Type 2 Diabetes Mellitus Treatment & Management

Management of Coronary Heart Disease There is contradictory epidemiologic evidence as to whether diabetes is in fact a CHD risk equivalent. For the present, however, that is the position adopted by most groups, such as the National Cholesterol Education Program (NCEP) and the ADA. [342] Although the risk for CHD is 2-4 times greater in patients with diabetes than it is in individuals without diabetes, control of conventional risk factors is probably more important in event reduction than is glycemic control. Control of hypertension, aspirin therapy, and lowering of LDL cholesterol levels are vitally important in reducing CHD risk. Aspirin The ADA recommends that patients with diabetes who are at high risk for cardiovascular events receive primary preventive therapy with low-dose, enteric-coated aspirin. For patients with aspirin hypersensitivity or intolerance, clopidogrel is recommended. [344] However, a randomized, controlled trial from Japan found that using low-dose aspirin as primary prevention did not reduce the risk of cardiovascular events in patients with type 2 diabetes. [345] These investigators subsequently reported that low-dose aspirin therapy reduces cardiovascular risk only in patients with a glomerular filtration rate (GFR) of 60-89 mL/min; low-dose aspirin had no beneficial impact if the GFR was above 90 mL/min or below 60 mL/min. [346] A study by Okada et al reported that low-dose aspirin therapy (81-100 mg) in patients with diabetes who are taking insulin or oral hypoglycemic agents does not reduce atherosclerotic events. [347] This is yet another argument against using low-dose aspirin for primary prevention of cardiovascular disease in patients with moderate or severe diabetes. Statins The Scandinavian Simvastatin Survival Study (4S) showed a 42% reduction in CHD events in diabetic patients with simvastatin therapy (mean dose 27 mg daily, with LDL reduction approximately 35%). Participants in 4S had known CHD and very high LDL cholesterol levels. [348] A smaller reduction was seen in the Heart Protection Study (HPS) in patients with CHD or other vascular disease and diabetes. [349] Patients in the HPS treatment arm received simvastatin 40 mg daily. Lesser degrees of risk reduction have been shown in other secondary prevention studies in patients treated with pravastatin with mild to moderate LDL cholesterol elevation at baseline. Atorvastatin, 10 mg daily, did not reduce CHD risk among diabetic patients with hypertension and no previous CHD who were enrolled in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). [350] In contrast, the Collaborative Atorvastatin Diabetes Study (CARDS) showed a significant reduction in CHD risk in patients with type 2 diabetes mellitus and 1 other risk factor when treated with atorvastatin 10 mg daily. [351] Some studies have suggested that statin therapy may be associated with an increased risk of developing diabetes. In a pooled analysis of data from five statin trials, intensive-dose statin therapy was associated with increased risk of new-onset diabetes compared with moderate dose statins. [352] A study by Ahmadizar et al of subjects over age 45 years who had no diabetes at baseline reported that compared with individuals who have never used statins, the risk of incident type 2 diabetes development in persons who have ever taken statins is 38% greater, with the likelihood being particularly high in persons with impaired glucose homeostasis and in individuals who are overweight/obese. However, analyses stratified at baseline for gender and body mass index (BMI) indicated that statin use was not significantly associated with type 2 diabetes in women or in persons with a normal body mass index (BMI). [353, 354] The American Diabetes Association (ADA) provided recommendations on the use of statins in patients with diabetes to align with those of the American College of Cardiology and the American Heart Association. [355] The ADA recommends statin use for nearly everyone with diabetes. The ADA guidelines divide diabetes patients by 3 age groups: Younger than 40 years: No statins for those with no cardiovascular disease (CVD) risk factors other than diabetes; moderate intensity or high-intensity statin doses for those with additional CVD risk factors (baseline LDL cholesterol 100 or greater, high blood pressure, smoking, and overweight/obesity); and high-intensity statin doses for those with overt CVD (including previous cardiovascular events or acute coronary syndrome). Age 40-75 years: Moderate-intensity statins for those with no additional risk factors, and high-intensity statins for those with either CVD risk factors or overt CVD. Older than 75 years: Moderate-intensity statins for those with CVD risk factors; and high-intensity statins for those with overt CVD. Lipid monitoring for adherence is recommended as needed, and annual monitoring is advised for patients younger than 40 years who have not yet started on statins. There is a new BMI cut point of 23 kg/m2 (instead of 25 kg/m2) for screening Asian Americans for prediabetes and diabetes, based on evidence that Asian populations are at increased risk at lower BMIs relative to the general population. The premeal glucose target of 70-130 mg/dL was changed to 80-130 mg/dL to better reflect new data that compared average glucose levels with HbA1c targets. The goal for diastolic blood pressure was raised to 90 mm Hg from 80 mm Hg to better reflect data from randomized clinical trials. (This follows ADA's 2013 shift from a systolic target of 130 mm Hg to 140 mm Hg.) With regard to physical activity, the document now advises limiting the time spent sitting to no longer than 90 min. The ADA does not support e-cigarettes as alternatives to smoking or to facilitate smoking cessation. Immunization against pneumococcal disease is recommended. A new HbA1c target of less than 7.5% for children is now recommended. HDL cholesterol therapy The benefits of raising HDL cholesterol levels in patients with type 2 diabetes remains uncertain. Some of the statin trials suggest that statin therapy eliminates some of the excess risk from low HDL cholesterol levels in patients with LDL cholesterol elevation at baseline. The Veterans Administration HDL Intervention Trial (VA-HIT) showed an approximately 22% reduction in CHD events in patients with diabetes and known CHD when HDL cholesterol levels were increased by approximately 6% by gemfibrozil. [356] This was a population with low LDL cholesterol levels, however, so whether these same benefits would accrue in patients with elevated LDL cholesterol who are treated with a statin before their low HDL cholesterol is addressed is unclear. Triglyceride therapy An elevated triglyceride level is a common abnormality in type 2 diabetes mellitus. However, whether therapy to reduce triglycerides helps to reduce CHD events has not been determined from clinical end-point trials. Revascularization The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) study, which was conducted in 2368 patients with type 2 diabetes mellitus and heart disease, showed no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy with insulin or insulin-sensitizing drugs. [357] These data emphasize the need to customize therapy to the patient’s circumstances and therapeutic goals.


