Health Bulletin 15/December/2023

Here are the top health stories for the day:

WHO calls for ban on flavored vapes

The World Health Organization (WHO) on Thursday urged governments to treat e-cigarettes similarly to tobacco and ban all flavours, threatening cigarette companies’ bets on smoking alternatives.

Some researchers, campaigners and governments see e-cigarettes, or vapes, as a key tool in reducing the death and disease caused by smoking. But the U.N. agency said “urgent measures” were needed to control them.

For more details, check out the link given below:

WHO Calls For Ban On Flavoured Vapes, Treating E-Cigarettes The Same As Tobacco

NMC hosps alerted after man tests positive for Zika virus

The Nashik Municipal Corporation (NMC) has issued a cautionary alert to all hospitals under its jurisdiction following a positive Zika virus case approximately one month ago. The infected individual, a 22-year-old, received successful treatment in a private hospital, with blood and urine samples subsequently sent to the National Institute of Virology (NIV) Pune for further analysis, confirming the Zika virus infection.

Conducting an extensive survey in the Bharat Nagar slum area of Nashik, where the patient resides, the Nashik Municipal Corporation has proactively sent samples from all 91 women in the locality to the NIV for testing. Given the significance of protecting pregnant women from Zika, these women have been advised to sleep under mosquito nets. Authorities assured the public that there is no cause for panic, asserting control over the situation.

Delay in treatment of cancer patient leading to death: GTB hospital, doctors held negligent, slapped Rs 5 lakh compensation

Noting that the apathetic approach of the hospital and its doctors towards the gravity of the ailment raises a presumption as regards to the failure of treating doctors in clinical judgment and choosing the right course of action in time, the Delhi State Consumer Disputes Redressal Commission has upheld the District Forum’s order that found GTB Hospital and its two doctors guilty of negligence and delay in treating a cancer patient who eventually succumbed to the disease.

The District Commission had directed the facility and the doctors to jointly pay a lump sum compensation of Rs 5 lakhs to the heirs (complainants) of the deceased patient.

For more details, check out the link given below:

Delay In Treatment Of Cancer Patient Leading To Death: GTB Hospital, Doctors Held Negligent, Slapped Rs 5 Lakh Compensation

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COPD treatment: CDSCO nod to AstraZeneca India to market triple drug combination inhalation aerosol

Bangalore: Biopharmaceutical company AstraZeneca India has announced that it has received Central Drugs Standard Control Organisation (CDSCO) approval to market its inhalation aerosol, a triple combination of budesonide (160 mcg), glycopyrrolate (9 mcg), and formoterol fumarate (4.8 mcg). The pressurized metered dose inhaler is recommended for the treatment and maintenance of patients with chronic obstructive pulmonary disease (COPD).

COPD is the second leading cause of death in India, accounting for more than 50% of chronic respiratory diseases. It is the third leading cause of death worldwide. Coughing, difficulty breathing, wheezing, and fatigue are the symptoms of the disease. Smoking or using tobacco in any form, sedentary lifestyle choices, and air pollution are all risk factors for COPD.
The damage from exacerbations due to COPD extends beyond the lungs. The risk of a cardiovascular event rises dramatically during a severe hospitalised exacerbation.

“In comparison to currently available dual therapies, this triple combination therapy is proven to considerably lower the rate of moderate to severe exacerbations, mortality rates, and increase lung function. The inhalation aerosol is highly recommended for all patients with a history of multiple exacerbations,” the Company stated.

Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India added, “Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. The triple combination therapy has clinically demonstrated a significant reduction in the rate of moderate or severe exacerbations as compared with other available dual therapies. The indication improves lung function, helps with COPD symptoms and prevents flare-ups. We are also looking at the possibility of extending benefit towards the complete spectrum of respiratory disorders like chronic bronchitis, emphysema, or both.”

Dr. Sanjeev Panchal, Country President & Manging Director, AstraZeneca India, said, “COPD is probably an underprioritized disease around the world. In India, government has already demonstrated its intent to manage COPD better by including it in National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases and Stroke (NPCDCS). With this approval, we are bringing science based novel therapy to India and bridging access to better therapies that can transform outcomes for COPD patients. This approval is also a strong example of innovative drug delivery technique that can target a common therapeutic challenge thereby reducing mortality as well as overall COPD disease burden.”

Read also: AstraZeneca gets CDSCO panel Nod to study anti-cancer drug Volrustomig in women with cervical cancer

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Standards of Care in Diabetes 2024: ADA updates recommendations on hypoglycemia prevention and management

USA: The American Diabetes Association (ADA) has released an updated “Standards of Care in Diabetes 2024,” which is available online and is published as a supplement to the January 2024 issue of Diabetes Care.

