HealthDay News – From 2012 to 2018, there were substantial increases in naloxone dispensing with considerable regional variation, according to research published in the August 6 early-release issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Gery P. Guy Jr, PhD, from the CDC in Atlanta, and colleagues analyzed retail pharmacy data from IQVIA (a health care, data science, and technology company) to examine US naloxone dispensing. Factors associated with naloxone dispensing were assessed at the county level.

The researchers observed a substantial increase in the number of naloxone prescriptions dispensed from retail pharmacies from 2012 to 2018, including a 106% increase from 2017 to 2018. For every 69 high-dose opioid prescriptions, one naloxone prescription was dispensed nationally in 2018. Substantial regional variation was noted in naloxone dispensing, including 25-fold variation across counties; the lowest rates were seen in the most rural counties. Naloxone dispensing also varied widely by prescriber specialty. Out-of-pocket costs were required for a higher percentage of naloxone prescriptions paid for with Medicare than prescriptions paid for with Medicaid and commercial insurance (71.1 vs 43.8 and 41.5%, respectively).

“Comprehensively addressing the opioid overdose epidemic will require efforts to improve naloxone access and distribution in tandem with efforts to prevent initiation of opioid misuse, improve opioid prescribing, implement harm reduction strategies, promote linkage to medications for opioid use disorder treatment, and enhance public health and public safety partnerships,” the authors write.

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Jamal S. Rana, MD, PhD, from Kaiser Permanente Northern California in Oakland, and colleagues examined whether or not heavy episodic drinking days (HED; i.e., “binge” drinking), in conjunction with habitual drinking, impacts CVD risk among US adults. The analysis included 697,985 adults (43% women) who, in 2014 to 2015, reported drinking alcohol as part of regular health care screening.

The researchers found that for men and women (aged 18 to 65 years), those with high total consumption (≥15 drinks/week for men; 8 or more drinks/week for women) had higher odds of CVD compared with those with moderate (3 to 14 drinks/week for men; 3 to 7 drinks/week for women) or low (1 to 2 drinks/week for men or women) consumption. Associations were stronger among those reporting any HED (5 or more drinks on any day in past 3 months for men and 4 or more for women; 20.8%). For men older than 65 years, CVD risk was not increased with or without HED. For women older than 65 years and HED, moderate and high total consumptions more than doubled the odds of CVD vs that seen with low consumption.

“Women feel they’re protected against heart disease until they’re older, but this study shows that even when you’re young or middle aged, if you are a heavy alcohol user or binge drink, you are at risk for coronary heart disease,” Rana said in a statement.

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HealthDay News — For Black adults who smoke, adaptation to varenicline and/or bupropion plus nicotine patch (NP) does not improve abstinence rates compared with NP monotherapy, according to a study published online June 20 in JAMA Network Open.

Nicole L. Nollen, PhD, from the University of Kansas School of Medicine in Kansas City, and colleagues examined the efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily in a randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC). Both groups received 18 weeks of pharmacotherapy with follow-up through week 26. The ADT group included 196 individuals who received an NP and up to two pharmacotherapy adaptations (varenicline at week 2 and bupropion at week 6 if needed), while the UC group included 196 individuals who received NP throughout.

The researchers observed no significant difference in verified 7-day abstinence by treatment group at 12, 18, or 26 weeks. Of the 71.8% of the ADT participants who received pharmacotherapy adaptations, 8.1% were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had carbon monoxide-verified abstinence at week 2 had significantly increased odds of being abstinent at week 12 compared to those who did not respond to treatment (28.7 vs 7.8%; odds ratio, 4.6).

“Findings highlight the continued need to identify effective treatment, particularly for those at high risk for cessation failure and those disproportionately impacted by tobacco-related disease,” the authors write.

Several authors disclosed financial ties to industry.

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HealthDay News — A federal appeals court has ruled that for now, Juul Labs can continue to sell its electronic cigarettes on the US market.

The Friday ruling came in response to the company seeking a temporary emergency hold while it appeals a ban of its products that was issued Thursday by the US Food and Drug Administration.

