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ACP InternistWeekly



In the News for the Week of 10-4-11




Highlights

Updated guideline released on PAD diagnosis and management

An updated guideline on diagnosis and management of peripheral artery disease was released last week by the American College of Cardiology Foundation and the American Heart Association, in conjunction with several other medical organizations. More...

Saw palmetto doesn't ease lower urinary tract symptoms in men

Saw palmetto extract, even up to three times the standard daily dose, had no more effect on lower urinary tract symptoms in men than placebo, a study found. More...


Test yourself

MKSAP Quiz: establish care for diabetes and hypertension

This week's quiz asks readers to evaluate a 60-year-old man with type 2 diabetes mellitus and hypertension who seeks to establish medical care. More...


Drug therapy

SSRI increases bleeding risk after MI

Patients who received a selective serotonin reuptake inhibitor after acute myocardial infarction were at higher risk of bleeding, a study found. More...

Statins worked even for MI patients with low LDL

Statin therapy was beneficial for post-myocardial infarction patients who had low-density lipoprotein cholesterol levels under 70, a study found. More...


Imaging

MRIs safe for ICDs and pacemakers, if proper protocol followed

Magnetic resonance imaging can be performed safely in patients with certain pacemakers and implantable cardioverter-defibrillators as long as expert staff are on hand to monitor and intervene if needed, a study found. More...


Heart failure

Isolated diastolic hypotension a risk factor for heart failure

Isolated diastolic hypotension is an independent risk factor for heart failure similar in magnitude to isolated systolic hypertension, researchers reported. More...


From ACP Internist

The next issue of ACP Internist is online and coming to your mailbox

October's issue of ACP Internist features stories on internists for pro sports teams, cardiovascular disease in the elderly and teaching medicine to Iraqi physicians, among others. More...


Cartoon caption contest

Put words in our mouth

ACP InternistWeekly wants readers to create captions for our new cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service. More...

Editorial note: ACP InternistWeekly will not be published next week due to the Explorers' Day holiday.


Physician editor: Darren Taichman, MD, FACP




Highlights


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Updated guideline released on PAD diagnosis and management

An updated guideline on diagnosis and management of peripheral artery disease (PAD) was released last week by the American College of Cardiology Foundation and the American Heart Association, in conjunction with several other medical organizations.

The guideline, which updates 2005 recommendations on the subject, expands criteria for using the ankle-brachial index (ABI), recommends increased efforts to ensure access to smoking cessation services, encourages improved antiplatelet and antithrombotic therapy, and more precisely defines interventions to avoid limb amputation and to treat aortic aneurysms. Specific recommendations include:

  • The ABI should first be performed in patients 65 years of age or older, compared with 70 years of age or older according to the 2005 guideline;
  • Current and former smokers should be asked about tobacco use at each visit and should be proactively offered support to help them quit, such as counseling, pharmacologic therapies and/or formal smoking cessation programs;
  • Aspirin plus clopidogrel may be considered in patients with symptomatic atherosclerotic lower-extremity PAD to reduce risk for cardiovascular events;
  • Balloon angioplasty is a reasonable first-line treatment for patients with severe PAD who may need amputation and are expected to live for two years or less. For those expected to live more than two years, bypass surgery is a reasonable option; and
  • Open repair for abdominal aortic aneurysms is reasonable in patients who are good candidates for surgery but can't comply with periodic long-term surveillance after endovascular repair.

The guideline was developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. It was published online Sept. 29 by the Journal of the American College of Cardiology and Circulation.

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Saw palmetto doesn't ease lower urinary tract symptoms in men

Saw palmetto extract, even up to three times the standard daily dose, had no more effect on lower urinary tract symptoms in men than placebo, a new trial has found.

Researchers performed a randomized, double-blind, multicenter, placebo-controlled trial at 11 clinical sites in North America between June 5, 2008 and Oct. 10, 2010 to examine whether increasing doses of saw palmetto extract affected lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH). Participants were male volunteers who were at least 45 years or age with a peak uroflow rate of 4 mL/s or greater and an American Urological Association Symptom Index (AUASI) score of 8 to 24 at two screening visits. The AUASI contains seven items for self-assessed frequency of lower urinary tract symptoms, with a score range of 0 to 35.

