Study reveals long-term asthma control with tezepelumab beyond treatment cessation

UK: In a significant stride forward in asthma treatment research, the extended follow-up from the 2-year DESTINATION study sheds light on the dynamics of biomarkers and clinical outcomes following the cessation of tezepelumab, a novel biologic therapy. The findings offer valuable insights into the long-term effects of tezepelumab discontinuation on asthma control and inflammatory biomarkers.

“Our analysis demonstrates the benefits of continued tezepelumab treatment in managing patients with severe, uncontrolled asthma, compared with stopping treatment after two years,” the researchers stated in Annals of Allergy, Asthma & Immunology. Tezepelumab for severe asthma maintained its efficacy after two years of treatment cessation.

The analysis revealed that biomarker suppression, and improved clinical outcomes achieved during two years of treatment with tezepelumab did not rebound but gradually waned after cessation of tezepelumab treatment in patients with severe, uncontrolled asthma. During the 40-week follow-up period after treatment cessation, none of the outcomes assessed returned to baseline levels. 

The DESTINATION study, a landmark trial in asthma management, evaluated the efficacy and safety of tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in patients with severe, uncontrolled asthma. It found that long-term tezepelumab treatment resulted in reduced asthma exacerbations, reduced biomarker levels, and improved lung function and symptom control in patients with severe, uncontrolled asthma.

Building upon the initial findings, in the extended follow-up, Christopher E. Brightling, University of Leicester, Leicester, UK, and colleagues explored the time course of changes in biomarkers and clinical manifestations following treatment cessation after two years of tezepelumab treatment.

DESTINATION was a two-year, phase 3, multicenter, randomized, placebo-controlled, double-blind study of tezepelumab treatment in severe asthma patients (12–80 years old). Patients received their last treatment doses at week 100 and could enroll in an extended follow-up (EFU) period from week 104 to 140.

Change over time in clinical outcomes and key biomarkers were assessed in tezepelumab versus placebo recipients for 40 weeks after stopping treatment. Of 569 patients enrolled in the EFU period, the analysis included 426 patients (289 received tezepelumab and 137 placebo).

The researchers reported the following findings:

  • Over the 40 weeks after the last tezepelumab dose, there was a gradual increase from weeks 4–10 in blood eosinophil counts (BEC), fractional exhaled nitric oxide (FeNO) levels and Asthma Control Questionnaire-6 scores, with gradual reduction in pre-bronchodilator forced expiratory volume in 1 second such that BECs, FeNO levels and clinical outcomes returned to placebo levels; however, none of these outcomes returned to baseline levels.
  • Total immunoglobulin E levels increased from week 28 and remained well below placebo and baseline levels during the 40 weeks after the last tezepelumab dose.

“The overall results of this analysis demonstrate the benefits of continuation of tezepelumab treatment in the management of asthma in patients with severe, uncontrolled asthma, compared with stopping treatment after 2 years,” the study stated.

In conclusion, the extended follow-up from the DESTINATION study provides valuable insights into the long-term effects of tezepelumab cessation on biomarkers and clinical outcomes in patients with severe asthma. These findings hold promise for the development of targeted therapies and personalized treatment approaches, ultimately improving the lives of individuals living with this chronic respiratory condition.

Reference:

Brightling CE, Caminati M, Llanos JP, Caveney S, Kotalik A, Griffiths JM, Lundahl A, Israel E, Pavord ID, Wechsler ME, Porsbjerg C, Corren J, Gołąbek M, Martin N, Ponnarambil S. Biomarkers and clinical outcomes after tezepelumab cessation: extended follow-up from the 2-year DESTINATION study. Ann Allergy Asthma Immunol. 2024 Apr 30:S1081-1206(24)00280-1. doi: 10.1016/j.anai.2024.04.031. Epub ahead of print. PMID: 38697286.

Powered by WPeMatico

Renal Pelvis Urine Density Linked to Severe Infections in Post-Lithotripsy Patients: Study

China: In a groundbreaking multi-center prospective study, researchers have unearthed a crucial association between renal pelvis urine density and the peril of severe infectious complications in patients with symptom-free hydronephrosis following shock wave lithotripsy (SWL). The findings, which have significant implications for post-lithotripsy patient care, were published in the latest edition of the renowned medical journal Urolithiasis.

