COVID-19
SUD linked to higher susceptibility, poor outcomes
A study funded by the National Institutes of Health has found that substance use disorders (SUDs) increase a person's risk for COVID-19 and its complications.
Investigators analyzing nonidentifiable electronic health records of millions of US patients found that although patients with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The effect was strongest for opioid use disorder, followed by tobacco use disorder. Those with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization or death) compared with other patients. In addition, Black patients with a recent opioid use disorder diagnosis were over four times more likely to develop COVID-19 than White patients.
The investigators say that their findings underscore the need for healthcare professionals to closely monitor patients with SUDs and develop action plans to help shield them from COVID-19 and poor outcomes.
Source: National Institutes of Health/National Institute on Drug Abuse. Substance use disorders linked to COVID-19 susceptibility. News release. September 14, 2020.
INSULIN DELIVERY
Automated device approved for young children
The FDA has approved a hybrid closed loop diabetes management device for insulin delivery in children ages 2 to 6 years with type 1 diabetes. Called the MiniMed 770G System, it automatically monitors glucose levels and provides appropriate basal insulin doses with little or no input from the child or caregiver. According to the FDA, it is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for these younger pediatric patients.
The device includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch and catheter connected to the pump for insulin delivery. It measures glucose levels every five minutes and automatically adjusts insulin delivery as needed. Users must also manually request insulin doses to counter carbohydrate consumption at mealtime.
This device is not approved for use in children younger than age 2 or in patients who require less than eight units of insulin per day. Risks associated with use of the system include hypoglycemia, hyperglycemia, and skin irritation around the device's infusion patch. The FDA is requiring the manufacturer to conduct a postmarketing study to evaluate device performance in real-world settings.
Source: US Food and Drug Administration. FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young pediatric patients. News release. August 31, 2020.
NICOTINE HARMS
Many providers misunderstand the risks
Although nicotine is highly addictive, most tobacco-related disease is caused by other chemicals present in tobacco or tobacco smoke. A recent study indicates that most US healthcare providers wrongly believe that nicotine is a direct cause of cancer, chronic obstructive pulmonary disease (COPD), and cardiovascular disease. In fact, the strongest evidence for direct causality is for neurodevelopmental birth defects. Only limited evidence supports nicotine causality for cancer and cardiovascular disease, and data on nicotine causality for COPD are scarce.
A national mail survey exploring physicians' knowledge and communication about tobacco use targeted six specialties: family medicine, internal medicine, OB/GYN, cardiology, pulmonary/critical care, and hematology/oncology. Responses from over 560 physicians were included in the analysis, which showed that:
* 83% strongly agreed that nicotine directly contributes to cardiovascular disease.
* 81% strongly agreed that nicotine directly contributes to COPD.
* 80% strongly agreed that nicotine directly contributes to cancer.
* Only 33% strongly agreed that nicotine directly contributes to birth defects. About 30% did not answer this question, a potential indicator of "do not know."
The authors say that these misperceptions mirror those in the population at large and note that in one previous study, 60% of nurses incorrectly perceived nicotine as carcinogenic.
"It is vital that physicians understand the actual risk of nicotine given that they are critical in the prescribing and recommendation of FDA-approved [smoking cessation] products," the authors write. Healthcare professionals must be able to accurately communicate risks to patients "in an evolving tobacco marketplace which may include low-nicotine cigarettes, which are not safer than traditional cigarettes."
Source: Steinberg MB, Manderski MT, Wackowski OA, Singh B, Strasser AA, Delnevo CD. Nicotine risk misperception among US physicians. J Gen Intern Med. [e-pub September 1, 2020]
RISDIPLAM
First oral drug for spinal muscular atrophy
The FDA has approved risdiplam (Evrysdi) to treat patients age 2 months and older with spinal muscular atrophy (SMA), an often fatal genetic disease affecting muscle strength and movement. This is the first oral drug approved to treat SMA.
SMA causes weakness and muscle wasting due to loss of lower motor neurons. Risdiplam is classified as a survival of motor neuron 2-directed RNA splicing modifier. In one small clinical trial, 81% of patients were alive without the need for permanent artificial ventilation after 23 months or more of treatment, considered a marked improvement from typical disease progression without treatment.
Risdiplam is provided as a powder that is reconstituted by a pharmacist for administration as an oral solution. The most common adverse reactions are fever, diarrhea, and rash. Risdiplam was granted orphan drug and fast-track designation and priority review.
Source: US Food and Drug Administration. FDA approves oral treatment for spinal muscular atrophy. News release. August 6, 2020.
ACUTE MYELOID LEUKEMIA
Combination product prolongs survival
The prognosis is poor for older adults with acute myeloid leukemia (AML). Previous research suggested that the combination of azacitidine and venetoclax could be a promising therapy for these patients. Azacitidine is a pyrimidine nucleoside analogue of cytidine. Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein.
In a recent study designed to test the efficacy of azacitidine added to venetoclax, 431 previously untreated patients with confirmed AML were randomly assigned to receive azacitidine plus either venetoclax or placebo. The primary end point was overall survival.
The incidence of complete remission was higher with azacitidine-venetoclax than with the control regimen (36.7% versus 17.9%), as was the composite of complete remission or complete remission with incomplete hematologic recovery (66.4% versus 28.3%). Adverse reactions included nausea (44% of patients in the azacitidine-venetoclax group versus 35% of those in the control group) and grade 3 or higher thrombocytopenia (45% versus 38%), neutropenia (42% versus 29%), and febrile neutropenia (42% versus 19%). Infections of any grade occurred in 85% of the patients in the azacitidine-venetoclax group and 67% of those in the control group. Serious adverse reactions occurred in 83% of patients in the test group and 73% of those in the control group.
"While this combination represents a key advance in AML therapy, improving both remission and survival rates in newly diagnosed patients with AML, many unfortunately will still relapse," said lead author Courtney D. DiNardo in a statement. Further research is planned.
The research was supported by AbbVie and Genentech and several authors disclosed financial ties to the pharmaceutical industry.
Source: DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383:617-629.