Increased hospitalization rate observed in COVID patients with cannabis use, reveals JAMA study

A recent study published in the Journal of American Medical Association raised questions about the potential health risks associated with cannabis use in COVID-19 patients which highlights the complexity of this relationship when other factors are considered. The research determined whether cannabis and tobacco use are linked to adverse health outcomes from COVID-19 that accounts for other known risk factors.

This retrospective cohort study in the Midwest US analyzed electronic health record data from February 1, 2020 to January 31, 2022. The study included a total of 72,501 patients who had COVID-19 during at least one medical visit. The research examined the association between substance use (specifically cannabis and tobacco) and the severity of COVID-19 outcomes such as hospitalization, intensive care unit (ICU) admission and all-cause mortality.

The participants in the study had a mean age of 48.9 years, with 59.7% being female. Among the participants, 13.4% were current smokers, 24.4% were former smokers and 9.7% were current cannabis users. The study also documented current cannabis use and tobacco smoking as reported in medical encounters.

The findings revealed that current tobacco smoking was significantly associated with an increased risk of hospitalization, ICU admission, and all-cause mortality in COVID-19 patients, even after adjusting for various factors such as comorbidities and vaccination status. Also, the odds of hospitalization were 1.72 times higher for current smokers, ICU admission was 1.22 times more likely and the risk of all-cause mortality was 1.37 times greater when compared to non-smokers.

While current cannabis users showed a significantly higher risk of hospitalization and ICU admission, this study did not find a significant association between cannabis use and all-cause mortality. The odds of hospitalization for cannabis users were 1.80 times higher, and the odds of ICU admission were 1.27 times higher, but the odds of all-cause mortality did not increase significantly.

The results of this study suggest that cannabis use might be an independent risk factor for COVID-19 complications, separate from the effects of cigarette smoking and other risk factors such as vaccination status, comorbidities and demographics. Yet, the lack of a significant link between cannabis use and mortality underlines the need for further research to fully understand the implications. Overall, the study illuminates the importance of comprehensive risk assessments that account for various factors, including substance use, to better foresee and manage the health outcomes of COVID-19 patients.

Reference:

Griffith, N. B., Baker, T. B., Heiden, B. T., Smock, N., Pham, G., Chen, J., Yu, J., Reddy, J., Lai, A. M., Hogue, E., Bierut, L. J., & Chen, L.-S. (2024). Cannabis, Tobacco Use, and COVID-19 Outcomes. In JAMA Network Open (Vol. 7, Issue 6, p. e2417977). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2024.17977

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Energy drinks tied to risk of life-threatening cardiac arrhythmias among genetic heart diseases patients: Study

Consumption of energy drinks linked to risk of life-threatening cardiac arrhythmias among patients with underlying genetic heart diseases suggests a study published in the Heart Rhythm.

Energy drinks potentially can trigger life-threatening cardiac arrhythmias. It has been postulated that the highly stimulating and unregulated ingredients alter heart rate, blood pressure, cardiac contractility, and cardiac repolarization in a potentially proarrhythmic manner. The purpose of this study was to describe our experience regarding sudden cardiac arrest (SCA) occurring in proximity to energy drink consumption in patients with underlying genetic heart diseases. The electronic medical records of all SCA survivors with proven arrhythmias referred to the Mayo Clinic Windland Smith Rice Genetic Heart Rhythm Clinic for evaluation were reviewed to identify those who consumed an energy drink before their event. Patient demographics, clinical characteristics, documented energy drink consumption, and temporal relationship of energy drink consumption to SCA were obtained. Results: Among 144 SCA survivors, 7 (5%; 6 female; mean age at SCA 29 ± 8 years) experienced an unexplained SCA associated temporally with energy drink consumption. Of these individuals, 2 had long QT syndrome and 2 had catecholaminergic polymorphic ventricular tachycardia; the remaining 3 were diagnosed with idiopathic ventricular fibrillation. Three patients (43%) consumed energy drinks regularly. Six patients (86%) required a rescue shock, and 1 (14%) was resuscitated manually. All SCA survivors have quit consuming energy drinks and have been event-free since. Overall, 5% of SCA survivors experienced SCA in proximity to consuming an energy drink. Although larger cohort studies are needed to elucidate the incidence/prevalence and quantify its precise risk, it seems prudent to sound an early warning on this potential risk.