The study revealed a positive linear association between Hounsfield units (HU) in renal pelvis urine and the risk of severe infectious complications in patients with ureteral stones and symptom-free hydronephrosis after SWL, irrespective of gender, age, BMI, stone location, stone size, and hydronephrosis grade. The findings might be helpful in the SWL treatment decision-making process.

“There was a linear association between higher HU values and increased infection risk, & a cut-off value of 12.0 HU was determined, providing 85.94% specificity and 78.59% sensitivity,” the researchers reported.

Shock wave lithotripsy, a commonly employed non-invasive procedure for kidney stone removal, has revolutionized urological practice over the past few decades. However, despite its effectiveness, certain patients develop symptom-free hydronephrosis post-SWL, posing a clinical conundrum regarding optimal management strategies and risk assessment for potential complications. So, finding easy-to-obtain and reliable predictors of severe infectious complications after shock wave lithotripsy is a major clinical need, particularly in symptom-free hydronephrosis.

Zhenhua Li, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of China, and colleagues aimed to prospectively investigate the predictive value of Hounsfield units in renal pelvis urine for the risk of severe infectious complications in patients with ureteral stones and symptom-free hydronephrosis after SWL.

For this purpose, the researchers conducted a multi-center prospective study from June 2020 to December 2023. The HU of renal pelvis urine was measured by non-enhanced computed tomography. The severe infectious complications included septic shock, sepsis, and systemic inflammatory response syndrome. Finally, the researchers enrolled 1,436 patients with ureteral stones.

The researchers reported the following findings:

  • 8.9% of patients experienced severe infectious complications after SWL treatment.
  • After adjusting confounding variables, compared with the patients in the lowest renal pelvis urine density quartile, the OR for the highest quartile was 32.36.
  • There was a positive linear association between the HU value of renal pelvis urine and the risk of severe infectious complications after SWL.
  • This association was also seen stratified by age, gender, BMI, stone size, stone location and hydronephrosis grade.
  • The nonlinear association employed by restricted cubic splines is not statistically significant.
  • The AUROC and 95%CI of renal pelvis urine density were 0.895.
  • The cut-off value was 12.0 HU with 78.59% sensitivity and 85.94% specificity.

“The findings underscored the potential of renal pelvis urine density, measured in HU, as a reliable predictor for infectious complications post-SWL in patients with ureteral stones and symptom-free hydronephrosis,” the researchers wrote.

Reference:

Liu, D., Liu, J., Li, Z. et al. The association between renal pelvis urine density and the risk of severe infectious complications in patient with symptom-free hydronephrosis after shock wave lithotripsy: a multi-center prospective study. Urolithiasis 52, 72 (2024). https://doi.org/10.1007/s00240-024-01572-5

Powered by WPeMatico

Cytisinicline can help people quit vaping, shows JAMA study

Eleven million U.S. adults use e-cigarettes to vape nicotine, and about half of them say that they want to stop, but many have trouble doing so because nicotine is an addictive drug.

A plant-based medication called cytisinicline may be an effective therapy to help them stop vaping, according to the results of a new clinical trial co-led by an investigator from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system. The trial’s findings are published in JAMA Internal Medicine.

In the double-blind randomized clinical trial, 160 adults who vaped nicotine but did not currently smoke cigarettes were assigned to take either oral cytisinicline or placebo tablets for 12 weeks. All participants had weekly behavioral support to stop vaping.

At the end of treatment, participants receiving cytisinicline were more than twice as likely as those receiving placebo to have successfully abstained from vaping for weeks 9 to 12 (31.8% vs 15.1%, p=.04). The drug was well tolerated, with comparable rates of side effects between the groups. The study was conducted at Massachusetts General Hospital and 4 other sites.

“No medication has been approved by the FDA for vaping cessation in the United States,” said lead author Nancy A. Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center and a professor of medicine at Harvard Medical School. “Our study indicates that cytisinicline might be an option to fill this gap and help adult vapers to stop using e-cigarettes.”

The team tested cytisinicline for vaping because the drug binds to nicotine receptors on brain cells. In their previous clinical trial, the research team found that cytisinicline helped people to quit smoking traditional cigarettes. They hypothesized that it might also help people to stop vaping nicotine. “The results of our study need to be confirmed in a larger trial with longer follow-up,” said Rigotti, “but they are promising.”

