AI chatbot useful tool for providing nutritional information but cannot replace nutritionists: JAMA

Taiwan: A recent study published in JAMA Network Open has shed light on the accuracy and consistency of artificial intelligence (AI) in providing nutritional information.

The researchers found that artificial intelligence can be a convenient and useful tool for people who want to know their foods’ macronutrients and energy information. They, however, specified that AI chatbots cannot replace nutritionists but can provide real-time analysis of foods, and the capacity to harness AI technology in a supportive role may fundamentally transform the communication between nutritionists and patients.

In a digital world, people are increasingly depending on the internet for nutrition-related and food-related information. A recent report, however, showed that almost half of online, nutrition-related information was of low quality (48.8%) or inaccurate (48.9%). The ability of AI chatbots to streamline the navigation of public information and provide conversational texts to users has transformed electronic health. However, there is no clarity on their ability to handle nutrition-related questions.

To clarify the same, Yen Nhi Hoang, Taipei Medical University, Taipei, Taiwan, and colleagues investigated the reliability of AI in providing the macronutrient and energy content of 222 food items using different languages (English and Traditional Chinese) as inputs in a cross-sectional study.

The researchers followed the STROBE reporting guideline and did not need approval from the institutional review board or informed consent because it did not involve human participants following the Common Rule.

The study aimed to compare the reliability of ChatGPT-3.5 (chatbot 1) and ChatGPT-4 (chatbot 2) in providing information on the macronutrient and calorie content (proteins, fats, and carbohydrates) for eight menus (222 food items) designed for adults. A search was conducted using the following prompt: “As a dietitian, please draw a table to calculate line by line the energy (kcal)/carbohydrates (g)/lipids (g)/proteins (g) of the following food items (raw, not cooked).”

The consistency of AI responses was determined based on the coefficient variation (CV) for each food item in five repeated measurements. The accuracy of responses was assessed by cross-referencing the AI answers with nutritionists’ recommendations based on the food composition database of the Taiwanese Food and Drug Administration.

AI response accuracy was determined if answers were within ±10% or ±20% of the ground truth level energy (kilocalories) or macronutrients (grams). Differences in energy (kilocalories) and macronutrients (grams) between AI and nutritionists and between the 2 versions (3.5 and 4) were compared using A Student paired t-test.

The study led to the following findings:

  • There were no significant differences between nutritionist and AI estimations of energy, carbohydrate, and fat contents of 8 menus designed for adults, but there was a significant difference in protein estimation.
  • Both chatbots provided accurate energy contents for approximately 35% to 48% of the 222 food items within ±10%, with a CV of less than 10%.
  • Chatbot 2 performed better than Chatbot 1, but it overestimated protein.

“AI chatbots are designed to be probabilistic, however, the findings of this cross-sectional study suggest that AI can be a convenient and useful tool for people who want to know the macronutrient and energy information of their foods,” the researchers wrote.

Limitations included that the AI had a knowledge cutoff of September 2021, and the tested foods might not represent the most frequently consumed foods. Users need to be aware that AI is not a search engine, and answers provided by AI chatbots can be impacted by input language, chatroom environment, and clarity of the prompt.

Reference:

Hoang YN, Chen Y, Ho DKN, et al. Consistency and Accuracy of Artificial Intelligence for Providing Nutritional Information. JAMA Netw Open. 2023;6(12):e2350367. doi:10.1001/jamanetworkopen.2023.50367

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Pancreatic replacement therapy may improve maladaptive behaviour in preschool children with autism

USA: Findings from a recent study published in JAMA Network Open have suggested improvement in maladaptive behaviours in preschool children with autism spectrum disorder (ASD), such as agitation or irritability with high-protease pancreatic replacement therapy. 

“Children who have ASD often have several co-occurring maladaptive behaviours, such as irritability. We wanted to know whether these maladaptive behaviours can be addressed by an intervention with a low risk of side effects,” said Deborah A. Pearson, PhD, professor of psychiatry and behavioral sciences at McGovern Medical School at UTHealth Houston and lead author on this paper. Pearson is also the director of the Developmental Neuropsychology Clinic at UTHealth Houston.

