Trending Topics in Health-System Pharmacy
Preventing HIV in adolescents
In late April, CDC issued updated clinical considerations on pre-exposure prophylaxis (PrEP) in adolescents. Published in MMWR Recommendations and Reports, the guideline addresses topics that are unique to the adolescent population.
FDA approved the fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for adults in 2012 and expanded the indication in 2018 to allow TDF/FTC to be used for PrEP in adolescents weighing at least 77 lb who are at risk for acquiring HIV.
In 2019, FDA approved the combination product tenofovir alafenamide (TAF)/FTC as PrEP for adolescents and adults weighing at least 77 lb, excluding those at risk for acquiring HIV through receptive vaginal sex because of the lack of clinical data on the efficacy of TAF/FTC in cisgender women.
CDC indicates that it’s important for providers to consider PrEP safety data, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, the approach to the adolescent patient’s clinical visit, and medication initiation, adherence, and persistence during adolescence when treating patients in this age group.
Providers should partner with the adolescent patient for PrEP decisions, recognizing the patient’s autonomy to the extent allowable by law and including parents in the conversation about PrEP when it is safe and reasonable to do so. CDC recommends a comprehensive approach to adolescent health, including considering PrEP as one possible part of providing medical care to adolescents who inject drugs or engage in sexual behaviors that place them at risk for acquiring HIV.
Clinicians should also implement strategies to address medication adherence as a routine part of prescribing PrEP, including more frequent clinical follow-up.
Using SGLT2 inhibitors to decrease the incidence of AF
The sodium–glucose cotransporter-2 (SGLT2) inhibitors are known to lower blood pressure, reduce weight, and reduce cardiovascular disease in patients with type 2 diabetes. Given that atrial fibrillation (AF) and atrial flutter (AFL) are associated with both diabetes and its related comorbidities—including hypertension, obesity, and heart failure—a research team led by Stephen D. Wiviott, MD, from Brigham and Women’s Hospital and Harvard Medical School studied whether SGLT2 inhibitors could also reduce the risk of AF/AFL.
In the DECLARE-TIMI 58 trial, Wiviott and colleagues evaluated the efficacy and safety of the SGLT2 inhibitor dapagliflozin versus placebo in 17,160 patients with type 2 diabetes and either known coronary artery disease (CAD) or multiple risk factors for CAD.
The study results, published in the April 14 issue of Circulation, showed that dapagliflozin reduced the risk for AF/AFL events by 19% compared with placebo in both patients with preexisting AF/AFL and those without.
Statins beneficial for preventing ischemic stroke
In an effort to determine whether statin therapy is associated with an increased risk of intracerebral hemorrhage, researchers at the University of Tennessee conducted a meta-analysis to estimate the risk versus benefit of statin treatment in cerebral hemorrhage and ischemic events.
Their work, published on the American Academy of Neurology website, was to be presented at the academy’s annual meeting, which was canceled due to the COVID-19 pandemic.
A total of 19 clinical studies and 35,842 patients were included in the study. The results showed that the risk of combined primary and secondary intracerebral hemorrhage was not significantly associated with statin use.
Sensitivity analysis showed a trend toward a higher risk of secondary intracerebral hemorrhage among those who were assigned to statin treatment, but the risk of cerebral ischemia (stroke and transient ischemic attack) was significantly lower in patients who received statin treatment.
The authors concluded that the benefits of statin therapy to prevent ischemic stroke greatly exceed the risk of intracerebral hemorrhage.
Deprescribing AChEIs for patients with severe dementia
Older adults with dementia are often prescribed acetylcholinesterase inhibitors (AChEIs), as they have been shown to have a modest effect on dementia symptoms such as cognition. As dementia advances, however, both clinicians and families are hesitant to discontinue these medications even though little is known about their effectiveness in patients with severe dementia.
In a study published in the April issue of the Journal of the American Geriatrics Society, Niznik and colleagues at the University of North Carolina School of Medicine evaluated the impact of deprescribing AChEIs on risk of all‐cause events (hospitalizations, emergency department visits, and mortality) and serious falls or fractures in older nursing home residents with severe dementia.
The researchers analyzed Medicare claims and prescription data from 37,000 nursing home residents with severe dementia. These patients were primarily white (78.7%), female (75.5%), and aged 80 years or older (77.4%).
Deprescribing AChEIs was associated with an increased likelihood of all‐cause negative events in unadjusted models but not in models adjusted for comorbidities, concurrent medications, and other factors. However, deprescribing was associated with a reduced likelihood of serious falls or fractures in unadjusted models and remained significant in adjusted models.
The authors concluded that deprescribing AChEIs was not associated with a significant increase in the likelihood of all‐cause negative events and was associated with a reduced likelihood of falls and fractures in older nursing home residents with dementia. Their findings suggest that deprescribing AChEIs is a reasonable approach to reduce the risk of serious falls or fractures without increasing the risk for all‐cause events.
Oral step-down antibiotic therapy effective for infective endocarditis, study shows
Conventional wisdom holds that I.V. antibiotic administration is necessary for treatment of infective endocarditis (IE). However, antibiotics are now available that can achieve the necessary blood levels after oral administration, and recent studies of oral step-down antibiotic treatment indicate that oral antibiotics may be equally effective.
In a recent study published in JAMA Internal Medicine, Spellberg and colleagues at the University of Southern California Medical Center described the results of a literature review to determine whether evidence supports the use of oral step-down antibiotic therapy for IE.
Their search identified 21 observational studies and 3 randomized clinical trials evaluating the effectiveness of oral antibiotics for treating IE, typically after an initial course of I.V. therapy. The researchers found abundant data demonstrating the therapeutic effectiveness of oral step-down versus I.V.-only antibiotic therapy for IE, with no contrary data identified.
In the largest trial, at 3.5 years follow-up, patients randomized to receive oral step-down antibiotic therapy had a significantly improved cure rate and mortality rate compared with those who received I.V.-only therapy.
The researchers concluded that use of highly orally bioavailable antibiotics as step-down therapy for IE should be incorporated into clinical practice after clearing bacteremia and achieving clinical stability with I.V. regimens.