The e-cigarette maker had asked the court to pause what it called an “extraordinary and unlawful action” by the FDA that would have required it to immediately halt its business, the Associated Press reported.

When issuing the ban last week, the FDA said Juul’s application left regulators with significant questions and did not include enough information to evaluate any potential health risks. Meanwhile, Juul said it submitted enough information and data to address all issues raised.

The products include the Juul vaping device and four types of Juul pods: pods labeled Virginia Tobacco flavor at nicotine concentrations of 5 and 3%, and menthol-flavored pods at nicotine concentrations of 5 and 3%, the FDA said.

The FDA has already banned the sale of fruit-flavored e-cigarettes after critics claimed the products targeted teens. Regulators have since been reviewing thousands of applications for vaping products after tightening their oversight of the electronic cigarette market.

Associated Press Article

HealthDay News — The heavily criticized US Food and Drug Administration tobacco program promised changes on Friday, including a 5-year strategic plan to better outline priorities.

“As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle,” FDA Commissioner Robert Califf, MD, said in a statement. “Our ability to keep pace with these changes will depend on immediate, short-term, and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products.”

The agency has faced criticism from antitobacco advocates, the industry, and lawmakers for its past work in cigarette and vaping regulation, the Associated Press reported. An external review commissioned last summer released a report in December that called the FDA “reactive and overwhelmed.” Its workforce was struggling to manage tobacco and largely unauthorized e-cigarettes, the report stated.

The new FDA strategic plan is expected to outline efforts on e-cigarettes, as well as to be more transparent about FDA decisions, such as mass rejection of applications from e-cigarette makers.

Regulators would like to “better communicate” with companies about how the FDA makes decisions, said Brian King, tobacco chief for the agency. “Some things will take longer than others, but we’re committed to getting everything done that we’ve outlined as expeditiously as possible,” King told the AP. The FDA will also meet with the US Department of Justice on efforts to crack down on the fruit- and candy-flavored e-cigarettes that appeal to teens, King added.

Hundreds of warning letters to vaping retailers and e-cigarette manufacturers are sometimes ignored, the FDA noted. King said the FDA relies on the Justice Department on when to bring on lawsuits. The two agencies have announced lawsuits and fines in recent months. “Those are the first of their kind, and I hope they’re a wake-up call to industry that if you are violating the law we are going to use the full portfolio of our enforcement activities to ensure that you comply,” King told the AP.

Associated Press Article

Yakubu Bene-Alhasan, MD, MPH, from Medstar Health in Baltimore, and colleagues used data from the National Institutes of Health “All of Us” Research Program to examine the association between the frequency of marijuana use and new-onset heart failure. The researchers found there were 2958 events within a median follow-up of 45 months from a final population of 156,999 patients. Daily marijuana use was associated with an increased risk for incident heart failure compared with never use (adjusted hazard ratio, 1.34; 95% CI interval, 1.04 to 1.72). After the addition of coronary artery disease diagnosis as a time-varying covariate in the main model, the association was attenuated and no longer significant (adjusted hazard ratio, 1.27; 95% CI, 0.99 to 1.62).

Avilash Mondal, MD, from Nazareth Hospital in Philadelphia, and colleagues examined the association between CUD in elderly nonsmokers with established cardiovascular disease risk and MACCE. The researchers found that 13.9% of 28,535 elderly cannabis users reported MACCE episodes. Compared with the non-CUD cohort, the CUD cohort reported higher MACCE (odds ratio, 1.20), all-cause mortality, dysrhythmia, acute myocardial infarction, transfer to other facilities, and home health care. In CUD users, chronic lung disease, renal disease, hypertension, and hyperlipidemia were predictors of MACCE episodes.

“The main public message is to be more aware of the increased risks and open the lines of communication so that cannabis use is acknowledged and considered,” Mondal said in a statement.

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HealthDay News — There is an almost linear association between alcohol intake and blood pressure (BP) in healthy adults, according to a review published online July 31 in Hypertension.