Reference:

Martinez KA, Bains S, Neves R, Giudicessi JR, Bos JM, Ackerman MJ. Sudden cardiac arrest occurring in temporal proximity to consumption of energy drinks. Heart Rhythm. 2024 Mar 16:S1547-5271(24)00189-9. doi: 10.1016/j.hrthm.2024.02.018. Epub ahead of print. PMID: 38842964.

Keywords:

Consumption, energy drinks linked, risk, life-threatening, cardiac, arrhythmias, patients, underlying, genetic heart diseases, study, Martinez KA, Bains S, Neves R, Giudicessi JR, Bos JM, Ackerman MJ, Caffeine; Catecholaminergic polymorphic ventricular tachycardia; Energy drinks; Genetic heart disease; Idiopathic ventricular fibrillation; Long QT syndrome; Sudden cardiac arrest.

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Longer Operation Time in Hip Hemiarthroplasty Increases Mortality and Complication Rates: Study

A recent study highlighted the significant impact of various factors, specially the operation time on mortality and complication rates in patients undergoing hip hemiarthroplasty (HHA) for femoral neck fractures. This research spanned between January 2017 and December 2023 and screened a total of 552 eligible cases to uncover the key determinants that affect the patient outcomes post-surgery.

The study revealed that prolonged operation time is a crucial factor which influence the patient outcomes. For every additional minute of surgery, the odds of undergoing complications increased by 2.2%. Also, an operation time exceeding 86 minutes dramatically elevated the risk of mortality by 111.8% when compared to shorter procedures. These findings highlight the necessity of efficient surgical practices to minimize risks.

During the 90-day follow-up period, the study recorded a mortality rate of 9.1% and a complication rate of 6.2%. Among the complications notied, the infections were the most common which comprised 32.3% of cases. Other complications included dislocations (14.7%), trochanteric avulsions (20.7%), periprosthetic fractures (11.8%), nerve injuries (11.8%) and deep vein thrombosis (8.8%).

Apart from operation time, several other factors were found to significantly influence patient outcomes, which were;

  • The odds of mortality increased by 8.8% for each additional year of age. This highlights the elevated vulnerability of older patients undergoing HHA.
  • Surgeries performed by certified orthopedic surgeons showed a 61.5% reduction in mortality rates when compared to the procedures performed by trainees. This suggests the importance of surgical expertise and experience in enhancing patient survival rates.
  • Male patients expressed a 168.7% higher risk of mortality when compared to female patients that indicated a gender disparity in outcomes that warrants further investigation.

The findings of this retrospective analysis illuminate the major importance of minimizing operation time during hip hemiarthroplasty to reduce the risk of complications and mortality. Also, the study highlights the need for experienced surgeons, especially for older and male patients who are at elevated risk. These insights can inform surgical best practices and enhance the patient care in orthopedic settings. Overall, the clear cut-off of 86 minutes for operation time serves as an important benchmark for surgical teams to effectively optimize procedures and ensure better patient prognoses.

Source:

Ramadanov, N., Salzmann, M., Voss, M., Hable, R., Hakam, H. T., Prill, R., Dimitrov, D., & Becker, R. (2024). The influence of operation time for hip hemiarthroplasty on complication rates and mortality in patients with femoral neck fracture: a retrospective data analysis. In Journal of Orthopaedic Surgery and Research (Vol. 19, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s13018-024-04797-7

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Simple test for flu could improve diagnosis and surveillance, finds study

Fewer than one percent of people who get the flu every year get tested, in part because most tests require trained personnel and expensive equipment. Now researchers have developed a low-cost paper strip test that could allow more patients to find out which type of flu they have and get the right treatment.

