Welcome to HCV rewind, a weekly digest of news, research and a look at today's headlines.
New At Projects In Knowledge
Projects In Knowledge just released a new webcast discussing stopping rules and response-guided HCV therapy for patients undergoing treatment with boceprevir or telaprevir:
Hepatitis C — Challenges to Response-Guided Therapy and Stopping Rules – Webcast:
Are you confident in applying response-guided therapy to your patients with chronic hepatitis C undergoing boceprevir- or telaprevir-based triple therapy? Do you know which patients are eligible? Do you know how the rules vary between therapies? In this case-based webcast, Elizabeth Goacher, PA, and Steven L. Flamm, MD, will show you how to apply response-guided therapy and stopping rules in clinical practice. “Challenges to Response-Guided Therapy and Stopping Rules,” is part of the HCV Care and Guidance: Practical Education and Resources.
Hepatitis C — DAA Treatment: A Guide for Managing the HCV Epidemic – Webcast:
Additionally, released in May, is a webcast with Ira M. Jacobson, MD, and Hashem B. El-Serag, MD, MPH, covering the following topics; CDC guidelines, DAAs, FDA approved PIs, SVR12, and Interferon free regimens in development, ending with a roundtable discussion.
*Like any site offering continuing medical education (CME), a free quick registration is required.
New At The Journal Of Hepatology
GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C
Published on Jul 9, 2012 by jhepatology
Prof. Eric Lawitz discusses his manuscript "A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C"
http://dx.doi.org/10.1016/j.jhep.2011.12.029
New At HCV Advocate
HBV and HCV Advocate Hepatitis Blog: "Ask Me about Hepatitis C Palm Card"
http://dx.doi.org/10.1016/j.jhep.2011.12.029
New At HCV Advocate
HBV and HCV Advocate Hepatitis Blog: "Ask Me about Hepatitis C Palm Card"
Updated July 9 2012:
Hepatitis C Treatments in Current Clinical Development
New From
Hepatitis C: Postponing Pain
New At NATAP
HCV Research: new HCV drugs coming; interferon-free therapy
There are 4 new oral HCV drugs in the middle now of phase 3 studies, the last step before FDA approval & being in pharmacy - protease inhibitor TMC435, protease BI-335, NS5A BMS-052, and nucleotide GS-7977. Will we be able to combine 3 drugs in 1 regimen (protease+052+7977), we don't know? Small interferon-free studies reported at liver meeting EASL in April 2012 found 90-100% cure rates in treatment-naive patients: A phase 2 40-patient study at EASL in treatment-naives showed 100% SVR(cure) rate with 052+7977 with 24 weeks of therapy; 2 small phase 2 studies with protease ABT450/r+ a NNRTI+rbv found 90-95% SVR(cure) rates with only 12 weeks of therapy. Phase 3 for ABT450 is expected to begin soon....Continue reading....
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3, and GT1
This study is currently recruiting participants.
Verified July 2012 by Gilead Sciences ..Read more @ NATAP
HCV Viral Load Reduction Improved Inflammation, Fibrosis, Clinical Outcomes with PegIFn Lead-In Maintenance therapy in HALT-C
[from Jules: I don't know how many of you recall I protested and disagreed with the original report by the HALT-C investigators when they said in their initial presentation at AASLD several years ago that maintenance therapy was not useful & provided no improvement. I vehementky disagreed & said they were wrong, finally this publication agrees with me.]
In Case You Missed It:
Overcoming Barriers to Care for Hepatitis C - Perspective
Hepatitis C offers a window into contentious issues in health care reform. How can therapy be made more accessible, and if it is more accessible, how will we as a community pay for it? At a population level, improving the diagnosis and treatment of HCV infection will be expensive but will avert much illness and death from decompensated liver cirrhosis and hepatocellular carcinoma, the prevalence of which is projected to substantially increase over the next decade, at major cost to the community.2,3 The possibility of achieving future cost savings, particularly for disadvantaged groups, raises the question: can we afford not to improve the accessibility of treatment for hepatitis C?