The ADA’s Standards of Care for 2024 include new recommendations to screen for heart failure, type 1 diabetes risk, and peripheral arterial disease (PAD), along with new obesity management guidance. It also includes new recommendations related to bone health and liver disease. The Standards of Care are essentially the global guidelines for the care of individuals with diabetes and those at risk.

This article will focus mainly on updated recommendations on hypoglycemia prevention and management. Recommendations are described below:

Hypoglycemia Assessment, Prevention, and Treatment

  • History of hypoglycemia should be reviewed at every clinical encounter for all individuals at risk for hypoglycemia and evaluated as indicated.
  • Clinicians should screen all individuals at risk for hypoglycemia for impaired hypoglycemia awareness.
  • Clinicians should consider an individual’s risk for hypoglycemia when selecting diabetes medications and glycemic goals.
  • The use of CGM (continuous glucose monitoring) is beneficial and recommended for individuals at high risk for hypoglycemia.
  • Glucose is the preferred treatment for the conscious individual with glucose <70 mg/dL (<3.9 mmol/L), although any form of carbohydrate that contains glucose may be used. Fifteen minutes after initial treatment, repeat the treatment if hypoglycemia persists.
  • Glucagon should be prescribed for all individuals taking insulin or at high risk for hypoglycemia. Family, caregivers, school personnel, and others providing support to these individuals should know its location and be educated on how to administer it. Glucagon preparations that do not have to be reconstituted are preferred.
  • All individuals taking insulin A or at risk for hypoglycemia C should receive structured education for hypoglycemia prevention and treatment, with ongoing education for those who experience hypoglycemic events.
  • One or more episodes of level 2 or 3 hypoglycemia should prompt reevaluation of the treatment plan, including deintensifying or switching diabetes medications if appropriate.
  • Refer individuals with impaired hypoglycemia awareness to a trained healthcare professional to receive evidence-based intervention to help reestablish awareness of symptoms of hypoglycemia.
  • Ongoing assessment of cognitive function is suggested with increased vigilance for hypoglycemia by the clinician, patient, and caregivers if impaired or declining cognition is found.

Reference:

American Diabetes Association Professional Practice Committee; 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S111–S125. https://doi.org/10.2337/dc24-S006

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Zydus Lifesciences bags USFDA nod for HIV-1 drug Darunavir

Ahmedabad: Zydus Lifesciences Limited today announced that the Company has received final approval from the United States Food and Drug Administration
(USFDA) for Darunavir Tablets 600 mg and 800 mg, and tentative approval for 75 mg and 150
mg tablets (USRLD: Prezista Tablets, 75 mg, 150 mg, 600 mg, and 800 mg).

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency
Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection
in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients 3
years of age and older.

It must be –co-administered with Ritonavir and with other antiretroviral
agents.

The product will be manufactured at the group’s formulation manufacturing facility in
SEZ, Ahmedabad (India).

Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of USD 275 mn in
the United States (IQVIA MAT Oct. 2023).
The group now has 383 approvals and has so far filed over 440* ANDAs since the
commencement of the filing process in FY 2003-04.

Read also: Zydus, Daewoong Pharma collaborate to co-develop, commercialise Leuprolide Long-Acting Injectable in US

Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.

Read also: Zydus Lifesciences gets USFDA okay for acquired methemoglobinemia injection Methylene Blue

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Bestatin promising drug for treatment and prevention of periodontitis

Researchers have found in a new study that Bestatin may be a promising drug for treatment and prevention of periodontitis.  The findings of the  new study have been published in the Journal of Periodontology.

Chronic periodontitis (CP), the most prevalent dysbiotic bacteria-driven chronic inflammatory disease, is an underestimated global health problem in itself, and due to a causative relationship with other disorders such as cardiovascular diseases or Alzheimer disease. The Chronic periodontitis pathogenesis is primarily driven by Porphyromonas gingivalis in humans, and Porphyromonas gulae in dogs. These microorganisms initiate a pathogenic shift in the composition of the tooth-surface microflora. The objective of researchers was to evaluate antimicrobial effects of bestatin, a potential Chronic periodontitis drug candidate.

Researchers evaluated bestatin bacteriostatic efficiency against periodontopathogens in planktonic cultures via microplate assay, and mono- and multispecies oral biofilm models. Neutrophil bactericidal activities, such as phagocytosis, were investigated in vitro using granulocytes isolated from the peripheral blood. The therapeutic efficacy and the immunomodulatory function of bestatin was assessed in a murine model of Chronic periodontitis.