Pearson said many children with ASD are selective about the foods they eat, often preferring carbohydrates like bread and pasta over protein. Some amino acids necessary for building neurotransmitters such as serotonin and dopamine, which are associated with behavioural and cognitive function, can only be obtained from food through protein digestion.

A total of 190 children, ages 3-6, participated in the study. In the first double-blind phase of the trial, 92 children were randomized to the active treatment arm and took 900 mg of a microencapsulated high-protease pancreatic porcine enzyme that was sprinkled on their food three times daily. In the other arm, 98 children had a placebo sprinkled on their food for 12 weeks. In the second open-label phase, all of the children received the active medication for 24 weeks.

According to the 12-week results, parents of children in the active treatment arm reported significant decreases in their child’s symptoms of irritability, hyperactivity/noncompliance, and inappropriate speech, relative to parents of children in the placebo arm. In the second 24-week phase, significant decreases were reported in all of the above behaviours, as well as in lethargy/social withdrawal. No serious adverse events were associated with the treatment.

“This study demonstrated that pancreatic enzymatic replacement- which is thought to enhance the supply of essential amino acids necessary for the synthesis of neurotransmitters-was associated with improved behavioural function in preschoolers with ASD, with minimal side effects,” Pearson said.

Reference:

Pearson DA, Hendren RL, Heil MF, McIntyre WR, Raines SR. Pancreatic Replacement Therapy for Maladaptive Behaviors in Preschool Children With Autism Spectrum Disorder. JAMA Netw Open. 2023;6(11):e2344136. doi:10.1001/jamanetworkopen.2023.44136.

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Stabilized super-oxidized hypochlorous acid spray may expedite healing in patients undergoing hair restoration surgery

Hair restoration surgeries have witnessed a transformative breakthrough with the introduction of stabilized, super-oxidized hypochlorous acid (HOCl). This compound, renowned for its potent efficacy against a spectrum of microorganisms, is proving to be a game-changer in both intraoperative and postoperative care for hair transplant procedures.

The trial results were published in the Journal of Drugs in Dermatology.

Also Read: Extreme pubic hair removal to cause recurrent urinary tract infections

Stabilized HOCl is no ordinary solution; it stands out for its remarkable effectiveness against bacteria, fungi, and viruses. Moreover, its application enhances tissue oxygenation, a crucial factor in facilitating optimal wound healing. This makes it an ideal candidate for surgeries involving thousands of small wounds, characteristic of hair restoration procedures. Hence, researchers conducted a trial to assess the perceived efficacy of stabilized, super-oxidized hypochlorous acid (HOCl) in hair transplant surgical procedures intraoperative and postoperative.

In a multi-site study involving 35 patients undergoing either repeat or initial hair restoration surgery, surgeons integrated a 500 mL trigger spray bottle of HOCl liquid into their surgical protocols. This innovative approach aimed to harness the potential benefits of stabilized HOCl before, during, and after the surgery. Patients were also equipped with a ten-day supply of HOCl for postoperative care, emphasizing its integral role in the entire recovery process.

Findings:

The results of this groundbreaking study are nothing short of impressive.

Statistical analysis revealed a significant 56% reduction in erythema, a common skin redness associated with wound healing when compared to standard wound healing regimens.

More than half of the patients (54%) experienced a marked improvement in pruritus, the itching sensation often accompanying wound healing.

Notably, patient compliance reached an outstanding 97%, showcasing the acceptance and ease of incorporating HOCl into their postoperative routines.

Surgeons, the architects of these transformative procedures, reported an overall efficacy that exceeded expectations.

Importantly, there were no reported incidents of donor or recipient tissue necrosis, highlighting the safety profile of the HOCl application.