The study's main outcome measure was the change in AUASI score from baseline to 72 weeks. Secondary outcome measures were urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, and study participants' global assessments, along with indices of sexual function, sleep quality, prostatitis symptoms and continence. The study results were published in the Sept. 28 Journal of the American Medical Association.

A total of 357 men were randomly assigned to receive gelcaps containing 320 mg of saw palmetto (n=176) or placebo (n=181) and were included in the modified intention-to-treat analysis. Participants' mean age was 61 years, and their mean baseline AUASI score was 14.6 points. The initial dose of the study drug was one gelcap per day, increasing to two gelcaps per day at 24 weeks and three gelcaps per day at 48 weeks. Overall, mean AUASI scores decreased by 2.20 points in the saw palmetto group (95% CI, 3.04 to 0.36 points) and by 2.99 points in the placebo group (95% CI, 3.81 to 2.17 points) between baseline and 72 weeks. The mean difference for change in AUASI score from baseline to 72 weeks was 0.79 point in favor of placebo. No secondary outcome measure improved with saw palmetto compared to placebo. No participants reported adverse effects that could be clearly attributed to the study drug.

The authors noted that their study tested only one preparation of saw palmetto extract and that some of the study participants may have had lower urinary tract symptoms for reasons other than BPH. However, they concluded that saw palmetto extract was no better than placebo for any of the outcomes studied, even at amounts up to three times the standard daily dose.

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Test yourself


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MKSAP Quiz: establish care for diabetes and hypertension

A 60-year-old man with type 2 diabetes mellitus and hypertension visits the office to establish medical care. He reports monitoring his blood pressure and blood glucose measurements at home with good results. He had a cholesterol panel checked approximately 5 years ago, at which time he was instructed by his prior physician to exercise, lose weight, and reduce his intake of dietary cholesterol. He has made some lifestyle changes, which he believes have helped his blood pressure and glucose control. His hypertension has been treated for 15 years and his diabetes for 5 years. His daily medications include lisinopril, amlodipine, metformin, and aspirin.

On physical examination, blood pressure is 128/65 mm Hg and pulse is 76/min. BMI is 26. The remainder of the physical examination is normal.

Laboratory studies:

Total cholesterol 215 mg/dL (5.6 mmol/L)
Triglycerides 185 mg/dL (2.1 mmol/L)
HDL cholesterol 39 mg/dL (1.0 mmol/L)
LDL cholesterol 145 mg/dL (3.8 mmol/L)
Hemoglobin A1c 6.5%

Which of the following medications is the best choice for reducing this patient's risk of cardiovascular disease?

A) Colestipol
B) Ezetimibe
C) Niacin
D) Simvastatin

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

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Drug therapy


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SSRI increases bleeding risk after MI

Patients who received a selective serotonin reuptake inhibitor (SSRI) after acute myocardial infarction were at higher risk of bleeding, a new study found.

The retrospective cohort study included 27,000 patients discharged from a Canadian hospital following an acute myocardial infarction (MI). All of the patients were taking some form of antiplatelet therapy: 14,426 were on aspirin (ASA), 2,467 received clopidogrel and 9,475 took both. Some of the patients also received an SSRI in combination with aspirin (406 patients), with clopidogrel (45) or both (239). The study followed the patients until death, readmission due to bleeding or repeat MI, or the end of the study period.

The addition of the SSRI to the antiplatelet regimens was associated with an increased risk of bleeding, researchers found. Compared to patients taking only aspirin, patients in the ASA plus SSRI group had a 42% increased risk of bleeding (95% confidence interval [CI] for hazard ratio, 1.08 to 1.87). The use of an SSRI, aspirin and clopidogrel all together increased risk by 57% compared to just dual antiplatelet therapy (95% CI for hazard ratio, 1.07 to 2.32). The study also found a higher bleeding risk in patients taking clopidogrel with an SSRI than those on clopidogrel alone, but the patient population was too small to prove significance.

