Guest guest Posted December 1, 2011 Report Share Posted December 1, 2011 1.%% M 11/14/11 FDA Requests More Data for Iluvien More studies are needed to approve an intravitreal insert that releases cortico-steroid fluocinolone acetonide (Iluvien) intended for diabetic macular edema (DME) FDA stated that it was unable to approve the Iluvien new drug application because [it] did not provide enough data to support the claim that Iluvien is safe & effective in the Rx of pts with DME. FDA states that the risks for adverse reactions shown for Iluvien [trial of 771pts] were significant & were not offset by the benefits. Adverse effects involved cataract extraction in 80- 87% of all pts. Elevated intraocular pressure was also observed & 4% of pts required trabeculoplasty.[glaucoma surg] 2 additional clinical trials will be needed to show that the product is safe & effective for the proposed indication. %% prior report AAO 10/31/11 Iluvien- Novel Eye Insert Improves DME A study of an intravitreal insert (Iluvien) that releases a sustained & controlled amount of the corticosteroid fluocinolone acetonide improved visual acuity for up to 3 years in pts with DME. [These data are] particularly exciting, as they demonstrate that a single insert can provide rapid & sustained improvement in visual acuity for up to 36 months, " said presenter.The drug is injected into the eye in the form of a cylindrical polymer which is so tiny that 32 can fit on a grain of rice. Once injected, the drug slowly percolates out... About 75% of the pts required only 1 implant, 20% required a second, & 4- 6% a third implant. A decision from theFDA regarding its approval is expected within weeks. study funded by Alimera Sciences, manufacturer 2.%% M 11/11 Identifying Early Microvascular Abnormalities in Type 2 Abstract - Microvascular[smallest blood vessels] changes occur early in DM. Doppler ultrasound enables non-invasive identification of ocular microvascular abnormalities [34 pts] Intro- Microvascular functional & structural abnormalities occur early in DM & may precede development of disease in susceptible organs such as the eye & kidney. Key Messages Analysis of blood flow waveforms [behind eyeball] circulation in T2 revealed abnormalities which were most pronounced when waveforms were captured close to the eye, suggesting that the abnormalities are due to microvascular disease. 3.%% M 11/19 Visual Impairment (VI) Becoming Less Likely in DM The age-adjusted percentage of people with T1 & T2 reporting VI dropped from 23.7% in 1997 to 16.7% in 2010, according to Nat. Health Interview Survey data...But the decrease did not affect all subgroups equally. In particular, blacks with DM did not show significantly less VI in 2010 than in 1997. Authors note: " The decline.. might be attributable, in part, to better control of VI risk factors (e.g., better blood glucose, BP, & lipid control), improved detection & treatment of eye problems..An alternative explanation...is that the large & sustained increase of new cases of DM since the 1990s might have led to a large number of persons who have not had diabetes long enough to develop VI. " 4.%% M 11/21 Omega-3 Fatty Acids [O3a] Protect Against Arrhythmia & Fatal MI - Patients with DM who have had a heart attack may get protection from future ventricular arrhythmias & fatal heart attacks by eating daily recommended doses of O3a. [1014pts;40m] randomly assigned to 1 of 4 groups given margarines containing different amounts of O3a components. The group that received a combination of all 3 fatty acids, EPA, DHA, & ALA. experienced an 84% lower incidence of ventricular arrhythmia-related events than the group receiving placebo. That combo group also experienced a 72% lower incidence of combined arrhythmia & fatal heart attack. Funding includes: Netherlands Heart Foundation, NIH 5.