Silvia Di Federico, from the University of Modena and Reggio Emilia in Italy, and colleagues conducted a systematic review of studies conducted in healthy adults that reported on the association between alcohol intake and BP. The analysis included seven studies with 19,548 participants and a median follow-up of 5.3 years.

The researchers identified a substantially linear positive association between baseline alcohol intake and changes over time in systolic BP (SBP) and diastolic BP (DBP), with no indication of an exposure-effect threshold. Compared with no consumption, average SBP was 1.25 and 4.90 mm Hg higher and average DBP was 1.14 and 3.10 mm Hg higher for 12 or 48 g daily alcohol consumption, respectively. An almost linear association was seen between baseline alcohol intake and SBP changes in both men and women and for DBP in men, while an inverted U-shaped association was identified in women. In both Asians and North Americans, alcohol intake was positively associated with BP change, apart from DBP in North Americans.

“Future research should assess the association in women and in different age groups, both of which are currently characterized by limited availability of relevant data,” the authors write.

One author disclosed receiving speaker’s fees from Bayer, Daiichi Sankyo, Janssen, and Sanofi.

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In a health advisory the agency sent out to health care providers, officials said any provider who has such a patient should report the case to local health authorities. The agency added that it is working with the US Food and Drug Administration and state and local partners to investigate the link. But there are already clues: State labs have found “extremely high” levels of lead in certain lots of cinnamon applesauce pouches that have since been recalled by WanaBana, Schnucks, and Weis.

In its initial alert on the recall issued late last month, the FDA said 4  children in North Carolina had been found to have high levels of lead in their blood that was linked to the WanaBana products. Cases of high blood lead levels in children have now been reported in 14 states: Alabama, Arkansas, Louisiana, Maryland, Missouri, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Washington.

The pouches were sold by retailers including Amazon, Dollar Tree, and Sam’s Club. The FDA has warned families not to eat or serve these products and encourages them to throw out the pouches or return them to the store where they bought them for a refund. Caregivers should take any children who may have eaten these products to have blood tests to check for lead exposure, the CDC added.

The companies involved are working to find the source of the contamination in these products, the agency added.

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The Food and Drug Administration (FDA) has approved Amphastar’s New Drug Application (NDA) for naloxone hydrochloride nasal spray 4mg for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.

Naloxone hydrochloride nasal spray is an opioid antagonist designed using the Company’s proprietary nasal delivery device. It is a prescription medication intended for immediate administration as emergency therapy in settings where opioids may be present.

The product is supplied as a carton containing 2 unit-dose devices; each device delivers a single spray containing 4mg of naloxone hydrochloride (equivalent to 3.6mg of naloxone). The device is ready to use and does not require priming or testing prior to administration.

Commenting on the FDA nod, Dr Jack Zhang, Amphastar’s President and Chief Executive Officer, said: “The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product.”

References

1. Amphastar Pharmaceuticals receives FDA approval for Naloxone Hydrochloride Nasal Spray 4mg. News release. Amphastar Pharmaceuticals. March 8, 2023. Accessed March 9, 2023. https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096.
2. Naloxone Hydrochloride Nasal Spray. Package insert. Amphastar Pharmaceuticals; 2023. Accessed March 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf.

The Food and Drug Administration (FDA) has expanded the approval for Anavip^® (crotalidae immune F(ab’)₂ [equine]; Rare Disease Therapeutics) to include management of adult and pediatric patients with copperhead and cottonmouth/water moccasin envenomations. Previously, Anavip was only approved for rattlesnake envenomation.

Anavip contains venom-specific F(ab’)₂ fragments of immunoglobulin G that bind and neutralize venom toxins, facilitating redistribution away from target tissues and elimination from the body. Due to its long half-life, Anavip reduces the likelihood of coagulopathic effects, and eliminates the need for additional doses commonly required with shorter-acting antivenom. In clinical trials, patients with signs of North American pit viper envenomation achieved control of local injury and coagulopathy following early antivenin treatment with Anavip.

Anavip is supplied as a sterile lyophilized preparation in single-use vials. Treatment should be administered as soon as possible after a bite in patients who develop any signs of envenomation.

