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

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ACP DiabetesMonthly



In the News for the month of October 2013




Highlights

Admission hyperglycemia in AMI patients may indicate developing or unrecognized diabetes

Hyperglycemia at hospital admission for acute myocardial infarction (AMI) may indicate developing or unrecognized diabetes in patients with no history of the condition, according to a new study. More...

Nurse phone coaching program didn't improve outpatient glycemic control

A nurse-delivered phone coaching initiative that aimed to improve outpatients' glycemic control wasn't more successful than usual care, a new study found. More...

Stepwise insulin intensification non-inferior to basal-bolus regimen

Stepwise prandial insulin intensification provided glycemic control that was non-inferior to a full basal-bolus regimen after 32 weeks, with significantly lower hypoglycemia risk and better patient satisfaction, an industry-funded study found. More...


Test yourself

MKSAP Quiz: Treating hyperlipidemia and type 2 diabetes

This month's quiz asks readers to evaluate a 56-year-old man who received a diagnosis of type 2 diabetes mellitus 6 months ago and is returning for follow up. More...


From ACP InternistWeekly

Score predicts diabetes remission after Roux-en-Y surgery

Researchers created a new score, based on four variables, which can help predict whether a patient will have remission of type 2 diabetes after Roux-en-Y gastric bypass surgery. More...


From ACP HospitalistWeekly

Intensive insulin after PCI didn't reduce infarct size

Intensive use of insulin to regulate hyperglycemia in acute coronary syndrome (ACS) patients did not reduce infarct size, and may have caused harm, a new study found. More...


From ACP Internist

Diabetic foot care begins with bare feet

Get advice on heading up a care team that intervenes early and often to prevent the ulcerations, pressure points and neuropathies that can progress to infection and possibly amputation in the October ACP Internist. More...


From ACP Journal Club

Insulin pumps with a sensor and threshold-suspend reduced nocturnal hypoglycemia in type 1 diabetes

Patients with type 1 diabetes and documented nocturnal hypoglycemia who were randomized to receive sensor-enhanced insulin pump therapy with a threshold-suspend feature had reduced nocturnal hypoglycemia and no difference in glycated hemoglobin levels compared to those on sensor-augmented insulin pump therapy alone, a recent study found. More...


Tool of the month

Advice for patient education about diet

When counseling patients with type 2 diabetes about their diets, some general principles may be helpful. More...


Keeping tabs

Spotlight on European Association for the Study of Diabetes conference

The annual meeting of the European Association for the Study of Diabetes was held in Barcelona, Spain in September. Research presented at the meeting covered risks of sulfonylureas, pioglitazone and macular edema, treatment intensification and erectile dysfunction. More...


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



Highlights


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Admission hyperglycemia in AMI patients may indicate developing or unrecognized diabetes

Hyperglycemia at hospital admission for acute myocardial infarction (AMI) may indicate developing or unrecognized diabetes in patients with no history of the condition, according to a new study.

Researchers studied a national cohort of consecutive patients admitted to 127 Veterans Affairs (VA) hospitals with AMI but no known diabetes from October 2005 to March 2011. Patients were determined to have signs of diabetes at discharge or 6 months after discharge based on diagnostic codes, medication prescriptions, and elevated hemoglobin A1c values. The study authors used regression modeling to examine the association between hyperglycemia at admission (defined as a serum glucose level above 140 mg/dL) and later evidence of diabetes. Results were published early online on Oct. 2 by Diabetes Care.

A total of 10,499 patients, 98% of them men, were admitted to VA hospitals with AMI but no known diabetes. Of these, 1,761 (16.8%) had hyperglycemia at admission. This group was more likely than those without admission hyperglycemia to be older than 65, to present with a diagnosis of ST-elevation MI, and to have a TIMI (Thrombolysis in Myocardial Infarction) risk score greater than 3. Six months after the index hospitalization, 208 (11.8%) patients with admission hyperglycemia and 443 (5.1%) without had new evidence of diabetes (P<0.001).

