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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 11, 2017

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Potential Benefits of Testosterone Therapy in Older Men
Probiotics Prevent C. difficile Infection in Hospitalized Adults
Pharmacologic Treatment of Hypertension in Older Adults
Intravenous Contrast May Pose No Risk to Kidneys
Antibiotic Prophylaxis Before Dental Procedures in Patients with Orthopedic Implants

JAMA Intern Med 2017 Feb 21
Potential Benefits of Testosterone Therapy in Older Men
In randomized trials, hemoglobin levels rose in anemic men, and bone density increased.
In three studies, researchers evaluated effects of testosterone therapy in older men. Two of these were from the Testosterone Trials (T Trials), a series of seven linked studies, in which 788 men (mean age, 72) with total testosterone levels <275 ng/dL were randomized to testosterone gel (to maintain testosterone levels of 300–800 ng/dL), or placebo for 1 year. Sexual and physical function outcomes were published earlier (NEJM JW Gen Med Mar 15 2016 and N Engl J Med 2016; 374:611).
In one T Trial, 16% of men had anemia (hemoglobin level, ≤12.7 g/dL); anemia was unexplained in half of these men. Increases in hemoglobin levels of at least 1.0 g/dL occurred in significantly more testosterone recipients than placebo recipients (53% vs. 17%); this effect occurred in men with and without known causes of anemia. The authors imply that low serum testosterone actually might be responsible for some cases of unexplained anemia.
In another T Trial, bone outcomes were assessed in 211 men at baseline and after treatment. Testosterone recipients had significantly greater increases than placebo recipients in several measures of bone density and strength, but the study was too small and too short in duration to assess fracture risk.
Finally, in a retrospective U.S. cohort study, researchers examined adverse cardiovascular events in ≈44,000 men with total testosterone levels <300 ng/dL; about 9000 men received testosterone therapy (which increased median testosterone level from 212 ng/dL to 318 ng/dL), and 35,000 did not. During median follow-up of 3.4 years, adverse cardiovascular events occurred less often in testosterone recipients than in nonrecipients (17 vs. 24 events/1000 person-years; adjusted hazard ratio, 0.67).
COMMENT: These results add a few new pieces to the puzzle of whether testosterone therapy benefits hypogonadal older men. However, the two randomized trials were too small and too short for researchers to assess clinical outcomes or harmful side effects. And the cohort study — with results that differ from those of several other observational studies — was subject to confounding by unmeasured variables. In the absence of results from larger, longer trials, detailed shared decision making still is strongly recommended.
CITATION(S): Roy CN et al. Association of testosterone levels with anemia in older men: A controlled clinical trial.JAMA Intern Med 2017 Feb 21; [e-pub].

- Snyder PJ et al. Effect of testosterone treatment on volumetric bone density and strength in older men with low testosterone: A controlled clinical trial. JAMA Intern Med 2017 Feb 21; [e-pub].

- Cheetham TC et al. Association of testosterone replacement with cardiovascular outcomes among men with androgen deficiency. JAMA Intern Med 2017 Feb 21; [e-pub]. (http://dx.doi.org/10.1001/jamainternmed.2016.9546)
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Gastroenterology 2017 Feb 10
Probiotics Prevent C. difficile Infection in Hospitalized Adults
Efficacy was greater when introduced sooner after antibiotics initiation.
Despite positive results of prior systematic reviews for the efficacy of probiotics in preventing Clostridium difficile infection in hospitalized patients, current guidelines do not recommend their use in this setting.
In a systematic review of probiotic use in hospitalized patients to prevent C. difficile infection in patients started on antibiotics, 19 randomized trials were identified, including 3277 patients randomized to probiotic intervention and 2984 to placebo. Results of a meta-analysis of these data were as follows:

COMMENT: These results suggest that initiation of probiotics is appropriate in all hospitalized patients started on antibiotics.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Shen NT et al. Timely use of probiotics in hospitalized adults prevents clostridium difficile infection: A systematic review with meta-regression analysis. Gastroenterology 2017 Feb 10; [e-pub].
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Ann Intern Med 2017 Jan 17
Pharmacologic Treatment of Hypertension in Older Adults
For older patients (age, ≥60), a new guideline recommends starting treatment when systolic blood pressure is ≥150 mm Hg.
Sponsoring Organizations: American College of Physicians (ACP); American Academy of Family Physicians (AAFP)
Target Audience: All clinicians
This joint guideline presents evidence on benefits and harms of treating to higher versus lower systolic blood pressure (SBP) targets in older adults (age, ≥60) with hypertension. Recommendations are based on a systematic review of randomized controlled trials (for primary outcomes) and observational studies (for harms).