%% M 11/16 Blood Pressure, Lipids and Glucose in T2 How Low Should We Go? Re-Discovering Personalized Care Epidemiological studies have clearly shown a direct relationship between the levels of BP, blood sugar, & LDL, & complications of DM. Although 'lower should be better', the results of recent clinical trials examining the benefits of normalizing risk factor levels have been counter-intuitive and, have called into question this notion. Intro & Blood Pressure [a very long discussion, tables etc of a number of trials-]. From Table 3. Target levels of BP, HbA1c, & lipids in pts with diabetes according to current guidelines & position statements – ADA = BP 130/80 HbA1c 6.5% with avoidance of hypoglycemia Lipids (mmol/L)LDL 2.6–3.4 HDL 1.15 TG 1.7..Conclusions - In the management of glucose, BP & lipids, recent clinical trials have clearly established that lower is not always better in T2 . Although optimal targets for these risk factors have not been firmly established, the trials have provided vital information & a better understanding of what targets are appropriate. .. some pt subgroups might respond differently to aggressive risk factor management. Our challenge is how to identify these pts & deliver truly personalized DM care that maximizes benefit & minimizes harm. www.medscape.com/viewarticle/750760_print 6.delete 7.%% M 11/12 Intensive T1 Diabetes Therapy Lowers Kidney Failure Risk Intensive therapy for T1 lowers the long-term risk for impaired glomerular filtration rate (GFR), a predictor of end-stage kidney disease & a risk factor for CV disease & death. Kidney Week 2011: American Society of Nephrology 44th Annual Meeting. 8. Delete 9.%% M 11/16 Neuropathy an Underappreciated Cause of Erectile Dysfunction (ED) has traditionally been associated with vascular problems, but a new study reveals that men with severe peripheral neuropathy frequently report ED, as well as failure with phospho-diesterase type-5 inhibitors. [av age 54] 10.%%M 11/16 Non-type 1 Non-type 2 Diabetes Mellitus Abstract - Monogenic forms of ß-cell diabetes (previously known as MODY) have been broadly divided according to age of presentation, into neonatal & adolescent/adult forms (the latter previously termed maturity onset DM of the young – MODY). In summary, this is an interesting case of a 51-year-old woman with DM who does not fit the classical categories of either T1 or T2..A genetic test for common gene mutations associated with monogenetic DM was recently done on the pt & the result was positive for a mutation in the HNF1-a gene. 11.%%M 11/15 Prospective Associations of Vitamin D With ß-Cell Function & Glycemia Cohort Study Aim- examine the prospective associations of baseline vitamin D (25(OH)D) with insulin resistance (IR), ß-cell function, & glucose homeostasis in subjects at risk for T2. [489pts;3yrs] Conclusions - Higher baseline vitD independently predicted better ß-cell function & lower glucose response level supporting a potential role for vit D in type 2 diabetes etiology. 12.%% M 11/22 Diabetics on Dialysis Do Better With Higher HbA1c - Hemoglobin A1c Researchers [38,000pts] have discovered that the desirable range for HbA1c is higher for DM pts on dialysis than guidelines recommend for the general diabetic population. Both high & low levels were associated with an increased risk for death, Am Soc Nephrology 44th Annual Meeting.. More than half the patients on dialysis in the US have diabetes. U.Wash. School of Medicine expert said. " I think it's fair to say that the recommendation for an A1c of about 7% or less will stand for people with new-onset DM who are relatively young & [who have] limited comorbidities, I think the guidelines will promote individualizing therapy.. For people who are at high risk of hypoglycemia, which is most people with advanced chronic kidney disease or with limited life expectancy & multiple comorbidities, clinicians should consider a more liberal target. " 13.%% MP Comparative efficacy of oral anti-diabetic drugs in preventing the development of T2. Diab Med. 2011; 28(8):Systematic literature search of MEDLINE, EMBASE...Conclusion: Of the oral anti-diabetic drugs evaluated to prevent T2,thiazolidinediones [actos] were associated with the greatest risk reduction compared with control & associated with greater risk reduction than biguanides [metformin..]. Alpha-glucosidase inhibitors [gyset,precose] & biguanides performed similarly, & better than control, while sulphony-lureas [glucotrol, glyburide] provided no significant benefit. 14.