Of these 651 patients, 169 (26.0%) had new evidence of diabetes before discharge and the remainder had new evidence in the 6 months afterward. Seventy-one patients whose diabetes was diagnosed before discharge (46.7%) had hyperglycemia at admission. In addition, 267 of the 651 patients with new evidence of diabetes (41%) had a hemoglobin A1c level of 6.5% or greater but no related diagnostic codes or prescriptions, which suggested that their diabetes was unrecognized. A significant association was seen between admission hyperglycemia and subsequent diabetes after multivariable adjustment (odds ratio, 2.56; 95% CI, 2.15 to 3.06).

The authors noted that their results may not be generalizable because the study was conducted in a mostly male population of U.S. veterans cared for in the VA health system. They also pointed out that their study was observational and retrospective, that the prevalence of diabetes may have been underestimated and that some diabetic diagnoses at admission may have been incorrect, among other limitations. However, they concluded that 1 out of 6 patients with AMI but no known diabetes had admission hyperglycemia, which was in turn associated with a 2.5-fold higher risk for evidence of diabetes in the 6 months after hospitalization.

"In addition, a significant number of these patients may have unrecognized diabetes and thus represent an important opportunity to appropriately identify and treat them," they wrote. "Accordingly, systematic screening for diabetes among hyperglycemic AMI patients may provide opportunities for prompt identification, improved risk-stratification, institution of optimal diabetes and AMI treatments, and improved outcomes."


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Nurse phone coaching program didn't improve outpatient glycemic control

A nurse-delivered phone coaching initiative that aimed to improve outpatients' glycemic control wasn't more successful than usual care, a new study found.

Four-hundred-and-seventy-three patients from 59 Australian primary care practices were randomized to receive usual care or a coaching intervention delivered by practice nurses without prescribing rights. All patients had type 2 diabetes, defined as hemoglobin A1c (HbA1c) >7.5% within the past 12 months. Nurses in the intervention practices were trained for two days in a phone coaching program which aimed to provide eight phone and one in-person coaching sessions per patient.

Coaching sessions dealt with lifestyle issues, medication adherence and dosing, self-monitoring and self-advocacy. In particular, the coaching program aimed to help patients learn to negotiate with physicians on intensifying their medication, if needed. The program was adapted for diabetes patients from an evidence-based intervention for patients with cardiovascular risk. The study's main outcome was HbA1c level at 18 months after baseline. Results were published Sept. 18 by BMJ.

There was no significant difference between groups in HbA1c level at 18 months follow up; there also were no significant differences in most clinical measures, though intervention patients were more likely to attain a healthy body mass index of less than 25 (P<0.03). Patient attrition rates were 5% in each group. The median number of coaching sessions for the 236 intervention patients was three, and 25% of intervention patients had no sessions. Of patients who got at least one session, the median number of sessions was four.

Nurses spent a median of 30 minutes per session to deliver coaching and craft individual action plans. Holders of health care cards (low-income patients) were more likely to receive 1 to 4 coaching sessions than non-health care card holders. Only 18% of phone calls included advice about intensifying medications, and only 70% documented current medications.

The intervention may have been more successful if the nurses had undergone a longer training period and/or if more of the intended phone sessions had been delivered, the authors wrote. "Clearly the intensity of the intervention was a problem in our study as patients who received coaching only received a median of three telephone calls despite support for the practice nurses from the research team," they wrote. Still, the study was designed to be conducted in a real-world setting, so the fact that most patients didn't receive the intended intervention "may be best seen as an outcome rather than a limitation," they wrote.


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Stepwise insulin intensification non-inferior to basal-bolus regimen

Stepwise prandial insulin intensification provided glycemic control that was non-inferior to a full basal-bolus regimen after 32 weeks, with significantly lower hypoglycemia risk and better patient satisfaction, an industry-funded study found.

Researchers conducted a 32-week, randomized, treat-to-target trial at 150 sites in 7 countries from Oct. 27, 2010 to April 25, 2012. The study was funded by Novo Nordisk. Results appeared online in The Lancet Diabetes & Endocrinology on Sept. 25.

In this trial, 401 patients (mean age 59.8 years; mean diabetes duration 12.6 years; mean hemoglobin A1c [HbA1c] 7.9%) were randomized to either stepwise intensification or full basal-bolus treatment. Patients in the basal-bolus group received insulin aspart before every meal, while patients in the stepwise group received one bolus dose with the largest meal and added doses before the next largest meal at 11 weeks and again at 22 weeks if their HbA1c remained at 7% or above.