The test, developed by a team from the Broad Institute of MIT and Harvard and Princeton University, and supported by the US Centers for Disease Control and Prevention, uses CRISPR to distinguish between the two main types of seasonal flu, influenza A and B, as well as seasonal flu subtypes H1N1 and H3N2. It can also identify strains that resist antiviral treatment, and with further work, could potentially detect swine and avian flu strains, including H5N1, which is currently infecting cattle.

Appearing in The Journal of Molecular Diagnostics, the results could help improve outbreak response and clinical care by bringing tests that are accurate, low-cost, and fast to doctors’ offices and labs across the US and in other countries.

“Ultimately, we hope these tests will be as simple as rapid antigen tests, and they’ll still have the specificity and performance of a nucleic acid test that would normally be done in a laboratory setting,” said Cameron Myhrvold, co-senior author on the study along with Pardis Sabeti, an institute member at the Broad and a professor at Harvard University and the Harvard T.H. Chan School of Public Health, as well as a Howard Hughes Medical Institute investigator. Myhrvold, who is currently an assistant professor at Princeton University, was a postdoctoral researcher in Sabeti’s lab when the study began.

SHINE a light

The test is based on a technology called SHINE, which was developed by Sabeti’s lab in 2020 and uses CRISPR enzymes to identify specific sequences of viral RNA in samples. The researchers first used SHINE to test for SARS-CoV-2, and later to distinguish between the Delta and Omicron variants. Then, in 2022, they began adapting the assay to detect other viruses they knew were always circulating: influenzas. They wanted to create tests that could be used in the field or in clinics rather than hospitals or diagnostic labs with expensive equipment.

“Using a paper strip readout instead of expensive fluorescence machinery is a big advancement, not only in terms of clinical care but also for epidemiological surveillance purposes,” said Ben Zhang, co-first author on the study, a medical student at Harvard Medical School and an undergraduate researcher in Sabeti’s lab when the study began.

Typical diagnostic approaches such as polymerase chain reaction (PCR) require lengthy processing times, trained personnel, specialized equipment, and freezers to store reagents at -80°C, whereas SHINE can be conducted at room temperature in about 90 minutes. Currently, the assay only requires an inexpensive heat block to warm the reaction, and the researchers are working to streamline the process with the goal of returning results in 15 minutes.

The researchers also adapted SHINE to distinguish between different flu strains. In the future, they say the assay could be adapted to detect two different viruses with similar symptoms, such as influenza and SARS-CoV-2.

“Being able to tease apart what strain or subtype of influenza is infecting a patient has repercussions both for treating them and public health interventions,” said Jon Arizti-Sanz, a postdoctoral researcher in Sabeti’s lab and co-first author on the study.

For example, the tests could help clinicians decide whether to use Oseltamivir, a common antiviral that is effective for only some strains, Arizti-Sanz added. In the field, rapid testing could also help scientists collect samples more strategically during an outbreak to better monitor how the virus is spreading.

Next, the researchers are adapting SHINE to test for both avian and swine influenza strains. “With SARS-CoV-2 and now flu, we’ve shown that we can easily adapt SHINE to detect new or evolving viruses,” Arizti-Sanz said. “We’re excited to apply it to H5N1.”

Reference:

Yibin B. Zhang, Jon Arizti-Sanz, A’Doriann Bradley, Tinna-Solveig F. Kosoko-Thoroddsen, Pardis C. Sabeti, Cameron Myhrvold, CRISPR-Based Assays for Point-of-Need Detection and Subtyping of Influenza, Journal of Molecular Diagnostics, https://doi.org/10.1016/j.jmoldx.2024.04.004.

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Prenatal fluoride exposure associated with increased neurobehavioral problems among newborns: Study

Mother-child pairs in Los Angeles, California, prenatal fluoride exposure is associated with increased neurobehavioral problems suggests a new study published in JAMA.

