhibition (HI) titers against all three influenza virus strains that were included in seasonal influenza vaccines recommended during the study period (8--10). In one study, prespecified criteria for superiority, defined as when the lower 95% confidence limit of 1) a ratio of geometric mean HI titers is >1.5 for at least two strains and 2) the difference in fourfold rise of HI titers is >10% for at least two strains, were demonstrated for persons aged ≥65 years who received Fluzone High-Dose compared with Fluzone for influenza A(H1N1) and influenza A(H3N2) antigens. Prespecified criteria for noninferiority to Fluzone were demonstrated for the influenza B antigen (6,9). Whether the higher postvaccination immune responses observed among Fluzone High-Dose vaccine recipients will result in greater protection against influenza illness is unknown.

Solicited injection site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared with standard Fluzone, but typically were mild and transient (8--10). In the largest study, 915 (36%) of 2,572 persons who received Fluzone High-Dose, compared with 306 (24%) of 1,275 persons who received Fluzone, reported injection site pain ≤7 days after vaccine administration. In the same study, significantly more Fluzone High-Dose recipients (1.1%) reported moderate (>100.4°F--≤102.2°F [>38°C--≤39°C]) to severe (>102.2°F [>39°C]) fever, compared with Fluzone recipients (0.3%)(9).

ACIP Guidance for Use of Fluzone High-Dose

Fluzone High-Dose may be used for persons aged ≥65 years. All persons aged ≥6 months are recommended for annual influenza vaccination beginning with the 2010--11 influenza season. ACIP has not expressed a preference for any specific licensed inactivated trivalent influenza vaccine, including Fluzone High-Dose, for use in persons aged ≥65 years (4). Data demonstrating greater protection against influenza illness after vaccination with Fluzone High-Dose are needed to evaluate whether Fluzone High-Dose is a more effective vaccine for persons aged ≥65 years. A 3-year postlicensure study of the vaccine effectiveness of Fluzone High-Dose compared with standard dose inactivated influenza vaccine (Fluzone) was begun in 2009 and should be completed in 2012. As with other inactivated influenza vaccines, Fluzone High-Dose should not be administered to anyone with a known hypersensitivity to egg proteins or influenza vaccine. Adverse events after receipt of any vaccine should be reported to the Vaccine Adverse Event Reporting System at http://vaers.hhs.gov.

References
1.Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004;292:1333--40.
2.Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003;289:179--86.
3.Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine 2006;24:1159--69.
4.CDC. ACIP provisional recommendations for the use of influenza vaccines. Atlanta, GA, US Department of Health and Human Services, CDC; 2010. Available at http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf . Accessed April 23, 2010.
5.CDC. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR 2009;58(No. RR-8).
6.Sanofi Pasteur, Inc. Fluzone and Fluzone High-Dose [prescribing information]. Swiftwater, PA: Sanofi Pasteur, Inc.; 2009. Available at http://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm195479.pdf . Accessed April 23, 2010.
7.Food and Drug Administration. Influenza virus vaccine for the 2010--2011 season. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration; 2010. Available at http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/post-marketactivities/lotreleases/ucm202750.htm. Accessed April 23, 2010.
8.Couch RB, Winokur P, Brady R, et al. Safety and immunogenicity of a high dosage trivalent influenza vaccine among elderly subjects. Vaccine 2007;25:7656--63.
9.Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis 2009;200:172--80.
10.Keitel WA, Atmar RL, Cate TR, et al. Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med 2006;166:1121--7.

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Licensure of a High-Dose Inactivated Influenza Vaccine for Persons Aged ≥65 Years (Fluzone High-Dose) and Guidance for Use --- United States, 2010

CONSUMO EXCESIVO DE ANTIBIÓTICOS - AMÉRICA LATINA

CONSUMO EXCESIVO DE ANTIBIÓTICOS - AMÉRICA LATINA

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
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Fecha: 29 de abril, 2010
Fuente: SciDevNet
http://www.scidev.net/en/news/antibiotic-use-increases-in-latin-america-.html
Referencia original: Rev Panam Salud Publica. 2010;27(3):219-25
[Editado por Jaime Torres y Jorge González]

El consumo promedio de antibióticos en los ocho países con el mercado farmacéutico más grande de América Latina aumentó casi 10 por ciento entre 1997 y 2007. Así lo indica un estudio sobre tendencias en el consumo de estos fármacos en la región, publicado recientemente en la Revista Panamericana de Salud Pública.

Los autores analizaron cifras de venta de antibióticos con y sin prescripción médica en farmacias, clínicas privadas y hospitales de Argentina, Brasil, Chile, Colombia, México, Perú, Uruguay y Venezuela.

