American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP DiabetesMonthly



In the News for the month of June 2014




Highlights

Adding insulin to metformin may increase risk for nonfatal CV events, all-cause mortality versus adding a sulfonylurea

Adding insulin to metformin as second-line therapy may increase risk for nonfatal cardiovascular events and all-cause mortality compared with adding a sulfonylurea, according to a recent study. More...

Diabetes associated with higher risk of coronary heart disease in women than men

Women with diabetes have a more than 40% higher risk of incident coronary heart disease than men, a new meta-analysis found. More...

HbA1c levels appear to be higher in older patients

HbA1c levels appear to increase as patients age, independent of glucose levels and insulin resistance, according to a new study. More...


Test yourself

MKSAP quiz: Pneumonia vaccination of type 2 diabetes patient

This month's quiz asks readers to evaluate a 58-year-old man with type 2 diabetes mellitus, hypertension, and hyperlipidemia as a new patient. More...


From Annals of Internal Medicine

Update in Endocrinology highlights top diabetes research of 2013

Ten studies from 2013 with potential to change endocrinology practice were summarized in Annals of Internal Medicine's annual Update in Endocrinology, published in the June 3 issue. More...


From ACP InternistWeekly

New recommendations on insulin pump use

The American Association of Clinical Endocrinologists and the American College of Endocrinology offered guidance on optimal and safe use of insulin pumps in a recent consensus statement. More...

Higher-potency statins associated with more new diabetes cases

Patients taking higher-potency statins for secondary prevention are more likely to develop diabetes than those on lower-potency statins, a recent study found. More...


CDC update

Number of Americans with diabetes up to 29 million, CDC estimates

More than 29 million people in the U.S., 9.3% of the population, have diabetes, according to a new estimate from the Centers for Disease Control and Prevention. More...


Keeping tabs

Spotlight on bariatric surgery

Three comparisons of bariatric surgery and medical management for obese type 2 diabetes patients were recently published in journals of the American Medical Association. More...


Physician editor: Daisy Smith, MD, FACP



Highlights


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Adding insulin to metformin may increase risk for nonfatal CV events, all-cause mortality versus adding a sulfonylurea

Adding insulin to metformin as second-line therapy may increase risk for nonfatal cardiovascular events and all-cause mortality compared with adding a sulfonylurea, according to a recent study.

Researchers conducted a retrospective cohort study using the Veterans Health Administration, Medicare, and National Death Index databases to investigate the preferred second-line therapy after metformin failure. Included patients were veterans who initially received metformin from 2001 through 2008 and then added insulin or a sulfonylurea. Each patient who added insulin was matched with 5 patients who added a sulfonylurea. For the primary analyses, patients were followed through September 2011, while for the cause-of-death analyses, they were followed through September 2009. The study's primary composite outcome was acute myocardial infarction (AMI), stroke hospitalization, or all-cause death; secondary outcomes were cardiovascular disease events (AMI and stroke combined), all-cause deaths, and a composite including AMI, stroke, and cardiovascular death. The study was published in the June 11 Journal of the American Medical Association.

Ninety-five percent of the study patients were men, and 70% were white. Overall, 178,341 patients were initially receiving metformin monotherapy. Of these, 2,948 added insulin and 33,990 added a sulfonylurea. After propensity score matching, there were a total of 2,436 patients who added insulin and 12,180 who added a sulfonylurea. At the time the second drug was added, patients had been taking metformin for a median of 14 months (interquartile range, 5 to 30 months), and their median HbA1c level was 8.1% (interquartile range, 7.2% to 9.9%). Patients were followed for a median of 14 months (interquartile range, 6 to 29 months) after treatment intensification.

One hundred seventy-two primary outcome events occurred in the insulin group versus 634 in the sulfonylurea group (42.7 vs. 32.8 events per 1,000 person-years; adjusted hazard ratio, 1.30; P=0.009). No statistically significant difference was seen in AMI and stroke rates (10.2 vs. 11.9 events per 1,000 person-years; adjusted hazard ratio, 0.88; P=0.52) or in rates of the secondary outcome (22.8 vs. 22.5 events per 1,000 person-years; adjusted hazard ratio, 0.98; P=0.87). All-cause mortality rates did differ significantly according to second-line treatment (33.7 vs. 22.7 events per 1,000 person-years; adjusted hazard ratio, 1.44; P=0.001).

The authors noted that their study may have been missing some data on medication refills, that the sample size of patients receiving insulin was relatively small, and that most of the included patients were white men, among other limitations. However, they concluded that in diabetic patients receiving metformin, insulin added as second-line therapy versus a sulfonylurea was associated with increased risk for nonfatal cardiovascular outcomes as well as all-cause mortality. "These findings require further investigation to understand risks associated with insulin use in these patients and call into question recommendations that insulin is equivalent to sulfonylureas for patients who may be able to receive an oral agent," the authors wrote.