Reference:

Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. Published online May 06, 2024. doi:10.1001/jamainternmed.2024.1313.

Powered by WPeMatico

Mindfulness training enhances opioid addiction treatment: JAMA

Supplementing standard opioid addiction treatment with Mindfulness Oriented Recovery Enhancement (MORE)-an intervention that incorporates mindfulness training, savoring skills, and cognitive reappraisal-cuts program dropout rates by 59 percent and relapses by 42 percent, according to Rutgers-led research.

These trial results come from Rutgers Health amid unprecedented opioid abuse. An estimated 10 million Americans misuse opioids or have opioid use disorder, while annual overdose deaths have exceeded 80,000.

Treatment with methadone or buprenorphine-alone or in combination with cognitive behavioral therapy-is imperfect. Half of all people drop out of treatment within a year, and half of all people who continue treatment keep using opioids.

“Better treatment protocols could save thousands of lives per year, and the data we have from our pilot study and this phase II trial suggest mindfulness training may create a genuinely better treatment protocol,” said Nina Cooperman, an associate professor of psychiatry at Rutgers Robert Wood Johnson Medical School and first author of the study published in JAMA Psychiatry.

Mindfulness training teaches people to focus on the present moment, without judgment, and on sensory inputs such as the feeling of breathing in and out. Previous studies demonstrating that such training can prevent addiction to opioid pain medication led Cooperman’s team to ask whether similar techniques could help people who already have an opioid use disorder.

A small pilot study found that mindfulness training combined with methadone treatment produced good outcomes. The pilot’s success paved the way for this larger study, which, in turn, has justified two large-scale studies that could change standards of care.

The current trial provided eight two-hour sessions to 77 of 154 patients in methadone treatment for opioid use disorder.

“Opioid use disorder changes your brain so that opioid use becomes the only thing that feels rewarding. MORE helps people retrain themselves to find healthy experiences rewarding again by focusing mindfully on the taste of a meal, the beauty of a landscape or the smell of a flower,” said Cooperman, who added the program literally includes observing and smelling roses during sessions.

Mindfulness training also gives people another tool for handling cravings.

“Cognitive behavioral therapy, which is common in treatment programs, teaches people to reframe their thoughts and distract themselves from cravings,” Cooperman said. “Mindfulness training teaches them to stay present with the craving and notice that they pass. Both strategies can work, so both are valuable.”

The success of mindfulness training in Cooperman’s study may stem from its ability to help patients manage pain. Most patients began the study with significant chronic pain-and, thus, a strong incentive to use pain-killing opioids-but patients who received MORE reported a 10 percent reduction in pain over the 16 weeks of the study.

Looking forward, Cooperman and her team are working on larger studies, which are designed to provide further evidence for the efficacy of MORE and to optimize protocols for use in the real world.

“We still have lots of open questions. How can we train clinicians to implement MORE in treatment programs? What is the best structure for implementing MORE-in-person or virtual? Our current research is working to answer some of these questions,” Cooperman said. “The findings from this study suggest MORE really can improve outcomes for a lot of people in substance abuse treatment.”

Reference:

Cooperman NA, Lu S, Hanley AW, et al. Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2024;81(4):338–346. doi:10.1001/jamapsychiatry.2023.5138.

Powered by WPeMatico

High-frequency ultrasound noninvasive tool for detecting peri-implant mucositis and PI disease progression: Study

High-frequency ultrasound noninvasive tool for detecting peri-implant mucositis and PI disease progression suggests a study published in the Journal of Clinical Periodontology.

A study was done to apply high-frequency ultrasound (HFUS) echo intensity for characterizing peri-implant tissues at healthy and diseased sites and to investigate the possible ultrasonographic markers of health versus disease. Sixty patients presenting 60 implants diagnosed as healthy (N = 30) and peri-implantitis (N = 30) were assessed with HFUS. HFUS scans were imported into a software where first-order greyscale outcomes [i.e., mean echo intensity (EI)] and second-order greyscale outcomes were assessed. Other ultrasonographic outcomes of interest involved the vertical extension of the hypoechoic supracrestal area (HSA), soft-tissue area (STA) and buccal bone dehiscence (BBD), among others. Results: HFUS EI mean values obtained from peri-implant soft tissue at healthy and diseased sites were 122.9 ± 19.7 and 107.9 ± 24.7 grey levels (GL); p = .02, respectively. All the diseased sites showed the appearance of an HSA that was not present in healthy implants (area under the curve = 1). The proportion of HSA/STA was 37.9% ± 14.8%. Regression analysis showed that EI of the peri-implant soft tissue was significantly different between healthy and peri-implantitis sites. HFUS EI characterization of peri-implant tissues shows a significant difference between healthy and diseased sites. HFUS EI and the presence/absence of an HSA may be valid diagnostic ultrasonographic markers to discriminate peri-implant health status.