A study was done to examine associations of third trimester maternal urinary fluoride (MUF) with child neurobehavior at age 3 years in the US. This prospective cohort study utilized urine samples archived from 2017 to 2020 and neurobehavioral data assessed from 2020 to 2023 from the Maternal and Developmental Risks from Environmental and Social Stressors (MADRES) pregnancy cohort, which consisted of predominately Hispanic women residing in Los Angeles, California. Cohort eligibility criteria at recruitment included being 18 years of age or older, less than 30 weeks’ gestation, and a fluent English or Spanish speaker. Exclusion criteria included having a disability preventing participation or provision of informed consent, being HIV positive or incarcerated, and having a multiple gestation pregnancy. There were 263 mother-child pairs who completed the 3-year study visit. In this analysis, women who reported prenatal smoking were excluded. Data analysis was conducted from October 2022 to March 2024. Neurobehavior was quantified using the Preschool Child Behavior Checklist (CBCL), which included composite scores for Total Problems, Internalizing Problems, and Externalizing Problems. CBCL composite T scores range from 28 to 100. T scores from 60 to 63 are in the borderline clinical range, whereas scores above 63 are in the clinical range. Linear and logistic regression models adjusted for covariates were conducted. Results A total of 229 mother-child pairs (mean [SD] maternal age, 29.45 [5.67] years; 116 female children [50.7%] and 113 male children [49.3%]) who had MUFSG measured were included in the study. Median (IQR) MUFSG was 0.76 (0.51-1.19) mg/L, and 32 participants (14.0%) had a Total Problems T score in the borderline clinical or clinical range. A 1-IQR (0.68 mg/L) increase in MUFSG was associated with nearly double the odds of the Total Problems T score being in the borderline clinical or clinical range (odds ratio, 1.83; 95% CI, 1.17-2.86; P = .008), as well as with a 2.29-point increase in T score for the Internalizing Problems composite (B = 2.29; 95% CI, 0.47-4.11; P = .01) and a 2.14-point increase in T score for the Total Problems composite (B = 2.14; 95% CI, 0.29-3.98; P = .02). In this prospective cohort study of mother-child pairs in Los Angeles, California, prenatal fluoride exposure was associated with increased neurobehavioral problems. These findings suggest that there may be a need to establish recommendations for limiting fluoride exposure during the prenatal period.

Reference:

Malin AJ, Eckel SP, Hu H, et al. Maternal Urinary Fluoride and Child Neurobehavior at Age 36 Months. JAMA Netw Open. 2024;7(5):e2411987. doi:10.1001/jamanetworkopen.2024.11987

Keywords:

Malin AJ, Eckel SP, Hu H, mother-child, pairs, Los Angeles, California, prenatal fluoride, exposure, associated, increased, neurobehavioral problems

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Lumateperone as adjunct significantly reduces depression symptoms in patients with major depressive disorder phase 3 trial shows

Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This trial, in conjunction with our previously reported positive Phase 3 study, Study 501, forms the basis for our lumateperone sNDA for the adjunctive treatment of MDD. We expect to submit this sNDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024.

“We are confident that the efficacy results from Studies 501 and 502, along with the favorable safety and tolerability profiles from these studies, will make lumateperone a drug of choice for patients suffering with MDD who are having an inadequate response to antidepressant therapy,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We are very pleased with the robust efficacy results from Study 502 which are consistent with the compelling results from Study 501. These results, further support our vision for CAPLYTA to become a leading option for patients and providers across mood disorders.”

Lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint in Study 502 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6. In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 10.2 points for placebo (LS mean difference = -4.5 points; p<0.0001; ES= 0.56). Numerical improvement versus placebo on the MADRS total score was seen as early as Week 1 (p=0.0504) and statistically significant separation starting at Week 2 and maintained throughout the study.

Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score compared to placebo at Week 6 (p<0.0001; ES= 0.51). Statistically significant separation on the CGI-S versus placebo was observed starting at Week 3 and maintained throughout the study.