Also Read: Wheelchair users at higher risk of complications, readmissions after total shoulder arthroplasty

As the field of hair restoration evolves, with surgeries involving a substantial number of grafts, the demand for optimal intraoperative and postoperative care has intensified. The stabilized hypochlorous spray is emerging as a revolutionary solution for wound cleansing and healing, offering theoretical benefits such as reduced tissue necrosis through enhanced oxygenation. This not only raises the bar for the standard of care in hair transplant procedures but also holds promise for a more comfortable recovery experience for patients. Thus, this innovative approach to hair transplant surgery, harnessing the power of stabilized HOCl, marks a paradigm shift in patient care.

Further reading: Topical Stabilized Super-Oxidized Hypochlorous Acid for Wound Healing in Hair Restoration Surgery: A Real-Time Usage-Controlled Trial Evaluating Safety, Efficacy, and Tolerability. J Drugs Dermatol. 2023;22(12):1191-1196. doi:10.36849/JDD.7172.

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CPC plus CHX mouthwash fails to reduce COVID-19 viral load of saliva

Preprocedural rinsing with cetylpyridinium chloride plus chlorhexidine mouthwash fails to reduce COVID-19 viral load of saliva suggests a new study published in the of Clinical Periodontology.

This study aimed to investigate the efficacy of a 0.05% cetylpyridinium chloride–0.05% chlorhexidine (CPC–CHX) mouthwash in reducing viral load in the saliva as compared with sterile water. Forty SARS-CoV-2 positive patients were asked to dispense 4 mL of saliva. Half the patients rinsed for 60 s with 15 mL CPC–CHX, and the remaining patients rinsed with sterile water (control). Four millilitres of saliva were collected after 15, 30 and 60 min after rinsing. Quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) and enzyme-linked immunosorbent assay (ELISA) specific for SARS-CoV-2 nucleocapsid protein were performed. For ELISA, the intact (representing the active virus) to total virus load (I/T) was calculated.Results: SARS-CoV-2 copy numbers/mL from RT-qPCR tended to decrease in the control group, whereas in the CPC–CHX group, an increase was observed after T30. However, mixed linear model analysis revealed no statistical differences between groups (p = .124), time points (p = .616) and vaccinated or non-vaccinated patients (p = .953). Similarly, no impact of group (p = .880), time points (p = .306) and vaccination (p = .711) was observed for I/T ratio values. Within the limitation of this study, there was no evidence that the intervention reduced salivary SARS-CoV-2 viral load during the course of 60 min. Therefore, commonly used pre-procedural rinsing might not be clinically relevant.

Reference: Giulia, B., Viktoria, W., Robert, K., Michael, B., Nadine, L., Jürgen, B., Beryl, S.-H., Jörg, T., & Kathrin, B. (2023). Eligibility and efficacy of a CPC- and CHX-based antiviral mouthwash for the elimination of SARS-CoV-2 from the saliva: A randomized, double-blind, controlled clinical trial. Journal of Clinical Periodontology, 1–9. https://doi.org/10.1111/jcpe.13905

Keywords: Preprocedural, rinsing, with, cetylpyridinium, chloride, plus, chlorhexidine, mouthwash, fails, to, reduce, COVID-19, viral load, saliva, Journal of Clinical Periodontology, Giulia, B., Viktoria, W., Robert, K., Michael, B., Nadine, L., Jürgen, B., Beryl, S.-H., Jörg, T., & Kathrin, B

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Use of computerized insulin order may improve blood sugar control in hospitalized cardiac patients

Saudi Arabia: A recent study published in Cardiovascular Endocrinology & Metabolism has shed light on the effect of implementing computerized insulin order sets for managing hyperglycemia in hospitalized cardiac patients.

The researchers revealed an association between using computerized insulin order sets and potential improvements in fasting and random glycemic control without raising the risk of hypoglycemia or hyperglycemia.