New At GastroHep.TV
Immuno-Gastroenterology: A New Multi-Disciplinary Journal
The sections covered by Immuno-Gastroenterology include: 1. hepatobiliary diseases (autoimmune hepatitis, primary biliary cirrhosis/primary sclerosing cholangitis and overlap syndromes, alcoholic and non-alcoholic fatty liver diseases, viral hepatitis, drug-induced liver diseases); 2. liver regeneration and transplantation; 3. stem cells in gastrointestinal, pancreatic and liver diseases; 4. hepatobiliary cancer immunology; 5. gastrointestinal and pancreatic cancer immunology; 6. inflammatory bowel diseases immunology; 7. autoimmune pancreatic diseases; 8. gut immune system (includes innate and adaptive immune system, hormones, intestinal epithelial immune barrier, homeostasis, microbiota, commensal bacteria, etc.); 9. Helicobacter pylori; 10. brain-gut axis/neurodegenerative immune mechanisms/disorders; and 11. nutritional immunology, immunological tolerance and autoimmunity, autophagy in the adaptive immune response, and immunosenescence...Continue Reading....
New At Pharmalot
What’s In A Name? A New Fight Over Biosimilars
The sparring over biosimilars between drugmakers and their generic rivals has shifted to a new playing field – the name game. To be specific, brand-name drugmakers and biotechs want the FDA to ensure that any and every biosimilar has a unique non-proprietary, or generic, name that will distinguish the medicine from the reference product, or original biologic.
Because a biosimilar or interchangeable biological product is highly similar to, but not the same as, its respective reference product, it would be inappropriate, from a patient safety perspective, to permit the use of the same name for biological products that are not the same,” the PhRMA and BIO trade groups wrote to FDA commish Margaret Hamburg in a June 25 letter. “Unique names will be necessary to ensure appropriate pharmacovigilance. Thus, it is essential that each biological medicine have a unique non-proprietary name.”
Continue Reading...
***Biosimilars are copycat versions of expensive biotechnology drugs. Although technically these "biosimilars" are not called generic.
Example of biologics made with recombinant DNA technology:
Erythropoietin = Epogen / stimulation of red blood cell production
HCV Transmission Clinical Setting
A Colorado dentist who reused syringes and needles to administer drugs to patients possibly exposing them to HCV, HBV and AIDS.
In New Hampshire, health officials have confirmed four additional cases of hepatitis C at Exeter Hospital, bringing the total to 31 people testing positive since the investigation began in late May.
Updated: 07/12/2012
DENVER- State health officials allege a Colorado dentist reused syringes and needles to administer drugs to patients, possibly exposing them to the virus that causes AIDS or to hepatitis.
The Colorado health department said Thursday no specific infections have been linked to the offices of the dentist, identified as Stephen Stein.
The Colorado health department said Thursday no specific infections have been linked to the offices of the dentist, identified as Stephen Stein.
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Stein's attorney, Victoria Lovato, didn't immediately return a call seeking comment.
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It wasn't clear when alleged practice started but officials say it didn't continue past June 2011.
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Also unclear is how many patients might be involved. Officials say anyone who received intravenous drugs under Stein's care between September 1999 and June 2011 may have been exposed to human immunodeficiency virus or HIV, hepatitis B or hepatitis C.
Health officials say Stein isn't currently practicing.
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Also unclear is how many patients might be involved. Officials say anyone who received intravenous drugs under Stein's care between September 1999 and June 2011 may have been exposed to human immunodeficiency virus or HIV, hepatitis B or hepatitis C.
Health officials say Stein isn't currently practicing.
Read complete story - Patients of oral surgeon advised to get tested for HIV, hepatitis
4 more hepatitis C cases confirmed in NH outbreak
4 more hepatitis C cases confirmed in NH outbreak
Altogether, 31 people have tested positive for the same strain of the disease since the investigation began in late May. State officials suspect a worker's misuse of drugs led to the outbreak.