Reference:

Galarraga-Vinueza, M. E., Barootchi, S., Mancini, L., Sabri, H., Schwarz, F., Gallucci, G. O., & Tavelli, L. (2024). Echo-intensity characterization at implant sites and novel diagnostic ultrasonographic markers for peri-implantitis. Journal of Clinical Periodontology, 1–12. https://doi.org/10.1111/jcpe.13976

Keywords:

High-frequency, ultrasound, noninvasive, tool, detecting, peri-implant, mucositis, PI disease progression, study, Journal of Clinical Periodontology, Galarraga-Vinueza, M. E., Barootchi, S., Mancini, L., Sabri, H., Schwarz, F., Gallucci, G. O., & Tavelli, L.

Powered by WPeMatico

Microarray patches safe and effective for vaccinating children: Lancet

The phase 1/2 randomized trial compared results from the measles and rubella vaccine delivered by a microarray patch, a small sticking plaster-like device with an array of microscopic projections that painlessly penetrate the skin and deliver the vaccine, or by conventional injection with a needle and syringe.

The trial, which involved 45 adults (18-40 years old), 120 toddlers (15-18 months old) and 120 infants (9-10 months old) in The Gambia, found giving the measles and rubella vaccine by a microarray patch induced an immune response that was as strong as the response when the vaccine was given by conventional injection.

Over 90% of infants were protected from measles and all infants were protected from rubella following a single dose of the vaccine given by the microarray patch. The measles and rubella vaccine used in the study has been given to many millions of children globally by conventional injection and is known to provide reliable protection.

The trial found no safety concerns with delivering the measles and rubella vaccine using a microarray patch.

The trial was led by researchers from the Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene & Tropical Medicine (LSHTM) and supported by the US Centers for Disease Control and Prevention. The patch was developed and manufactured by Micron Biomedical Inc, who sponsored and supported all aspects of the trial. Funding came from the Bill & Melinda Gates Foundation. Results are published in The Lancet.

The researchers hope microarray patches could help to achieve the very high levels of population immunity required to control childhood diseases such as measles and rubella, with WHO recommending at least 95% two-dose measles vaccine coverage and rubella requiring 80% population immunity. Microarray patches have been determined to be the highest priority innovation for overcoming barriers to immunization in low-resource settings.

In low-resource settings microarray patches have several advantages over conventional vaccination technologies. They promise to be easier to transport and to eliminate, or vastly reduce, the need for cold storage (refrigeration) of vaccines, both major barriers to reaching remote areas across sub-Saharan Africa. Microarray patches also do not need to be administered by a medical professional and it is expected that volunteers would be able to give the vaccines after only brief training. Unlike conventional needles and syringes, the microarray patches do not risk ‘needlestick’ injuries which can transmit infections such as hepatitis and HIV.

In countries, such as the UK, which have well-resourced childhood vaccination programmes, but which have also experienced rapid increases in measles cases recently due to low immunization coverage, microarray patches could offer greater convenience and a pain-free alternative to conventional injections. The hope is that offering vaccinations in a patch could encourage more parents, particularly those in disadvantaged areas, to get their child vaccinated.

Professor Ed Clarke, a paediatrician who leads the Vaccines and Immunity Theme at MRC Unit The Gambia at LSHTM and co-author, said: “Although it’s early days, these are extremely promising results which have generated a lot of excitement. They demonstrate for the first time that vaccines can be safely and effectively given to babies and young children using microarray patch technology. Measles vaccines are the highest priority for delivery using this approach but the delivery of other vaccines using microarray patches is also now realistic. Watch this space.”