Como unidad de medida usaron la Dosis Diaria Definida (DDD) por 1.000 habitantes. Así, si la DDD es 10, quiere decir que 10 personas de cada 1.000 consumen cada día una dosis del antibiótico. Mientras en 1997 el consumo promedio fue de 10,92 DDD, en 2007 se elevó a 11,99 DDD. Esto equivale a un aumento de 9,8 por ciento.

El consumo más alto de antibióticos en 1997 lo registró México (15,69 DDD), seguido de Argentina (14,37), Chile (14,07), Colombia (12,17) y Venezuela (11,18). El menor uso lo registraron Perú (7,91), Brasil (6,51) y Uruguay (5,43).

Diez años más tarde, encabezaba la lista Argentina (16,64), seguida de Venezuela (15,99), Perú (13,50), México (13,26) y Chile (12,53). El consumo más bajo estuvo en Brasil (7,01), Colombia (8,07) y Uruguay (8,9).

"No existe acuerdo sobre un DDD adecuado. Sin embargo, Holanda tiene el consumo más bajo de antibióticos en Europa (10 DDD) y su morbilidad y mortalidad por enfermedades infecciosas no es mayor que otros países europeos", dijo a SciDev.Net Veronika Wirtz, investigadora del Instituto Nacional de Salud Pública en Cuernavaca (México) y coautora del estudio.

En el período analizado, Colombia mostró la mayor reducción en el uso de antibióticos (33,7 por ciento) y Perú la mayor alza (70,6 por ciento). Los autores no encontraron asociación entre el consumo de antibióticos y el nivel de ingreso del país o el tipo de seguro de salud.

Estos hallazgos coinciden con "la creciente resistencia a los antibióticos en América Latina", atribuible a la automedicación, prescripciones innecesarias y falta de regulaciones para restringir la venta, afirman. Los autores sugieren estar atentos a patrones de resistencia que podrían afectar a algunos tipos de antibióticos, como
macrólidos y quinolonas.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]

-- ProMED-ESP

[Comentario: El uso; mejor dicho, el mal uso de los antibióticos es una práctica
endémica en América Latina. Las cifras presentadas llaman a reflexión, particularmente el marcado aumento en el consumo de antibióticos en Perú y la reducción del mismo en Colombia. En el primer caso, la apertura del mercado y las facilidades para la importación de productos farmacéuticos hacen que se disponga - por ejemplo - de 37 marcas diferentes de ciprofloxacina, de precios muy variables y con un control de calidad insuficiente. Si a ello se agrega la automedicación, la sugerencia de uso de antibióticos por parte de empíricos (desde amistades y familiares hasta dependientes de farmacias), el uso de antibióticos en esquemas absolutamente inapropiados o en combinación con antiinflamatorios y corticosteroides
(medicamentos que por la naturaleza de su efecto afectan la llegada del antibiótico al lugar de la infección) y el mal uso de dichos compuestos por algunos profesionales de la salud (mala prescripción de dosis, intervalos de uso y duraciones de tratamiento inadecuadas), se tiene el escenario perfecto para el aumento del uso de antibióticos, con el consiguiente aumento de la resistencia a dichos compuestos, tal
como se ha evidenciado en numerosas publicaciones. Urge, pues, que las autoridades de salud emprendan campañas educativas permanentes dirigidas hacia la población en referencia al uso racional de los antibióticos; hacer cumplir la ley, puesto que la venta de antibióticos sin receta es la regla general; y también realizar actividades educativas para los profesionales de la salud, instándoles a que prescriban el antibióticos sobre la base de evidencia o de una sospecha fundamentada y no para cubrirse las espaldas o tranquilizar a un paciente ansioso y demandante. Moderador Jorge González. ]
-----
ProMED-mail
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ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
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PESTE BUBÓNICA, BROTE FAMILIAR - PERÚ (CHICAMA)

PESTE BUBÓNICA, BROTE FAMILIAR - PERÚ (CHICAMA)

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
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Fecha: 29 de abril, 2010
Fuente: La Industria, Perú
http://www.laindustria.pe/index.php?option=com_content&task=view&id=14137&Itemid=17
[Editado por J. Torres]

Un nuevo brote de peste bubónica detectó el personal de Salud del establecimiento de Chicama, jurisdicción de Ascope. Hasta el momento se han reportado tres casos en menores de edad, de 10,12 y14 años, todos miembros de una familia.

El gerente Regional, Henry Rebaza Iparraguirre, expresó a laindustria.pe su preocupación y dijo que existe un probable muerto, a consecuencia de la enfermedad, que los médicos especialistas buscan confirmar la presunción, a través de investigaciones en el laboratorio.

La enfermedad vuelve a reaparecer después de ocho meses que se focalizó un brote en el sector Santa Clara, donde se registraron 15 casos, pero fue controlado con una serie de medidas sanitarias. Esta aparición de casos estuvo asociado a un brote en Cajamarca. "Este mal reaparece en el Perú después de 12 años", dijo el epidemiólogo Pedro Díaz Camacho.