%% MP 11/23 Traffic pollution may be linked to diabetes risk Study found that people living in urban areas with high levels of nitrogen dioxide, a pollutant found in traffic exhaust, were 4% more likely to be diagnosed with DM than those living in neighborhoods with cleaner air. DM risk jumped by 10% in physically active people & 12% in non- smokers. Previous research has found that diabetics appear to be more vulnerable to the harmful health effects of air pollution than nondiabetics. [52,000 residents of Denmark's 2 largest cities;10yr] The link between long-term exposure to air pollution & DM also appeared to be greater in women in this study. This may have to do with a sex-related difference in susceptibility to air pollution or could reflect the fact that women in Denmark have historically spent more time in the home than men. Considerable evidence indicates that particles in air pollution, small enough to make their way into the bloodstream, contribute to inflammation throughout the body. Which in turn, may lead to an increased risk of heart attack, stroke, heart failure & a number of chronic diseases, including diabetes & asthma. Air pollution has a similar effect on blood vessels as cigarette smoke, an environmental health scientist U. British Columbia said. But, unlike cigarette smoke, air pollution is something to which everyone is exposed. 15.%% MP 11/25 Managing Diabetes During the Holidays Having DM shouldn't stop you from enjoying holiday celebrations & travel. The most important step is preparing. Before you go, take these steps to make sure you stick to your healthy meal plan. Eat a healthy snack to avoid overeating at the party. Ask what food will be served, so you can see how it fits into your meal plan. Bring a nutritious snack or dish for yourself & others. At a party or holiday gathering, follow these tips to avoid overeating & to choose healthy foods. If you're at a buffet, fix your plate & move to another room away from the food, if possible. Choose smaller portions. Choose low-calorie drinks such as sparkling water, unsweetened tea or diet beverages. If you select an alcoholic beverage, limit it to one drink a day for women, two for men, & drink only with a meal. Watch out for heavy holiday favorites such as hams coated with a honey glaze, turkey swimming in gravy & side dishes loaded with butter, sour cream, cheese or mayonnaise. Instead, choose turkey without gravy & trim off the skin, or other lean meats. Look for side dishes & vegetables that are light on butter, & other extra fats & sugars, such as marshmallows. Watch the salt. Focus on friends, family and activities instead of food. Take a walk after a meal, or join in the dancing at a party. Make sure you remember to take care of your diabetes while traveling. Check blood glucose (sugar) more often than usual, because a changing schedule can affect levels. Pack twice the amount of DM supplies you expect to need, in case of travel delays. Keep snacks, glucose gel, or tablets with you in case your BS drops. Make sure you keep your medical insurance card & emergency phone numbers handy, including your doctor's name & phone number. Carry medical identification that says you have DM. Keep time zone changes in mind so you'll know when to take medication. If you use insulin, make sure you also pack a glucagon emergency kit. Keep your insulin cool by packing it in an insulated bag with refrigerated gel packs. Wash hands often with soap and water. Try to avoid contact with sick people. Reduce your risk for blood clots by moving around every hour or two. Pack a small cooler of foods that may be difficult to find while traveling, such as fresh fruit, sliced raw vegetables, & fat-free or low- fat yogurt. Bring a few bottles of water instead of sweetened soda or juice. Pack dried fruit, nuts, and seeds as snacks - measure out small portions (¼ cup) in advance. If you're flying & do not want to walk through the metal detector with your insulin pump, tell a security officer that you are wearing an insulin pump & ask them to visually inspect the pump & do a full-body pat-down. Place all diabetes supplies in carry-on luggage. Keep medications & snacks at your seat for easy access. Don't store them in overhead bins. Have all syringes & insulin delivery systems (including vials of insulin) clearly marked with the pharmaceutical preprinted label that identifies the medications. Keep it in the original pharmacy labeled packaging. When drawing up your dose of insulin, don't inject air into the bottle (the air on your plane will probably be pressurized). National Diabetes Education Program 16.