Results

Bestatin exhibited bacteriostatic activity against both P. gingivalis and P. gulae, and controlled the formation and species composition of the biofilm. We demonstrated that bestatin promotes the phagocytosis of periodontopathogens by neutrophils. Finally, we found that providing bestatin in the animal feed prevented alveolar bone resorption.

They showed that in a murine model of Chronic periodontitis bestatin not only shifted the biofilm species composition from pathogenic to a commensal one, but also promoted bacteria clearance by immune cells and alleviated inflammation. Taken together, these results suggest that bestatin is a promising drug choice for the treatment and/or prevention of periodontitis and clinical trials are required to fully evaluate its potency.

Reference:

Kaminska, M, Benedyk-Machaczka, M, Adamowicz, K, et al. Bestatin as a treatment modality in experimental periodontitis. J Periodontol. 2023; 94: 1338–1350. https://doi.org/10.1002/JPER.22-0614

Keywords:

Bestatin, promising, drug, for, treatment, prevention, periodontitis, Kaminska, M, Benedyk-Machaczka, M, Adamowicz, K

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Synthetic Glucocorticoids use tied to Neuropsychiatric Effects, depression and mania most common

A recent systematic review and meta-analysis shed light on the neuropsychiatric effects of synthetic glucocorticoids, commonly used in treating various diseases. Glucocorticoids, known for their efficacy, are associated with neuropsychiatric adverse effects, prompting researchers to delve into their prevalence and severity. This study was published in The Journal Of Clinical Endocrinology & Metabolism by Anne-Sophie C A M Koning and colleagues.

The comprehensive analysis involved 49 studies, encompassing various patient populations, types, doses, and durations of synthetic glucocorticoid use. Here are the significant findings regarding neuropsychiatric adverse effects among glucocorticoid users:

  • Depression (22%): The proportion of patients experiencing depression following glucocorticoid use was reported at 22% (95%CI 14%-33%).
  • Mania (11%): Neuropsychiatric effects extended to mania, with an 11% prevalence (95%CI 2%-46%) observed among users.
  • Anxiety (8%): Approximately 8% of patients reported anxiety (95%CI 2%-25%) as an adverse effect.
  • Delirium (16%): Delirium was noted in 16% of cases (95%CI 6%-36%).
  • Behavioural Changes (52%): A substantial 52% of users reported experiencing behavioural changes (95%CI 42%-61%).

Psychiatric Scores:

Further analysis evaluated questionnaire scores between glucocorticoid users and non-users:

  • Depression (SMD 0.80): Glucocorticoid users showed higher scores for depression (SMD of 0.80 (95%CI 0.35-1.26)), suggesting a greater incidence of depressive symptoms.
  • Mania (SMD 0.78): Similarly, mania scores were elevated in users (SMD of 0.78 (95%CI 0.14-1.42)), indicating increased manic symptoms post glucocorticoid use.

The study underscores the substantial neuropsychiatric adverse effects associated with synthetic glucocorticoid use. Notably, depression and mania demonstrated the most pronounced associations with glucocorticoid treatment. Researchers emphasize the critical need for awareness among healthcare professionals and patients regarding the potential neuropsychiatric side effects upon initiating glucocorticoid therapy. The findings highlight the necessity for more structured investigations into the incidence and underlying pathways of these adverse effects.

Reference:

Koning, A.-S. C. A. M., van der Meulen, M., Schaap, D., Satoer, D. D., Vinkers, C. H., van Rossum, E. F. C., van Furth, W. R., Pereira, A. M., Meijer, O. C., & Dekkers, O. M. Neuropsychiatric adverse effects of synthetic glucocorticoids: a systematic review and meta-analysis. The Journal of Clinical Endocrinology and Metabolism,2023. https://doi.org/10.1210/clinem/dgad701

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Use of diffusion optics technology spectacle lenses may prevent juvenile myopia progression

Researchers have found in a new study that Use of diffusion optics technology spectacle lenses may prevent juvenile myopia progression. 

The findings of the new study have been published in the British Journal of Ophthalmology.

Mutations in the L/M cone opsin gene array cause abnormally high perceived retinal contrast and the development of myopia. Environmental factors may also lead to high visual contrast and cause myopia. Diffusion optics technology (DOT) lenses are designed to reduce contrast signalling in the retina and slow myopia progression.

The Control of Myopia Using Peripheral Diffusion Lenses Efficacy and Safety Study (CYPRESS, NCT03623074) is a 36-month, multicentre, randomised, controlled, double-masked trial evaluating two investigational spectacle lenses versus control lenses in myopic children aged 6–10, with a planned interim analysis at 12 months. The primary endpoints are change from baseline in axial length (AL) and spherical equivalent refraction (SER).