CUHK Develops a Novel Faecal Test that can Detect Polyps and Early Colon Cancers with Sensitivity Over 90%

The faecal immunochemical test (FIT) is commonly used to screen for colorectal cancer but it has low sensitivity (around 50%) for early cancer detection and fails to detect polyps. The Faculty of Medicine at The Chinese University of Hong Kong (CU Medicine) has developed the world’s first faecal “bacterial gene markers” test (M3) based on metagenomic analysis of over 1,100 cancer subjects. The sensitivity of this non-invasive test is 94% for colorectal cancer detection which is comparable to that of a colonoscopy. The test can also accurately detect polyp recurrence with over 90% sensitivity. It is the first test to offer a non-invasive approach to screen for polyp recurrence. The novel test can spare patients from an unnecessary colonoscopy thus reducing the risk of invasive testing and the pressure on medical services. The research findings on early colon cancer detection have been published in the high impact international medical journal Gut.   Early Detection and Treatment of Colorectal Cancer Improves Survival     According to statistics of the Hong Kong Cancer Registry on colorectal cancer diagnosed between 2010 and 2017, the 5-year survival rate of patients with stage I colorectal cancer was 96%, but it dropped dramatically to less than 10% when patients were diagnosed at stage IV. Early diagnosis and treatment of cancers are associated with a favourable prognosis. As most colorectal cancers originated from polyps, early detection and removal of polyps can prevent the development of cancer.     Major Shortcomings of Current Screening Tools for Colorectal Cancer and Polyps     Current colorectal cancer screening tools have two major shortcomings. Firstly, FIT cannot accurately detect early colorectal cancer with less than 50% sensitivity and a high false-negative rate. Secondly, no non-invasive tool exists for the detection of recurrent polyps. These patients need to undergo surveillance colonoscopy on a regular basis to detect polyp recurrence. The inconvenience and discomfort of repeated colonoscopies deter many people from having the examination. It also adds a huge demand to the existing burden for colonoscopy services.             Bacterial Gene Markers Test Has the Potential to Enhance Effectiveness of Colorectal Cancer Screening     Using data from metagenomics sequencing, the research team from CU Medicine identified a group of four unique bacterial DNA markers, known as M3, which is effective in detecting colorectal cancer. Through analysis of stool samples from over 1,100 participants, including individuals with colorectal cancer and polyps, M3 CRC showed a 94% sensitivity in detecting colorectal cancer. The sensitivity of M3 is comparable to that of a colonoscopy for cancer detection (94%) and supersedes that of FIT for early cancer (50%) and polyp (<10%) detection.     The research team also tested the accuracy of M3 in the detection of recurrent polyps. They followed over 200 subjects who had undergone polyp resection within 5 years. They found that subjects who developed polyp recurrence had higher levels of M3 in their stool samples than those without recurrence. Using their novel proprietary detection algorithms, the M3 CRC test showed a remarkable sensitivity of over 90% for detecting recurrence of polyps. Professor Jun YU, Professor of the Department of Medicine and Therapeutics at CU Medicine, highlighted, “The M3 CRC test is the result of our research team’s hard work for over a decade. We have successfully identified novel faecal bacterial markers that can accurately detect colorectal cancer and polyps which can now serve as a non-invasive tool for many patients and their families.” Professor Jessie Qiao Yi LIANG, Research Associate Professor of the Department of Medicine and Therapeutics at CU Medicine added, “Our recent study further showed that the clinical application of M3 is not limited only to cancer detection but it can also be applied to predict polyp recurrence. With this new innovation, we are hopeful that the number of unnecessary colonoscopies could be reduced.”     Professor Siew Chien NG, Associate Director of the Centre for Gut Microbiota Research at CU Medicine, stated, “This discovery is based on our unique metagenomic dataset of thousands of subjects. The data are reproducible and can potentially be applied globally. Unlike blood tests or colonoscopic procedures that need clinic or hospital visits, this test only requires a small sample of stool and can be performed at home. The bacterial gene markers test can detect cancer early, when it can be cured. We are thrilled to report that it can also detect polyps, making colorectal cancer prevention a reality”.     Professor Francis KL CHAN, Dean of Medicine and Director of the Centre for Gut Microbiota Research at CU Medicine regarded this new innovation as a prime example of successful translational research whereby scientific findings can be transformed into a clinical screening tool. He remarked, “Globally, approximately 2,800 million people are eligible for colorectal cancer screening. The potential of bacterial gene markers is huge. Not only can it assist us in prioritising medical resources, it will also bring benefit to both individual patients and society as a whole.”


