ADA recommendations increase blood pressure target to below 140 mm Hg systolic in diabetic patients

ACP Hospitalist

A higher maximum systolic blood pressure target for diabetics is one of the most significant changes in the American Diabetes Association's 2013 Standards of Medical Care.′

The standards, which are revised annually, are based on the most current scientific evidence and provide guidance on treating children and adults with all types of diabetes. They were published online Dec. 20, 2012, and in a special supplement to the January 2013 Diabetes Care.

Several changes were made to the recommendations for 2013, the most significant being an increase in the systolic blood pressure goal for many people with diabetes from less than 130 mm Hg to less than 140 mm Hg. The revision was based on several new meta-analyses showing little additional benefit from lower targets, according to a press release. However, lower targets may still be appropriate for some patients, for example those who are younger or have a higher risk of stroke, the recommendations noted.

Another recommendation change affects hospitalized patients who have not been previously diagnosed with diabetes. If such patients have risk factors for diabetes and exhibit hyperglycemia during hospitalization, physicians should consider obtaining a hemoglobin A1c test, the standards now say. The standards have also been updated to reflect new recommendations from the Centers for Disease Control and Prevention on hepatitis B vaccination. Diabetic patients age 19 to 59 should be vaccinated, and vaccination should be considered for those 60 and over.

Recommendations on self-monitoring of blood glucose for patients who take multiple doses of insulin per day have also changed. Previously, the recommendations called for self-monitoring three or more times a day. The 2013 standards specify that these patients should test their blood glucose prior to meals and snacks, occasionally after eating, at bedtime, before exercise, when hypoglycemia is suspected or has occurred and prior to critical tasks such as driving.

The new recommendations also contain changes regarding diabetes self-management education, screening and treatment of cardiovascular risk factors in prediabetes, and emphasizing statin therapy over specific low-density lipoprotein cholesterol goals. A summary of the revisions and an executive summary of the standards are online.

Adding antiplatelets to dabigatran, warfarin elevates major bleeding risk

ACP Hospitalist

The risk of major bleeding is increased when antiplatelet drugs are added to either dabigatran or warfarin, a new subgroup analysis confirmed.

Researchers performed a post-hoc analysis of an earlier trial showing that a 150-mg dose of dabigatran was superior and a 110-mg dose was non-inferior to warfarin for preventing stroke and systemic embolism in atrial fibrillation patients. In the subgroup analysis, researchers compared the safety and efficacy of the 110-mg and 150-mg doses of dabigatran to warfarin in subgroups of patients with and without concomitant aspirin or clopidogrel treatment. Results were published online Dec. 27 by Circulation.

Nearly 7,000 of the original study's 18,113 patients received an antiplatelet at some point during the study. Eight hundred and twelve patients took both aspirin and clopidogrel, 5,789 took aspirin alone, and 351 took clopidogrel alone. A history of prior myocardial infarction or coronary artery disease, hypertension, paroxysmal atrial fibrillation, male sex and diabetes were more common among patients who took antiplatelets.

Use of concomitant antiplatelets was associated with a higher rate of major bleeding (4.4% vs. 2.6%), regardless of whether patients took warfarin or either dose of dabigatran (overall hazard ratio [HR], 2.01; 95% CI, 1.79 to 2.25). The absolute risk of bleeding was lowest with the 110-mg dose of dabigatran (3.9% per year), followed by the 150-mg dose of dabigatran (4.4% per year) and warfarin (4.8% per year) in those who also took antiplatelets (P=0.05 for 110-mg dabigatran vs. warfarin; P=0.38 for 150-mg dabigatran vs. warfarin).

Risk of major bleeding was higher among patients taking dual antiplatelets vs. those taking single antiplatelets (HR, 2.31 vs. 1.60; P<0.001 for trend in all treatment groups), with absolute risk lowest with 110-mg dabigatran. Similar trends were seen with major, minor and extracranial bleeding, but not intracerebral hemorrhage, which had a low event rate.