Anyone who was treated at the lab since October 2010 has been asked to get tested, either at the hospital or at alternate sites in Hampton and Portsmouth.
In addition to the 31 cases, 12 people have been identified with a hepatitis C strain that does not match the one identified from the outbreak, said Jose Montero, state director of public health.
"These results do not require us to change the timeline for testing," he said, adding health officials are trying to reach about 50 patients from the cardiac catheterization lab list who still need to have their blood drawn for testing.
Hepatitis C is a blood-borne viral infection that can cause liver disease and chronic health issues.
A number of lawsuits have been filed against Exeter Hospital. At the start of July, almost 60 former patients of the hospital had filed suit. Of those, at least 47 patients have signed on to a class-action lawsuit, as well as 12 others who have each filed individual lawsuits.
The hospital has not commented on the lawsuits or on a criminal investigation.
Read more here.....
Research
Magnetic resonance elastography vs diffusion-weighted imaging for hepatic fibrosis staging
7/13/2012 GastroHep.com News
The latest issue of Hepatology compares the performance of magnetic resonance elastography with diffusion-weighted imaging for the staging of hepatic fibrosis...
High-grade liver inflammation may predict treatment response in patients with HCV
Patients with chronic hepatitis C who experienced a higher degree of liver inflammation were more responsive to treatment with interferon alpha and ribavirin in a recent study....
PEG-IFN treatment in hypertensive patients with HCV may cause retinopathy
Patients with chronic hepatitis C, particularly those with hypertension, were prone to developing retinopathy during treatment with pegylated interferon alpha and ribavirin in a recent study...
Can zinc enhance response interferon therapy for patients with HCV-related liver disease?
Patients with liver disease may be at risk of zinc depletion. Zinc supplementation has been shown to contribute to inhibition of liver fibrosis and improvement in hepatic encephalopathy. However, little is known about the anti-inflammatory effect of zinc on hepatitis C virus (HCV)-related chronic liver disease. The standard of care for chronic HCV has improved markedly since the approval of interferon (IFN) therapy more than a decade ago. Over the past 20 years, IFN therapy has improved to more effectively eliminate the virus, progressing from single IFN therapy to combination therapy with ribavirin (RBV) and finally to pegylated IFN (PEG-IFN) therapy. However, even combined therapy with PEG-IFN and RBV for 48 wk is unable to eliminate the virus in some 40% of hepatitis C cases, particularly those with genotype 1b and high viral load. Treatment options for patients who have relapsed or are refractory to treatment with PEG-IFN and RBV therefore need to be critically assessed. This paper overviews the relationship between chronic liver disease and zinc metabolism.
View the complete text here, or Download PDF.
Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma: Subanalyses of a Phase III Trial
Sorafenib is used to treat unresectable hepatocellular carcinoma (a type of liver cancer that cannot be treated with surgery). Sorafenib is in a class of medications called multikinase inhibitors. It works by slowing the spread of cancer cells. The drug is also used to treat advanced renal cell carcinoma (a type of cancer that begins in the kidneys).
In the (SHARP) trial; Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol, sorafenib improved overall survival and was found to be safe in patients with well-preserved liver function and advanced disease . An Asia-Pacific trial confirmed those findings.
Nevertheless, they conclude that “the efficacy and safety of sorafenib, relative to placebo, in patients with advanced HCC and well-preserved liver function do not appear to be affected by baseline health status, disease etiology, tumor burden, tumor stage, or prior therapy.”
“All together,” added Dr. Bruix, “the information provided by the SHARP trial and the Asian-Pacific trial with sorafenib has represented a major breakthrough for patients diagnosed with this disease.”
View the abstract here, and the article from Reuters Health here.