During the 32-week treatment, the proportion of participants who withdrew was significantly higher in the basal-bolus group (52 [26%]) than in the stepwise group (28 [14%]; P=0.002). After 32 weeks, HbA1c change from baseline was −0.98% (95% CI, −1.09 to −0.87) for the stepwise group and −1.12% (95% CI, −1.23 to −1.00) for the basal-bolus group (mean treatment difference, 0.14; 95% CI, −0.02 to 0.30; P=0.0876). Significantly more patients in the basal-bolus group reached their target HbA1c at the end of the first treatment period (odds ratio [OR], 6.85; 95% CI, 4.12 to 11.39; P<0.0001) and second treatment period (OR, 2.38; 95% CI, 1.56 to 3.64; P<0.0001), but this difference was not significant by the end of the trial (OR, 1.36; 95% CI, 0.90 to 2.07; P=0.15). Finally, patients were significantly more satisfied with the stepwise approach than with the basal-bolus approach (P=0.0072).

In the basal-bolus group, hypoglycemia rates increased rapidly between weeks 0 and 10, and seemed to decline slightly during the remainder of the trial, the authors noted. In the stepwise treatment group, the rate of hypoglycemia increased slightly over the first 10 weeks, fell during weeks 10 through 21, and then remained at around the same level through the end of the trial. Patients in the stepwise group had fewer overall hypoglycemic episodes than did those in the basal-bolus treatment group (rate ratio, 0.58; 95% CI, 0.45 to 0.75; P<0.0001). Adverse events did not differ between the two groups, and the most common were nasopharyngitis, influenza, diarrhea, headache, peripheral edema and wrong drug given.

Researchers wrote, "This regimen is an attractive alternative to initiation of full basal-bolus insulin replacement involving four injections per day. The stepwise approach consists of fewer injections, fewer associated glucose measurements, less burden on the patient in terms of titrating insulin doses, lower risk of hypoglycemia, less weight gain, and better adherence than the basal-bolus approach."

An editorialist outlined how starting prandial insulin in a stepwise manner can be done in a practical way. The patient identifies which meal has the most carbohydrates, and takes 4 to 6 units of a rapid-acting insulin analogue, ideally 10 to 15 minutes before eating. The dose is then adjusted once or twice a week so that the next prandial or bedtime glucose reading is at target (less than 130 mg/dL). If the HbA1c remains above target, a second and third dose can be added if needed. The editorialist wrote, "Clinicians should be aware that every addition of a prandial dose of insulin to a patient's daily regimen increases the risk of hypoglycemia, and therefore should be weighed against potential benefits of intensifying therapy."



Test yourself


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MKSAP Quiz: Treating hyperlipidemia and type 2 diabetes

A 56-year-old man comes to the office for a follow-up evaluation. Since receiving a diagnosis of type 2 diabetes mellitus 6 months ago, he has been eating a low-fat, high-fiber, high-carbohydrate diet and walking for 20 minutes at night. The patient has never smoked and drinks no alcohol. He originally took metformin to treat his diabetes but stopped because of persistent diarrhea. Current medications are glyburide and ramipril.

mksap.gif

On physical examination, temperature is 36.8 °C (98.2 °F), blood pressure is 129/76 mm Hg, pulse rate is 76/min, and respiration rate is 15/min; BMI is 22. Other physical examination findings are normal.

Laboratory studies show: alanine aminotransferase 102 units/L; aspartate aminotransferase 96 units/L; cholesterol: total 264 mg/dL (6.83 mmol/L), LDL 157 mg/dL (4.07 mmol/L), HDL 42 mg/dL (1.09 mmol/L); fasting glucose 196 mg/dL (10.9 mmol/L); hemoglobin A1c 9.8%; iron studies normal; triglycerides 437 mg/dL (4.94 mmol/L); hepatitis virus negative.

Bedtime neutral protamine Hagedorn (NPH) insulin is initiated.

Which of the following is the most appropriate treatment of his hyperlipidemia?