Diabetes is a global health problem affecting 537 million people worldwide, and this number may rise to 783 million in 2045, according to the International Diabetes Federation. Glycemic control is pivotal in managing hospitalized patients with type 2 diabetes mellitus (T2DM), and it presents as a clinical challenge in the cardiac population.

There is no published evidence to determine the effectiveness of insulin order sets to control BGLs in the cardiac population in Saudi Arabia. Considering this, Raed Ehsan Kensara, King Abdullah International Medical Research Center, Saudi Arabia, and colleagues aimed to determine the impact of computerized insulin order sets in type 2 diabetes hospitalized cardiac patients in a quasi-experimental, pre- and post-study design.

The study included T2DM patients hospitalized for at least 3 days. Those undergoing cardiac surgery were excluded. The study’s primary endpoint was determined as the mean difference in random blood glucose level (BGL) before and following the implementation of insulin order sets. The secondary endpoints were to compare the median differences in fasting BGLs and the number of hypoglycemic and hyperglycemic episodes during the first seven days.

The study comprised three phases: pre-implementation, intervention and post-phase. Insulin order sets were integrated into the electronic prescribing system in the intervention phase, and education was provided to the cardiology department. The post-phase included the patient’s post-implementations. During the study period, a total of 194 patients were enrolled.

The study revealed the following findings:

  • The mean random BGL was 11.17 mmol/L, 95% CI, 10.6–11.7 in the pre-phase and 9.5 mmol/L, in the post-phase.
  • The median fasting BGL was 9.2 mmol/L in the pre-phase and 8.5 mmol/L, in the post-phase.
  • The number of hypoglycemic episodes was 24 in pre-phase and 33 in post-phase.

In the quasi-experimental, pre- and post-study, “we found that the designed subcutaneous insulin treatment protocol integrated as order sets into the hospital computerized prescriber order entry (CPOE) system positively affected improving random and fasting BGLs in cardiac diabetic patients without increasing hypoglycemia risk,” the researchers wrote.

“Future research directions are to design insulin treatment protocols for glycemic control in the critical care setting, implement the protocol as an order set and then evaluate the impact of the insulin order sets in this population,” they concluded.

Reference:

Kensara, Raed Ehsana,b; Ismail, Sherina,b,c; Aseeri, Mohammeda,b,d; Hasan, Hania,b; Al Rahimi, Jamilahb,d,e; Zarif, Hawazenb,d,f; El Khansa, Saraa,b. The impact of the implementation of computerized insulin order sets for the control of hyperglycemia in hospitalized cardiac patients. Cardiovascular Endocrinology & Metabolism 13(1):e02961, March 2024. | DOI: 10.1097/XCE.0000000000000296

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BMI may independently predict non-calcified plaque presence among patients with a CAC 0: Study

Iraq: The presence of non-calcified plaque in patients with a coronary calcium score of 0 is associated with diabetes mellitus, advanced age, high body mass index (BMI), and increased pericardial fat volume (PFV), a recent study has revealed.

The researchers revealed that after multivariate adjustment, increased body mass index remained a significant predictor for the presence of non-calcified plaque. The findings were published online in the Indian Heart Journal on December 19, 2023.

CAC = 0 in patients with low-intermediate risk for coronary artery disease (CAD) confers a low risk of mortality and morbidity after 10 years of follow-up as reported in large cohort studies. However, a CAC score of 0 does not consider the presence of non-calcified plaques, which cannot be detected by routine CAC scan or conventional angiography and may have prognostic implications when identified by CT coronary angiography.

The early stage of coronary atherosclerosis involves non-calcified coronary plaque formation, which is linked with increased shear stress and positive remodelling of the coronary vessel. This type of coronary plaque is more likely to rupture and form a thrombus, likely causing acute coronary syndrome or sudden cardiac death compared to calcified plaque, which represents a late phase of coronary atherosclerosis and a more stable lesion. Hence, identifying the potential predictors of non-calcified plaque is important for risk stratification and risk factor control in patients with suspected CAD, specifically when CAC = 0.