Tandem use of antiplatelets and anticoagulants is common, the authors noted, and this analysis suggests the relative risk of bleeding is similar for dabigatran and warfarin. The risk rose 50% with one antiplatelet and doubled with two, they noted. Because absolute (not relative) rates of bleeding seemed lower with 110 mg of dabigatran, however, this dose may be preferable "in patients in whom bleeding risk is of concern, such as those requiring dual antiplatelet therapy," the authors wrote. Editorialists wrote that the 110-mg dose of dabigatran might be a safer alternative in patients who require low-dose aspirin in particular. Regardless, treatment with both agents "needs to be highly personalized, taking into account the thrombotic and bleeding risk of each individual patient," the editorialists wrote.

Separately, the U.S. Food and Drug Administration warned in late Decemberthat patients with mechanical heart valves should not use dabigatran to prevent major stroke or blood clots. Researchers recently stopped a trial of mechanical heart valve patients in Europe because the patients taking dabigatran were more likely than those taking warfarin to experience strokes, heart attacks and blood clots that formed on the valves. They also had more bleeding after valve surgery. Physicians should transition all patients with mechanical heart values who take dabigatran to another medication, the alert said.

More restrictive blood transfusion rates may be better for upper GI bleeds

ACP Hospitalist

A blood transfusion threshold of 7 g/dL of hemoglobin significantly improved outcomes in patients with acute upper gastrointestinal bleeding compared to 9 g/dL, a study found.

Researchers randomly assigned 444 patients with severe acute upper gastrointestinal bleeding to a restrictive transfusion strategy (transfusion when hemoglobin fell below 7 g/dL with a target range post-transfusion of 7 to 9 g/dL) and 445 patients to a liberal strategy (transfusion when hemoglobin fell below 9 g/dL with a target range post-transfusion of 9 to 11 g/dL). Safety and efficacy of both strategies were compared.

Results appeared in the Jan. 3 New England Journal of Medicine.

A total of 225 patients assigned to the restrictive strategy did not receive transfusions compared with 65 assigned to the liberal strategy (51% vs. 15%;P<0.001). The restrictive-strategy group had a higher survival rate at six weeks compared to the liberal-strategy group (95% vs. 91%; hazard ratio [HR] for death with restrictive strategy, 0.55; 95% CI, 0.33 to 0.92; P=0.02).

Deaths attributed to unsuccessfully controlled bleeding occurred in three patients in the restrictive-strategy group and in 14 patients in the liberal-strategy group (0.7% vs. 3.1%; P=0.01). Complications of treatment were the cause of death in one patient in the restrictive-strategy group and two in the liberal-strategy group. Hemorrhage was controlled and death was due to associated diseases in 19 patients in the restrictive-strategy group and 25 in the liberal-strategy group.

Less bleeding occurred in the restrictive-strategy group compared with the liberal-strategy group (10% vs. 16%; P=0.01), and there were fewer adverse events (40% vs. 48%; P=0.02). Further bleeding was significantly lower with the restrictive strategy group after adjustment for baseline risk factors (HR, 0.68; 95% CI, 0.47 to 0.98). Length of hospital stay was shorter in the restrictive-strategy group than in the liberal-strategy group.

Patients who had bleeding associated with a peptic ulcer had a slightly higher probability of survival with the restrictive strategy than with the liberal strategy (HR, 0.70; 95% CI, 0.26 to 1.25). Patients with cirrhosis and Child-Pugh class A or B disease in the restrictive-strategy group had a significantly higher probability of survival (HR, 0.30; 95% CI, 0.11 to 0.85), but those with cirrhosis and Child-Pugh class C disease did not (HR, 1.04; 95% CI, 0.45 to 2.37).

Researchers noted that improvement in survival rates observed with the restrictive transfusion strategy "was probably related to a better control of factors contributing to death, such as further bleeding, the need for rescue therapy, and serious adverse events. All these factors were significantly reduced with the restrictive strategy."

Studies Suggest Medications To Increase HDL Levels May Not Benefit Patients.

On the front page of its Personal Journal section, the Wall Street Journal  (1/8, D1, Weaver, Subscription Publication) reports on the lack of benefit found in trials testing medications that raise HDL cholesterol. For instance, one NIH-funded study found that niacin did not benefit patients who were already on statins. Some researchers believe that increasing HDL levels with medications may not be as beneficial as when HDL is raised naturally. Now, given the string of studies suggesting little benefit to the approach, researchers are concerned that drugmakers may abandon future research on medications to increase HDL.