%% NIH11/24 The A1C Test and Diabetes The A1C test is a blood test that provides information about a person’s average levels of blood glucose, also called blood sugar [bS], over the past 3 months. The A1C test is sometimes called the hemoglobin A1c, HbA1c, or glycohemoglobin test. [it] is the primary test used for management & research of DM. The A1C test is based on the attachment of glucose to hemoglobin, the protein in red blood cells that carries oxygen. In the body, red blood cells are constantly forming & dying, but typically they live for about 3 months. Thus, the A1C test reflects the average of a person’s BS levels over the past 3 m. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7% Can the A1C test be used to diagnose T2 & pre-diabetes? Yes. Because the A1C test does not require fasting & blood can be drawn for the test at any time of day, experts are hoping its convenience will allow more people to get tested thus, decreasing the number of people with undiagnosed DM. However, some medical organizations continue to recommend using blood glucose tests for diagnosis. Are diabetes blood test results always accurate? All laboratory test results can vary from day to day & from test to test. Results can vary within the person being tested. A person’s BS levels normally move up and down depending on meals, exercise, sickness, and stress. Can the A1C test give false results? Yes, The A1C can be unreliable for diagnosing or monitoring DM in people with certain conditions that are known to interfere with the results. Interference should be suspected when A1C results seem very different from the results of a blood glucose test. People of African, Mediterranean, or Southeast Asian descent, or people with family members with sickle cell anemia or a thalassemia are particularly at risk of interference. People in these groups may have a less common type of hemoglobin, known as a hemoglobin variant, that can interfere with some A1C tests. Most people with a hemoglobin variant have no symptoms & may not know that they carry [it]. People with false results from one type of A1C test may need a different type of A1C test for measuring their average blood glucose level. What A1C target should people have? People will have different A1C targets depending on their DM history & general health. People should discuss their A1C target with their health care provider. People with DM can reduce the risk of complications by keeping A1C levels below 7%. Maintaining good BS control will benefit those with new-onset diabetes for many years to come. However, an A1C level that is safe for one person may not be safe for another. For example, keeping an A1C level below 7% may not be safe if it leads to problems with hypoglycemia, also called low blood glucose. Less strict blood glucose control, or an A1C between 7 & 8%- or even higher in some circumstances - may be appropriate in people who have limited life- expectancy long-standing DM & difficulty attaining a lower goal, severe hypoglycemia, advanced diabetes complications such as chronic kidney disease, nerve problems, or CVD. NIH Publication No.11–7816 Sept 2011 National Diabetes Information Clearinghouse 17.%% 11/24 MNT A Natural Fatty Acid Used In Manufacturing Can Modulate Glucose Control Decanoic acid, a saturated fatty acid, acts as a modulator of (PPAR receptors) that play a key role in glucose & lipid metabolism. Decanoic acids, also known as " Capric acid, " occurs naturally in coconut oil & palm kernel oil, as well as in the milk & animal fats of some mammals. It is used in organic synthesis & is common in the manufacture of perfumes, dyes, lubricants, greases, rubber, plastics, food additives & pharmaceuticals " We studied a nuclear receptor(PPAR?) that plays a key role in glucose & lipid metabolism & is the molecular target of the thiazolidinedione (TZD) [avandia, actos] class of antidiabetic drugs, which have been shown to have negative side effects such as weight gain, fluid retention, & increased risk for CV diseases, " author said. The team used a technique known as X-ray crystallography to determine exactly how & why the drug compounds work in molecular detail, which can then help drug developers engineer more potent drugs that have fewer unwanted side effects. 18.