Internal Medicine News
Risk Profiles and Treatment Patterns Among Men Diagnosed as Having Prostate Cancer and a Prostate-Specific Antigen Level Below 4.0 ng/mL
Despite controversy over the benefit of prostate-specific antigen (PSA) screening, little is known about risk profiles and treatment patterns in men diagnosed as having prostate cancer who have a PSA value less than or equal to 4.0 ng/mL. This study found that most men diagnosed as having prostate cancer with a PSA threshold below 4.0 ng/mL had low-risk disease but underwent aggressive local therapy. Lowering the biopsy threshold but retaining our inability to distinguish indolent from aggressive cancers might increase the risk of overdiagnosis and overtreatment.
Generic Version of Lovenox Okayed
The FDA has approved the first generic low molecular weight heparin product -- a generic version of Lovenox (enoxaparin sodium injection) for the prevention of deep vein thrombosis.
Approval was given to Sandoz of Broomfield, Colo. -- a unit of Novartis AG -- to make the following strengths of the injectable anticoagulant -- 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL, 120 mg/0.8 mL, and 150 mg/mL.
The FDA's decision came following consideration of a citizen petition filed in 2003 by Aventis Pharmaceuticals (now sanofi-aventis), maker of the branded form of enoxaparin sodium (Lovenox).
Trimethoprim-Sulfamethoxazole–Induced Hyperkalemia in Patients Receiving Inhibitors of the Renin-Angiotensin System
Trimethoprim therapy can cause hyperkalemia and is often coprescribed with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). The objective of this study was to characterize the risk of hyperkalemia-associated hospitalization in elderly patients who were being treated with trimethoprim-sulfamethoxazole along with either an ACEI or an ARB. Compared with amoxicillin, the use of trimethoprim-sulfamethoxazole was associated with a nearly 7-fold increased risk of hyperkalemia-associated hospitalization concluding that among older patients treated with ACEIs or ARBs, the use of trimethoprim-sulfamethoxazole is associated with a major increase in the risk of hyperkalemia-associated hospitalization relative to other antibiotics.
Increased Risks in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone
Studies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for type 2 diabetes. To determine if the risk of serious cardiovascular harm is increased by rosiglitazone compared with pioglitazone, the other thiazolidinedione marketed in the United States. This was a nationwide, observational, retrospective, inception cohort of 227 571 Medicare beneficiaries aged 65 years or older (mean age, 74.4 years) who initiated treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006-June 2009 and who underwent follow-up for up to 3 years after thiazolidinedione initiation. Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older.
Migraine Headache and Ischemic Stroke Risk: An Updated Meta-analysis
Observational studies, including recent large cohort studies that were unavailable for prior meta-analysis, have suggested an association between migraine headache and ischemic stroke. This article performed an updated meta-analysis to quantitatively summarize the strength of association between migraine and ischemic stroke risk and found that migraine is associated with increased ischemic stroke risk. These findings underscore the importance of identifying high-risk migraineurs with other modifiable stroke risk factors. Future studies of the effect of migraine treatment and modifiable risk factor reduction on stroke risk in migraineurs are warranted.
Oral and IV Steroids In COPD Exacerbations Shows No Difference
Systemic corticosteroids are beneficial for patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease (COPD); however, their optimal dose and route of administration are uncertain. This article in this weeks JAMA showed that among patients hospitalized for acute exacerbation of COPD low-dose steroids administered orally are not associated with worse outcomes than high-dose intravenous therapy.
Hemoglobin A1C Levels Show Limitations
A previous study of participants with prediabetes found that hemoglobin A1c (HbA1c) levels differed between black and white participants with no differences in glucose concentration. This study evaluated whether black–white differences in HbA1c level are present in other populations and across the full spectrum of glycemia. It found that Black persons have higher HbA1c levels than white persons across the full spectrum of glycemia, and the differences increase as glucose intolerance worsens. These findings could limit the use of HbA1c to screen for glucose intolerance, indicate the risk for complications, measure quality of care, and evaluate disparities in health.