“Anavip, with its ease of dosing and reduction of late coagulopathies, is now a vital treatment option for not only rattlesnake envenomated patients, but for all patients with any North American pit viper envenomation, a group that prior to this approval, has had very limited treatment options.”

References

1.    Rare Disease Therapeutics, Inc. announces new expanded FDA Approved Indication for antivenom Anavip^® for treatment of North American Pit Viper envenomation. [press release]. Franklin, TN: Rare Disease Therapeutics, Inc.; April 5, 2021. 

2.    Anavip [package insert]. Franklin, TN: Rare Disease Therapeutics, Inc.; 2021.

CSX-1004 works by binding to fentanyl and fentanyl analogs in the bloodstream, thereby sequestering the fentanyl molecules and neutralizing them before they reach the brain. The Fast Track designation was based on nonhuman data demonstrating that a single dose of CSX-1004 could block the respiratory depressant effects of high doses of fentanyl for up to 28 days.

A first-in-human study (ClinicalTrials.gov Identifier: NCT06005402) has been initiated and will evaluate the safety, tolerability, and pharmacokinetics of CSX-1004 in healthy volunteers. The study is expected to enroll 32 individuals aged 18 to 50 years. The investigational treatment will be administered as an intravenous infusion across a range of doses.

“Fast Track designation by the FDA is an important milestone and recognizes the potential for CSX-1004 to help address an unprecedented public health crisis that claims a life every seven minutes in the US,” said Andy Barrett, PhD, Chief Scientific Officer at Cessation. “We are encouraged by the FDA’s decision as it reflects the need for novel treatments that can potentially stem the tide of untimely fentanyl-related deaths.”

This is the second lawsuit that the plaintiffs, the African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association, have filed against the US Food and Drug Administration over delays in banning menthol cigarettes.

The first lawsuit, filed in 2020, demanded that the FDA add menthol to its list of prohibited flavors for public health reasons. Once the agency began to take action on the issue, that lawsuit was dismissed.

In the latest lawsuit, the groups claim the agency missed a March deadline for issuing a final rule on a menthol ban. Menthol cigarettes are particularly popular in the Black community.

“Because of defendants’ inaction, tobacco companies have continued to use menthol cigarettes to target youth, women and the Black community, all to the detriment of public health,” the lawsuit stated.

“As African American physicians, we are deeply disturbed at the continuing delays in FDA’s finalizing of the ban on menthol cigarettes,” Dr Yolanda Lawson, president of the National Medical Association, said in a news release announcing the lawsuit. “Our patients, more than any other group, become disabled and die prematurely due to the continued use of these cigarettes.”

All flavored cigarettes except menthols were first banned in 2009. The FDA has been considering a menthol ban for more than a decade, CNN reported.

“We’re extremely disappointed to be forced to file this second lawsuit against the FDA in support of protecting Americans from menthol cigarettes,” Laurent Huber, executive director of Action on Smoking and Health, said in the news release. “The FDA’s own research confirms that a menthol ban would save lives; there is no scientific reason to delay finalizing this rule.”

The FDA told CNN that it does not comment on pending litigation, but “remains committed to issuing the tobacco product standards for menthol in cigarettes and characterizing flavors in cigars as expeditiously as possible; these rules have been submitted to [the Office of Management and Budget] for review, which is the final step in the rule-making process.”

But the plaintiffs said the time for action is long past due.

“The relentless and racist tobacco industry targeting has killed too many members of the Black community,” Carol McGruder, co-chair of the African American Tobacco Control Leadership Council, said in the news release. “If Black lives truly matter, then we must end the sale of menthol cigarettes and do it now!”

Studies on the benefits of a menthol ban are plentiful.

Over a 20-year period, it could lower health care costs among all adult smokers by about $1.62 billion, a recent study found. It would also save up to 654,000 lives within 40 years, including 255,000 Black lives, a 2022 study found.

Meanwhile, a 2020 study showed that while 43% of all adult smokers smoked menthols, more than 83% of Black smokers did. But within five years, the elimination of menthol cigarettes could close the gap in lung cancer deaths, another report found.

