COVID-19 TREATMENTS
WHO recommends against remdesivir use
Because evidence of effectiveness is lacking, the World Health Organization (WHO) issued a conditional recommendation against the use of remdesivir to treat COVID-19 in hospitalized patients regardless of disease severity. The recommendation was developed by an international panel of experts tasked with developing guidelines that match scientific standards with the speed required to respond to an ongoing pandemic.
In October, the WHO Solidarity Trial, an international clinical trial investigating effective treatments for COVID-19, published interim results. The panel reviewed these data as well as three other randomized controlled trials. In all, the panel considered data from over 7,000 patients across the four trials and concluded that remdesivir had no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes. The panel called for more research, especially to provide higher certainty of evidence for specific patient groups, and encouraged continued enrollment in trials evaluating remdesivir.
Source: World Health Organization. WHO recommends against use of remdesivir in COVID-19 patients. News release. November 20, 2020.
OSTEOARTHRITIS
Warfarin increases risk of joint replacement
In a study of adults ages 40 to 89 with atrial fibrillation, warfarin use was associated with an increased risk for knee and hip replacement due to osteoarthritis (OA). Knee and hip replacements are considered an indicator of end-stage OA.
The nested case-control study compared warfarin, a vitamin K antagonist, with direct oral anticoagulants (DOAC), which are not vitamin K antagonists. The researchers identified 913 subjects with knee or hip replacements who were age- and gender-matched 4:1 with 3,652 controls (mean age 74, 46% female). Of the 913 subjects, about 65% were warfarin users and 35% were DOAC users. Among the 3,652 control subjects, 56% were warfarin users and 44% were DOAC users.
After adjustment for potential confounders, the findings showed that warfarin users had increased odds of knee or hip replacement compared with DOAC users, and the risk increased with duration of warfarin use. The researchers concluded that these findings support "the importance of adequate vitamin K and its dependent proteins in limiting progression of OA and raises the consideration of using DOACs over warfarin when indicated in those with or at risk of OA." The study was presented at the American College of Rheumatology's annual meeting in November.
Sources: Ballal P, Peloquin C, Boer C, Neogi T. Warfarin use and risk of knee and hip replacement. ACR Convergence 2020, Abstract # 0934. American College of Rheumatology. Warfarin use significantly increases risk of knee and hip replacement in people with OA. News release. November 6, 2020.
FOOD ALLERGIES
FDA asks that sesame be listed on labels
Because many people are allergic to sesame, the FDA has issued a draft guidance asking food manufacturers to voluntarily declare sesame in the ingredient list on food labels. Although it is labeled on most products containing sesame, sesame is not required to be declared by name in all circumstances, such as when it is used as a "flavor" or "spice." In addition, some condiments such as tahini contain sesame but are not identified as such in the labeling. The FDA has received reports of allergic reactions, such as urticaria, vomiting, wheezing, and anaphylaxis, that may have been triggered by products with undeclared sesame or products that contain sesame such as tahini.
Federal law requires manufacturers to clearly label all foods containing one of the eight major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Because sesame is not one of these allergens, the FDA is asking for voluntary compliance. Teach patients with food allergies to read product labels carefully and warn them that some potential allergens such as sesame may not be clearly labeled on all products.
Source: US Food and Drug Administration. FDA encourages manufacturers to clearly declare all uses of sesame in ingredient list on food labels. News release. November 10, 2020.
RX-TO-OTC SWITCH
Topical treatment for head lice available OTC
Through a process called a prescription (Rx)-to-OTC switch, the FDA has made Sklice (ivermectin) lotion, 0.5% available without a prescription. Indicated for topical treatment of head lice in patients age 6 months and older, the product was initially approved in 2012 for use by prescription only.
Rx-to-OTC switches are usually initiated by the manufacturer of a prescription drug. The manufacturer must provide data demonstrating not only that the drug is safe and effective when used as directed, but also that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
Sklice will be marketed in the US as a nonprescription drug and will no longer be available by prescription.
Source: US Food and Drug Administration. FDA approves lotion for nonprescription use to treat head lice. News release. October 27, 2020.
DIABETIC KIDNEY DISEASE
Finerenone slows disease progression
Based on short-term trials, finerenone is known to reduce albuminuria in patients with chronic kidney disease (CKD) and type 2 diabetes, but its long-term effects on kidney and cardiovascular function are unknown. Classified as a nonsteroidal selective mineralocorticoid receptor antagonist, finerenone was studied in a major trial designed to test the hypothesis that the drug slows CKD progression and reduces cardiovascular morbidity and mortality among patients with advanced CKD and type 2 diabetes. In the double-blind trial, 5,734 patients with CKD and type 2 diabetes were randomly assigned to receive finerenone or placebo in a 1:1 ratio. The primary composite outcome was kidney failure, a sustained decrease of at least 40% in the estimated glomerular filtration rate from baseline, or death from renal causes. The key secondary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
During a median follow-up of 2.6 years, a primary outcome event occurred in about 18% of patients in the finerenone group versus 21% of patients in the placebo group. In addition, a key secondary outcome event occurred in 13% of patients in the finerenone group versus 15% of those in the placebo group. The frequency of adverse reactions was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2% versus 0.9%, respectively). However, the evidence suggests that finerenone causes less clinically meaningful hyperkalemia than spironolactone, a well-established and widely used steroidal mineralocorticoid receptor antagonist. The study authors concluded that in patients with CKD and type 2 diabetes, "treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo."
Source: Bakris GL, Agarwal R, Anker SD, et al., for the FIDELIO-DKD Investigators. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. [e-pub October 23, 2020]