2 Minute Medicine Rewind December 12, 2016

Adjuvant sunitinib in high-risk renal cell carcinoma after nephrectomy

Sunitinib is a vascular endothelial growth factor pathway inhibitor used for treatment of metastatic renal cell carcinoma, however its efficacy in the setting of patients with non-metastatic renal cell carcinoma at high risk for recurrence after nephrectomy has not been largely studied. In this phase 3 randomized control trial, 615 patients with non-metastatic renal cell carcinoma at high risk for recurrence after nephrectomy were randomized in a 1:1 ratio to either 50 mg per day of sunitinib or placebo on a 4-weeks-on, 2-weeks-off schedule for one year. Median disease-free survival, the primary outcome, was 6.8 years for those on sunitinib and 5.6 years for those on placebo (HR 0.76, p = 0.03). Grade 3 and grade 4 adverse events, including palmar-plantar erythrodysesthesia, neutropenia, hypertension, and thrombocytopenia, occurred more often in sunitinib patients (48.4% for grade 3 and 12.1% for grade 4) than in placebo patients. No difference in rates for serious adverse events, were observed between the groups. This trial provides preliminary results that the adjuvant sunitinib may provide longer disease-free survival but may carry with it more adverse events. Researchers are hopeful but indicate more studies are needed for a consistently positive disease-free survival outcome.

Announcements versus conversations to improve HPV vaccination coverage

Even though the HPV vaccine has been licensed for a decade, vaccination rates have been persistently low. In fact, the completion rate for all three doses in 2014 was only 34% for girls and 21% for boys aged 13 to 15. In this 2015 randomized control trial, researchers sought to determine the effectiveness of training providers to discuss the vaccine using either presumptive “announcements” or participatory “conversations.” 30 pediatric and family medicine clinics in central North Carolina were randomized to no training, 1-hour announcement training, where providers are taught to make brief, strong recommendation statements that assume parents are ready to vaccinate, or 1-hour conversation training, where providers initiate a more open-ended discussion with parents about the vaccination. Results showed that of the 17,173 adolescents aged 11 or 12 from the immunization registry, a larger increase in HPV vaccination coverage of one dose or more occurred for the announcement group versus control (5.4% difference, 95% CI: 1.1% to 9.7%). A 4.6% increase was observed for girls and a 6.2% increase for boys. Interestingly, no significant difference existed for the conversation group versus control. Neither training increased coverage for older adolescents aged 13 through 17. Therefore, this study emphasizes the importance of training providers to use strong, presumptive announcements to increase HPV vaccine initiation rates in young adolescents.

Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema

Egg allergy prevalence has increased over the last two decades, yet there is no consensus on whether an early stepwise exposure to the food item would decrease egg allergy likelihood. In order to study whether giving this type of exposure to infants with eczema would help prevent egg allergy at 1 year of age, researchers conducted this double-blind, randomized control trial from two centers in Japan. 147 infants between 4 to 5 months of age with eczema were randomized in a 1:1 ratio to either 50 mg of oral heated egg powder daily from 6 to 9 months and 250 mg per day subsequently from then until 12 months, or to a placebo. Eczema therapy was initiated at the beginning of the study and maintained aggressively throughout to avoid any exacerbations. At 12 months of age, only 8% of the egg exposure group had a confirmed egg allergy, the primary outcome, versus 38% of the placebo group (risk ratio 0.221 , 95% CI: 0.090 to 0.543, p = 0.0001). The early egg exposure group had more admissions to the hospital than the placebo group (10% vs. 0%), but no other significant differences existed for adverse events. Japanese researchers conclude that introduction of heated egg in a stepwise manner before one year of age may decrease development of egg allergy later on.

Dual health care system use and high-risk prescribing in patients with dementia

The 2003 Medicare Part D legislation aimed to improve access to essential medications. However, expanding prescription access to veterans, especially those with dementia, outside the realm of the Department of Veteran Affairs (VA) increases risks of unsafe prescribing. This large retrospective cohort study aimed to examine the effect of dual health care system use versus VA-only use on potentially unsafe medication (PUM) prescribing in national VA outpatient facilities in 2010. 75,829 Medicare-enrolled veterans with dementia were included, among which 80% were VA-only users and 20% were dual VA-Medicare D users. Researchers utilized four indicators: exposure to Healthcare Effectiveness Data and Information Set high-risk prescriptions (PUM-HEDIS), exposure to prescriptions with an Anticholinergic Cognitive Burden score of 3 or higher (PUM-ACB), antipsychotic prescription (PUM-antipsychotic), and exposure to potentially harmful drugs based on any definition of PUM (any-PUM). Not only did dual users have a greater odds of PUM-antipsychotic exposure (OR 1.5, 95% CI: 1.4 to 1.6), they had more than double the odds of PUM-HEDIS exposure (OR 2.4, 95% CI: 2.2 to 2.8), PUM-ACB (2.1, 2.0 to 2.2), and any-PUM (2.2, 2.2 to 2.3). Dual users also had an average of 44.1 more days of any PUM exposure. Authors suggest that dual system use without adequate information sharing may compromise continuity and lead to increased unsafe prescribing.

Everolimus-eluting stents or bypass surgery for left main coronary artery disease

The current standard of care for obstructive left main coronary artery disease is coronary artery bypass grafting (CABG). Drug-eluting stents are coated with a drug that is released over time to help prevent restenosis by limiting tissue overgrowth, and are available as an alternative treatment. In this randomized control trial, 1905 patients with left main CAD of low or intermediate anatomical complexity were randomized to either percutaneous coronary intervention (PCI) with everolimus-eluting stents or CABG to determine whether drug-eluting stents is an acceptable alternative to CABG. The primary end point was rate of death from any cause, stroke, or MI at 3 years. This occurred in 15.4% of PCI patients and 14.7% of CABG patients (p = 0.02 for noninferiority, HR 1.00, 95% CI: 0.79 to 1.26). Secondary outcomes included death, stroke, or MI at 30 days were observed in 3.9% of PCI patients and 7.9% of CABG patients (p < 0.001 for noninferiority). Death, stroke, MI, or ischemia-driven revascularization at 3 years occurred in 23.1% of PCI patients and 19.1% of CABG patients (p = 0.01 for noninferiority). Researchers concluded that PCI with everolimus-eluting stents was noninferior to CABG in regards to death rate, stroke, or MI at 3 years.

Image: PD

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