“The administration continues to miss the opportunity to leave a significant, lasting public health legacy, save lives and reach their Cancer Moonshot goals by not finalizing these rules,” Dr Karen Knudsen, CEO of the American Cancer Society and the Cancer Action Network, said in a news release supporting the move.

The American Lung Association (ALA) is also not part of the lawsuit, but expressed its support.

“The FDA’s findings show that menthol cigarettes are not appropriate for the protection of public health. It is frustrating that the continued delay of the menthol rules compelled our partners to go back to court,” ALA President and CEO Harold Wimmer said in a news release.

The FDA will likely have about two months to respond to the lawsuit in court, the groups’ attorney, Christopher Leung, told CNN.

The White House did not respond to a request for comment on the lawsuit, CNN reported.

More information

The American Lung Association has more on menthol cigarettes.

SOURCES: African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association, news release, April 1, 2024; CNN

HealthDay News — During April 2022 to March 2023, the number of reported US electronic cigarette (e-cigarette) poisoning exposure cases increased, according to research published in the June 23 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Nicole A. Tashakkori, MPH, from the US Food and Drug Administration in Silver Spring, Maryland, and colleagues examined the number and characteristics of e-cigarette exposed cases in the US by analyzing data from the National Poison Data System for April 1, 2022, to March 31, 2023.

The researchers found that 7043 e-cigarette exposure cases were reported during April 1, 2022, to March 31, 2023, representing a 32% increase from 476 to 630. Overall, 87.8% of exposures occurred among children aged 5 years or greater. The most common exposure routes were inhalation or nasal (61.0%) and ingestion or oral (40.0%). Hospital admission occurred in 0.6% of e-cigarette exposure cases, and 8.3% of exposures required treatment at a health care facility. In 0.2 and 1.9% of exposure cases, respectively, a major and moderate effect were experienced. One reported case resulted in death. About one-half of reported cases resulted in a minor effect or no reported effect (27.2 and 19.1%, respectively). Of the 342 cases with brand information, Elf Bar was the most commonly reported brand (60.8%).

“Health care providers; the public health community; e-cigarette manufacturers, distributors, sellers, and marketers; and the public should be aware that e-cigarettes have the potential to cause poisoning exposure and are a continuing public health concern,” the authors write.

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HealthDay News — Electronic cigarette use is associated with increased odds of stroke, myocardial infarction, and angina or coronary heart disease, according to a study presented at the American Stroke Association International Stroke Conference, held from February 6 to 8 in Honolulu.

Paul M. Ndunda, MD, and Tabitha M. Muutu, MD, from the University of Kansas School of Medicine-Wichita, analyzed data from 66,795 respondents to the 2016 Behavioral Risk Factor Surveillance System (BRFSS) who reported ever regularly using e-cigarettes and a control group of 343,856 respondents who reported never using e-cigarettes. The authors examined the correlation between e-cigarette use and stroke.

Twenty-one percent of BRFSS respondents reported ever using e-cigarettes. The researchers found that compared with nonusers, e-cigarette users had significantly lower mean age (44 vs 57 years), mean body mass index (27.7 vs 28.1kg/m²), and rate of diabetes (9.8 vs 12.1%). E-cigarette users had increased adjusted odds of stroke, myocardial infarction, and angina or coronary heart disease compared with controls (odds ratios, 1.71, 1.59, and 1.4, respectively). 

“The American Heart Association cautions against the use of e-cigarettes, stating that e-cigarettes containing nicotine are tobacco products that should be subject to all laws that apply to these products,” according to an association press release. “The Association also calls for strong new regulations to prevent access, sales and marketing of e-cigarettes to youth and for more research into the product’s health impact.”

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Gregory Yates and Emily Melon, from Manchester Royal Infirmary in the United Kingdom, gathered descriptive data on the use of psychedelic trip killers by analyzing posts made on Reddit, a publicly available, anonymous social media website. A total of 128 relevant threads were identified from 2015 to 2023, yielding 709 posts.