La peste es una enfermedad infecciosa aguda, provocada la bacteria _Yersinia Pestis_, perteneciente a la familia de las Enterobacterias.

Una vez que las células bacterianas han sido introducidas mediante la picadura de la pulga de rata dentro del ser humano, las células bacterianas se desplazan por el torrente sanguíneo hasta los nódulos linfáticos, donde generan pequeñas hinchazones denominadas bubones.

Personal del centro de salud de Chicama, el 21 del corriente, identificó a los pacientes con ganglios linfáticos (bubones) en el cuerpo, síntoma de la peste.. La sospecha movilizó al personal de salud y a adoptar acciones inmediatas. Aunque los pacientes informaron que los síntomas aparecieron el 15 de abril.

ACCIONES INMEDIATAS

Rebaza Iparraguirre informó que el personal de salud, tanto de la zona como especialistas de la Gerencia de Salud desarrollan una serie de actividades preventivas y de control. "Hacemos diagnóstico de laboratorio, búsqueda activa de casos a 300 metros de las viviendas de los pacientes, tratamiento para 14 probables contactos, captura de roedores en el ámbito interno y externo de las viviendas para capturar al o animales enfermos", expresó.

El funcionario contó que también realizan educación sanitaria en la zona para prevenir la enfermedad. "La recomendación es que toda persona con fiebre y ganglios linfáticos acuda al centro de salud más cercano", anotó Rebaza Iparraguirre.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]
-- ProMED-ESP
...jt
*#########################*
ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
**************************

INFECCIÓN NOSOCOMIAL, NEONATOS, MUERTES - BRASIL (ALAGOAS)

INFECCIÓN NOSOCOMIAL, NEONATOS, MUERTES - BRASIL (ALAGOAS)

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
http://www.isid.org

Fecha: 28 de abril, 2010
Fuente: ANSA Latina
http://www.ansa.it/ansalatina/notizie/notiziari/brasil/20100428202535070620.html
[Editado por J. Torres]

La Secretaría Estadal de Salud de Alagoas, noreste de Brasil, investiga la muerte de recién nacidos en la Maternidad Escola Santa Mónica, pública y vinculada con la Universidad de Ciencias de la Salud de ese estado.

Según asesores de prensa del hospital, 21 bebés murieron desde inicios de abril en ese centro médico, cinco de ellos víctimas de infección hospitalaria tardía -adquirida después del nacimiento. Equipos de Vigilancia Sanitaria del gobierno visitaron el martes y hoy la maternidad, y deben concluir en los próximos días los
resultados de la inspección.

La dirección de la maternidad informó a la prensa local que es la unidad es "referencia" en atención a embarazadas y recién nacidos de "alto riesgo", y que por eso "es común registrar nacimientos de prematuros y bebés con otras enfermedades, que no resisten los problemas de salud". Pero, agregó la fuente, la preocupación "ahora es la alta reincidencia de infecciones" y también "el déficit de neonatólogos".
Comunicado por: Jaime R. Torres
-- ProMED-ESP
...jt
*########################*
ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
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WILL SEE YOU AGAIN

WILL SEE YOU AGAIN ON FRIDAY APRIL 30

Management of Asthma (Adult and Pediatric) - VA/DoD Clinical Practice Guidelines

Management of Asthma (Adult and Pediatric)

The guideline describes the critical decision points in the Management of Asthma and provides clear and comprehensive evidence based recommendations incorporating current information and practices for practitioners throughout the DoD and VA Health Care systems. The guideline is intended to improve patient outcomes and local management of patients with Asthma.

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Management of Asthma (Adult and Pediatric) - VA/DoD Clinical Practice Guidelines

Estrogen and progestogen use in postmenopausal women: 2010 position statement of The North American Menopause Society

Estrogen and progestogen use in postmenopausal women: 2010 position statement of The North American Menopause Society

NAMS has submitted updated guidelines on estrogen and progestogen use in postmenopausal women.
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http://www.menopause.org/PSht10.pdf

Abstract
Objective: To update for both clinicians and the lay public the evidence-based position statement published by The North American Menopause Society (NAMS) in July 2008 regarding its recommendations for menopausal hormone therapy (HT) for postmenopausal women, with consideration for the therapeutic benefit-risk ratio at
various times through menopause and beyond.

Methods: An Advisory Panel of clinicians and researchers expert in the field of women_s health was enlisted to review the July 2008 NAMS position statement, evaluate new evidence through an evidence-based analysis, and reach consensus on recommendations. The Panel_s recommendations were reviewed and approved by the NAMS
Board of Trustees as an official NAMS position statement. Also participating in the review process were other interested organizations who then endorsed the document.