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Diabetes associated with higher risk of coronary heart disease in women than men

Women with diabetes have a more than 40% higher risk of incident coronary heart disease than men, a new meta-analysis found.

Researchers reviewed PubMed for prospective cohort studies published between 1966 and early 2013 that included sex-specific relative risk estimates for incident coronary heart disease (CHD) in people with and without diabetes. Multiple adjusted results were used in the primary analyses; at least one other risk factor besides age had to be used in adjustment. Researchers used random-effects meta-regression analyses to obtain sex-specific relative risks. Their analysis included data from 64 cohorts, 858,507 people, and 28,203 incident CHD events.

Overall, the relative risk (RR) for incident CHD associated with diabetes versus no diabetes was 2.82 in women (95% CI, 2.35 to 3.38) and 2.16 in men (95% CI, 1.82 to 2.56). The multiple-adjusted relative risk ratio for incident CHD was 44% higher in women than men with diabetes, with no significant heterogeneity between studies. The sex difference in diabetes-related risk remained consistent across subgroups defined by age and region and didn't change after exclusion of non-fatal CHD incidents. Results were published in the May Diabetologia.

Past studies have suggested women have more undertreatment of cardiovascular risk factors than men, but the authors said they don't think this fully accounts for the excess CHD risk in diabetic women. Instead, they suspect the excess risk for women may result from "a greater deterioration in cardiovascular risk profile combined with more prolonged exposure to adverse levels of cardiovascular risk factors among prediabetic women," they wrote.

A cross-sectional study of 680 primary care patients with type 2 diabetes, published online April 15 by Diabetes Technology & Therapeutics, found that composite control of cardiovascular risk factors was significantly lower in women than men (5.9% control in women vs. 17.3% in men; adjusted odds ratio, 2.90). The composite factors measured were HbA1c level of <7%, blood pressure of <130/80 mm Hg, and low-density lipoprotein level of <100 mg/dL (2.6 mmol/L). "It is imperative that women are informed about [cardiovascular disease] risk factors, educated on how to reduce them, and aggressively treated to avoid adverse outcomes," the authors concluded.


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HbA1c levels appear to be higher in older patients

HbA1c levels appear to increase as patients age, independent of glucose levels and insulin resistance, according to a new study.

Researchers used data from the Screening for Impaired Glucose Tolerance (SIGT) study and the National Health and Nutrition Examination Survey (NHANES) to perform a cross-sectional analysis examining HbA1c level and age. The study's objectives were to investigate whether age differences in HbA1c could affect diabetes screening and management; whether age effects were related to unrecognized diabetes and prediabetes, insulin resistance, or postprandial hyperglycemia; and whether age affects the diagnostic accuracy of HbA1c. The results were published online June 5 by Diabetic Medicine.

A total of 1,573 patients who participated in the SIGT study from 2005 to 2008 and 1,184 patients who participated in NHANES from 2005 to 2006 were included in the current analysis. Mean age was similar in both studies (48 years in the SIGT study vs. 47 years in NHANES). In the SIGT study, 58% of patients were black and 58% were women, while 32% of patients were black and 46% were women in NHANES.

In univariate analyses, the authors found that glucose intolerance and HbA1c levels both increased with age, by 0.085% per 10 years in the SIGT study and 0.094% per 10 years in NHANES. In all patients from both studies, HbA1c increased 0.08% per 10 years in patients without diabetes and 0.07% per 10 years in patients whose glucose tolerance was normal (P<0.001 for all comparisons). In multivariate analyses that included patients with normal glucose tolerance, a statistically significant relationship remained between age and HbA1c level (P<0.001) after adjustment for race, body mass index, waist circumference, fasting and 2-hour plasma glucose levels, and other variables. In addition, as age increased, the specificity of HbA1c criteria for diagnosing prediabetes decreased significantly (P<0.0001).

The authors noted that they were unable to evaluate the effects of kidney function and anemia and that their results may not be generalizable to all patients, among other limitations. However, they concluded that based on their results, increasing age is associated with increasing HbA1c levels, and the association cannot be solely attributed to age-related increases in insulin resistance, postprandial hyperglycemia, and insulin resistance. They also pointed out that the effect of age is clinically significant, estimating that an 80-year-old patient with normal glucose tolerance would have an HbA1c level 0.35% greater than a 30-year-old patient with normal glucose tolerance and the same glucose levels.

"While underlying mechanisms need further study, age differences should be taken into consideration when using HbA1c for the diagnosis, screening and management of diabetes and prediabetes, and for comparisons of provider and healthcare system performance," the authors wrote.