Association Between Arterial Hyperoxia Following Resuscitation From Cardiac Arrest and In-Hospital Mortality
Laboratory investigations suggest that exposure to hyperoxia after resuscitation from cardiac arrest may worsen anoxic brain injury; however, clinical data are lacking. This study was a multicenter cohort study using the Project IMPACT critical care database of intensive care units (ICUs) at 120 US hospitals between 2001 and 2005. Patients were divided into 3 groups defined a priori based on PaO2 on the first arterial blood gas values obtained in the ICU. Hyperoxia was defined as PaO2 of 300 mm Hg or greater; hypoxia, PaO2 of less than 60 mm Hg (or ratio of PaO2 to fraction of inspired oxygen <300); and normoxia, not classified as hyperoxia or hypoxia. Of 6326 patients, 1156 had hyperoxia (18%), 3999 had hypoxia (63%), and 1171 had normoxia (19%). The hyperoxia group had significantly higher in-hospital mortality, 63%, compared with the normoxia group, 45%, and the hypoxia group 57%. Among patients admitted to the ICU following resuscitation from cardiac arrest, arterial hyperoxia was independently associated with increased in-hospital mortality compared with either hypoxia or normoxia.
Statins Have Wide Range of Unintended Adverse Effects
Statins appear to have no significant association with a large number of diseases, but they may have a wide range of unintended adverse effects, according to data published in the May 20 online edition of the BMJ. Julia Hippisley-Cox, M.D., and Carol Coupland, Ph.D., of the University of Nottingham in the United Kingdom, conducted a prospective open cohort study of 2,004,692 patients aged 30-84, including 225,922 (10.7 percent) of whom were new users of statins, to quantify the unintended effects of statins according to type, dose and duration of use. The researchers found that statins were not significantly associated with risk of Parkinson's disease; rheumatoid arthritis; venous thromboembolism; dementia; osteoporotic fracture; gastric, colon, lung, renal, breast or prostate cancer; or melanoma. However, statin use was linked to a decreased risk of esophageal cancer, but an increased risk of moderate or serious liver dysfunction, acute renal failure, moderate or serious myopathy and cataract. The adverse effects were similar across all types of statins with the exception of liver dysfunction risk, which was highest for fluvastatin. All increased risks were highest in the first year and persisted during treatment.
Long Term Diabetes Drug (Metformin) Linked To Gradually Worsening Vitamin B-12 Deficiency
Individuals with diabetes type 2 who are treated for long periods with metformin are at risk of developing gradually worsening vitamin B-12 deficiency - in other words, the vitamin deficiency grows with time, according to new research published today in the British Medical Journal (BMJ). Individuals who had been given metformin were found to have a 19% reduction in their vitamin B-12 levels, compared with those in the placebo group, who had virtually no change in their levels during the study.
Moreover, the drop in levels of vitamin B-12 by metformin was not temporary, but continued, and got worse over time.
Diagnostic Accuracy and Clinical Utility of Noninvasive Testing for Coronary Artery Disease
Computed tomography coronary angiography (CTCA) has become a popular noninvasive test for diagnosing coronary artery disease. A study in the Annals of Internal Medicine compared the accuracy and clinical utility of stress testing and CTCA for identifying patients who require invasive coronary angiography (ICA). The results suggested that computed tomography coronary angiography seems most valuable in patients with intermediate pretest probability of disease and are more accurate than stress imaging, because the test can distinguish which of these patients need invasive angiography. These findings need to be confirmed before CTCA can be routinely recommended for these patients.
B-Vitamin Therapy Increases Progression of Diabetic Nephropathy
Hyperhomocysteinemia is frequently observed in patients with diabetic nephropathy. B-vitamin therapy (folic acid, vitamin B6, and vitamin B12) has been shown to lower the plasma concentration of homocysteine. A study in this weeks JAMA sought to determine whether B-vitamin therapy can slow progression of diabetic nephropathy and prevent vascular complications. This study found that among patients with diabetic nephropathy, high doses of B vitamins compared with placebo resulted in a greater decrease in GFR and an increase in vascular events.
Migraine Patients to Wait for Triptan Alternative
Scandinavian researchers writing in The Lancet gave a warm review to an investigational drug for migraine, but patients in the U.S., at least, will have a wait before it reaches them.
The drug, telcagepant, antagonizes the calcitonin gene-related peptide (CGRP) receptor and has completed phase III studies. Its manufacturer, Merck, was initially expected to seek FDA approval last year.