A. Begin a fibrate now
B. Begin a statin now
C. Begin a statin after results of liver chemistry studies normalize
D. Begin nicotinic acid (niacin) now
E. Begin either a fibrate or nicotinic acid after results of liver chemistry studies normalize

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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Score predicts diabetes remission after Roux-en-Y surgery

Researchers created a new score, based on four variables, which can help predict whether a patient will have remission of type 2 diabetes after Roux-en-Y gastric bypass surgery.

The score, which the researchers named the DiaRem score, was created based on a retrospective cohort study of 690 patients with type 2 diabetes who had the surgery at one hospital in 2004 to 2011. Patients were followed for partial or complete remission lasting at least 12 months after surgery. Partial remission was defined as hemoglobin A1c (HbA1c) less than 6.5% and fasting blood glucose less than 126 mg/dL, while complete remission was an HbA1c less than 6.0% with fasting blood glucose less than 100 mg/dL, both with no antidiabetic medication. Results were published by The Lancet Diabetes & Endocrinology on Sept. 13.

After examining 259 variables, researchers identified four that best predicted partial or complete remission in the 463 surgical patients (63%) who achieved either type of remission. Insulin use before surgery was the strongest predictor (patients who used insulin were least likely to have remission), so it was given the most weight (10 points in the 22-point score). Other factors that predicted remission were younger age, lower HbA1c and not taking the combination of both insulin-sensitizing agents (other than metformin) and sulfonylureas.

Among patients with the lowest scores, 88% had remission after surgery, compared to only 0.5% of the highest-scoring patients. The researchers validated their findings in two replication cohorts and concluded that their DiaRem score could be used preoperatively to predict diabetes remission after Roux-en-Y (but not other types of bariatric surgery). This study also found for the first time that, among patients who took insulin, use of incretin mimetics increased the chance of remission, a finding that needs further confirmation, the authors noted.

The score could help with treatment selection for diabetes and management of expectations in patients who are undergoing Roux-en-Y, an accompanying comment noted. However, more research is needed to validate the findings and assess the effects of surgery on other endpoints, including mortality. Clinicians should also remember that even patients who are unlikely to achieve diabetes remission from surgery may see significant benefits from the procedure, the comment concluded.



From ACP HospitalistWeekly


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Intensive insulin after PCI didn't reduce infarct size

Intensive use of insulin to regulate hyperglycemia in acute coronary syndrome (ACS) patients did not reduce infarct size, and may have caused harm, a new study found.

The prospective, open-label study was conducted at a large teaching hospital in the Netherlands. Between 2008 and 2012, 294 patients admitted with ACS and a plasma glucose of 140 to 288 mg/dL were randomized to either intensive glucose management (intravenous insulin therapy targeted at plasma glucose levels of 85 to 110 mg/dl) or conventional management (no insulin therapy unless plasma glucose exceeded 288 mg/dl). Patients with insulin-dependent diabetes before admission were excluded from the study. Results were published online Sept. 9 by JAMA Internal Medicine.

Percutaneous coronary intervention (PCI) was performed on 93.6% of the study patients, at a median of about 30 minutes after admission. The primary endpoint of the study was high-sensitivity troponin T about 72 hours after admission, with secondary endpoints the area under the curve of creatine kinase, myocardial band, release and myocardial perfusion scintigraphy at six weeks. The intensive group (whose median glucose was 112 mg/dl) showed an insignificant decrease in infarct size, as measured by all the endpoints, compared to the conventional group. Although severe hypoglycemia was rare, the intensive group did have a higher incidence of death or spontaneous second myocardial infarction (8 patients [5.7%] vs. 1 [0.7%]; P=0.04).

One possible explanation for the lack of effect is the timing of insulin therapy; it was often delayed until after PCI, a median of five hours after symptom onset. It's also possible that elevated plasma glucose was a marker of severity, rather than a causal factor, the authors speculated. They also noted that rapid delivery of PCI could have limited infarct sizes to the point that glucose control didn't provide further benefits. Based on the lack of benefit and possibility of harm observed, "strict, but not too strict, glucose control" seems to be the appropriate strategy, the authors concluded.

They called for additional research to focus on patients with persistently elevated glucose after PCI, as well as the association between intravenous insulin and early second myocardial infarction. An accompanying commentary also suggested a large trial targeting glucose to 140 mg/dl or below, noting that although this study did not show a significant benefit in infarct size, there was a trend favoring intensive glucose management, and other studies show promise with insulin treatment of hyperglycemia in patients with myocardial infarction.