Acidosis in Renal Transplant Patients May Be Related to Diet

Renal and Urology News

Diet may contribute to metabolic acidosis in renal transplant recipients (RTRs), according to investigators.

In a study of 707 (RTRs), Else van den Berg, MD, of University Medical Center Groningen in Groningen, the Netherlands, and colleagues found that patients with high intake of animal protein, such as from meat, fish, and fish, and low intake of fruits and vegetables had significantly lower serum bicarbonate and serum pH.

Dr. van den Berg and her colleagues explained that many RTRs have metabolic acidosis, which may adversely impact cardiometabolic processes, such as blood pressure (BP) and insulin resistance, and interfere with the proper functioning of multiple tissues.

“Modification of the diet by increasing fruit and vegetable intake and decreasing intake of animal protein might improve acid-base balances in RTRs,” the authors concluded in an online report in theClinical Journal of the American Society of Nephrology.

The researchers assessed metabolic acid load by measuring 24-hour urinary net acid excretion (NAE). They defined acidosis as a serum bicarbonate level below 24 mmol/L. Overall, acidosis was present in 31% of subjects.

After adjusting for age, gender, body surface area, medication use, estimated glomerular filtration rate, time since transplantation, and smoking behavior, NAE was inversely associated with serum bicarbonate and serum pH. NAE was positively associated with acidosis, but was not associated with insulin resistance and high BP.

The researchers observed that their findings, if confirmed by prospective and interventional studies, might have implications for clinical practice. Acidosis is highly prevalent among RTRs, they noted, so venous blood gas analysis should be performed occasionally because it provides important information on acid-base status relatively easily, they noted. “If acidosis is confirmed, attention should be paid not only to known risk factors such as graft function but also to dietary habits,” they stated.

On the basis of their results, the investigators reported, daily enrichment of the diet with 100 grams of vegetables and 100 grams of fruits and elimination of 50 grams of meat and 20 grams of cheese would decrease NAE by 15 mEq/day and serum bicarbonate levels would ris by about 0.5 mmol/L.

Study strengths included a large sample size and the use of 24-hour urine samples, which allowed direct measurement of NAE as a marker of metabolic acid load as well as estimation of dietary acid load based on dietary recall. Study limitations included its observational and cross-section design, which does not allow for proving causality.

From the January 2013 Issue of Renal And Urology News »

Free Online Courses for Health Care Professionals

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CDC's Chronic Kidney Disease Initiative Announces the Launch of Its New Surveillance System Web Site

The Centers for Disease Control and Prevention’s Chronic Kidney Disease (CKD) Initiative announces the launch of the new CKD Surveillance System Web site,www.cdc.gov/ckd/surveillance, which provides fast facts and surveillance trends. Be sure to share this useful resource with your colleagues and partners. CKD, which affects 26 million Americans, is a condition in which the kidneys are damaged and cannot filter blood as well as possible. CKD is a progressive disease that can lead to complications, including kidney failure, if it is not treated.Adults with diabetes or hypertension are at an increased risk of developing CKD.

The CKD Surveillance System documents the burden of CKD and its risk factors in the United States population over time and tracks the progress of efforts to prevent, detect, and manage CKD. Some of the features of the new web site include: Separate gateways for CKD surveillance topics and ability to search by topic. Customizable graphics and maps of CKD surveillance data. An interactive application to view U.S. trends by age, sex, or race. Access to fast facts and U.S. data tables. Downloadable charts that can be used in grant applications, reports, articles, and publications. Data for monitoring trends in health consequences of CKD and health care capacity. Data for monitoring progress toward Healthy People 2020 kidney disease objectives. Largest comprehensive collection of CKD data. Resources that can be used for targeted patient and provider education. National Chronic Kidney Disease Fact Sheet 2010. CDC, through its Division of Diabetes Translation, leads the CKD Initiative. This effort is designed to provide comprehensive public health strategies for promoting kidney health. These strategies seek to prevent and control risk factors for CKD, to raise awareness, to promote early diagnosis, and to improve outcomes and quality of life for those living with CKD. For more information about chronic kidney disease, please visit www.cdc.gov/ckd. For more information about diabetes, please visit www.cdc.gov/diabetes .