%% M11/28 Thrombolysis [=clot busting] Benefits Patients With Prior Stroke, DM. Ischemic stroke Pts with prior stroke & DM might still be candidates for thrombolytic therapy. [29,500 pts review of data] " Experience among a large number of patients with DM, with prior stroke, or with both conditions suggests that all 3 subsets of pts derive the same benefit from this Rx as other patients with acute stroke, " Dr. Lees U.Glascow said. The Simplified Management of Acute Stroke Using Revised Treatment protocol considers all ischemic stroke pts for thrombolysis, regardless of common tPA exclusion criteria, " contending that such criteria are consensus- based, not evidence- based. " 19.%%M11/1 HDL: The Next Frontier in Reducing Atherosclerosis and Cardiovascular Risk in T2? Slides - E. Bruckert MD, A Stalenhoef, MD, A von Eckardstein, MD Dyslipidemia[abnormal fat levels] in the pt with T2 contributes not only to the risk for atherosclerosis [hardening of the arteries] but also to the development & progression of micro & macro vascular disease. [vision, nerve problems etc]Lipid- lowering therapy has focused primarily on lowering low-density lipoprotein cholesterol (LDL-C) levels. However, even aggressive LDL-C lowering may not fully address CV disease risk in diabetics. Guidelines often give special consideration regarding high-density lipoprotein cholesterol (HDL-C) to higher-risk populations, including pts with DM On this slide, you can see one of the meta-analyses [half a million pts]showing the increased risk in men & women when they have DM. The longer the duration, the higher the risk for CVD If we look to the future, despite statin therapy we know that these patients still have a high risk for CVD..we know that HDL-C is a major player. Is there any specific problem with HDL in diabetic patients? A von Eck MD, PhD: Yes. DM pts are characterized by quantitative changes of HDL & HDL-C levels tend to be lower in [these pts]low HDL-C is a risk factor of getting DM & is also associated, with an increased risk for MI. In the last 2-3 yrs we have learned that HDL has beneficial effects on beta-cell function- it stimulates insulin secretion, improves insulin resistance & survival of beta cells. The problem, is that what we measure in the clinical lab as HDL-C is not the casual molecule. It's not the cholesterol in HDL that protects from athero-sclerosis. It's only an indirect measure of particle number & size. The complicated situation with HDL is that it's a class of lipoproteins that consist of thousands of different subclasses. There are more than 80 proteins associated with HDL which are modified by glycation [sugar metabolism] & also by oxidation. These modifications change the quality of HDL. They lose their function, for example, to induce [out flow of cholesterol. If we improve HDL metabolism it's not only to increase HDL-C levels but also to improve its function Dr. Bt: So we know now that the drugs such as nicotinic acid or fibrates which might increase slightly HDL-C tend to decrease CVD. Do these drugs act on HDL function? There is really a need for newer medications, which are in development right now. One of those is the cholesteryl ester transfer protein (CETP) inhibitors, which is a way of increasing HDL, hopefully also maintaining the functionality of HDL, so that reverse cholesterol transport is improved. Also, other functions of HDL should remain intact. One of the means to increase HDL is the inhibition of CETP. The first drug was torcetrapib. l. Unfortunately, this trial had to be stopped after 1.5 years - Despite the fact that HDL was increased by more than 70% & LDL was decreased by more than 20%, we saw this excess morbidity/ mortality. But afterwards it appeared that this was caused by off-target toxicity of this drug. It appears that torcetrapib increases aldosterone, raising BP.. About 1% of the Japanese population have mutations in the CETP gene which increases the HDL-C level in this pop. In the beginning, this was thought to be the reason why the life expectancy in Japan was higher than in other countries ..The drugs that will inhibit this protein in terms of cholesterol level or distribution between LDL & HDL make this an important target because it will increase HDL-C & decrease LDL-C. The 2 other inhibitors, dalcetrapib & anacetrapib, were promising enough in phase 2 studies to develop big clinical outcome studies to show whether this kind of treatment increasing