Adherence to Hepatitis C Treatment Interventions: A Comparative Effectiveness Review
A report conducted by the Evidence-based Practice Center (EPC)for the Agency for Healthcare Research and Quality (AHRQ) looked at adherence interventions with virological response, particularly SVR in patients undergoing dual and triple HCV therapy. In the systematic review researchers searched MEDLINE, PubMed, CENTRAL, PsycInfo, EMBASE, and CINHAL from 2001 through December 2011, as well as reference lists of relevant review articles. The review highlights the 80/80/80 rule used in hepatitis C literature; defined as taking 80% ribavrin and 80% interferon 80% of the time to increase SVR, finding the rule has two major limitations. First, this definition will no longer be applicable to the triple antiviral therapy for genotype 1 HCV patients. Second, there seems a continuous relationship between the level of adherence and the treatment response so defining adherence vs. nonadherence based on an arbitrary threshold may thus be suboptimal
Finally, as noted earlier, many of the studies we found were of poor quality, with inadequate reporting of study design and intervention details. Future studies should include clearer and more detailed reporting of study design and conduct. Studies need to provide sufficient information about how adherence interventions are undertaken, including the parties of undertaking intervention, such details of interventions such as intervention components, intensity, and duration. Studies should also describe methodological characteristics in more details. Randomized controlled trials should report details on patient selection, allocation, and followup. In the results, the data on loss to followup should be clearly reported. Cohort studies should provide detail on collected variables, sources of data, accuracy of measurements, and approaches that are used to minimize bias. In addition, studies should be more explicit and clear in defining and measuring adherence. Ideally, study reports should include a section to describe the definition and measurement of adherence.
View a summary of the report or download full text here.
Current and former smokers at risk for recurrent hepatitis post-liver transplantation
Transplant recipients who smoke or have smoked increase their risk of viral hepatitis reinfection following liver transplantation according to new research available in the July issue of Liver Transplantation - Findings suggest that tobacco in cigarettes may adversely affect immune system response in patients transplanted for viral hepatitis...
Protecting the hearts of those waiting for kidney and liver Transplants
As thousands of Americans await a life-saving kidney or liver transplant, medical teams are paying close attention to another organ: their hearts...
Additional Articles and Research For The Week Of July 9th:
Treatment of Patients With HCV Related Cirrhosis: Many Rewards With Very Few Risks
Patients with HCV-related compensated cirrhosis are the group most to benefit from antiviral treatment as viral clearance has been shown by several retrospective studies to reduce rates of liver complications.
Connecting Enzymes and Diseases - Researcher seeks insight into hepatitis C and Alzheimer’s
Ultimately, the work could provide important insights into the workings of chronic hepatitis C infection, which afflicts an estimated 180 million people worldwide, including more than 4 million in the United States, and Alzheimer’s disease, the most common form of dementia, which affects one in every eight Americans older than 65.
H. Pylori in HCV-related Chronic Hepatitis and Cirrhosis
What does the latest research tell us about the connection between H. pylori disease and the potential to develop HCV-related chronic liver disease and hepatocellular carcinoma?
This new study looks at the possible link.
Alcoholic hepatitis linked to hepatitis C risk
Hepatitis C virus (HCV) is more common in patients with alcoholic hepatitis than the general population, but infections may be going undetected, US data show.
HIV AIDS
Research suggests potential cause of HIV-associated dementia and depression
on July 12th, 2012
Researchers say the findings could lead to the development of new therapeutic interventions, which may also be useful in treating patients suffering from other brain ailments that appear to develop in the same way such as the elderly....
UW scientists discover why human body cannot fight HIV infection
University of Washington researchers have made a discovery that sheds light on why the human body is unable to adequately fight off HIV infection.
Levels of hepatitis C virus higher among African-Americans and males
Epidemiologists have determined that levels of hepatitis C virus (HCV) found among injection drug users (IDUs) were higher in individuals who are male or African American even after differences in other factors were considered...
Other Health News
Staph Infections Tied To Misuse Of Drug Vials
By Jessica Camille Aguirre
Misuse of a medical vials can spread infections.
Ten people were hospitalized and one was found dead after contracting staph infections from injections received at health clinics in Delaware and Arizona in early spring, according the Center for Disease Control and Prevention.