Telehealth Privacy and Security Tips

In response to social distancing recommendations resulting from the COVID-19 pandemic, healthcare providers are rapidly deploying remote or virtual healthcare services to sustain care for their patients. In many cases, telehealth approaches are new to the patient and the provider. Not withstanding, maintaining patient privacy remains important. Below are some critical recommendations to maintain patient privacy and security in these challenging times. The following link contains recommendations from the Department of Health and Human Services: Buzz, a HIPAA-complaint platform enables providers to conduct secure video conferences or calls with patients quickly, easily & seamlessly. FOR HEALTHCARE PROVIDERS Before Telehealth Sessions Always use HIPAA-compliant applications to help reduce security and privacy risks. Share updated privacy and security practices with your patients, using different communications channels such as posting them on your website, or by phone or email when offering appointment reminders. Share some of the tips provided below with your patients to safeguard their health information during telehealth sessions. During Telehealth Sessions  Always use a private space and limit the number of people who participate in a session. For providers, this means only permitting personnel directly involved in the patient’s care and individuals the patient permits to participate in the session. Secure private room from which you are conducting telehealth sessions (e.g., close the door and post a sign outside the door, indicating unauthorized individuals should not enter while your session is underway). We recommend to use headsets and limit audio being heard by others and position screens out of the line of sight of others. Enable all available encryption and privacy modes when using telehealth applications and notify patients that these third-party applications could potentially introduce privacy risks if the procedures are not followed. Limit the information requested to what is necessary to treat the patient. Don’t forget to sign out of or close applications and turn off all microphones, cameras, and monitors once the telehealth session is complete. Additional Practices Run updates for equipment and applications as soon as they are available, to take advantage of the latest security capabilities. Secure any notes, written materials, electronic devices, and storage media when not conducting patient sessions. Avoid saving patient data on personal or shared devices and implement device authentication measures. Use applications that maintain records of patient interactions  during each session. This will be important to address any future concerns regarding accessing records and managing privacy or security breaches. Immediately report a privacy or security breach, using your existing procedures for doing so if any patient information is lost, accessed, or disclosed inappropriately while scheduling, facilitating, or conducting a telehealth session. FOR PATIENTS Before Telehealth Sessions Be aware of updated privacy and security practices from your healthcare provider. Contact your healthcare provider with any questions or concerns you have about the privacy and security of the information shared during your telehealth session. During Telehealth Sessions Pick a private location. Hold your telehealth session in a location away from others, such as a room with a door so that you can control who hears your conversation. Secure your device. Follow your healthcare provider’s instructions for securing the device that you use for your telehealth session. Log out of your telehealth session when you are done. Remove unnecessary items. Before beginning a conversation with your healthcare provider, make sure you remove items that are not needed to discuss your health concerns. Technology devices such as home security cameras, voice assistants, or other devices you are not using to contact your healthcare provider should be removed to make sure they do not capture potentially sensitive information. Control your background. Be aware of what will be displayed in the background during a video call and remove any personal information you do not want to share.


MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines

Dr June Raine, MHRA Chief Executive said: We are committed to getting safe and effective COVID-19 vaccines to the UK public. This means ensuring that existing COVID-19 vaccines can continue to be used in the most effective way possible. We know that a person’s immunity may decline over time after their first vaccine course. I am pleased to confirm that the COVID-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses. This is an important regulatory change as it gives further options for the vaccination programme, which has saved thousands of lives so far. It will now be for the JVCI to advise on whether booster jabs will be given and if so, which vaccines should be used. We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include booster jabs. Background The current supply of the COVID-19 vaccines made by Pfizer and AstraZeneca has been authorised on an emergency use basis by the MHRA under Regulation 174 of the Human Medicine Regulations 2012 and the changes today have been made to the Regulation 174 Product Information only. Both vaccines are also authorised under Conditional Marketing Authorisations (CMAs) but changes to these would follow a different procedure. Vaccines covered by CMAs can also be used as part of a deployment programme via “off-label” use under a prescriber’s direction. This regulatory decision follows a careful review of available data on safety and effectiveness of booster or supplementary vaccine doses by the MHRA and the independent Commission on Human Medicines (CHM), which  advises the government. For more information, please see the product information: AstraZeneca vaccine, Pfizer vaccine