From ACP Internist


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Diabetic foot care begins with bare feet

Get advice on heading up a care team that intervenes early and often to prevent the ulcerations, pressure points and neuropathies that can progress to infection and possibly amputation in the October ACP Internist.



From ACP Journal Club


.
Insulin pumps with a sensor and threshold-suspend reduced nocturnal hypoglycemia in type 1 diabetes

Patients with type 1 diabetes and documented nocturnal hypoglycemia who were randomized to receive sensor-enhanced insulin pump therapy with a threshold-suspend feature had reduced nocturnal hypoglycemia and no difference in glycated hemoglobin levels compared to those on sensor-augmented insulin pump therapy alone, a recent study found.

The study was published in the July 18 New England Journal of Medicine. A summary of the study was published in the July ACP DiabetesMonthly. The following commentary by Rozalina McCoy, MD, and Steven Smith, MD, was published in the ACP Journal Club section of the Sept. 17 Annals of Internal Medicine.

Hypoglycemia, particularly nocturnal hypoglycemia, is the most common important adverse effect of diabetes therapy, causing considerable morbidity and occasional mortality. The ASPIRE study examined the effect of nocturnal sensor-augmented pump devices equipped with an automated insulin suspension feature on the incidence and duration of nocturnal hypoglycemia in adolescents and adults with type 1 diabetes. They found that both were decreased, but not eliminated, without concomitant change in glycated hemoglobin levels compared with standard insulin pumps and continuous glucose monitors.

Although these results are promising, important questions remain. Without a hypoglycemia/suspension alert mechanism, patients may remain unaware of the episode and thus fail to address the cause of hypoglycemia, thereby allowing it to recur. Indeed, despite suspension of insulin release, hypoglycemia persisted 2 hours after suspension (i.e., at time of insulin resumption) in 33% of suspension events. Also, generalizability of the ASPIRE study to clinical practice is uncertain because it excluded patients most likely to benefit from this technology—those with a history of severe hypoglycemia—and relied on a technically trained health care team.

It is important to keep in mind that our primary goal should not be solely hypoglycemia detection and acute management, but rather prevention of hypoglycemia and hyperglycemia. Behavioral assessment and intervention should complement technology, and providers must work with patients to determine why hypoglycemia occurred in the first place, probing for an excessive basal insulin rate, miscalculated prandial insulin dosing, unaccounted for physical activity, or disproportionate insulin correction as a reaction to hyperglycemia. Technology alone is often insufficient.



Tool of the month


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Advice for patient education about diet

When counseling patients with type 2 diabetes about their diets, keep in mind the following general principles:

  • Note that there is no single, specific diet for diabetes that applies to all patients; individualized planning should be the goal.
  • Consider referral to a dietician
  • Stress the importance of moderation.
  • Base calorie recommendations on the goal of achieving near-ideal body weight.
  • Use a reasonable starting formula of 10 calories per pound of current body weight plus 20% for sedentary patients, 33% for those who engage in light physical activity, 50% for moderately active patients, and 75% for those who are heavily active.
  • Avoid saturated fats.
  • Follow a regular meal schedule, particularly if on insulin.
  • Note that frequent small meals might aid in weight loss and in control of blood-glucose level.
  • Choose complex carbohydrates (e.g., starches, cereals) over simple sugars.

This content is from ACP Smart Medicine, the College's new web-based clinical decision support tool developed specifically for internal medicine physicians. Information about ACP Smart Medicine is online.



Keeping tabs


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Spotlight on European Association for the Study of Diabetes conference

The annual meeting of the European Association for the Study of Diabetes was held in Barcelona, Spain in September. Highlights of the research presented at the meeting include:

Patients whose first-line therapy for type 2 diabetes was a sulfonylurea had significantly increased risk of death compared to those on metformin monotherapy, according a retrospective analysis of data from the United Kingdom. The analysis included almost 100,000 patients (more than 15,000 of them on sulfonylureas), and the increased mortality in the sulfonylurea patients persisted even in the direct- and propensity-matched cohorts. While noting that confounding could have occurred, the researchers concluded "treatment with first-line monotherapy with sulfonylureas should be reconsidered."