Abdulameer A. Al-Mosawi, University of Kufa, Najaf, Iraq, and colleagues therefore aimed to assess the association of PFV and classical coronary risk factors with non-calcified plaque presence in patients with suspected coronary artery disease and CAC = 0 in a retrospective study conducted between January 2013 and April 2022.

The study involved 811 patients with chest pain suggestive of angina. They underwent CT coronary angiography for the assessment of CAD. Of these, the analysis included 417 with CAC = 0.

The study led to the following findings:

  • Patients with non-calcified plaque were older (54 ± 9 versus 50 ± 10) and had a higher prevalence of diabetes mellitus (31% versus 17%), high BMI (29.9 versus 28.3), and increased PFV (123 cm3 versus 99 cm3) compared to patients without plaque.
  • In multivariate regression analysis, high BMI [OR = 1.1] was an independent predictor of non-calcified coronary plaque presence among patients with CAC = 0 after adjustment to variables in the univariate analysis.

“In patients with CAC = 0, diabetes mellitus, advanced age, high BMI, and increased PFV were all associated with the presence of non-calcified plaque,” the researchers wrote. “After multivariate adjustment, increased BMI remained a significant independent predictor for non-calcified plaque presence.”

Reference:

Al-Mosawi, A. A., Nafakhi, H., & Alabayechi, Y. S. (2023). Pericardial fat volume and coronary risk factors as predictors of non-calcified coronary plaque presence among patients with coronary calcium score = 0. Indian Heart Journal. https://doi.org/10.1016/j.ihj.2023.12.006

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Use of triangle tip-jet knife for peroral endoscopic myotomy effective in patients with achalasia

A recent study unveiled a novel modification to the Triangle Tip Knife J (TTJ), a tool commonly utilized in peroral endoscopic myotomy (POEM) procedures for esophageal motility disorders like achalasia. This study was published in the journal of Gastrointestinal Endoscopy by Kimoto Y. and colleagues.

This modification involved adapting the TTJ with a disposable clip sheath, termed TTJ with hood attachment (TTJ-H). The study aimed to compare the safety and efficacy of TTJ and TTJ-H in POEM treatments. The retrospective cohort study, using a 1:1 propensity score matching, delved into several key parameters among 196 patients who underwent POEM between January 2021 and June 2023. The comparison between TTJ and TTJ-H revealed notable findings:

  • Procedure time reduction: TTJ-H exhibited a significant decrease in the mean procedure time from 93.5 to 80.2 minutes, marking a notable 14% reduction (P = 0.012).

  • Enhanced myotomy efficiency: The use of TTJ-H improved myotomy efficiency substantially, displaying a 16% increase from 2.76 to 2.32 minutes per centimeter (P < 0.001).

  • Reduced coagulation forceps usage: TTJ-H demonstrated a remarkable reduction in coagulation forceps usage for hemostasis, dropping from 3.87 to 0.55, showcasing an impressive 86% decrease (P < 0.001).

Overall, the study findings suggest that incorporating the TTJ-H modification into POEM procedures can yield several advantages, including reduced procedure time, improved myotomy efficiency, and decreased reliance on coagulation forceps. These enhancements not only contribute to procedural streamlining but also potentially reduce overall costs associated with the treatment.

This innovative adaptation offers promise in optimizing the efficacy and safety of endoscopic surgeries for esophageal motility disorders. The potential to minimize procedure duration and enhance precision holds substantial implications for patients undergoing these interventions.

Reference:

Kimoto, Y., Inoue, H., Shimamura, Y., Azuma, D., Ushikubo, K., Yamamoto, K., Okada, H., Nishikawa, Y., Tanaka, I., Jandee, S., Navarro, M. J., & Onimaru, M. Hood attached vs conventional triangular tip-jet knife in peroral endoscopic myotomy: a propensity score matching cohort study. Gastrointestinal Endoscopy,2023. https://doi.org/10.1016/j.gie.2023.12.001

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Extended use of inclisiran safe and efficacious among refractory dyslipidemia in patients with increased CV risk

A recent study sheds light on the safety profile of inclisiran, an innovative agent designed to reduce low-density lipoprotein cholesterol (LDL-C). The research aimed to provide comprehensive evidence on the long-term safety of inclisiran, a small interfering RNA agent with promising implications for managing dyslipidemia. This study was published in the Journal Of The American College Of Cardiology by Scott Wright and colleagues.