Results: Current evidence supports a consensus regarding the role of HT in postmenopausal women, when potential therapeutic benefits and risks around the time of menopause are considered. This paper lists all these areas along with explanatory comments. Areas that vary from the 2008 position statement are noted. A suggested reading list of key references published since the last statement is also provided.

Conclusions: Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms; to treat or reduce the risk of certain disorders, such as osteoporosis or fractures in select postmenopausal women; or both. The benefit-risk ratio for menopausal HT is favorable for women who initiate HT close to menopause but decreases in older women and with time since menopause in previously untreated women.

Key Words: Bioidentical hormones Y Breast cancer Y Cardiovascular disease Y Cognitive decline Y Coronary heart disease Y Dementia Y Depression Y Diabetes mellitus Y Endometrial cancer Y Estrogen Y Estrogen progestogen therapy Y Estrogen therapy Y Hormone replacement therapy Y Hormone therapy Y Menopause Y Mood Y NAMS Y
Osteoporosis Y Ovarian cancer Y Perimenopause Y Postmenopause Y Premature menopause Y Premature ovarian insufficiency Y Progestogen Y Sexual function Y Stroke Y Total mortality Y Urinary health Y Quality of life Y Vaginal atrophy Y Vaginal health Y Vasomotor symptoms Y Venous thromboembolism Y Women_s Health Initiative.

This NAMS position statement has been endorsed by:
1 HealthyWomen (formerly the National Women_s Health Resource Center),
2 Asociacio´n Mexicana para el Estudio del Climaterio (AMEC),
3 Society of Obstetricians and Gynaecologists of Canada (SOGC)
4 The Endocrine Society,
5 American Medical Women_s Association (AMWA),
and
6 National Association of Nurse Practitioners in Women_s Health (NPWH).

NGC - Compare - Comparison: MANAGEMENT OF GENITAL HERPES

NATIONAL GUIDELINE CLEARINGHOUSE™ (NGC)
GUIDELINE SYNTHESIS
MANAGEMENT OF GENITAL HERPES
GUIDELINES BEING COMPARED

1.British Association for Sexual Health and HIV (BASHH). 2007 national guideline for the management of genital herpes. London (UK): British Association for Sexual Health and HIV (BASHH); 2007. 26 p. [107 references]

2.Centers for Disease Control and Prevention (CDC). Diseases characterized by genital ulcers. Sexually transmitted diseases treatment guidelines 2006. MMWR Morb Mortal Wkly Rep 2006 Aug 4;55(RR-11):14-30. [222 references]

3.Society of Obstetricians and Gynaecologists of Canada (SOGC). Genital herpes: gynaecological aspects. J Obstet Gynaecol Can 2008 Apr;30(4):347-53. [21 references]

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NGC - Compare - Comparison

Tobacco control.

GUIDELINE TITLE
Tobacco control.

BIBLIOGRAPHIC SOURCE(S)
Michigan Quality Improvement Consortium. Tobacco control. Southfield (MI): Michigan Quality Improvement Consortium; 2009 Sep. 1 p.

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: Michigan Quality Improvement Consortium. Tobacco control. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Sep. 1 p.

** REGULATORY ALERT **
FDA WARNING/REGULATORY ALERT
Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

July 1, 2009 - Chantix or Champix (Varenicline) and Zyban or Wellbutrin (bupropion or amfebutamone): The U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

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Tobacco control.

Screening, diagnosis and referral for substance use disorders.

GUIDELINE TITLE
Screening, diagnosis and referral for substance use disorders.

BIBLIOGRAPHIC SOURCE(S)
Michigan Quality Improvement Consortium. Screening, diagnosis and referral for substance use disorders. Southfield (MI): Michigan Quality Improvement Consortium; 2009 Aug. 1 p.

GUIDELINE STATUS
This is the current release of the guideline.

Michigan Quality Improvement Consortium. Screening, diagnosis and referral for substance use disorders. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Aug. 1 p.

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Screening, diagnosis and referral for substance use disorders.

Medical management of adults with osteoarthritis.

GUIDELINE TITLE
Medical management of adults with osteoarthritis.

BIBLIOGRAPHIC SOURCE(S)
Michigan Quality Improvement Consortium. Medical management of adults with osteoarthritis. Southfield (MI): Michigan Quality Improvement Consortium; 2009 Aug. 1 p.

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: Michigan Quality Improvement Consortium. Medical management of adults with osteoarthritis. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Aug. 1 p.

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Medical management of adults with osteoarthritis.

Medical management of adults with hypertension.

GUIDELINE TITLE
Medical management of adults with hypertension.

BIBLIOGRAPHIC SOURCE(S)
Michigan Quality Improvement Consortium. Medical management of adults with hypertension. Southfield (MI): Michigan Quality Improvement Consortium; 2009 Aug. 1 p.

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: Michigan Quality Improvement Consortium. Medical management of adults with hypertension. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Aug. 1 p.

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Medical management of adults with hypertension.