Test yourself


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MKSAP quiz: Pneumonia vaccination of type 2 diabetes patient

A 58-year-old man is evaluated as a new patient. A review of his previous records shows he received a pneumococcal vaccination 6 years ago when he was admitted to the hospital with community-acquired pneumonia. He feels well with no acute symptoms.

mksap.gif

He has type 2 diabetes mellitus, hypertension, and hyperlipidemia. Medications are insulin glargine, metformin, lisinopril, and simvastatin. Results of the physical examination are unremarkable.

When should this patient receive an additional pneumococcal vaccination?

A. Today
B. Today and repeat every 5 years
C. Today and at age 65 years
D. At age 65 years
E. No further pneumococcal vaccinations are required

Click here or scroll to the bottom of the page for the answer and critique.


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From Annals of Internal Medicine


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Update in Endocrinology highlights top diabetes research of 2013

Ten studies from 2013 with potential to change endocrinology practice were summarized in Annals of Internal Medicine's annual Update in Endocrinology, published in the June 3 issue.

annals.jpg

Four of the studies dealt with diabetes, including effects of lifestyle modifications, risks of dementia, and costs and benefits of bariatric surgery.

Annals of Internal Medicine's Diabetes Collection is available online.



From ACP InternistWeekly


.
New recommendations on insulin pump use

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology offered guidance on optimal and safe use of insulin pumps in a recent consensus statement.

The document, published in the May Endocrine Practice, updates a consensus statement issued by AACE in 2010. The new statement adds information about improvements in pump technology, including the first pump with a system to suspend insulin therapy if a low-glucose reading is noted and a disposable insulin delivery system for type 2 diabetes. The statement also reviews data on the use of pumps in specific patient populations, such as children, pregnant women, and type 2 diabetics (including continuous subcutaneous use of concentrated regular U-500 insulin). The statement's section on patient safety issues has also been updated.

The statement offers recommendations on selection of patients for insulin pump use. The ideal candidate for a pump has either type 1 diabetes or intensively managed, insulin-dependent type 2 diabetes; performs 4 or more insulin injections and blood glucose measurements daily; and is motivated, willing, and able to use the technology safely and effectively, including maintaining frequent contact with a health care team.

The statement also discusses use of pumps in hospitals and recommends that if a hospitalized patient is not able to manage his or her own pump, the specialist(s) responsible for ambulatory pump management should be contacted. Hospital patients and physicians should also be encouraged not to discontinue pump infusions and should contact specialists as needed. The April ACP Hospitalist also discusses inpatient management of insulin pumps.

The consensus statement also offers a number of recommendations on education and training of patients who use pumps. Initial and ongoing training should be provided by a multidisciplinary team under the direction of an experienced endocrinologist or diabetologist. The statement also provides data on comparisons of different pumps, safety issues, and cost-effectiveness.


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Higher-potency statins associated with more new diabetes cases

Patients taking higher-potency statins for secondary prevention are more likely to develop diabetes than those on lower-potency statins, a recent study found.

The multicenter observational study included more than 130,000 U.S., Canadian, and British patients who were started on a statin after hospitalization for a major cardiovascular event or procedure. They were all 40 years of age or older and were first prescribed a statin between January 1997 and March 2011. The main outcome was new onset of diabetes, measured by a hospitalization for diabetes or a prescription for insulin or an oral antidiabetic drug. None of the patients had been diagnosed with diabetes as of their initial cardiac hospitalization.

The patients taking higher-potency statins had a significantly higher risk of developing diabetes in the first 2 years of taking the drugs (rate ratio [RR] compared to lower-potency users, 1.15; 95% CI, 1.05 to 1.26). The risk difference was greatest in the first 4 months of use (RR, 1.26; 95% CI, 1.07 to 1.47). Results were published by BMJ on May 29.

Use of higher-potency statins instead of lower-potency ones is associated with a moderate increase in diabetes risk in this secondary prevention population, the study authors concluded. These results are similar to those of some other meta-analyses and have plausible mechanisms to explain them. Some experts argue that the increased risk of diabetes is outweighed by greater protection against cardiovascular events with the higher-potency drugs, but their data come from trials that were not specifically designed to record diabetes events, the authors said.

Head-to-head comparisons of higher- and lower-potency statins have shown no difference in mortality or serious adverse events, so given this lack of benefit, clinicians should consider the risk of diabetes when choosing a statin for secondary prevention of cardiovascular disease, the authors concluded.



CDC update


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Number of Americans with diabetes up to 29 million, CDC estimates

More than 29 million people in the U.S., 9.3% of the population, have diabetes, according to a new estimate from the Centers for Disease Control and Prevention.

That's an increase from the agency's previous estimate of 26 million in 2010, a press release said. According to other calculations in the National Diabetes Statistics Report, 1 in 4 diabetes cases are undiagnosed and 86 million U.S. adults have prediabetes.

The full report is online.