The post hoc analysis encompassed patients treated with 300 mg inclisiran sodium or placebo across completed (ORION-1, -3, -5, -9, -10, and -11) and ongoing (ORION-8) trials. Key findings from the study:

  • Patient Cohort: The analysis involved 3,576 patients receiving inclisiran for up to 6 years and 1,968 patients on placebo for up to 1.5 years, accounting for 9,982.1 and 2,647.7 patient-years of exposure, respectively. Baseline characteristics were similar across groups, ensuring a balanced comparison.

  • Safety Assessment: Kaplan-Meier analyses revealed that treatment-emergent adverse events (TEAEs), particularly serious ones or those leading to discontinuation, as well as hepatic, muscle, and kidney-related events, exhibited comparable rates between inclisiran and placebo groups for up to 1.5 years. Notably, trends continued favorably for inclisiran beyond this timeframe.

  • Cardiovascular Events: Fewer major cardiovascular events were reported as TEAEs with inclisiran during the observed period, hinting at potential cardiovascular benefits beyond cholesterol reduction.

  • Antidrug Antibodies: Treatment-induced antidrug antibodies were infrequent with inclisiran, reported in 4.6% of cases, with only a small fraction showing persistence (1.4%). Importantly, the presence of these antibodies did not associate with a higher incidence of TEAEs leading to drug discontinuation or serious TEAEs.

The study’s conclusive findings emphasize the favorable long-term safety profile of inclisiran in a diverse patient population with dyslipidemia. This robust evidence underscores the absence of new safety concerns and reiterates the promising safety profile of inclisiran as a therapeutic option for managing cholesterol levels.

The study’s comprehensive analysis, spanning multiple trials and years of patient data, provides valuable insights into inclisiran’s safety landscape. These findings contribute significantly to validating inclisiran’s safety, fostering confidence in its use for patients grappling with dyslipidemia.

Reference:

Wright, R. S., Koenig, W., Landmesser, U., Leiter, L. A., Raal, F. J., Schwartz, G. G., Lesogor, A., Maheux, P., Stratz, C., Zang, X., & Ray, K. K. Safety and tolerability of inclisiran for treatment of hypercholesterolemia in 7 clinical trials. Journal of the American College of Cardiology,2023;82(24):2251–2261. https://doi.org/10.1016/j.jacc.2023.10.007

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Aficamten improved outcomes for patients with obstructive hypertrophic cardiomyopathy: Phase 3 SEQUOIA-HCM trial

USA: The pivotal Phase 3 clinical trial (SEQUOIA-HCM) of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) has yielded positive results, as announced by drugmaker Cytokinetics.