Key Findings

Initiate treatment in older adults with SBP persistently ≥150 mm Hg to achieve a target SBP of <150 mm Hg (strong recommendation, high-quality evidence).
In older adults with previous stroke or TIAs, consider treating to <140 mm Hg to lower risk for recurrence (weak recommendation, moderate-quality evidence).
In older adults at high cardiovascular (CV) risk, consider treating to <140 mm Hg to lower risk for stroke or adverse cardiac events (weak recommendation, low-quality evidence). Patients at high CV risk include those with known vascular disease, most patients with diabetes, patients with chronic kidney disease (CKD), patients with metabolic syndrome or 10-year CVD risk ≥15%, and older patients (age, ≥75).
COMMENT: The Joint National Committee (JNC) 8 guideline caused controversy by recommending a higher systolic treatment threshold for older patients than for younger patients and those with diabetes or CKD (<150 vs. <140 mm Hg; NEJM JW Gen Med Jan 15 2014 and JAMA 2014; 311:507). This guideline takes a similar approach and advises a target SBP of <150 mm Hg for older patients (age, ≥60) and suggests that we consider additional lowering of SBP for patients with previous stroke or TIA, or for those at high CV risk. The authors acknowledge the influence of the SPRINT trial in making the latter recommendation for patients at high CV risk. However, note that, in SPRINT, researchers compared SBP targets of 120 mm Hg and 140 mm Hg (although measured BPs probably were lower than typical office BPs, given the SPRINT protocol), and it excluded patients with previous stroke or diabetes (NEJM JW Gen Med Dec 15 2015 and N Engl J Med 2015; 373:2103). A recurring theme within the guideline was the need to individualize treatment goals for each patient.
CITATION(S):Qaseem A et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: A clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med 2017 Jan 17; [e-pub].
- Weiss J et al. Benefits and harms of intensive blood pressure treatment in adults aged 60 years or older: A systematic review and meta-analysis. Ann Intern Med 2017 Jan 17; [e-pub].
-Pignone M and Viera AJ.Blood pressure treatment targets in adults aged 60 years or older. Ann Intern Med 2017 Jan 17; [e-pub].
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Ann Emerg Med 2017 Jan 19
Intravenous Contrast May Pose No Risk to Kidneys
A rigorous observational study finds no evidence that use of contrast for computed tomography in the emergency department is dangerous for the kidneys.
It is an article of faith in emergency medicine and radiology that the intravenous contrast used for computed tomography (CT) may cause kidney injury. In a retrospective cohort study, investigators at a U.S. academic emergency department (ED) compared the incidence of acute kidney injury among three groups of patients: 7201 who underwent contrast-enhanced CT, 5499 who underwent unenhanced CT, and 5234 who did not undergo CT. Patients met stringent inclusion criteria, including baseline creatinine of 0.4–4.0 mg/dL.
Patients who underwent contrast-enhanced CT were no more likely to develop acute kidney injury than those who underwent unenhanced CT (odds ratio, 1.0) or those who did not undergo CT (OR, 1.0). After controlling for baseline characteristics by propensity-score matching, the results were the same. In addition, there were no differences among the groups in renal outcomes at 6 months.
COMMENT: Our understanding of contrast-induced nephropathy is largely informed by studies that predated the use of low-osmolar and iso-osmolar contrast agents, and by extrapolation from angiography, which involves higher contrast loads. In the absence of a randomized trial, a retrospective cohort study with propensity score matching provides the best evidence we can hope for in the search for a causal relationship between contrast use and nephropathy. This rigorous study suggests that modern contrast-enhanced CT techniques are not risky for the kidneys in patients with creatinine levels ≤4 mg/dL.
How this finding should inform practice is difficult to answer given the varied added benefit from contrast in different situations. If contrast-enhanced CT is essential for ruling out a serious condition and no alternative test is readily available, this study should reassure emergency physicians and radiologists to proceed with the scan, even in patients with creatinine levels as high as 4 mg/dL. If a patient has an elevated creatinine after contrast-enhanced CT, a causal relationship should not be assumed, and the providers who ordered and performed the study in good faith should not be faulted.
CITATION(S): Hinson JS et al. Risk of acute kidney injury after intravenous contrast media administration. Ann Emerg Med 2017 Jan 19; [e-pub].
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J Bone Joint Surg Am 2017 Jan 18; 99:161
Antibiotic Prophylaxis Before Dental Procedures in Patients with
Orthopedic Implants