HDL is beneficial & will reduce CV morbidity & mortality. This first study (REVEAL) will study 30,000 pts with CVD or diabetes & symptomatic coronary artery disease in order to see whether Rx with anacetrapib will reduce major CV events. Another promising drug, dalcetrapib, is also in clinical outcome studies. In the dal-PLAQUE study dalcetrapib was compared with placebo. These 2 drugs, do not have the toxicity that has been shown with torcetrapib on BP [conclusions] Dr. Bt: We can see that, in fact, in diabetic patients HDL-C is very complex. .one of the most important messages is that HDL predicts events in DM pts there is a lot of work to do on the qualitative aspect of HDL-C. We know now that we have promising compounds. We need to prove that these compounds decrease CVD; the answer to this will be revealed by these randomized trials in a few years. 20.%% M 11/23 What Did We Learn About Diabetes in 2011? G. A. Nichols, PhD Game-Changing Research in Diabetes Although a " cure " for DM remains elusive, researchers made significant strides in expanding our knowledge of DM this past year. This review covers studies that have changed or will change the management of DM as well as efforts to prevent it & eventually, find a cure. %%Preventing Diabetes to Prevent Cardiovascular Disease [CVD] The Multi-Ethnic Study of Atherosclerosis [hardening of arteries] - a prospective cohort study to investigate prevalence. & progression of subclinical CVD in persons without known CVD at baseline. [7.5 yrs] T2 was associated with increased CV incidence after adjustment for demographics & traditional risk factors compared with subjects not having T2 The current study by Yeboah & team suggests .. the threshold of fasting glucose that is independently associated with CVD risk may be above the threshold for a DM diagnosis. In that context, prevention of DM takes on new meaning– that preventing diabetes would result in significant cost savings, not to mention the improvement in quality of life that results from reduction in morbidity & mortality. Both patients & clinicians may be inclined to deal with diabetes when it arrives, rather than preventing its arrival, perhaps because the benefits of prevention have not been elucidated. Here, we have evidence that prevention does indeed matter. If avoiding DM is not sufficient motivation for pts to take the necessary preventive steps, perhaps avoiding CVD may provide further impetus. If so, clinicians may be able to use these results to encourage patients to engage in helpful lifestyle modifications. %%Reversal of Diabetes With Negative Energy Balance: [11pts] Lim & team tested the hypothesis that acute negative energy balance alone could reverse T2 by normalizing beta cell function & insulin sensitivity. The subjects were studied before & after 1, 4, & 8 weeks on a 600 kcal/day diet. After 8 wks pts lost a mean of 33.7lb, fasting plasma glucose normalized. & first-phase insulin response increased Why Is This a Game Changer? Gastric bypass surgery has been shown to quickly resolve diabetes in many pts early after surgery, well before the metabolic improvements can be attributed to substantial weight loss. Thus, there is growing interest in surgically treating DM in patients who are morbidly obese, but this is obviously a highly invasive & costly approach. If diabetes resolution is the goal, & the resolution is a by-product of the caloric restriction that follows gastric bypass, then these results pose the question: why not intervene with the caloric restriction but avoid the surgery? During a 12-week postintervention follow-up, glucose levels began to rise, so the results may not be sustainable once the severe caloric restriction ends. Bypass surgery allows many pts to stop taking DM meds for several years, although those benefits appear to be temporary for the majority of pts. At the very least, results of this study suggest a potential way to identify patients who will likely respond well metabolically to gastric bypass surgery. Even among T2 who are not candidates for surgery, this study can be used as a motivational tool. The clinician can say with confidence, " You can get rid of diabetes in just 1 week if you lose 10 pounds in that week. " Few pts will be able to achieve such a result on their own, but it may be what they need to hear to get them moving