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

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ACP DiabetesMonthly



In the News for the month of August 2014




Highlights

Intensive therapy associated with decreases in certain cardiovascular events, new ACCORD analysis finds

Despite the ACCORD study finding an increased risk of death from cardiovascular causes with intensive glucose-lowering therapy, rates of myocardial infarction, coronary revascularization, and unstable angina were lower in patients on an intensive regimen, a new analysis of the trial data found. More...

Risk for poor outcomes appears higher in diabetic patients with lacunar stroke

Patients with diabetes who have lacunar stroke are at higher risk for death and recurrent stroke than patients without diabetes, according to a recent study. More...


Test yourself

MKSAP quiz: Treatment plan for obesity and diabetes

This month's quiz asks readers to evaluate a 42-year-old-man with type 2 diabetes, hypertension, and hyperlipidemia for obesity treatment. More...


From ACP InternistWeekly

Nurse-managed protocols associated with modest improvement in control of chronic conditions, analysis finds

Medication titration by nurses according to protocols was associated with a modest improvement in control of chronic diseases in outpatient practice, a recent review and meta-analysis found. More...


FDA update

Empagliflozin approved to treat type 2 diabetes

Empagliflozin (Jardiance), a sodium glucose co-transporter 2 inhibitor, was recently approved to treat type 2 diabetes in addition to diet and exercise, the FDA announced last week. More...


Keeping tabs

Spotlight on office visits for diabetes

New data on how often diabetes patients visit their physicians were provided by 2 recent analyses. More...


Physician editor: David V. O'Dell, MD, FACP



Highlights


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Intensive therapy associated with decreases in certain cardiovascular events, new ACCORD analysis finds

Despite the ACCORD study finding an increased risk of death from cardiovascular causes with intensive glucose-lowering therapy, rates of myocardial infarction, coronary revascularization, and unstable angina were lower in patients on an intensive regimen, a new analysis of the trial data found.

The analysis included 10,251 adults ages 40 to 79 with type 2 diabetes, a mean HbA1c of 8.3%, and risk factors for ischemic heart disease who were randomized to an intensive-therapy HbA1c target of less than 6.0% or a standard target of 7.0% to 7.9%. Both groups used the same drugs to achieve control, including metformin, insulin, sulfonylureas, meglitinides, thiazolidinediones, acarbose, and incretins. Patients followed up at least every 4 months to check therapeutic goals and monitor outcomes and adverse effects. Results were published by The Lancet on Aug. 1.

Patients were followed for a mean of 3.7 years during the active treatment of intensive glucose lowering and a mean of 4.8 years including follow-up periods. There were 1,263 ischemic heart disease events during the active trial and 1,619 during the follow-up period. Compared with the standard-therapy group, participants in the intensive-therapy group had fewer myocardial infarctions than in the standard-therapy group during active treatment (hazard ratio [HR], 0.80; 95% CI, 0.67 to 0.96; P=0.015) and the entire study (HR, 0.84, 95% CI, 0.72 to 0.97; P=0.02).

Findings were similar for the composite outcome of myocardial infarction, coronary revascularization, and unstable angina (active treatment period: HR, 0.89; 95% CI, 0.79 to 0.99; entire study period: HR, 0.87; 95% CI, 0.79 to 0.96). In addition, there was a lower rate of coronary revascularization in the intensive group for the entire treatment period but not before treatment transition (HR, 0.84; 95% CI, 0.75 to 0.94). There was also a lower rate for unstable angina alone during the full follow-up period (HR, 0.81; 95% CI, 0.67 to 0.97).

The study's findings could help clinicians identify patients in whom the benefit of intensive glycemic control would clearly outweigh any harm, the authors noted.

They wrote, "Whereas our findings suggest that glucose-lowering interventions can reduce the risk of ischemic heart disease, they do not nullify the previous observation that the overall cardiovascular benefits of 3.7 years of intensive glycemic control are outweighed by the risk of death. Nevertheless, they are consistent with the hypothesis that dysglycemia is causally related to ischemic heart disease and strongly indicate the need for further investigation of this relation." The authors concluded, "Raised glucose concentration is a modifiable risk factor for ischaemic heart disease in middle-aged people with type 2 diabetes and other cardiovascular risk factors."


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Risk for poor outcomes appears higher in diabetic patients with lacunar stroke

Patients with diabetes who have lacunar stroke are at higher risk for death and recurrent stroke than patients without diabetes, according to a recent study.

Researchers performed a cohort study that compared patients with and without diabetes who had lacunar strokes and were participating in the international Secondary Prevention of Small Subcortical Strokes (SPS3) trial. The goal of the study was to analyze data on patient characteristics, infarct locations, and recurrent vascular strokes in diabetic patients with lacunar stroke. Features at study entry and prognosis during 3.6-year follow-up were compared in patients with and without diabetes. The study results were published online July 17 by Stroke.

A total of 3,020 patients were included in the analysis, 1,106 of whom (37%) had diabetes mellitus. The mean duration of diabetes was 11 years in patients with a diagnosis of diabetes at study entry. An independent association was observed between diabetes and slightly younger age (63 vs. 64 years; P<0.005), Hispanic ethnicity (36% vs. 28%; P<0.0001), ischemic heart disease (11% vs. 6%; P=0.002), and peripheral vascular disease (5% vs. 2%; P<0.0004).