The infection clusters were described in the latest Morbidity and Mortality Weekly Report.
Seven people were infected at a Delaware orthopedic clinic and four people at a pain management clinic in Arizona after receiving injections from drug vials intended for use with a single patient but that were instead used multiple times, the report and state health officials said.
Patients at the Arizona clinic were infected with methicillin-resistant Staphylococcus aureus, or MRSA, and patients in both outbreaks were hospitalized.
One patient was found dead at home six days after receiving treatment at the Arizona clinic, but the report says Arizona officials didn't declare MRSA the official cause of death.
The outbreaks are two of 20 that have been caused by misuse of single-dose vials since safety standards were reinforced in 2007, according to the CDC.
Needles or syringes weren't reused in either clinic, according to Arizona and Delaware state health officials, unlike a high-profile series of hepatitis C infections at a clinic in Las Vegas a few years back. But vials containing drugs intended for one person were used multiple times.
Drugs in single-use vials lack preservatives that prevent the growth of bacteria and subsequent spread of infections between people, CDC spokeswoman Rosa Herrera told Shots.
Health workers sometimes reuse vials when the amount of medicine they contain exceeds the dose needed for a single patient. One factor in the Delaware outbreak was a national shortage of single-dose vials of the anesthetic bupivacaine.
"Medications come in very large vials, but they're often only approved for use in one person," Herrera said. "Health care providers see that as waste. There's a desire to use what you've paid for. And they don't understand that they're putting their patients at risk."
Herrera said CDC is urging clinics dealing with shortages to split doses safely in pharmacies — not where patients receive treatment.
Of the ten patients hospitalized, the stays ranged from three to 41 days. One patient treated in Arizona also needed long-term care, according to the report.
According to Delaware and Arizona health officials, both clinics remain in operation.
Source- http://nhpr.org/post/staph-infections-tied-misuse-drug-vials
The infection clusters were described in the latest Morbidity and Mortality Weekly Report.
Seven people were infected at a Delaware orthopedic clinic and four people at a pain management clinic in Arizona after receiving injections from drug vials intended for use with a single patient but that were instead used multiple times, the report and state health officials said.
Patients at the Arizona clinic were infected with methicillin-resistant Staphylococcus aureus, or MRSA, and patients in both outbreaks were hospitalized.
One patient was found dead at home six days after receiving treatment at the Arizona clinic, but the report says Arizona officials didn't declare MRSA the official cause of death.
The outbreaks are two of 20 that have been caused by misuse of single-dose vials since safety standards were reinforced in 2007, according to the CDC.
Needles or syringes weren't reused in either clinic, according to Arizona and Delaware state health officials, unlike a high-profile series of hepatitis C infections at a clinic in Las Vegas a few years back. But vials containing drugs intended for one person were used multiple times.
Drugs in single-use vials lack preservatives that prevent the growth of bacteria and subsequent spread of infections between people, CDC spokeswoman Rosa Herrera told Shots.
Health workers sometimes reuse vials when the amount of medicine they contain exceeds the dose needed for a single patient. One factor in the Delaware outbreak was a national shortage of single-dose vials of the anesthetic bupivacaine.
"Medications come in very large vials, but they're often only approved for use in one person," Herrera said. "Health care providers see that as waste. There's a desire to use what you've paid for. And they don't understand that they're putting their patients at risk."
Herrera said CDC is urging clinics dealing with shortages to split doses safely in pharmacies — not where patients receive treatment.
Of the ten patients hospitalized, the stays ranged from three to 41 days. One patient treated in Arizona also needed long-term care, according to the report.
According to Delaware and Arizona health officials, both clinics remain in operation.
Source- http://nhpr.org/post/staph-infections-tied-misuse-drug-vials
..