The study authors noted that previous studies have reported increased bleeding with SSRIs that have a higher affinity to serotonin, a finding that was not replicated by this research. This study was limited by its observational nature, reliance on billing information, and lack of data on compliance with medication regimens. Still, the authors concluded that physicians should cautiously weigh the benefits of SSRI therapy against the risk of bleeding in post-MI patients with major depression. The study was published online by the Canadian Medical Association Journal on Sept. 26.

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Statins worked even for MI patients with low LDL

Statin therapy was beneficial for post-myocardial infarction (MI) patients who had low-density lipoprotein (LDL) cholesterol levels under 70, a new study found.

The observational study included about 1,000 Korean patients who had an acute myocardial infarction and an LDL below 70 (measured within 24 hours of MI). About 600 of them received a statin and about 450 did not. They were followed for a year for a primary composite endpoint of major adverse cardiac events, including death, recurrent MI, target vessel revascularization and coronary artery bypass grafting.

Patients in the statin group had a significantly lower risk of the primary endpoint (adjusted hazard ratio [HR], 0.56; P=0.015), a difference driven by their decrease in cardiac death (HR, 0.47; P=0.031) and coronary revascularization (HR, 0.45; P=0.013). The two groups did not show any difference, however, in all-cause death, recurrent MI, and repeated percutaneous coronary intervention. The results were published online by the Journal of the American College of Cardiology on Oct. 3.

Statin treatment of patients with LDL below 70 is a controversial issue, the study authors acknowledged. They noted that such patients are usually older and likely to have other comorbidities. Subgroup analyses showed the most beneficial effects of statins in men, the elderly, smokers or ex-smokers, STEMI patients, and patients without diabetes, hypertension or prior dyslipidemia. High C-reactive protein levels were also associated with more benefit. The study authors concluded that statins are associated with improved outcomes in post-MI patients with LDL below 70, although they called for their findings to be confirmed by randomized trials on the subject.

The non-randomized nature of this study is a major limitation, an accompanying editorial said. In addition, patients' LDLs were not retaken after the initial measurement. However, based on this trial and others suggesting that statins have significant benefit in the year after MI, a placebo-controlled clinical trial of such statin therapy is worth considering, the editorialist concluded.

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Imaging


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MRIs safe for ICDs and pacemakers, if proper protocol followed

Magnetic resonance imaging (MRI) can be performed safely in patients with certain pacemakers and implantable cardioverter-defibrillators (ICD) as long as expert staff are on hand to monitor and intervene if needed.

annals.jpg

Up to 75% of patients with pacemakers and ICDs develop an indication to undergo MRIs. To define a protocol for scanning such patients, researchers at Johns Hopkins University in Baltimore, and Rambam Medical Center, in Haifa, Israel, enrolled patients from primary and subspecialty physicians between February 2003 and April 2010.

As most ICDs lack asynchronous pacing capacity, pacemaker dependent patients with ICDs were excluded. Patients with newly implanted ICD or pacemaker leads (less than 6 weeks) and those with abandoned or epicardial leads also were excluded, resulting in 438 patients with devices (54% with pacemakers and 46% with ICDs) who underwent 555 MRI studies. Results appeared in the Oct. 4 issue of Annals of Internal Medicine.

MRIs were done at a magnetic strength of 1.5 T. Pacing mode was changed to asynchronous for pacemaker-dependent patients and to inhibited for others. Tachyarrhythmia functions were disabled. Blood pressure, electrocardiography, oximetry and symptoms were monitored by a nurse with experience in cardiac life support and who had immediate backup from an electrophysiologist.

Researchers looked at whether exposure to electromagnetic interference might cause implantable devices to revert to a back-up programming mode known as "power-on-reset." In this mode, pacing is set to an inhibited mode and tachycardia therapies are enabled. There were three power-on-reset events. One occurred during cardiac MRI in a patient with a single-chamber ICD that had been implanted in 1999. The ICD did not attempt to deliver tachyarrhythmia therapy, but the patient experienced a pulling sensation in his chest and the MRI examination was discontinued.