The researchers found that the most commonly recommended trip killers were benzodiazepines and antipsychotics (46 and 18%, respectively). Trip killers were mainly discussed in reference to lysergic acid diethylamide, psilocybin mushrooms, and 3,4-methylenedioxymethamphetamine (235, 143, and 21, respectively). Of the posts, only 58 included warnings relating to the potential adverse effects of trip killers.

“We recommend that emergency physicians ask patients about trip killers if psychedelic drug use is suspected. This conversation should occur promptly on arrival to hospital, and before any benzodiazepines or antipsychotics are prescribed,” the authors write. “Doing so could offset an indirect risk to these patients, iatrogenic overdose, and will improve understanding of their mixed toxidrome.”

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Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.

“Today, we’re calling on organizations and businesses, big and small, public and private, across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”

Naloxone, sometimes sold under the brand name Narcan, is a medication that can rapidly reverse the effects of an opioid overdose. Research has shown that using the nasal spray doesn’t call for medical expertise and requires only minimal training.

In March 2023, the US Food and Drug Administration approved an over-the-counter Narcan spray, following that in July with the approval of the first generic nasal spray. Americans can now buy the sprays at pharmacies, grocery stores and vending machines.

Still, public health officials say naloxone can be hard to find and the price can be prohibitive for some, CNN reported.

Organizations that have already answered the White House challenge include the American Library Association, which is providing libraries with overdose response training for staff members and the public, as well as supporting the distribution of naloxone and overdose aid kits to the public, the White House said.

Meanwhile, Southwest Airlines has put naloxone in emergency medical kits on 65% of its planes and plans to stock 100% of its medical kits by the end of the year.

The need for naloxone is great: Overdose deaths spiked 30% between 2019 and 2020 and another 15% between 2020 and 2021, according to the U.S. Centers for Disease Control and Prevention, and synthetic opioids like fentanyl fueled the increase.

And provisional data published by the CDC in February suggests 2023 will be no different: More than 111,000 people died from a drug overdose in the 12-month period ending last September. Synthetic opioids, primarily fentanyl, were involved in more than two-thirds of those deaths.

More information

The National Institute on Drug Abuse has more on naloxone.

SOURCE: White House, news release, March 13, 2024; CNN

Faculty and students should be prepared to use it to help others, Rahul Gupta, MD, director of the White House Office of Drug Control Policy, and Miguel Cardona, secretary of education, said in a joint letter to educators. “We want to share resources that could help your school and community prevent drug use before it begins and keep students alive long enough to get the help they need in the event of an overdose or poisoning,” Gupta and Cardona wrote.

More than 5000 children and teens have died of drug overdoses involving fentanyl in the past 2 decades, according to data published recently in JAMA Pediatrics. More than half of those deaths occurred during the first 2 years of the COVID-19 pandemic. About 1500 children and teens died from fentanyl in 2021. That was 30 times higher than in 2013, when opioid deaths in the US began to rise. Most pediatric deaths from fentanyl are in 15- to 19-year-olds.

“A teenager today can log onto social media with a smartphone and buy what they think is an opioid pain medicine or a prescription stimulant to help them study — and instead die from one pill that actually has fentanyl in it,” Gupta and Cardona emphasized in their letter.

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HealthDay News — For adults with hypertension on drug therapy, especially men, smoking is associated with lower rates of blood pressure (BP) control, according to a study presented at ACC Latin America 2021, hosted by the American College of Cardiology and held virtually from November 5 to 6.

Márcio Gonçalves de Sousa, MD, PhD, from the Dante Pazzanese institute of Cardiology in São Paulo, Brazil, and colleagues conducted a retrospective evaluation of 710 adults with hypertension. BP was classified as controlled (C: less than 140/90 mm Hg), S1 (140 to 159 and/or 90 to 99 mm Hg), S2 (160 to 179 and/or 100 to 109 mm Hg), or S3 (greater than 180 and/or greater than 100 mm Hg). Patients were classified according to tobacco use as never smokers (NS), current smokers (CS), or former smokers.