Keeping tabs


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Spotlight on bariatric surgery

Three comparisons of bariatric surgery and medical management for obese type 2 diabetes patients were recently published in journals of the American Medical Association.

New observational data from the Swedish Obese Subjects study revealed the long-term effects of gastric banding, gastric bypass, or usual care on a study subset of more than 500 diabetic patients, all recruited between 1997 and 2001. Two years after surgery, 16.4% of control patients had diabetes remission (blood glucose <100 mg/dL [5.55 mmol/L] without medication) compared to 72.3% of surgery patients. However, at 15 years, remission rates had dropped to 6.5% in controls and 30.4% in surgery patients. The surgery group had a significantly lower rate of both microvascular (20.6 vs. 41.8 per 1,000 person-years) and macrovascular (31.7 vs. 44.2 per 1,000 person-years) complications. The results, published June 11 in the Journal of the American Medical Association, indicate that bariatric surgery is associated with more diabetes remission and fewer complications than usual care, but the findings require confirmation in randomized trials, the authors said.

Researchers from the U.S. conducted such a randomized trial, published on June 4 by JAMA Surgery, which assigned patients to either Roux-en-Y gastric bypass (RYGB) or an intensive medical and weight management program. They followed the 38 patients (who were age 21 to 65 years with a body mass index [BMI] of 30 to 42 kg/m2 and an HbA1c ≥6.5%) for a year after treatment. Patients in the surgery group had greater weight loss and improvement in cardiovascular risk factors. They were also more likely to achieve the study's main outcome of fasting glucose <126 mg/dL (7 mmol/L) and HbA1c <6.5% (58% vs. 16%; P=0.03). The study shows the potential utility of RYGB to treat type 2 diabetes, even in moderately obese patients, as well as the feasibility of randomized trials to evaluate this and other bariatric surgery approaches, the authors concluded.

However, a similar study, also published by JAMA Surgery on June 4, concluded that there are several potential challenges to randomized comparison of surgical and medical treatments for diabetes. The study compared RYGB, gastric banding, and an intensive weight loss intervention in patients age 25 to 55 years with diabetes and BMI between 30 and 40 kg/m2. After screening more than 600 patients, they randomized 69 among the 3 treatments, after which another 10% dropped out of the study. In an intention-to-treat analysis at 1 year, RYGB was associated with more mean weight loss and partial and complete remission from diabetes, followed by gastric banding, then the lifestyle intervention. No patients in the lifestyle group achieved remission, and both surgery groups had significant reductions in medication use. The authors concluded that these preliminary results suggest that RYGB is the most effective treatment, although the lower risk and reversibility of gastric banding may make it another treatment option for some patients. The results should be confirmed, but difficulties with recruitment and retention may pose obstacles to a large randomized, controlled trial, the authors concluded.


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MKSAP Answer and Critique



The correct answer is D. At age 65 years. This item is available to MKSAP 16 subscribers as item 74 in the General Internal Medicine section. Information about MKSAP 16 is available online.

This man should receive a single pneumococcal polysaccharide vaccination at age 65 years. Adults 65 years and older should be immunized against pneumococcal pneumonia. The vaccine contains 23 antigen types of Streptococcus pneumoniae and protects against 60% of bacteremic disease. The vaccine is also recommended in some populations of younger patients, including Alaskan natives and certain American Indian populations; residents of long-term care facilities; patients who are undergoing radiation therapy or are on immunosuppressive medication; patients who smoke; and patients with chronic pulmonary disorders (including asthma), diabetes mellitus, cardiovascular disease, chronic liver or kidney disease, cochlear implants, asplenia, immune disorders, or malignancies. There is no information on vaccine safety during pregnancy. The vaccine is reasonably effective, with high levels of antibody typically found for at least 5 years. Currently, immunocompetent persons vaccinated after age 65 years are not recommended to receive a booster. Immunocompetent persons vaccinated before age 65 years, such as this patient, should receive a single booster vaccination at age 65 years, or 5 years after their first vaccination if they were vaccinated between the ages of 60 and 64 years.

Immunocompromised patients (including those with HIV infection and kidney disease) as well as patients with asplenia should receive a single pneumococcal vaccine booster 5 years after their first vaccine. This strategy would be inappropriate for this patient.

Current recommendations do not support more than a single booster after initial pneumococcal vaccination for any persons. Hence, a strategy of vaccination every 5 years would be inappropriate.

All patients vaccinated before age 65 years need a booster at some point. Hence, withholding further pneumococcal vaccination is inappropriate.

Key Point

  • Immunocompetent persons who received the pneumococcal polysaccharide vaccine before age 65 years should receive a single booster vaccination at age 65 years, or 5 years after their first vaccination if they were vaccinated between the ages of 60 and 64 years.

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Test yourself

A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?

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