The other two patients had pacemakers implanted in 1997 and 2003 and were undergoing brain and cervical spine examinations, respectively. Both patients had occasional pacing inhibition associated with programming reversion to the inhibited pacing mode, but they were not pacemaker-dependent and completed their MRI examinations. None of the three patients had device dysfunction during long-term follow-up.

When the device was located in the MRI field of view, image distortion, signal voids or bright areas, and poor fat suppression occurred. Selecting imaging planes perpendicular to the plane of the device generator, shortening the echo time, and using spin echo and fast spin echo sequences reduced the effect. Artifacts occurred during thoracic exams, and because thoracic MRIs have a greater effect on the devices, they should be reserved for patients with an absolute clinical need, the study authors said.

Researchers noted that they did not test all available cardiac devices, that follow-up was unavailable in 43 patients (10%), and that some data were missing. Defibrillation threshold testing and randomization to a control group were not performed.

An editorialist commented that MRIs are not risk free, but the risks are quantitatively small. "[T]he risks of MRI in the presence of CRMDs [cardiac rhythm management devices], although potentially serious, have probably been overestimated and can be managed effectively in many cases. In our opinion, the presence of a CRMD should no longer be considered an absolute contraindication to MRI. Rather, the risks and benefits of MRI in a patient with a CRMD should be assessed on an individualized basis, as with any important medical decision."

To manage risks, practitioners should conduct MRIs only at 1.5 T, implants should be in place for at least six weeks to reduce movement of leads, and no epicardial or nonfunctioning leads should be present. "Most important, the equipment and experienced personnel necessary to manage any eventuality must be immediately available," the editorial concluded.

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Heart failure


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Isolated diastolic hypotension a risk factor for heart failure

Isolated diastolic hypotension (IDH) is an independent risk factor for heart failure similar in magnitude to isolated systolic hypertension (ISH), researchers reported.

To determine whether IDH, defined as diastolic blood pressure less than 60 mm Hg and systolic blood pressure equal to or greater than 100 mm Hg, was a risk factor for heart failure, researchers reviewed data from the Cardiovascular Health Study (CHS), a National Heart, Lung, and Blood Institute-funded, population-based, prospective study of Medicare-eligible community dwelling adults.

After excluding people with existing heart failure, missing blood pressure data or systolic blood pressure less than 100 mm Hg, researchers studied 5,376 participants with and without treated hypertension. The primary outcome was physician-diagnosed heart failure reported in patient charts. Secondary outcomes were all-cause mortality and other incident cardiovascular events. Results appeared online Sept. 26 at Hypertension.

During more than 12 years of median follow-up, 751 (14%) had IDH. Heart failure developed in 25% and 20% of matched participants with and without IDH, respectively (hazard ratio [HR] when IDH was compared with no-IDH, 1.33; [95% confidence interval [CI], 1.10 to 1.61]; P=0.004). The multivariable-adjusted HR for IDH-associated heart failure in prematch participants with systolic blood pressure more than 140 mm Hg was 1.43 (95% CI, 1.16 to 1.77; P=0.001). All-cause mortality occurred in 49% and 44% of matched participants with and without IDH, respectively (HR associated with IDH, 1.12; [95% CI, 0.98 to 1.28]; P=0.096). IDH had no significant association with acute myocardial infarction, angina pectoris, stroke, transient ischemic attack, or peripheral arterial disease.

The authors concluded, "Because intensive lowering of SBP (systolic blood pressure) may not reduce major cardiovascular events, taken together with the findings of the current study, it may be reasonable to keep DBP (diastolic blood pressure) ≥60 mm Hg in older adults with ISH. Future hypertension guidelines need to focus on optimal DBP parameters for older adults receiving antihypertensive therapy."