Intracranial stenosis of 50% or greater and infarcts of the brain stem or cerebellum were significantly more common in patients with diabetes (P<0.0001 for both comparisons). More extensive abnormalities of the white matter were also more common in diabetic patients, but the between-group difference was not significant after the authors adjusted for additional independent predictors (P=0.11). Recurrent stroke (hazard ratio [HR], 1.8; 95% CI, 1.4 to 2.3), recurrent ischemic stroke (HR, 1.8; 95% CI, 1.4 to 2.4), disabling or fatal stroke (HR, 1.8; 95% CI, 1.2 to 2.9), myocardial infarction (HR, 1.7; 95% CI, 1.0 to 2.8), and death (HR, 2.1; 95% CI, 1.6 to 2.8) were all more common in patients with diabetes than in those without. Risk of nonvascular death (HR, 1.6; 95% CI, 0.9 to 2.6) or major extracranial hemorrhages (HR, 0.88; 95% CI, 0.6 to 1.3) did not differ significantly by diabetes status.

The authors noted that they had no data about control of diabetes mellitus during follow-up and that the inclusion and exclusion criteria for the SPS3 trial may have introduced selection bias. However, they concluded that patients with diabetes and lacunar strokes have a distinctive risk factor profile along with infarct location, have double the prevalence of systemic and intracranial atherosclerosis, and "carry a substantially worse prognosis compared with patients without diabetes mellitus." They recommended further study of this high-risk subgroup.



Test yourself


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MKSAP quiz: Treatment plan for obesity and diabetes

A 42-year-old-man is evaluated for obesity. His weight has gradually increased over the past two decades and is currently 168.2 kg (370 lb). Five years ago, he was diagnosed with type 2 diabetes mellitus, hypertension, and hyperlipidemia. Over the past 6 months, he has unsuccessfully tried diet and exercise therapy for his obesity. He tried over-the-counter orlistat but could not tolerate the gastrointestinal side effects. Medications are metformin, lisinopril, and simvastatin. His total weight loss goal is 45.4 kg (100 lb).

On physical examination, temperature is normal, blood pressure is 130/80 mm Hg, pulse rate is 80/min, and respiration rate is 14/min. BMI is 48. Waist circumference is 121.9 cm (48 in). There is no thyromegaly. Heart sounds are normal with no murmur. There is no lower extremity edema.

Results of complete blood count, thyroid studies, and urinalysis are unremarkable.

Which of the following is the most appropriate management of this patient?

A. Bariatric surgery evaluation
B. Prescribe phentermine
C. Reduce caloric intake to below 800 kcal/d
D. Refer to an exercise program

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


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From ACP InternistWeekly


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Nurse-managed protocols associated with modest improvement in control of chronic conditions, analysis finds

Medication titration by nurses according to protocols was associated with a modest improvement in control of chronic diseases in outpatient practice, a recent review and meta-analysis found.

Researchers reviewed studies of patients with diabetes, hypertension, and hyperlipidemia published between 1980 and 2013 in which registered nurses titrated, or in some cases initiated, medications according to a protocol. They selected 18 studies (11 in Western Europe, 7 in the U.S.) with more than 20,000 patients for inclusion. Results were published in the July 15 Annals of Internal Medicine.

annals.jpg

In a meta-analysis, nurse-managed titration was associated with decreases in HbA1c level (−0.4%; 95% CI, −0.1% to −0.7%), systolic blood pressure (−3.68 mm Hg; 95% CI, −1.05 to −6.31 mm Hg), and diastolic blood pressure (−1.56 mm Hg; 95% CI, −0.36 to −2.76 mm Hg). The analysis also found statistically insignificant drops in cholesterol with protocol care: −0.24 mmol/L (−9.37 mg/dL) in total cholesterol and −0.31 mmol/L (−12.07 mg/dL) in low-density lipoprotein cholesterol.

The results show that the nurse-managed protocols were associated with a consistently positive effect on patient care, the authors concluded, although they noted that only 1 of the included studies reported on adverse effects. The failure of the literature to provide detailed descriptions of the interventions and the fact that most of the studies were conducted outside of the U.S. were other limitations. Still, the meta-analysis indicates that nurses can successfully titrate medications and that such team approaches may improve outcomes for stable, chronically ill patients, the study authors wrote.

Although the meta-analysis was limited and research is needed into the effects on complex or unstable patients, the results suggest that nurse-managed protocols could be part of the solution to the shortage and busyness of primary care physicians, according to an accompanying editorial. "Like it or not, outpatient medicine has become too complicated for physicians to handle by themselves," the editorialists wrote.



FDA update


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Empagliflozin approved to treat type 2 diabetes

Empagliflozin (Jardiance), a sodium glucose co-transporter 2 (SGLT2) inhibitor, was recently approved to treat type 2 diabetes in addition to diet and exercise, the FDA announced last week.