In this study, lumateperone 42 mg robustly improved depressive symptoms as reported by patients as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) (p<0.0001). The QIDS-SR-16 is a 16-item patient-rated scale of symptom severity in depression. It assesses nine key symptoms of depression: insomnia/hypersomnia, low mood, appetite/weight changes, impaired self-perception, concentration difficulties, loss of interest/pleasure, suicidal ideation, psychomotor agitation and fatigue.

Lumateperone was generally safe and well-tolerated in this study. The most common adverse events (≥5% and greater than twice placebo) were dizziness, somnolence, dry mouth, nausea, diarrhea and fatigue. Adverse events were mostly mild to moderate and resolved within the course of the study. These adverse events were generally similar to those seen in prior studies of lumateperone as a treatment for MDD, bipolar depression and schizophrenia.

In this study, 480 patients were randomized (1:1) to lumateperone 42 mg plus antidepressant or placebo plus antidepressant to evaluate the efficacy and safety of lumateperone as an adjunctive treatment to antidepressants in patients with MDD. The baseline MADRS total score was 30.8 for lumateperone 42 mg and 31.5 for placebo.

“MDD is the leading cause of disability in the world, where about two-thirds of patients fail to achieve remission with first-line treatment,” said Dr. Suresh Durgam, Executive Vice President, Chief Medical Officer of Intra-Cellular Therapies. “In both pivotal registrational studies, Study 501 and Study 502, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy. The consistent efficacy, safety and tolerability profile of lumateperone has the potential to be a compelling treatment option for MDD.”

About the Lumateperone Adjunctive MDD Program

Studies 501 and 502 evaluated lumateperone 42 mg as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy.

These are both multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose studies conducted globally in patients with a primary diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who have had an inadequate response to ongoing anti-depressant therapy.

Eligible patients had a minimum MADRS total score of 24, a minimum CGI-S score of 4 and an inadequate response to one or two SSRI/SNRIs (less than 50% improvement) following monotherapy treatment for at least 6 weeks duration.

The primary endpoint results from Studies 501 and 502 are as follows:

In the pooled safety data of Studies 501 and 502, the most common adverse events (≥5% and greater than twice placebo) with lumateperone versus placebo were: dizziness (16.6% v. 5.0%), dry mouth (12.6% v. 3.3%), somnolence (12.2% v. 2.3%), nausea (8.5% v. 4.0%) and fatigue (7.2% v. 1.2%).

About Major Depressive Disorder

Major Depressive Disorder (MDD) is a common mood disorder in the U.S. affecting an estimated 21 million adults each year. MDD represents the primary cause of disability in the world. Symptoms include sadness, hopelessness, helplessness, feelings of guilt, irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior. It can cause severe functional impairment, adversely affecting interpersonal relationships, and may impact quality of life. Approximately two-thirds of patients with depression fail to achieve remission with first-line treatment.

 

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Home phototherapy as effective as office phototherapy in treating psoriasis, finds study

A recent study tested the narrowband ultraviolet B phototherapy (NB-UVB) for psoriasis at home and found it to be noninferior to office treatment, based on the outcomes that matter to patients, clinicians and payers. The findings of from the LITE study suggest that home phototherapy can be an effective first-line treatment for the patients suffering from moderate to severe psoriasis.

Phototherapy or light therapy is a treatment method which involves the exposure of skin to ultraviolet light under medical supervision. It is commonly used to manage conditions like psoriasis. The patients typically undergo phototherapy sessions either at a the office of dermatologist or at home using specialized equipment. However, many challenges can possibly hinder access to office-based phototherapy like the limited availability in certain regions, the inconvenience of frequent visits and high copayments. While home phototherapy presents an important alternative, it is less frequently covered by insurance and some clinicians hesitate to recommend it.

The Light Treatment Effectiveness (LITE) study was conducted from 2019 to 2023 to address these issues. This extensive research initiative was carried forward by the National Psoriasis Foundation (NPF), the University of Pennsylvania Perelman School of Medicine and the University of Utah, and was funded by the Patient-Centered Outcomes Research Institute (PCORI). 