An online Lancet review by researchers from Sweden and Norway touted telcagepant as holding out hope for migraine patients with acute attacks that fail to respond to triptan drugs (Zomig, Imitrex).
Valsartan decreases the Incidence of Diabetes but not Cardiovascular Events
It is not known whether drugs that block the renin–angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance. An article in this months New England Journal of Medicine published an article which conducted a double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group and did not significantly reduce the incidence of either the extended cardiovascular outcome or the core cardiovascular outcome.
Early vs Late Tracheotomy Doesn't Show Difference for Prevention of Pneumonia in Mechanically Ventilated Adult ICU Patients
Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources. An article in this weeks JAMA looked at the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days. It found that among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia.
Effect of Early Cerebral Magnetic Resonance Imaging on Clinical Decisions in Infective Endocarditis
Neurologic complications of endocarditis can influence diagnosis, therapeutic plans, and prognosis. An article in this weeks Annals of Internal Medicine reviewed a single-center prospective study between June 2005 and October 2008 that looked at how early cerebral magnetic resonance imaging (MRI) affects the diagnosis and management of endocarditis in hospitalized adults. Endocarditis was initially classified as definite in 77 patients and possible in 50 and was excluded in 3. Sixteen patients (12%) had acute neurologic symptoms. Cerebral lesions were detected by MRI in 106 patients (82% [95% CI, 75% to 89%]), including ischemic lesions in 68, microhemorrhages in 74, and silent aneurysms in 10. Endocarditis therapeutic plans were modified for 24 (18%) of the 130 patients, including surgical plan modifications for 18 (14%). Overall, early MRI led to modifications of diagnosis or therapeutic plan in 36 patients (28% [CI, 20% to 36%]).
Cranberry Juice and Warfarin: When Bad Publicity Trumps Science
Based on anecdotal reports, the question of whether cranberry juice interacts with warfarin has been raised. An article in this month's American Journal of Medicine discussed and reviewed the potential mechanism, and systematically reviews case reports as well as clinical trials examining the possible interaction. It found that the randomized clinical trials and surrogate markers found no evidence to support the interaction between cranberry juice and warfarin. Because the moderate consumption of cranberry juice does not affect anticoagulation, we encourage the reexamination of initial warnings based on scientific evidence. We conclude that the initial precautionary warnings by administrating bodies are limited to anecdotal case reports and represent misleading conclusions.
Endovascular versus Open Repair of Abdominal Aortic Aneurysm
Few data are available on the long-term outcome of endovascular repair of abdominal aortic aneurysm as compared with open repair. An article in this weeks New England Journal of Medicine randomly assigned 1252 patients with large abdominal aortic aneurysms (5.5 cm in diameter) to undergo either endovascular or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups. The 30-day operative mortality was 1.8% in the endovascular-repair group and 4.3% in the open-repair group (adjusted odds ratio for endovascular repair as compared with open repair but by the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause.
Short Sleep Duration as an Independent Predictor of Cardiovascular Events
It is not known whether short duration of sleep is a predictor of future cardiovascular events in patients with hypertension. To test the hypothesis that short duration of sleep is independently associated with incident cardiovascular diseases (CVD), an article out of the Archives of Internal Medicine performed performed ambulatory blood pressure (BP) monitoring in 1255 subjects with hypertension (mean [SD] age, 70.4 [9.9] years) and followed them for a mean period of 50 (23) months. Overall it was shown that short duration of sleep is associated with incident CVD risk and the combination of the riser pattern and short duration of sleep that is most strongly predictive of future CVD, independent of ambulatory BP levels. Physicians should inquire about sleep duration in the risk assessment of patients with hypertension.