From Journal of Viral Hepatitis
Assessment of Factors Associated With Pre-diabetes in HCV Infection Including Direct and Dynamic Measurements of Insulin Action
N. A. Mukhtar; C. Ayala; J. J. Maher; M. Khalili
Discussion ONLY
View full text @ Medscape
In this study, we found high rates of pre-diabetes in our HCV population, similar to the prevalence observed in the general population. Non-Caucasian race predicted both IFG and IGT; BMI and liver inflammation predicted IFG; and insulin resistance was associated with IGT (IGT or combined IFG/IGT). In addition, both early phase and total insulin secretion (in relation to the degree of insulin resistance) were decreased in pre-diabetic states compared with individuals with NGT.
Studies in HCV-uninfected individuals have shown increasing age and BMI, male sex, Latino/Hispanic ethnicity, insulin resistance and dyslipidemia as risk factors for pre-diabetes.[3,16,17] Similarly, higher BMI, Latino ethnicity and higher degrees of insulin resistance were associated with pre-diabetes in HCV. However, whereas African American race has not been associated with pre-diabetes,[3] African Americans with HCV had high rates of pre-diabetes. Moreover, unlike prior studies of HCV-uninfected individuals, age and sex were not associated with pre-diabetes in HCV. These findings suggest that there may be a different phenotype of pre-diabetes in the HCV-infected population.
The precise nature of the complex interaction of host and viral factors that leads to the development of impaired glycemic control in patients with chronic HCV infection is poorly understood. Although inconsistent, several studies suggest that HCV alters glucose homoeostasis by interfering with insulin signalling through mechanisms that may be genotype-specific and influenced by higher levels of viral replication.[5,18] In addition, advanced stages of liver disease and steatosis have been associated with insulin resistance in HC.[5,19] In this study, viral factors, including HCV viral load, duration of infection and genotype, were not predictive of pre-diabetes. Furthermore, fibrosis and steatosis were not associated with pre-diabetes, possibly due to the fact that the majority of subjects had mild-to-moderate degrees of liver fibrosis and steatosis. However, the presence of liver inflammation was independently associated with IFG. HCV infection can directly induce insulin-signalling defects in the liver that lead to hepatic insulin resistance,[20–22] which is thought to be the principal metabolic abnormality in individuals with IFG.[23]
Different pre-diabetic states have unique insulin and glucose responses to oral glucose and whether these responses are altered within the context of HCV has not been previously assessed. In this study, the glucose and insulin responses during OGTT (Fig. 1) mimicked those observed in the HCV-uninfected population.[23] Accordingly, greater degrees of peripheral insulin resistance were detected among HCV-infected subjects with IGT as compared with NGT and IFG subjects. Moreover, consistent with prior studies in the HCV-uninfected individuals,[24,25] the early phase insulin response was impaired among those with IFG and IGT. Limited studies evaluating total insulin secretion adjusted for degree of insulin resistance have suggested that patients with IGT have a greater degree of impairment than patients with IFG.[24] In HCV, the most significant reduction in total insulin secretion was evident in the combined IFG/IGT group compared with subjects with NGT. However, overall, the abnormalities in insulin action and secretion characteristic of pre-diabetic states do not appear to be significantly altered by HCV infection.
Similar to other studies incorporating direct measurements of insulin resistance,[24,26] this study is limited by a small sample size. However, accurate assessment of peripheral insulin resistance by direct measurement using IST allows for adequate comparisons and performing this test would be impractical in a larger patient population. As the prevalence of pre-diabetic states and their pathophysiology have been extensively studied in the general population with a similar mean age (48 vs 46 years) and BMI (27 vs 28 kg/m2) to this HCV cohort, a control group of HCV-negative subjects was not included.[3] However, this study has allowed for the confirmation of prior findings or identification of distinguishing features associated with pre-diabetes within the context of HCV infection.