The primary objective of the LITE study was to evaluate and compare the effectiveness, safety and duration of treatment response between home-based and office-based narrowband ultraviolet B (NB-UVB) phototherapy for treating plaque or guttate psoriasis. The study included a diverse range of skin types to provide insights that are applicable across different demographics.

The participants in the LITE study were individuals aged 12 and older who had been diagnosed with plaque or guttate psoriasis and were candidates for phototherapy. The study population included individuals with a wide spectrum of skin tones, from very fair to very darkly pigmented skin, ensuring comprehensive and inclusive findings.

The LITE study meticulously analyzed the outcomes of home-based phototherapy and compared against those of clinic-based treatments by focusing on their effectiveness, safety and the duration of the treatment response. Also, the study explored whether skin color influenced the effectiveness of phototherapy.

The findings found that home phototherapy was non-inferior to office-based treatments. Both methods demonstrated excellent effectiveness and safety in the real-world settings across all skin types. This suggests that home phototherapy can serve as a first-line treatment option for psoriasis for individuals with no prior experience with phototherapy.

The results of the LITE study advocate for broader access to phototherapy treatments which highlight the potential of home phototherapy to provide a convenient, effective and safe option for managing psoriasis. The outcomes of this study could influence healthcare policies by pushing for better insurance coverage and encouraging the clinicians to consider home phototherapy as a critical alternative for the psoriasis patients.

Source:

The LITE study. (n.d.). Psoriasis.org. Retrieved May 28, 2024, from https://www.psoriasis.org/lite-study/

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Inhaled Insulin Shows Promise in Enhancing Type 1 Diabetes Management: INHALE-3 Trial

USA: Results from INHALE-3, a clinical trial investigating inhaled insulin in adults with type 1 diabetes, demonstrated its safety and efficacy in improving glycemic control. These findings suggest that inhaled insulin could serve as a viable alternative to traditional insulin delivery methods, offering potential benefits for patients seeking enhanced diabetes management options. The study, presented at the American Diabetes Association (ADA) annual meeting.on June 22, highlights significant insights into using this novel insulin formulation.

Dr. Irl B. Hirsch, the Study Chair from the University of Washington School of Medicine, emphasized the study’s implications, stating, “Our findings indicate that inhaled insulin may benefit patients actively engaged in diabetes self-care, aiming to further reduce hyperglycemia or seeking an alternative to insulin pumps.”
INHALE-3, classified as a Phase 4 randomized controlled trial, enrolled around 120 participants with type 1 diabetes using various insulin delivery methods and continuous glucose monitoring. Participants were assigned to either receive a regimen of insulin degludec combined with inhaled insulin Afrezza and CGM or continue with their usual care.
The study revealed that a higher percentage of participants using the inhaled insulin regimen achieved significant improvements in A1C levels compared to those continuing with standard care. Specifically, 21 percent of the inhaled insulin group achieved an A1C improvement exceeding 0.5 percent, contrasting with only 5 percent in the standard care group.
“Crucially, among participants starting with an A1C above 7 percent, none in the standard care group achieved levels below 7 percent by the end of the study, while 21 percent in the inhaled insulin group did,” noted Dr. Hirsch.
The primary trial endpoint was assessed at 17 weeks, followed by a 13-week extension phase where both groups utilized the degludec-inhaled insulin regimen. These findings underscore the potential of inhaled insulin as a beneficial addition to diabetes management strategies, offering patients a promising alternative for achieving improved glycemic control.
Moving forward, further research and clinical evaluation will be essential to fully elucidate the long-term benefits and optimal utilization of inhaled insulin in managing type 1 diabetes.
The primary focus of the study was the change in A1C levels, with secondary endpoints including alterations in time-in-range (TIR) and hypoglycemia monitored through continuous glucose monitoring (CGM), along with patient-reported outcomes assessing satisfaction with insulin delivery.
Furthermore, the research highlighted that 19 percent of participants who transitioned from an automated insulin delivery (AID) system to a combination of inhaled insulin and degludec achieved an A1C improvement exceeding 0.5 percent. Conversely, within the inhaled insulin group, 26 percent experienced a decline in A1C greater than 0.5 percent compared to 3 percent in the standard care group, illustrating the variability in response to inhaled insulin therapy.
Dr. Irl B. Hirsch emphasized the individualized nature of insulin therapy, stating, “It’s clear that inhaled insulin isn’t universally suitable for everyone. Understanding the appropriate dosing of basal and inhaled insulin is crucial for optimizing outcomes.”
Summarizing the symposium, Dr. Thomas Blevins of Texas Diabetes and Endocrinology reflected on the study’s insights and potential implications for clinical practice. “INHALE-3 provided valuable lessons. Inhaled insulin excels in controlling postprandial spikes, offers rapid action and clearance to minimize insulin stacking, and boasts discreet and convenient administration.”
However, Dr. Blevins cautioned against its use in patients with chronic pulmonary conditions like asthma or COPD or those hypersensitive to regular insulin. He stressed the importance of baseline and regular pulmonary function tests, including spirometry, even in asymptomatic patients initiating inhaled insulin therapy.
Looking ahead, Dr. Blevins underscored the need for refined guidelines and optimal practices in utilizing inhaled insulin, highlighting the role of shared decision-making between patients and healthcare providers in determining the suitability of this therapy.
As research continues to evolve, ongoing evaluation and adaptation of protocols will be essential to maximize the benefits of inhaled insulin while ensuring patient safety and satisfaction in managing type 1 diabetes.