Dr Ikechukwu Adigweme, from the Vaccines and Immunity Theme at MRC Unit The Gambia at LSHTM and co-author, said: “The positive results from this study are quite gratifying to us as a team. We hope this is an important step in the march towards greater vaccine equity among disadvantaged populations.”

The trial had several limitations. As it was the first trial to use microarray patches to deliver vaccine to children it had a small sample size and selected healthy adults, toddlers and infants. The researchers say larger trials of microarray patches are now being planned with broadly representative groups of children and infants to inform decisions about whether to recommend the patches for widespread use in childhood vaccination programmes.

Reference:

Ikechukwu Adigweme, Mohammed Yisa, Michael Ooko, Edem Akpalu, Andrew Bruce, A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial, The Lancet, https://doi.org/10.1016/S0140-6736(24)00532-4.

Powered by WPeMatico

Frail elderly patients undergoing risky surgery more prone to Complications and mortality, finds study

Frailty is a well-established predictor of complications and death after surgery. However, patients over 65 who undergo a high-risk operation in the emergency room are at significantly increased risk of postoperative complications and death in comparison to the same patients who are assessed solely on their level of frailty, according to a study published in the Journal of the American College of Surgeons (JACS).

In the United States, the elderly population is expected to double within the next 35 years. Emergency surgery for this population is challenging surgeons to consider more factors in decision making and plan for the most appropriate postoperative recovery.

“We are seeing a lot more elderly patients in the emergency department with acute surgical problems that require a major operation. And the outcomes for these individuals, compared to younger patients, are much worse,” said study co-author Raul Coimbra, MD, PhD, FACS, surgeon-in-chief of the Riverside University Health System in Moreno Valley, and a professor of surgery at Loma Linda University School of Medicine, both in California. “We need to counsel patients and their families about all the risks they are incurring when patients undergo a major emergency operation and be transparent about what to expect afterwards. Sometimes, the family believes the patient will return home. But in fact, a significant number of patients who have major surgery end up in nursing homes or rehab facilities and never go home.”

The researchers hypothesized that for the elderly population, the level of procedure risk (high or low) has a stronger impact on adverse outcomes when measured alongside frailty, compared with frailty status alone. Using the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), researchers examined the records of elderly patients (over age 65) who had undergone an emergency surgical procedure between 2018 and 2020. ACS NSQIP is the leading nationally validated, risk-adjusted, outcomes-based program to measure and improve the quality of surgical care in hospitals.

For the analysis, patients were classified as not frail, frail, and severely frail and then grouped according to procedure risk level — low-risk operations and high-risk operations. High-risk procedures included open cholecystectomy, open colectomy, laparoscopic colectomy, small bowel resection, and perforated ulcer repair. Low-risk procedures included appendectomies and cholecystectomies.

They then evaluated five outcomes-30-day mortality, 30-day postoperative complications, failure to rescue, hospital readmission, and 30-day reoperation. The purpose was to identify the impact of surgical procedure type on outcomes among elderly patients.

Key Findings

  • Of the study’s 59,633 elderly patient sample, 29.3% were classified as non-frail, 66.4% as frail, and 4.3% as severely frail.
  • Of those patients, 25,157 were in the low-risk procedure group and 34,476 in the high-risk procedure group.
  • Frailty and procedure risk were both associated with increased risk of mortality, postoperative complications, failure to rescue, and readmissions. However, when patients were grouped according to procedure risk versus frailty alone, procedure risk proved to be a stronger link to adverse outcomes.
  • For example, non-frail patients undergoing high-risk emergency surgical procedures had a 7.1% mortality rate, while the mortality rate of low-risk procedures was 0.2%. In contrast, frail and severely frail patients undergoing high-risk procedures had mortality rates of 11.5% and 25.8%, whereas mortality rates after low-risk procedures were 1.0% and 4.1%, respectively.
  • Among non-frail patients, high-risk procedures accounted for a 4-fold increase in surgical complications compared to low-risk procedures. Similarly, high-risk procedures also accounted for a 4-fold increase in surgical complications among frail and severely frail patients.
  • The difference between high-risk and low-risk procedures was at least four times greater in every outcome measure compared to frailty status alone. For instance, undergoing a high-risk procedure led to an 8-fold increase in 30-day mortality. In contrast, being severely frail resulted in a 3-fold increase in death within 30 days.