Orthostatic Syndromes Differ in Syncope Frequency
There are conflicting opinions on whether postural tachycardia syndrome predisposes to syncope. We investigated this relationship by comparing the frequency of syncope in postural tachycardia syndrome and orthostatic hypotension. Of 810 patients referred for postural tachycardia syndrome, 185 met criteria while another 328 patients had orthostatic hypotension. Of the postural tachycardia syndrome patients, 38% had syncope on head-up tilt, compared with only 22% of those with orthostatic hypotension (P<.0001). In the postural tachycardia group, syncope on head-up tilt was associated with a clinical history of syncope in 90%, whereas absence of syncope on head-up tilt was associated with a clinical history of syncope in 30% (P
<.0001). In contrast, syncope on head-up tilt did not bear any relationship to clinical history of syncope in the orthostatic hypotension group (41% vs 36%; P=.49). results demonstrate that syncope (both tilt table and clinical) occurs far more commonly in patients who have postural tachycardia syndrome than in patients with orthostatic hypotension. More Information on Postural Tachycardia Syndrome, also from the National Institute of Health
No Significant Difference in the Rate of Death Between Patients with Shock Treated with Dopamine or Norepinephrine
Both dopamine and norepinephrine are recommended as first-line vasopressor agents in the treatment of shock. There is a continuing controversy about whether one agent is superior to the other. A multicenter, randomized trial was conducted and assigned 1679 patients with shock to receive either dopamine or norepinephrine as first-line vasopressor therapy to restore and maintain blood pressure. There was no significant between-group difference in the rate of death at 28 days (52.5% in the dopamine group and 48.5% in the norepinephrine group; odds ratio with dopamine, 1.17; 95% confidence interval, 0.97 to 1.42; P=0.10). However, there were more arrhythmic events among the patients treated with dopamine than among those treated with norepinephrine (207 events [24.1%] vs. 102 events [12.4%], P<0.001). A subgroup analysis showed that dopamine, as compared with norepinephrine, was associated with an increased rate of death at 28 days among the 280 patients with cardiogenic shock but not among the 1044 patients with septic shock or the 263 with hypovolemic shock.
An Algorithm for Tuberculosis Screening and Diagnosis in People with HIV
Tuberculosis screening is recommended for people with human immunodeficiency virus (HIV) infection to facilitate early diagnosis and safe initiation of antiretroviral therapy and isoniazid preventive therapy. No internationally accepted, evidence-based guideline addresses the optimal means of conducting such screening, although screening for chronic cough is common. A study in the New England Journal of Medicine consecutively enrolled people with HIV infection from eight outpatient clinics. The presence of cough of any duration, fever of any duration, or night sweats lasting 3 or more weeks in the preceding 4 weeks was 93% sensitive and 36% specific for tuberculosis.In persons with HIV infection, screening for tuberculosis should include asking questions about a combination of symptoms rather than only about chronic cough. It is likely that antiretroviral therapy and isoniazid preventive therapy can be started safely in people whose screening for all three symptoms is negative, whereas diagnosis in most others will require mycobacterial culture.
Lactate Clearance vs Central Venous Oxygen Saturation as Goals of Early Sepsis Therapy
A study published in JAMA tested the hypothesis of noninferiority between lactate clearance and central venous oxygen saturation (ScvO2) as goals of early sepsis resuscitation. randomly assigned patients to 1 of 2 resuscitation protocols. The ScvO2 group was resuscitated to normalize central venous pressure, mean arterial pressure, and ScvO2 of at least 70%; and the lactate clearance group was resuscitated to normalize central venous pressure, mean arterial pressure, and lactate clearance of at least 10%. The study protocol was continued until all goals were achieved or for up to 6 hours.Thirty-four patients (23%) in the ScvO2 group died while in the hospital (95% confidence interval [CI], 17%-30%) compared with 25 (17%; 95% CI, 11%-24%) in the lactate clearance group. This observed difference between mortality rates did not reach the predefined –10% threshold concluding additional management to normalize lactate clearance compared with management to normalize ScvO2 did not result in significantly different in-hospital mortality.
Hyponatremia associated with in-hospital mortality and heightened resource consumption
A study out the Archives of Internal Medicine evaluated whether hospital-associated hyponatremia has an independent effect on all-cause mortality, hospital length of stay (LOS), and patient disposition. This cohort study included all adult hospitalizations at an academic medical center occurring between 2000-2007 for which an admission serum sodium concentration ([Na+]) was available. Community-acquired hyponatremia occurred in 37.9% of hospitalizations and was associated with adjusted odds ratios (ORs) of 1.52 for in-hospital mortality and 1.12 for discharge to a short- or long-term care facility and a 14% adjusted increase in LOS. Hospital-acquired hyponatremia developed in 38.2% of hospitalizations longer than 1 day in which initial serum [Na+] was 138 to 142 mEq/L. Hospital-acquired hyponatremia was associated with adjusted ORs of 1.66 for in-hospital mortality and 1.64 (95% CI, 1.55-1.74) for discharge to a facility and a 64% adjusted increase in LOS. The strength of these associations tended to increase with hyponatremia severity.