The researchers found that BP control rates were similar for men and women (36.1 and 32.5%, respectively), as was the prevalence of S1 (28.6 vs 22.9%), S2 (18.8 vs 24%), and S3 (16.5 vs 20.7%). BP categorization did not differ by gender for NS (C: 37.1 vs 34.9%; S1: 25.8 vs 22.3%; S2: 22.6 vs 21.7%; and S3: 14.5 vs 21.1%). Lower rates of BP control were seen for men and women who were CS (C: 9.1 vs 25.0%; S1: 30.0 vs 43.8%; S2: 18.2 vs 25.0%; and S3: 45.5 vs 6.3%).

“There is synergy between these two risk factors: hypertension exponentially increases the smoker’s cardiovascular risk and smoking increases the risk of hypertension, thus worsening their control,” Gonçalves de Sousa said in a statement.

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Brixadi^® (buprenorphine) extended-release subcutaneous injection is now available for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Brixadi contains buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. The approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02651584) that compared the long-acting subcutaneous treatment to an existing standard of care, sublingual buprenorphine/naloxone, in patients with moderate to severe OUD. 

Brixadi is available in either a weekly or monthly formulation for subcutaneous injection into the buttock, thigh, abdomen, or upper arm. The weekly injection can be administered to patients who have tolerated a single 4mg dose of a transmucosal buprenorphine‐containing product or those who are currently being treated with a transmucosal buprenorphine-containing product; injection sites should be alternated/rotated between injections. The monthly injection is appropriate for patients who are currently being treated with a transmucosal buprenorphine-containing product. 

The most common adverse reactions reported with Brixadi were injection site reactions (eg, pain, erythema, pruritus), headache, constipation, nausea, insomnia, and urinary tract infection. Brixadi carries a Boxed Warning associated with a risk for serious harm or death if the product is administered intravenously. Because of this risk, Brixadi is only available through a Risk Evaluation and Mitigation Strategy (REMS) program; treatment should be administered only in a health care setting by a health care provider who is certified in the REMS program.

Brixadi, a Schedule III controlled substance, is supplied as prefilled single-dose syringes in weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL) and monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL) doses. Doses of Brixadi (weekly) cannot be combined to yield an equivalent Brixadi (monthly) dose. The product does not require refrigeration.

“Brixadi is designed to align with how health care providers treat patients with OUD by offering multiple weekly and monthly dosing options to meet the patient where they are in their treatment journey,” said Paul Johnson, Chief Commercial Officer at Braeburn. “Health care providers and their patients with OUD will now have another FDA-approved option for long-acting, extended-release buprenorphine to address some of the challenges associated with the disease.”

Buprenorphine appears to be the optimal pharmacological treatment for neonatal abstinence syndrome (NAS), according to a network meta-analysis of randomized clinical trials (RCTs) published in JAMA Pediatrics.

To identify the most effective treatment for NAS, study authors searched various databases for RCTs where a pharmacological agent was used alone or in combination with adjuvant treatments. Length of treatment, defined as the number of days infants received drug therapy, was chosen as the primary outcome measure, while secondary outcomes included length of hospital stay, need for adjuvant treatment, and adverse events. Buprenorphine, clonidine, diluted tincture of opium and clonidine, diluted tincture of opium, morphine, methadone, and phenobarbital were all included in the length of treatment analysis.

Among the 18 studies included in the analysis (N=1072), sublingual buprenorphine was found to have the highest probability of being an optimal treatment for reducing the length of treatment (days: mean difference vs morphine, −12.75 [95% CI, −17.97 to −7.58]) and length of stay (days: mean difference vs morphine, −11.43 [95% CI, −16.95 to −5.82]) when compared with morphine and other therapies; morphine and phenobarbital monotherapies were found to be among the least effective treatments. “These findings are of particular interest within the existing observational literature, which finds that morphine and phenobarbital are the most frequently used pharmacological approaches in the United States and Canada,” the authors noted.

However, given the limitations of the evidence, the authors were unable to provide strong recommendations for any alternative therapy. “There is a need for a large multisite pragmatic trial that compares buprenorphine with other treatments before it can be universally accepted as a standard of care for treating NAS,” they concluded.

For more information visit Jamanetwork.com.