in the right direction (or moving at all!). %%Reversing Diabetes With Intensive Therapy - In this Chinese study, [48pt T2;1yr] the authors determined that intensive therapy partially restored beta-cell function & greatly restored insulin sensitivity. Why Is This a Game Changer? Current guidelines recommend initiating metformin therapy at the time of DM diagnosis, with the general goal of achieving glycated hemoglobin (A1c) < 7%. The results from this study suggest that a more aggressive approach of intensive therapy that quickly reduces fasting glucose to subdiagnostic levels may allow about half of patients to " reset " their metabolism & avoid further DM Rx for at least a year. This is a novel provocative approach During that year of " remission, " motivated pts would have time to implement lifestyle changes that might prevent DM " relapse " for even longer -perhaps indefinitely. Although this approach would not work for everyone, it presents an alternative to ongoing medication intensification, which most pts with diabetes can otherwise expect. %%Benefits of the DASH Diet [31 pts; randomly assigned to receive either the Dietary Approaches to Hypertension (DASH) diet or control diet for 8 weeks, then to receive the other diet for 8 more wks. Caloric intake was similar between the 2 diets, but the DASH diet had lower sodium intake; higher amounts of calcium, potassium, fiber; & more servings of fruit, vegetables, dairy, & whole grains. Patients lost a mean of 11 lb of body weight compared with 4.4 on the control diet. The DASH diet also produced more favorable changes in A1c, systolic & diastolic BP, fasting glucose, (LDL) & (HDL) cholesterol. Why is This a Game Changer? Remarkably, the DASH diet reduced A1c from 7.7% to 6.1% in just 8 wks, a reduction similar to that expected from most oral antihyperglycemic agents. These were not newly diagnosed pts & it appears that the subjects were relatively well controlled at baseline. Nonetheless, the A1c reductions came with an impressive 11 lb wt loss..Most patients with DM are already receiving at least 1 antihyperglycemic med, at least 1 BP med, & a statin, so it isn't uncommon for pts to have 5 or more prescriptions. Yet most patients remain uncontrolled re 1 or more risk factors. Here, we have results, albeit from a small study, that indicate additional medications may not be necessary if ptss are willing to try the DASH diet. Adherence to it will be a problem for some, but those same pts likely have trouble adhering to medications as well. %%Improving CV Risk With Modest Weight Loss: Wing & colleagues found that among overweight/obese individuals, the magnitude of weight loss at 1 year was strongly associated with improvements in glycemia, BP, triglycerides, & HDL . Compared with weight-stable pts , those who lost 5-10% of body wt had a 3.5 times greater probability [P] of achieving a 0.5% reduction in A1c, a 56% greater P of a 5-mm Hg reduction in systolic BP, a 69% greater P of a 5-mg/dL increase in HDL, & 2.2 times greater P of a 40-mg/dL reduction in triglycerides. Why Is This a Game Changer? Modest weight loss is almost universally recommended for overweight or obese T2 pts & a target loss of 5-10% of body weight is suggested by [includes ] CDC. This study provides previously lacking empirical support for this weight loss recommendation. Such modest weight loss appears to be sufficient to produce significant, improvements in CVD risk factors. %%Less Aggressive Glycemic Control for Older Patients [71,092 pts T2; aged = 60] Huang & team found that a target of A1c < 8.0% should be maintained in older patients to prevent complications & mortality, with the caution that A1c < 6% was associated with an increased mortality risk. Why Is This a Game Changer? Since 2006, the ADA has has recommended a target A1c of < 7% for all pts who can safely achieve it. Results from this study: relative to pts with A1c < 6%, those between 6%-6.9% & 7%-7.9% were 16% & 17% less likely to die, respectively. Only when A1c was 10% or greater was mortality increased relative to A1c < 6%. However, risk for acute metabolic, microvascular, & CV events was greater at all levels of A1c relative to A1c < 6%. Despite the observational nature of this study, the results provide guidance for caring for older pts with DM. It appears that an appropriate middle