Reference:

Beck RW, et al “The efficacy and safety of inhaled insulin used with insulin degludec compared with automated insulin delivery or multiple daily insulin injections in adults with type 1 diabetes — Results of the INHALE-3 randomized trial” ADA 2024.

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Sun Pharma Industries Gets CDSCO Panel Nod to assess safety and efficacy of Relugolix Tablets for advanced prostate cancer

New Delhi: In order to assess the safety and efficacy of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to the drug major Sun Pharmaceutical Industries for conducting the Phase-IV clinical trial.

This came after Sun Pharmaceutical Industries presented their Phase-IV clinical trial protocol to assess the safety and efficacy of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer as per the condition of manufacture and marketing permission granted by this office.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer.

The pathogenesis and progression of prostate cancer appear to be driven, at least in part, by the effects of testosterone. Androgen deprivation has been demonstrated to result in cell death and tumor regression in many well-differentiated prostate cancer cell lines; for this reason, androgen deprivation therapy (ADT) has become a standard in the treatment of prostate cancer, particularly in advanced disease.

Testosterone production in males is carried out in the Leydig cells of the testes and is stimulated by luteinizing hormone (LH), which itself is produced in the pituitary gland following the binding of gonadotropin-releasing hormone (GnRH) to corresponding GnRH receptors. Relugolix is a competitive antagonist of these GnRH receptors, thereby decreasing the release of LH and, ultimately, testosterone.

At the SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the Phase IV clinical trial protocol of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer presented by Sun Pharmaceutical Industries.

After detailed deliberation, the committee recommended the conduct of the trial as presented by the firm.

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FMGs who have sufficiently compensated classes in physical onsite in lieu of online classes gets NMC relief, eligible for one-year mandatory internship

After announcing its decision to not accept the compensatory certificates obtained by the Foreign Medical Graduates (FMGs), the National Medical Commission (NMC) has now modified its stand on the issue.
Issuing a notice on 19.06.2024, the Undergraduate Medical Education Board (UGMEB) of the Commission clarified that all the medical graduates from abroad who have sufficiently compensated classes in physical onsite in lieu of the online classes and who have cleared the equivalent exam to MBBS i.e. the screening test, shall be eligible for one-year mandatory internship.

For more information, click on the link below:

NMC Relief: FMGs Who Have Sufficiently Compensated Classes In Physical Onsite In Lieu Of Online Classes Eligible For One Year Mandatory Internship

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