An editorial cautioned that the results must be interpreted within the limited definition of IDH used by the researchers. In an elderly population, the cutoff of systolic blood pressure at 100 mm Hg would not be typical, especially with other cardiovascular comorbidities present. Despite the study's limitations, prediction of heart failure based on low diastolic blood pressure warrants further study, the editorial continued. But, "[O]nly clinical trials can establish whether further BP lowering in patients with ISH and low DBP is safe and beneficial in preventing heart failure and other CVD events."

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From ACP Internist


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The next issue of ACP Internist is online and coming to your mailbox

The October issue of ACP Internist is now online. Featured stories include:

acpi-20111004-sports.jpg

Sports internists treat players as patients. These internists turned their own athletic pursuits into careers with professional sports teams, treating high-caliber athletes as they practice and play. Working the sidelines, it's just another day not at the office.

Managing the elderly with cardiovascular disease. As patients are living longer, they're seeking more care for their cardiovascular diseases, as well as comorbidities such as diabetes. Effective therapy is possible in the older population, say the experts.

Medical mission in Iraq help train the next generation of doctors. U.S. military physicians are helping to train Iraq's next generation of doctors, as well as helping to restore an infrastructure smashed by decades of neglect, then combat.

More stories on making better diagnoses, avoiding practice audits and the MKSAP Quiz on hypertension are now online.

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Cartoon caption contest


.
Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

acpi-20111004-cartoon.jpg

E‑mail all entries to acpinternist@acponline.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.

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MKSAP Answer and Critique



The correct answer is D) Simvastatin. This item is available to MKSAP 15 subscribers as item 10 in the Pulmonary and Critical Care Medicine section. More information about MKSAP 15 is available online.

This patient has multiple risk factors for coronary artery disease (CAD), including diabetes mellitus, hypertension, and hypercholesterolemia. Given his age and risk factors, he is at high risk (20%) of having a CAD event within the next 10 years. The goal LDL cholesterol level for a patient with two or more risk factors for CAD is dependent on the 10-year risk for a CAD event based upon the Framingham risk equation. In patients with two or more risk factors and with an intermediate (10%-20%) 10-year risk, the goal LDL cholesterol level is below 130 mg/dL (3.4 mmol/L). However, in patients with two or more risk factors and a high risk (>20%) of a CAD event, the goal LDL cholesterol level is below 100 mg/dL (2.6 mmol/L). A statin is the first-line treatment for cholesterol reduction. In June 2011, the FDA issued new guidelines indicating that simvastatin dosing in patients taking amlodipine should not exceed 20 mg daily due to a drug-drug interaction and an increased risk of rhabdomyolysis. If simvastatin is selected in this case, it should be limited to 20 mg daily or less with appropriate monitoring of clinical and laboratory parameters. Other statins are not known to have a clear interaction with amlodipine and would be reasonable alternatives in this patient.

Colestipol interrupts bile acid reabsorption and reduces LDL cholesterol levels by 10% to 15%. It is often used as a second-line drug with statins because it acts synergistically to induce LDL receptors. However, it can interfere with the absorption of this patient's other medications, and for these reasons, is not the best initial management of his hyperlipidemia.

Although ezetimibe reduces LDL cholesterol levels by reducing cholesterol absorption from the intestine, there are presently no clinical trial results showing that this medication reduces cardiovascular disease events, in contrast to statins, such as simvastatin. Therefore, ezetimibe should be reserved as an adjunct to other cholesterol-lowering medications if goal level is not achieved or for patients intolerant or allergic to other proven medications.

Niacin is an effective medication for lowering LDL cholesterol and increasing HDL levels but is often not tolerated because of its side effects (nausea and flushing), particularly at the dosage needed to achieve adequate reduction of LDL cholesterol. Niacin would be a poor choice for this patient because it can cause glucose intolerance, potentially worsening his glucose control.

Key Point

  • The indication to initiate cholesterol-lowering medication as well as the goal level for treatment are dependent on the absolute level of LDL cholesterol and the estimated 10-year risk for a coronary artery disease event.

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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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