The pre-diabetic states are highly prevalent in the HCV population. Given its potential to disrupt insulin-signalling pathways, HCV may accelerate progression of these intermediate states of glucose homoeostasis. As such, early identification of pre-diabetes in the HCV population is needed to prevent the development of overt diabetes and its complications. Moreover, treatment of HCV infection may be indicated in patients with additional risk factors for diabetes. The findings of this study suggest that host factors play a more significant role than viral factors in the development of pre-diabetes among HCV-infected patients. However, HCV-induced liver inflammation was shown to be associated with IFG, and HCV infection may represent a significant risk factor for this condition. As such, aggressive HCV therapy in these individuals may be warranted. Furthermore, this study confirms that the abnormalities in insulin action characteristic of pre-diabetic states are preserved in the presence of chronic HCV infection. This finding supports future studies investigating the role of targeted pharmacologic treatment of pre-diabetes in HCV-infected patients...
Continue Reading @ Medscape
Discovery of Chemical That Affects Biological Clock Offers New Way to Treat Diabetes
Biologists at UC San Diego have discovered a chemical that offers a completely new and promising direction for the development of drugs to treat metabolic disorders such as type 2 diabetes—a major public health concern in the United States due to the current obesity epidemic...
Chemicals in personal care products may increase risk of diabetes in women
A study lead by researchers from Brigham and Women's Hospital shows an association between increased concentrations of phthalates in the body and an increased risk of diabetes in women. Phthalates are endocrine disrupting chemicals that are commonly found in personal care products such as moisturizers, nail polishes, soaps, hair sprays and perfumes....
American Diabetes Association, NIH/National Institute of Environmental Health Sciences
NICE issue new diabetes guidelines
Everyone over 40 should be tested for diabetes, says health watchdog,’ the Daily Mail has announced. The Mail is one of several news sources to have highlighted major new guidelines that aim to reduce the impact of type 2 diabetes on people.
The new guidelines have been published by the National Institute of Health and Clinical Excellence (NICE) and provide recommendations that are designed to:
- identify people at a potential high risk of developing the condition
- assess their individual risk with testing, and, if necessary
- offer lifestyle advice (such as advice on diet and exercise), to help prevent the condition in people who are at high risk, and advise on such things as dietary changes and increased physical activity
- feeling very thirsty
- going to the toilet a lot, especially at night
- extreme tiredness
- weight loss and loss of muscle bulk
Preventing type 2 diabetes from occurring in the first place would have a significant positive impact in terms of public health and the life of millions of people in this country.
The NICE guidelines report that diabetes currently affects almost 3 million people in the UK. Of these, 90% will have type 2 diabetes. The number of people with diabetes is estimated to rise to 5 million by 2025. A further 850,000 people in the UK are thought to have diabetes without knowing it.
What do the new NICE guidelines on type 2 diabetes say?
The NICE guidelines contain 20 detailed recommendations. These outline the best ways to identify people at high risk of type 2 diabetes and to encourage them to take steps to reduce their risk. In particular, it’s recommended that the following groups should be encouraged to have a risk assessment for type 2 diabetes so they can be offered advice to help prevent or delay the condition:
- All adults aged 40 and above (except pregnant women)
- Those aged 25-39 who are of South Asian, Chinese, African-Caribbean or Black African descent and other ethnic groups considered at high risk (except pregnant women)
- Adults with conditions that increase the risk of diabetes, such as high blood pressure, being very overweight (with a body mass index of 30 or above), or having a history of stroke
Certainly not at first, and it is important to make clear that screening will not be compulsory. What NICE are trying to achieve is to provide access to screening for type 2 diabetes in a range of more accessible places, not just your GP surgery or local hospital.
Screening for type 2 diabetes is relatively straightforward and does not require access to specially trained staff. So there is no reason that screening cannot be offered at:
- your job centre
- your local library
- your pharmacist
- your community centre
- your dentist
- your optician
How will this work in practice?
The NICE diabetes guidelines focus on identification and risk reduction. They call for the identification of people at risk of type 2 diabetes, using a staged (or stepped) approach. This involves using ‘validated risk assessment tools’ and questionnaires, and, where necessary, a blood test to confirm if someone is at high risk. The blood test, which measures glucose levels, would be based on either fasting blood glucose or a test called the HbA1c test, which measures how much glucose is stuck to haemoglobin.