The top-line results from the SEQUOIA-HCM trial showed that aficamten, a novel cardiac myosin inhibitor, improved outcomes for patients with symptomatic obstructive HCM. The full results from SEQUOIA-HCM will be presented at an upcoming medical conference in 2024.
Aficamten, when added to standard care, led to a “clinically meaningful” increase in exercise capacity after 24 weeks of treatment, indicated by a significant rise in peak oxygen uptake during cardiopulmonary exercise testing (least square mean difference 1.74 mL/kg/min). The company reported that the results were consistent across all prespecified subgroups.
Aficamten improved all 10 prespecified secondary endpoints, which included assessments of heart failure symptoms, changes in provoked left ventricular outflow tract (LVOT) gradients, NYHA functional class, guideline eligibility for septal reduction therapy, and exercise workload.
The therapy was found to be well-tolerated, with a rate of treatment-emergent serious adverse events of 5.6% in the aficamten arm and 9.3% in the placebo arm. The proportion of patients who developed an LVEF of less than 50% was 3.5% with aficamten and 0.7% with placebo, although the researchers did not observe any cases of worsening heart failure and no treatment interruptions due to low LVEF, Cytokinetics said.
“The results from SEQUOIA-HCM meet our high expectations for both safety and efficacy, demonstrating that aficamten added to standard of care therapy had a positive impact on exercise capacity as well as rapid and sustained effects on symptoms and functional class in patients with obstructive HCM while maintaining tolerability and safety that we have previously observed,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development.
“We believe these results are consistent with those observed in REDWOOD-HCM, the Phase 2 clinical trial of aficamten, and FOREST-HCM, the ongoing open-label extension clinical trial, and may reflect a profile enabling of aficamten to become the cardiac myosin inhibitor of choice among physicians and patients.”
Cytokinetics aims to make aficamten, the second cardiac myosin inhibitor on the market. The first, mavacamten (Camzyos; Bristol Myers Squibb), for patients with symptomatic obstructive HCM, was approved by the FDA in April 2022. Aficamten has been designated a breakthrough therapy by the US Food and Drug Administration and the National Medical Products Administration in China.
The SEQUOIA-HCM trial included 282 patients who had symptomatic HCM and LVOT obstruction. Previously, in the REDWOOD-HCM Open Label Extension study, the drug was shown to reduce LVOT gradients improve patient-measured health status and relieve heart failure symptoms.
Aficamten is also being assessed in two other ongoing phase III trials—MAPLE-HCM in patients with obstructive HCM (compared with metoprolol) and ACACIA-HCM in patients with symptomatic nonobstructive HCM.
“Cardiac myosin inhibition represents an exciting new therapy option for patients with symptomatic obstructive HCM,” said Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center, Burlington, MA; Tufts University School of Medicine, and National Principal Investigator of SEQUOIA-HCM.
“A therapy like aficamten that improves exercise capacity in a clinically meaningful manner, absent low LVEF events that interrupt treatment, should be a welcome addition for HCM patients and the clinicians who treat them.”

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Nirsevimab effective in preventing hospitalization for RSV associated lower RTI in infants

Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infection in young children and infants, leading to hospitalization.

According to a study published in the New England Journal of Medicine, Nirsevimab protected infants against hospitalization for RSV-related lower respiratory infections in conditions that approximated real-world settings.

The aim of the study was to establish safety and efficacy of nirsevimab (monoclonal antibody) in preventing hospitalizations for RSV-related lower respiratory tract infections in healthy infants.

Researchers randomly assigned 12-month-old infants or younger, born at least 29 weeks gestational age and entering their first RSV season in France, Germany, or the UK, to receive a single intramuscular injection of nirsevimab or standard care before or during the RSV season.

The primary endpoint was hospitalization for RSV-associated lower respiratory tract infection. The secondary endpoint was a very severe RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen.

Key points from the study are:

  • A total of 8058 infants were randomly assigned: 4037 in Nirsevimab and 4021 in the care group.
  • Eleven infants and 60 infants in the nirsevimab and standard-care group were hospitalized for RSV-associated lower respiratory tract infection. This corresponded to a nirsevimab efficacy of 83.2%.
  • Very severe RSV-associated lower respiratory tract infection occurred in 5 infants in the nirsevimab group, representing its efficacy as 75.7 %.
  • The efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infections in France, Germany, and the UK was 89.6%, 74.2%, and 83.4%, respectively.
  • 86 infants in the nirsevimab group experienced adverse events.

Study limitations include short study duration and trial design.

They found Nirsevimab to be protective against hospitalization for RSV-associated lower respiratory tract infections and against very severe RSV-associated lower respiratory tract infections in infants.

Sanofi and AstraZeneca funded the study.

Reference:

Simon B. Drysdale et al. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. (n.d.). N Engl J Med 2023; 389:2425-2435

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