ICU Catheter Infections Can Be Virtually Eliminated
Catheter-related infections aren't inevitable in the ICU, according to a quality initiative that maintained rates at nearly zero for three years in Michigan hospitals.
The maintenance phase, after initial implementation of low-tech measures such as handwashing and removal of unneeded catheters, saw no rebound in catheter-related infections, Peter J. Pronovost, MD, PhD, of Johns Hopkins, and colleagues reported online in BMJ. Full Text
Single Ultrasound for DVT May Suffice
For patients with suspected deep vein thrombosis, the risk of symptomatic venous thromboembolism after a single, negative whole-leg compression ultrasound examination is low, a meta-analysis showed. Pooled results from seven studies showed the risk to be just 0.57% (95% CI 0.25% to 0.89%) through three months of follow-up in patients who were not given anticoagulants, Scott Stevens, MD, of Intermountain Medical Center in Murray, Utah, and colleagues reported in the Feb. 3 issue of the Journal of the American Medical Association.
Hypocoaguability predicts 30-day ICU survival
Intensive care unit (ICU) patients with hypocoaguability on admission have an increased short-term risk for death, demonstrate the results of a thromboelastography (TEG) study. In addition, patients with hypocoaguability required more ventilator treatment, a higher rate of renal replacement therapy, and more blood products than patients with normal TEG results on admission to the ICU, the Danish team reports in the journal Blood Coagulation and Fibrinolysis.
Adding Fish Oil to IV May Speed Sepsis Recovery
Adding fish oil to intravenous solutions proved beneficial for intensive care patients with the potentially lethal blood infection known as sepsis, a new study finds. The study, published Jan. 19 in the journal Critical Care, compared 13 patients who received fish oil in the normal IV nutrient solution given to patients with sepsis, and 10 patients who received traditional solutions. The patients who received the fish oil had lower levels of inflammatory chemicals in their blood, achieved better lung function, and had a shorter hospital stay.
Insulin pumps may be better than shots
Pumps that deliver insulin to the body as needed may be more effective than insulin injections for helping people with type 1 diabetes keep their blood sugar under control, according to a new review of 23 studies comparing the two approaches.
Chlorhexidine–Alcohol versus Povidone–Iodine for Surgical-Site Antisepsis
A new study from the New England Journal of Medicine hypothesized that preoperative skin cleansing with chlorhexidine–alcohol is more protective against infection than is povidone–iodine. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections. The overall rate of surgical-site infection was significantly lower in the chlorhexidine–alcohol group than in the povidone–iodine group. Chlorhexidine–alcohol was significantly more protective than povidone–iodine against both superficial incisional infections and deep incisional infections
Continuation of Low-Dose Aspirin Therapy in Peptic Ulcer Bleeding
It is uncertain whether aspirin therapy should be continued after endoscopic hemostatic therapy in patients who develop peptic ulcer bleeding while receiving low-dose aspirin. In a parallel randomized, placebo-controlled noninferiority trial, in which both patients and clinicians were blinded to treatment assignment. It was shown that among low-dose aspirin recipients who had peptic ulcer bleeding, continuous aspirin therapy may increase the risk for recurrent bleeding but potentially reduces mortality rates. Larger trials are needed to confirm these findings.
Statins Decrease the Occurrence of Venous Thromboembolism in Patients with Cancer
Recent data suggest a reduction in the occurrence of venous thromboembolism in select groups of patients who use statins. The objective of this study is to evaluate the impact of statin use on the occurrence of venous thromboembolism in patients with solid organ tumor. The occurrence of venous thromboembolism was 18% (N=132), and 26% (N=194) were receiving statins. Among patients receiving statins, 8% (N=16) developed a venous thromboembolism compared with 21% (N=116) in the control group (odds ratio 0.33; 95% confidence interval, 0.19-0.57). American Journal of Medicine Abstract