For people identified as being at high risk, NICE calls for a ‘quality-assured, evidence-based intensive programme’ to change their lifestyle and prevent or delay the onset of type 2 diabetes. This would include a programme to:
- increase physical activity
- achieve and maintain weight loss
- increase dietary fibre and reduce fat intake, particularly saturated fat
Those found to have possible type 2 diabetes would be offered further tests and, if diagnosed, enter a ‘care pathway’ to be treated for the disease.
To implement these, NICE recommends national and local NHS bodies to act. NICE provides detailed ‘interactive pathways’ for professionals involved in diabetes prevention to help them offer the right care to people at risk of diabetes.
How do the new guidelines differ from the previous recommendations?
The new guidelines complement but do not replace previous recommendations from NICE on how to prevent or manage type 2 diabetes. This includes guidelines, published in May 2011, on reducing risk in the wider adult population, and other guidance on areas connected with diabetes, such as:
- cardiovascular disease
- obesity
- physical activity
- weight management
The guidelines are intended to be used alongside the NHS Health Check programme and the national vascular risk assessment programme for those aged 40-74. These programmes are currently being rolled out in England and aim to identify and treat diabetes, cardiovascular disease, stroke and kidney disease.
What will happen as the result of the guidelines?
NICE wants major initiatives nationally and locally, aimed at preventing type 2 diabetes. It hopes that these initiatives will include a body to oversee effective practice in type 2 diabetes prevention. Local NHS organisations will be expected to ensure that prevention of diabetes type 2 is a central part of their work.
What is the evidence that the guidelines are based on?
NICE says that the guidelines are based on the best available evidence, and included:
- reviews of the evidence
- economic modelling
- the testimony of experts
- commissioned reports
- comments from stakeholders
- fieldwork
How will these guidelines affect me?
The NICE guidelines are aimed at healthcare professionals rather than the public. However, in response to NICE’s recommendations, your GP or nurse may encourage you to identify your personal risk factors and encourage you to adopt or maintain a healthy lifestyle. If you are in an at risk group (for example, if you are over 40) you will be encouraged to assess your risk of this condition. One option open to you is to use the NHS Choices type 2 diabetes check tool .
If you are assessed at high risk you will probably be asked to contact your GP or practice nurse for a blood test (either the fasting glucose test or the HbA1c) to confirm the level of risk and to discuss how to reduce it through lifestyle changes. If you are diagnosed with type 2 diabetes, you should be placed on a ‘care pathway’ involving lifestyle changes and, where necessary, drug treatment.
Professor Mike Kelly, director of the Centre for Public Health Excellence at NICE said: "Type 2 diabetes is a very large-scale problem and it is important for people to know that it is preventable, and there are simple steps that can be taken to help reduce the risk of developing the disease. This guidance will help people to identify their own personal risk and highlights that by losing weight, being more active and improving their diet, they can prevent or delay type 2 diabetes."
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter.
Links to the headlines
Diabetes checks 'should be available in job centres'. BBC News, July 12 2012.
Adults over 40 urged to take risk assessment for type 2 diabetes. ITV News, July 12 2012.
Links to the science
NICE. Preventing type 2 diabetes: risk identification and interventions for individuals at high risk. July 2012
Off The Cuff
NBC News: 'Fake pharmacies' profiting on scarce drugs?
As patients in the U.S. struggle with ongoing shortages of critical prescription drugs, federal lawmakers are investigating so-called “fake pharmacies” that they say are trying to turn a profit by buying and reselling scarce medications.
When cancer patient Jay Cuetara, 50, of San Francisco arrived for a scheduled chemotherapy treatment last August, his infusion nurse told him one of his prescriptions, an injectable form of the drug fluorouracil, was out of stock.
“When my nurse told me that the drug wasn’t available, that I wouldn’t be able to do my chemo that day, I was literally shocked,” says Cuetara, who has stage IV rectal cancer. “How could this be happening in the United States of America?”
Continue Reading @ msnbc
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