Bulletin Today
CDC recommends new drug to protect infants from RSV
FDA approved nirsevimab-alip (Beyfortus—Sanofi/AstraZeneca) in July 2023. A few weeks later, on August 3, 2023, CDC’s ACIP voted unanimously to recommend the broad use of the new drug in infants and high-risk children for protection against respiratory syncytial virus (RSV).
Nirsevimab-alip is the first-ever drug to safeguard infants against RSV. CDC advisers who recommended its use described nirsevimab as a significant breakthrough against a respiratory disease that causes the deaths of as many as 300 children a year in the United States and is the primary cause of hospitalization among infants in the United States.
FDA said it approved the drug based on studies indicating that it safely prevented severe RSV-associated lower respiratory tract infections.
Although nirsevimab-alip is not a vaccine, it has a similar goal. The drug gives infants antibodies to neutralize the virus before their immune systems are sufficiently mature enough to combat the pathogens.
Nirsevimab-alip will usually require a single dose. Under FDA approval, infants can receive nirsevimab-alip at the start of an RSV season or during it if the season has already commenced. Children who are at high risk for developing severe RSV can receive a second dose for a second RSV season if they are younger than 2 years old, according to Sanofi.
The company expects to make nirsevimab-alip available in time for this year’s RSV season.
ACIP recommended the drug be offered to all infants born during the RSV season or to those who are less than 8 months old as they enter their first RSV season. They also recommended that high-risk children ages 8 months to 19 months receive a second dose of nirsevimab prior to their second RSV season.
ACIP’s third recommendation was to include nirsevimab in the Vaccines for Children program, even though the drug is not a vaccine. Inclusion in the program ensures that children of parents without health insurance can receive the drug at no cost.
Sanofi indicated to ACIP it will charge $495 per dose, which is costlier than a typical vaccine. ■
Landmark trial finds obesity drug cuts CVD risk significantly
New findings from the SELECT trial indicate that semaglutide (Wegovy) reduces the risk of major heart complications—heart attacks, strokes, and CV deaths—by 20%. The 5-year randomized trial of approximately 17,500 patients is the first to demonstrate that an obesity drug can have long-term CV benefits.
The trial included participants 45 years and older who were overweight or had obesity and who had established CVD.
Novo Nordisk said the drug seemed to have a “safe and well-tolerated profile” compared with prior studies of semaglutide. The company said it would offer detailed results from the trial at a conference later this year.
The drug’s high price, however, makes insurance coverage uncertain, and it’s unclear whether the new trial results may convince health insurers and employers to cover the therapy. ■
Disparities persist in Black adults’ stroke risk
According to the American Heart Association (AHA), significant disparities for stroke risk factors exist between Black adults and non-Black adults who have had a stroke.
Research findings published in AHA’s Stroke on August 3, 2023, found that major differences were seen at enrollment in the study for Black participants compared to non-Black participants. Black adults had a younger age (57.5 years old vs. 61 years old), and they had more incidences of high BP (95.2% vs. 87.5%), more prevalence of T2D (52.9% vs. 39.7%), higher average diastolic BP (82.4 mm Hg vs. 79.5 mm Hg), and lower physical activity PACE scores (2.7 vs. 3.3). A PACE score of 4 or above is considered moderately active and within target range.
“Modifiable stroke risk factor differences between Black and non-Black adults were found at enrollment; however, our study found these disparities may be resolved by tailoring care to include lifestyle coaching, medication alterations or additions if appropriate, access to routine health care support and regular physician follow-up,” said study coauthor Ashley Nelson, DO, in a press statement. “Intense risk factor management has an important role in improving or eliminating these risk factor disparities in Black adults.”
However, after 1 year of intensive medical intervention, some of the risk factors that increase the risk of stroke were reduced in the Black adults, according to research. Specifically, the average diastolic BP in Black patients dropped to 74.7 mm Hg compared to 75.5 mm Hg in all other participants, and the average PACE score increased among Black patients to 4.2 from 2.7. In comparison, the average PACE score among non-Black adults was 4.1, and the percentage of diuretic medication use doubled in Black adults. Researchers speculate that the increased use of thiazide diuretics may explain the notable decrease in average diastolic BP.
For the analysis, researchers examined health data from the SAMMPRIS randomized controlled trial conducted from 2008 to 2011 at 50 sites within the United States. They evaluated medication use and vascular risk factors, such as systolic BP, diastolic BP, LDL, blood glucose levels, and physical activity of Black and non-Black adults with a recent stroke event.
The non-Black participant group included white, Asian, and Hispanic adults, who were measured collectively.
The authors note that their research raises questions about other factors beyond physiology, medications, and regular follow-up that may help to reduce these disparities even further.