“What we also learned in this study is that a very significant number of elderly patients are coming to the emergency room for a major operation, urgently. And the reason is because elderly patients may not seek surgical care early on, and surgeons often shy away from solving the problems electively,” Dr. Coimbra said. “The problem is that diseases don’t disappear. They stay and progress and advance until these patients end up in the emergency department requiring an emergency operation.”

For elderly patients, putting off minor surgery may be detrimental to their long-term health and quality of life. The study authors hope these results will help shape new thinking about treating elderly patients earlier and about having more informed discussions with patients and their families about what to expect following emergency general surgery.

“The message from our study is that elderly patients should undergo surgical treatment when they first present with their disease. It should not be put off until complications develop to the point where an emergency operation is needed. Because that emergency operation is the most significant risk for mortality and complications,” he adds.

A major limitation of the study is that it is a retrospective study. Another limitation is that frailty is classified retrospectively. A more standardized description of frailty might have impacted the study’s findings.

Reference:

Zakhary, Bishoy BA, MPHa; Coimbra, Bruno C BSa,b; Kwon, Junsik MDa,c; Allison-Aipa, Timothy PhDa; Firek, Matthew BSa; Coimbra, Raul MD, PhD, FACSa,d,e. Procedure Risk vs Frailty in Outcomes for Elderly Emergency General Surgery Patients: Results of a National Analysis. Journal of the American College of Surgeons ():10.1097/XCS.0000000000001079, April 25, 2024. | DOI: 10.1097/XCS.0000000000001079.

Powered by WPeMatico

Optimal Pain Management Strategy Unveiled in Total Hip Arthroplasty Study

In a significant stride towards refining postoperative pain management
strategies following total hip arthroplasty, the RECIPE trial has shed light on
an innovative drug combination that showcases promise in reducing morphine
consumption and minimizing adverse events. The trial concluded that for adults
undergoing total hip arthroplasty, the combination of paracetamol, ibuprofen,
and dexamethasone proved to be the most effective in reducing morphine
consumption within the first 24 hours after surgery.

The trial results were published in the journal The Lancet Rheumatology.

Also Read: Robotic-assisted surgery and navigation do not alter the risk of PJI after total hip replacement surgery

Total hip arthroplasty often necessitates multimodal postoperative
analgesia, yet the optimal drug combination has remained uncertain. Hence
researchers conducted a randomized, blinded, and placebo-controlled trial at
nine Danish hospitals to investigate the relative benefits and potential harm
associated with different combinations of paracetamol, ibuprofen, and the
analgesic adjuvant dexamethasone in treating postoperative pain.


The Recipe trial was carried out between March 5, 2020, and Nov 15, 2022,
and a total of 1060 participants were enrolled in the trial. Adults scheduled
for total hip arthroplasty were randomly assigned to receive various
combinations of oral paracetamol 1000mg every 6h, oral ibuprofen 400 mg every 6
h, and a single dose of intravenous dexamethasone 24 mg. The primary outcome assessed was 24-hour intravenous morphine
consumption, with a predefined minimal important difference of 8 mg.


Findings:

  • The results, encompassing a modified intention-to-treat population of
    1043 participants, unveiled intriguing findings.

  • The combination of paracetamol, ibuprofen, and dexamethasone demonstrated
    the lowest 24-hour morphine consumption following surgery.

  • Although the differences did not reach the predefined minimal important
    threshold of 8 mg, the paracetamol plus ibuprofen plus dexamethasone group
    exhibited a significant reduction in morphine consumption compared to other
    combinations.


  • Moreover, the safety profile of this innovative drug combination proved
    to be highly favorable.

    Adverse events were reported in 35% of participants in the paracetamol
    plus ibuprofen plus dexamethasone group, showcasing a lower incidence compared
    to 38% in the ibuprofen plus dexamethasone group, 39% in the paracetamol plus
    dexamethasone group, and a higher incidence of 63% in the paracetamol plus
    ibuprofen group.


  • The adverse events primarily included differences in nausea, vomiting,
    and dizziness.
Also Read: High preoperative blood sugar may increase risk of periprosthetic joint infection after THA


This novel approach to postoperative analgesia holds promise in
revolutionizing pain management strategies for total hip arthroplasty patients.
The combination of paracetamol, ibuprofen, and dexamethasone not only
demonstrated efficacy in reducing morphine consumption but also exhibited a
safer adverse event profile, marking a significant advancement in optimizing
patient care.