ground for elderly patients may be A1c < 8% rather than 7%, & that A1c < 6% should be avoided. .. %%Pioglitazone & Bladder Cancer Risk: & team [30,173 pts] , short-term use of pioglitazone [actos] was not associated with an increased risk for bladder cancer but use for more than 2 years was (weakly) associated with increased risk. Why Is This a Game Changer? Last year, the FDA restricted access to rosiglitazone [avandia], leaving pioglitazone as the only thiazolidinedione (TZD) generally available. Although TZDs are not considered first-line Rx, many pts with DM have been exposed to them. FDA has approved new drug labels for pioglitazone-containing drugs that recommend not using it in pts with active bladder cancer & using [it] with caution in patients with a prior history of bladder cancer. 21.%% M 11/21 Bardoxolone -- Will Diabetic Nephropathy Finally Wave an Olive Branch? Hello. I am Dr. Bakris, Professor at the U. Chicago Pritzker School of Med...Today, we have the pleasure of speaking with Dr. Toto, Professor of Med at U.Texas South western Medical Center about a very hot topic: bardoxolone and the BEACON trial...Bardoxolone methyl is a synthetic molecule that is derived from a substance found in olive trees, among other places, as a compound called oleanolic acid. Bardoxolone has been shown to have anti-inflammatory & antioxidant effects in the cell. So at the cellular level, bardoxolone interacts with a substance called Nrf2. Nrf2 is a " master switch " that regulates the anti-inflammatory pathway in the cell.. BEACON is a multinational, double-blind, randomized, placebo-controlled trial of pts with T2 & nephropathy. The purpose of the study is to determine whether bardoxolone, can improve renal & cardiovascular outcomes. We know that when bardoxolone is given to people with T2 & chronic kidney disease [in a 56 day trial] there is a reduction in serum creatinine & therefore, an increase in estimated GFR, [Glomerular filtration rate is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute.]This trial is going to study more than 2400 patients for longer than 2 years, so we will have a good feeling for what is going on clinically with respect to the outcome data...[ to listen to whole video see http://www.medscape.com/viewarticle/753694?src=mp <http://www.medscape.com/viewarticle/753694?src=mp & spon=2> & spon=2] 22.%% MP 11/30 Diabetes Care.2011; 34(10): Yoga for oxidative stress - T2 [123pts] Conclusions: Yoga can be used as an effective therapy in reducing oxidative stress in T2. Yoga in addition to standard care helps reduce BMI & improve glycemic control in T2 patients. 23.%%MP Diabet Med. 2011;28(9):High prevalence of capillary abnormalities in pts with T1 & T2. Using nailfold videocapillaroscopy [video capillary study ] to evaluate the possible correlation with the typical diabetes mellitus microangiopathic [micro blood vessel abnormalities] lesions detectable in retinal blood vessels. [49pts T1 & T2; 39 controls]y. Conclusions: A high prevalence of nailfold capillary changes is detected in pts with DM. These abnormalities tightly correlate with retinal damage & may be expression of a generalized microvessel involvement in both Type 1 & Type 2. %% Abbreviations-acronyms fup-follow up; pt - patient; DM - diabetes Mellitus; T1- type 1 DM;T2 - type 2; DME - diabetic macular edema;DR - diabetic retinopathy; BS - blood sugar or glucose;HbA1C, glycated hemoglobin A1C; BP - blood pressure; NV- neovascularization; CVD - cardiovascular disease; CHD -coronary heart disease; MI -myocardial infarction/ heart attack ; OCT - optical coherence tomography; BCVA - best corrected visual acuity ;ADA - Am Diab Ass ; M- Medscape Web MD; MP- Medline Abstract, Medline Plus; MNT- Med News Today;NEI - Nat Eye Institute;SA-Scientific American Definitions via online Medical dictionaries. Disclaimer, I am a BSN RN but not a diabetic or diabetic educator. Reports are excerpted unless otherwise noted. [translations, explanations by thl] This project is done as a courtesy to the blind/visually impaired & diabetic communities. Dawn Wilcox RN BSN Coordinator The Health Library at Vista Center; an affiliate of the Stanford Hospital Health Library. contact above e-mail or thl@... Quote Link to comment Share on other sites More sharing options...
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