In the Veterans Administration system, many patients with cardiovascular risks are taking sulfonylureas, despite guidelines to the contrary, a retrospective cohort study found. Analyzing records from almost 150,000 patients, researchers found that a quarter of patients with existing cardiovascular disease or multiple cardiovascular risk factors were taking drugs in the class, about the same rate as patients at low risk of cardiovascular disease.

Use of pioglitazone was associated with development of diabetic macular edema (DME), according to a retrospective study using 2000 to 2011 data from a Japanese database. More than 20,000 type 2 diabetes patients were included, and of the 953 taking pioglitazone, the rate of DME was 1.5% compared to 0.45% in the overall group, leading researchers to conclude that pioglitazone may increase the risk of DME.

Delay in intensifying treatment of type 2 diabetes was associated with higher risk of cardiovascular events, a retrospective analysis found. More than 110,000 patients were studied, more than a quarter of whom had a hemoglobin A1c of 7% or higher a year after diabetes diagnosis. Patients in that group who didn't intensify treatment (addition of a second oral drug or insulin) within a year were significantly more likely to have a myocardial infarction, stroke or heart failure during study follow-up, supporting the cardiovascular benefits of early treatment intensification in patients with poor glycemic control, researchers concluded.

Erectile dysfunction in men with type 1 diabetes often reverses itself, especially after a short duration, according to new data from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications. More than 700 men were queried about impotence. Of the 198 with a single report of erectile dysfunction (ED), 67.7% regained potency within 5 years. The likelihood of regaining potency decreased with every consecutive year of ED, until those with 5 or more consecutive years had less than a 20% chance. The overall incidence of ED increased from 5.5% in first year (1994) of follow up, to 33.6% by year 16 (2009).


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MKSAP Answer and Critique



The correct answer is B. Begin a statin now. This item is available to MKSAP 16 subscribers as item 45 in the Endocrinology section. Information about MKSAP 16 is available online.

In addition to neutral protamine Hagedorn (NPH) insulin at bedtime, a statin should be added now to this patient's diabetes regimen. He has poorly controlled type 2 diabetes mellitus, and thus adding a bedtime basal insulin to his sulfonylurea is a reasonable step to improve his fasting plasma glucose level and hemoglobin A1c value. His liver chemistry studies show moderately elevated aminotransferase levels, but he has no other evidence of liver disease. This makes the diagnosis of nonalcoholic fatty liver disease most likely. In light of his diabetes and significant hypercholesterolemia, the addition of a statin is likely to be beneficial. Patients with nonalcoholic fatty liver disease are not necessarily at a higher risk of adverse outcomes from statin therapy than patients without the disease, and thus statins are a treatment option in these patients. In a study of 437 patients whose liver chemistry levels were up to three times the upper limit of normal, treatment with atorvastatin resulted in a threefold reduction in cardiovascular events (10% versus 30% in the nontreatment group) and a greater reduction in liver chemistry levels compared with patients not receiving a statin during 3 years of follow-up evaluation.

Fibrates are most effective for reducing the triglyceride level and have little impact on the LDL cholesterol level, the primary lipid target in this patient.

Starting the statin should not be delayed until after his glycemic control has improved or his liver chemistry tests normalize.

Nicotinic acid can lower the LDL cholesterol level and increase the HDL cholesterol level. Its use is typically limited by its adverse effects. Nicotinic acid can cause elevation of glucose and liver chemistry levels and may cause severe hepatocellular damage. Nicotinic acid would be relatively contraindicated in this patient with probable nonalcoholic fatty liver disease.

Key Point

  • Statins are a viable treatment option in patients with diabetes mellitus, hyperlipidemia, and nonalcoholic fatty liver disease.

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A 19-year-old man is evaluated for a sore throat, daily fever, frontal headache, myalgia, and arthralgia of 5 days' duration. He also has severe discomfort in the lower spine and a rash on his trunk and extremities. He returned from a 7-day trip to the Caribbean 8 days ago. The remainder of the history is noncontributory. Following a physical exam and lab studies, what is the most likely diagnosis?

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