“Many different approaches are needed to reduce and eliminate these disparities in Black adults,” Nelson said. “Access to health care, lifestyle coaching, early follow-up, and administration of appropriate medications after stroke may help to resolve it, but not wholly in terms of overall risk and all of the baseline disparities.” ■
Is PPI use connected to dementia risk?
Prolonged use of PPIs, which are designed to control acid reflux and other GI disorders, may raise the risk of dementia, according to a study published August 9, 2023, in Neurology.
The study included 5,712 older adults who were dementia-free at baseline, defined as visit 5 in the ongoing ARIC study.
The researchers reported that participants in the ARIC cohort who used PPIs for more than 4.4 years had a higher risk of dementia compared with those reporting no PPI use.
The participants were placed into four groups: those not using PPIs, those using them for up to 2.8 years, those using them for 2.8 to 4.4 years, and those using them for more than 4.4 years. Overall, 1,490 participants used PPIs, ranging from a minimum cumulative PPI use of 112 days to a maximum use of 20.3 years. Median use was 3.8 years, while mean use was 4.4 years. Over a median of 5.5 years, 585 people developed dementia. Only the participants who used PPIs for more than 4.4 cumulative years prior to visit 5 had a higher risk of developing dementia compared with those not using PPIs.
In a secondary analysis, the researchers examined the relationship between PPIs and dementia with histamine-2 receptor antagonists (H2Ras) as an active comparator. The results were similar, as more than 4.4 cumulative years of exposure to PPIs were associated with greater dementia risk compared with H2Ras. However, there was no association with use for shorter durations or current use. ■
Few adults receive medication for opioid use disorder
A study published August 7, 2023, in JAMA Network Open found that as drug overdose deaths have reached unprecedented levels in the United States, evidence-based treatments for substance use are severely underused.
The study, led by researchers at the National Institute on Drug Abuse and the National Center for Injury Prevention, found that only about one-third of adults with opioid use disorder (OUD) received any type of treatment for substance use, and only about one in five received medication to treat OUD.
The study focused on data from more than 47,000 adults who participated in the 2021 National Survey on Drug Use and Health, which is sponsored by the Substance Abuse and Mental Health Services Administration.
An estimated 2.5 million adults nationwide have OUD, for which FDA has approved therapies such as methadone, buprenorphine, and naltrexone.
The study noted significant differences for those who received medication to treat OUD. Men with OUD were six times more likely than women to receive OUD treatment, while white adults were 14 times more likely to receive treatment compared with Black adults.
Adults living in nonurban areas and unemployed adults were also less likely to receive OUD medications.
In addition, the study backs previous findings that indicated the use of telehealth improved treatment rates. Individuals who received substance use treatment through telehealth were nearly 40 times more likely to receive medications for OUD compared with those who did not receive telehealth treatment, according to the researchers. ■
CDC: MMR vaccinations fall for children
According to new CDC data, the rate of vaccinations against measles, mumps, and rubella (MMR) for kindergarteners has fallen below the optimum target rate of 95% for the second year in a row, declining to 93%.
“While this is a small decline, this is the lowest MMR rate reported in almost a decade and leaves approximately 250,000 school children unvaccinated and unprotected against measles, one of the world’s most contagious viruses,” a recent Kaiser Family Foundation brief said.
Vaccine hesitancy is likely playing a role.
The United States’ Healthy People 2030 target of 95% reflects the coverage rate deemed high enough to ensure herd immunity against community transmission. MMR vaccinations are regarded as critical because of the contagious nature of measles.
CDC advises that the initial dose of MMR vaccines be administered at the age of 12 months to 15 months, with a second dose given at 4 years to 6 years old. ■
Hospital pharmacists say drug shortages are affecting care
New survey findings from the American Society of Health-System Pharmacists (ASHP) showed that roughly 99% of health-system pharmacists said they are experiencing drug shortages. Nearly one-third of the respondents said the current shortages are “critically impactful,” causing facilities to delay, ration, or cancel procedures or treatments.
More than 1,000 ASHP members responded to the internal survey between late June and mid-July 2023. According to the findings, chemotherapy drugs are among the most pressing shortages, with 57% of pharmacists saying this category had a direct effect on patient care.
A separate survey released in June 2023 from major cancer centers found that 93% were unable to locate sufficient carboplatin, and 70% experienced shortages of cisplatin. Both are frequently used in combination to treat many forms of cancer.
Meanwhile, the ASHP survey also found that shortages of corticosteroids and other hormonal drugs, in addition to oral liquids such as amoxicillin, have had major effects on patient care.
More than 40% of health-system pharmacists said they have had to delay or cancel treatments or procedures because of a drug shortage. Furthermore, 85% said they have had to ration drugs, while 97% said they had to use therapeutic alternatives.
Approximately 85% of the pharmacists also said they would be willing to spend more for drug products from companies vetted by a quality recognition program. ■