As the medical community continues to
explore innovative solutions for postoperative pain relief, the RECIPE trial’s
findings provide a valuable contribution to the ongoing discourse, offering a
potential paradigm shift in enhancing the recovery experience for individuals
undergoing total hip arthroplasty.Top
of Form

Further reading: Steiness J, Hägi-Pedersen D, Lunn TH, et al. Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial. BMJ Open. 2022;12(9):e058965. Published 2022 Sep 1. doi:10.1136/bmjopen-2021-058965

Powered by WPeMatico

Rajasthan’s 2nd year MBBS student booked for impersonating in NEET 2024 exam

Mumbai- A 2nd-year MBBS student has been booked for posing as another student during the National Eligibility Entrance Test (NEET UG) 2024 exam. The student was caught after the biometrics did not match with the original student’s Aadhaar card.

After being exposed, the student was booked by the CBD Belapur police on the very day of the examination.

During the investigation, police found out that the 20-year-old girl was a second-year medical student pursuing an MBBS course from a medical college in Rajasthan. 

Also Read: Social media posts claiming NEET 2024 Paper Leak ‘Completely Baseless’: NTA issues clarification

The incident took place at DY Patil College in CBD Belapur, Navi Mumbai which was one of the centres for the NEET UG 2024 exam. The NEET UG 2024 exam was conducted on Sunday, May 5, 2024, from 2 pm to 5 pm, therefore before the exam began after the college conducted frisking and biometric testing of the students. During the testing, one of the student’s biometrics and the adhaar card were found mismatched.

Then, the supervisor informed college administrator Dr Debjani Dasgupta about the mismatch. In a bid to prevent chaos, the administrator ordered the supervisor to allow the student to appear in the examination and also to keep a watch on the student during the exam.

After the exam was over, the student was asked to check the biometrics once again but still it was mismatched. After this, the administrator informed the police about the incident and then the police reached the college for investigation. Police then registered a case under sections of the IPC and the Maharashtra Prevention of Malpractices Act, University, Board and Other Specified Examinations Act, 1982.

Also Read: Incorrect distribution of NEET 2024 question paper, NTA allows 120 aspirants to reappear in exam, denies ‘paper-leak’ claims

Speaking to the HT, a police officer from CBD Belapur police station said “When confronted, the dummy student confessed, revealing that her father had lost his job, and they were in desperate need of money, which led her to agree to participate in the deception. We are investigating further to find the money involved in the deal and if she has done this before. Presently, the case is registered against the student who posed as the dummy. However, we intend to pursue charges against the original student as well”.

Meanwhile, the dummy student has been served a notice as per CrPC.

Also Read:MBBS student Booked for allegedly hurling abuses at Doon Hospital’s HoD Gynaecology over attendance issue

Powered by WPeMatico

Biological E Gets CDSCO Panel Nod for Continued Safety study of 14-valent pneumococcal polysaccharide conjugate vaccine

New Delhi: The drug major Biological E has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDCSO) to conduct the Phase IV clinical study of the 14-valent pneumococcal polysaccharide conjugate vaccine (Adsorbed).

This came after Biological E presented the Phase IV clinical trial protocol titled “A Phase IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3+0) primary PCV vaccination as part of BECT051 and BECT061 studies”.

Pneumococcal polysaccharide vaccine can prevent pneumococcal disease. Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, which is an infection of the lungs.

Biological E’s PCV14 contains 14 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). Biological E’s PCV14 contains the largest number of serotypes in India and offers expanded protection against two new serotypes 22F and 33F. These new serotypes have been reported recently to be causing infections.

At the recent SEC meeting for vaccines held on 30th April 2024, the expert panel reviewed the Phase IV clinical trial protocol titled “A Phase IV multicentre follow-up study to assess the continued safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine in subjects, who received 3-dose (3+0) primary PCV vaccination as part of BECT051 and BECT061 studies”.
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase IV clinical trial as presented protocol.

Also Read:Justify Rationality of FDC Meropenem plus Sodium Carbonate plus Avibactam: CDSCO Panel Tells Akum Pharmaceutical

Powered by WPeMatico