New “appropriate-use criteria” remain ambiguous, with no scientific evidence to support them.
Several years ago, I presented a brief historical review of recommendations on antibiotic prophylaxis before dental procedures in patients with prosthetic joint implants (NEJM JW Gen Med May 15, 2013). In 2009, the American Academy of Orthopaedic Surgeons (AAOS) essentially had endorsed routine prophylaxis for all patients with prosthetic joints, with no time limit after the date of the orthopedic procedure. However, in a 2013 guideline issued jointly by the AAOS and the American Dental Association (ADA), clinicians were advised to “consider discontinuing the practice of routinely prescribing prophylactic antibiotics for patients with hip and knee prosthetic joint implants undergoing dental procedures.” The guideline indicated that no evidence justified prophylaxis and that several studies — albeit observational studies with limitations — argued against it. Nevertheless, the somewhat ambiguous wording, inviting clinicians to “consider” not prescribing antibiotics “routinely,” left the door open for those who still favored prophylaxis. This resulted in confusion for dentists, dentists' reliance on orthopedists to make these decisions, and a continuing practice of widespread, indefinite provision of antibiotic prophylaxis.
The latest iteration of this controversy is a new document entitled “Appropriate Use Criteria for the Management of Patients with Orthopaedic Implants Undergoing Dental Procedures.” The AAOS and ADA appointed an 11-member panel (5 orthopedists and 6 dentists) to identify criteria that might affect risk for developing infected orthopedic implants due to dental procedure–related bacteremia. Five risk criteria were chosen: invasiveness of the dental procedure, immunocompromised status, diabetes and glycemic control, previous history of prosthetic infection, and time since joint replacement.
Next, panel members generated 64 case scenarios that reflected various combinations of these putative risk factors and presented those scenarios to a separate voting panel consisting of nine dentists, three orthopedists, and two infectious disease specialists. The outcome of this process was a designation of “rarely appropriate,” “may be appropriate,” or “appropriate” for each scenario. For the 32 scenarios involving “dental procedures that do not result in the manipulation of gingival or periapical tissues, or perforation of the oral mucosa,” antibiotics always were considered to be “rarely appropriate,” regardless of presence of other risk factors.
However, few visits will fall into the “no manipulation” category, because most dental visits (including cleanings) do involve manipulation of gingival tissues. For the 32 scenarios describing visits with tissue manipulation, antibiotics were deemed “rarely appropriate” when no additional risk factors were present. But when such visits involved patients with other risk factors, voting panelists concluded that antibiotic prophylaxis “is appropriate” for 8 scenarios and “may be appropriate” for 17 scenarios — despite lack of evidence that antibiotic prophylaxis before dental procedures prevents implant infections, regardless of risk factors. The AAOS has provided an online calculator that gives a patient's “appropriateness” category when the five patient-specific variables are entered.
Although most patients will fall into the “rarely appropriate” category, I suspect that this latest AAOS document — based essentially on opinions of physicians and dentists whose expertise for addressing this issue is unclear — is unlikely to change practice substantially. The term “rarely appropriate” still leaves the door open for antibiotic prophylaxis, and the authors note that these ratings are “not meant to supersede clinician expertise … or patient preference.” My admittedly anecdotal impression (from speaking with a number of orthopedists and dentists during the past few weeks) is that most orthopedists will continue to recommend prophylactic antibiotics for at least several years after joint replacement surgery and that most dentists will defer to their patients' orthopedists. Notably, a 2016 consensus statement from Canada (representing orthopedists, dentists, and infectious disease specialists) recommends against prophylaxis.
Because patients with orthopedic implants and their dentists sometimes ask the primary care clinician (rather than the orthopedist) to prescribe prophylactic antibiotics, this topic is relevant to general practice. In my view, primary care clinicians are not obligated to prescribe antibiotics on behalf of orthopedists or dentists when supportive evidence is lacking and guidelines are ambiguous; hence, the orthopedist or dentist should assume responsibility for these prescribing decisions.
This article and its associated tables are available in pdf form at 
 free of charge.
CITATION(S): Quinn RH et al. The American Academy of Orthopaedic Surgeons appropriate use criteria for the management of patients with orthopaedic implants undergoing dental procedures. J Bone Joint Surg Am2017 Jan 18; 99:161. (http://dx.doi.org/10.2106/JBJS.16.01107)

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