EBM Focus is a free weekly e-newsletter published by DynaMed®. Research studies are selected each week that are “most likely to inform clinical practice” and are highlighted in the article with a brief overview. Here are the top summaries from 2020.
Putting Morning Meds for Hypertension To Bed — Nighttime Dosing Seems Better
Reference: Eur Heart J. 2019 Oct 22
Evidence supporting nocturnal dosing of antihypertensives for individual drugs from small trials has existed for many years. Now there are more convincing data from multiple primary care practices and backed up by scheduled ambulatory blood pressure monitoring (ABPM) from over 19,000 hypertensive patients followed for a median of 6.3 years. The Hygia Group was established in Spain to utilize ambulatory blood pressure monitoring routinely, but as this clinical trial shows, the ABPM data don’t add much to the primary outcomes of death and vascular events.
Reference: N Engl J Med. 2020 May 22
Respiratory disease due to COVID-19 had taken the lives of more than 400,000 people worldwide when this EBM Focus article was published (more than 1.8 million deaths as of today) and sent economies into freefall. A press release in late April suggested that remdesivir may improve clinical outcomes among patients with COVID-19. A month later, we had preliminary study results providing much-anticipated information about this potential therapy, a viral RNA polymerase inhibitor previously used to treat Ebola with in vitro activity against coronaviruses. The study population in this clinical trial was fairly sick: about 25 percent were intubated or on extracorporeal membrane oxygenation (ECMO), and 90 percent required oxygen. Data from 1,059 patients indicated a shorter time to recovery with remdesivir (11 vs. 15 days) but no significant difference in mortality; however, the possibility of benefit could not be excluded.
Remdesivir for COVID: Remain Skeptical
Reference: JAMA. 2020 Sep 15;324(11):1048-1057
In May, the FDA authorized emergency use of remdesivir in hospitalized patients with severe COVID-19 after publication of the ACTT-1 trial (above). A subsequent NIH guideline on treatment of COVID-19 recommended 10 days of remdesivir in patients requiring high-flow oxygen, BiPAP, mechanical ventilation, or ECMO, with five days for all other patients on supplemental oxygen. In late August, an open-label clinical trial sponsored by Gilead was published in JAMA evaluating remdesivir for hospitalized patients less ill than those in the ACTT-1 trial. This trial was consistent with ACTT-1 and was followed by an expanded FDA authorization of remdesivir for any patient hospitalized with COVID.
Hydroxychloroquine Still of Unproven Benefit for COVID-19
Reference: Ann Intern Med. 2020 Jul 16
There are few potential treatments for COVID-19 that have received more attention than hydroxychloroquine (HCQ). Early in the pandemic, uncontrolled studies suggested benefit in hospitalized patients, but subsequent observational data have found no evidence of benefit. A randomized placebo-controlled clinical trial examined potential benefits of HCQ in symptomatic outpatients treated early in their illness asking if HCQ could either decrease symptoms or reduce hospitalizations. Outcomes were not significantly different, and the results argue against the use of HCQ for patients with COVID-19.
Bold New Recommendations for Cervical Cancer Screening
Reference: CA Cancer J Clin. 2020 Jul 30
Deaths from cervical cancer have plummeted for women participating in Pap screening since it was introduced in the 1950s. We have learned in the last few decades that high-risk serotypes of human papillomavirus (HPV) infection cause almost all cervical cancer and that HPV testing is a more sensitive marker for cervical intraepithelial neoplasia (CIN) than cytology when using colposcopy and biopsy as the gold standard. Moreover, combining the two methods (co-testing) doesn’t add much to sensitivity or specificity. We also know that most young women who contract HPV in their late teens or early 20s will clear the virus within two years without intervention. For these reasons and others, the USPSTF announced guidelines in 2018 recommending cytology without HPV testing for women aged 21-30 every three years followed by HPV testing every five years (or cytology every three years or co-testing) for women aged ≥ 30 years. But now, the American Cancer Society (ACS) is recommending commencement of cervical cancer screening with HPV testing alone every five years from age 25 to 65. Cytology is an acceptable alternative but is clearly considered to be not as predictive of cancer development.
Honorary mention for favorite title:
Reference: JAMA Netw Open. 2019 Dec 2;2(12)