Safety and effectiveness of empagliflozin were evaluated in 7 clinical trials involving 4,480 patients with type 2 diabetes, which showed that the drug improved HbA1c levels compared to placebo, according to an FDA press release. The most common side effects are urinary tract infections and female genital infections. The drug can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. Patients who are elderly, have impaired renal function, or are on diuretics appeared to be more susceptible to this risk.

Empagliflozin has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylureas, pioglitazone, and insulin. It should not be used to treat people with type 1 diabetes, diabetic ketoacidosis, severe renal impairment, or end-stage renal disease. The FDA is requiring 4 postmarketing studies to investigate cardiovascular outcomes and pediatric use.



Keeping tabs


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Spotlight on office visits for diabetes

New data on how often diabetes patients visit their physicians were provided by 2 recent analyses.

In an interrupted time series study published in the July/August Annals of Family Medicine, researchers from Group Health in Seattle analyzed more than 18,000 diabetic patients' use of office visits, secure e-mailing, and telephone encounters as their practice transitioned to be a patient-centered medical home (PCMH). Over the 3 studied periods (before, during, and after the transition), office visits for these patients declined by a total of 8% (from 0.93 visit per quarter to 0.90 to 0.86). During that time, use of secure e-mailing increased significantly, leading to an increase in overall patient-practice contacts from 3.46 per quarter to 3.95 during the transition to 4.44 after. The researchers also did patient-level regression analyses, where they found that patients' increasing use of e-mail and phone contacts was associated with an increase in their office visits. The results suggest that chronically ill patients do not use alternate means of communication with their clinicians as a substitute for in-person visits and patients may instead take the opportunity to address previously unmet needs, the study authors speculated. Future research should look at whether e-mails and phone calls reduce emergency or inpatient services, they suggested.

Physician visits by diabetes patients across the U.S. were tallied in a recent National Center for Health Statistics Data Brief, published by the CDC on July 31. In 2010, patients with diabetes made 113.3 million visits to office-based physicians, according to the brief, which is based on the National Ambulatory Medical Care Survey. Patients with diabetes who were age 65 and over had the highest rate of visits at 1,380 visits per 1,000 persons. The vast majority of the visits (87%) involved patients who had other chronic conditions in addition to diabetes. At 85% of visits, medications were either prescribed or continued, and many of the visits involved polypharmacy. Five or more drugs were prescribed or continued at 60% of the visits by elderly patients. The researchers noted that such data are useful for observing progress toward the Healthy People 2020 goal of reducing the burden of diabetes as well as the effects of changing standards of care.


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MKSAP Answer and Critique



The correct answer is A. Bariatric surgery evaluation. This item is available to MKSAP 16 subscribers as item 150 in the General Internal Medicine section. Information about MKSAP 16 is available online.

This patient should be referred for bariatric surgery. For patients with class III obesity (BMI ≥40) or class II obesity (BMI 35.0-39.9) with obesity-related complications, the National Institutes of Health Consensus Development Conference recommends consideration of bariatric surgery if diet, exercise, and/or medication are ineffective. Patients should be motivated and well informed about this option and undergo multidisciplinary evaluation by a medical, surgical, psychiatric, and nutritionist team. The most common procedure is gastric bypass surgery, but laparoscopic banding is becoming common, as well. Bariatric surgery results in more dramatic and sustained weight loss than nonsurgical interventions and leads to improvement in obesity-related complications (diabetes mellitus, obstructive sleep apnea, hypertension, and hyperlipidemia). This patient has not attained his goal weight loss after a 6-month trial of diet and medication and has obesity-related complications that likely will improve with weight loss.

Phentermine is a sympathomimetic drug that is FDA-approved for short-term use (up to 12 weeks) as an adjunctive treatment of obesity. This patient's weight loss goal is 45.4 kg (100 lb), which will take much longer than 12 weeks. In addition, most persons regain any weight that is lost with this medication upon its discontinuation.

Restricting caloric intake to below 800 kcal/d (a very-low-calorie diet) is no more effective for long-term weight loss than a moderate strategy of restricting intake to 500-1000 kcal/d below what is estimated to maintain current body weight. In addition, long-term compliance with a very-low-calorie diet is nearly impossible.

Exercise is an important part of a comprehensive weight loss program that focuses on lifestyle modification. However, the patient has already not benefited from an exercise program. It is unlikely that exercise alone will meet his weight loss goals.

Key Point

  • Bariatric surgery should be considered for patients with BMI of 40 or greater or BMI of 35.0 to 39.9 with obesity-related complications in whom diet, exercise, and/or medication are ineffective.

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ACP DiabetesMonthly is a monthly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.

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Test yourself

A 66-year-old man comes for a preoperative evaluation before total joint arthroplasty of the left knee. He has a 25-year history of rheumatoid arthritis. He has had progressive pain in his left knee with activity, which limits his ability to hike. The patient has similar pain in the right knee, but it is less severe. He reports no recent morning stiffness. He is able to climb two or three flights of stairs without chest pain or shortness of breath. He has no other medical problems and reports no additional symptoms. Medications are methotrexate and folic acid. Following a physical exam and lab tests, what is the next best step in management?

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