Results

In all 256 children (58% female; mean age at screening, 8.1 years) were dispensed spectacles. Across all groups, baseline averages were AL 24.02 mm (SD±0.77 mm), SER −2.01 D (SD±0.9 D) using manifest refraction, and SER −1.94 D (SD±1.0 D) using cycloplegic autorefraction. At 12 months, mean difference in SER progression for test 1 versus control was −0.40 D (p<0.0001), representing a 74% reduction and −0.32 D for Test 2 (p<0.0001), representing a 59% reduction. The difference in AL progression for test 1 versus control was 0.15 mm (p<0.0001) and test 2 versus control was 0.10 mm (p=0.0018).

Reseachers concluded that 12-month results from this ongoing trial demonstrate the safety and effectiveness of Diffusion optics technology (DOT) spectacles for reducing myopic progression.

Reference:

Rappon J, Chung C, Young G, et alControl of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS) British Journal of Ophthalmology 2023;107:1709-1715.

Keywords:

Use, diffusion, optics, technology, spectacle, lenses, may, prevent, juvenile, myopia, progression, British Journal of Ophthalmology

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Valproate Use Linked to Brain Volume Reduction in Epilepsy Patients

Recent study unveiled important findings about the impact of valproate (VPA) use on the brain volume of individuals with idiopathic generalized epilepsy. The crucial results of the extensive study were published in Epilepsia Journal.

The study employed voxel-based morphometry on magnetic resonance imaging (MRI) and focused on 112 patients currently using VPA (VPA+ group), 81 not using VPA (VPA– group), and 120 healthy subjects for comparison.

The findings indicated significant gray matter (GM) volume reduction in the VPA+ group in various brain regions, including the bilateral cerebellum, hippocampus, insula, caudate nucleus, medial frontal cortex/anterior cingulate cortex, primary motor/premotor cortex, medial occipital cortex, and anteromedial thalamus. When compared to the control group, the VPA– group also exhibited GM volume reduction in the anteromedial thalamus and right hippocampus/temporal cortex.

The study found distinctive differences the VPA+ group, when compared to the VPA– group which showed more extensive GM volume reduction in the bilateral cerebellum, primary motor/premotor cortex, and medial frontal cortex/anterior cingulate cortex.

These findings found the potential adverse effects of VPA on brain structure, particularly in the frontal cortex and cerebellum. The study suggests that the use of VPA may contribute to cortical thinning and GM volume reduction, urging caution while interpreting morphometric MRI studies involving individuals taking VPA.

The study emphasizes the importance of considering VPA use as a potential confounding factor in studies exploring brain morphometry. Understanding these associations is crucial not only for clinicians prescribing VPA but also for researchers aiming to accurately interpret MRI data in epilepsy studies. Further investigations are imperative to validate the clinical implications and long-term effects of these structural changes that were observed in epilepsy patients using VPA.

Source:

Shin, J. H., Song, M. J., & Kim, J. H. (2023). Valproate use associated with frontal and cerebellar gray matter volume reductions: A voxel‐based morphometry study. In Epilepsia. Wiley. https://doi.org/10.1111/epi.17825

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Point-of-care PCR may help guide antibiotic choice and improve pneumonia treatment

Community-acquired pneumonia (CAP) is a leading cause of hospitalization and death. Timely antibiotic treatment is crucial to prevent complications like bacteremia, sepsis, organ failure, and death. Initial treatment is often empiric, and an uncertain or delayed diagnosis can lead to broad-spectrum antibiotic use. This contributes to adverse effects, such as Clostridioides difficile infection and super-infections with resistant bacteria, and can worsen patient outcomes and contribute to antibiotic resistance.

A study published in PLOS ONE has concluded that using respiratory POC does not appear to be effective in reducing antibiotic use in a setting with low antimicrobial resistance and already prudent antibiotic use. However, it may help ensure targeted and appropriate treatment in a restrictive antibiotic setting and support a restrictive strategy. The COVID-19 pandemic and low transmission of common respiratory viruses during the study period may have impacted the results.

We need rapid and accurate detection of pathogens in community-acquired pneumonia (CAP) to use appropriate antibiotics and slow down antibiotic resistance development. The study aimed to compare the effect of adding point-of-care (POC) polymerase chain reaction (PCR) detection of respiratory pathogens to standard care with standard care only (SCO) on antibiotic prescriptions after acute hospital admission.

They conducted an open-label, multicenter, parallel-group, superiority RCT at three Danish medical emergency departments from March 2021 to February 2022. Adults with suspected CAP during daytime weekdays were included and randomly assigned (1:1) to POC-PCR or SCO analysis of respiratory samples. Two hundred ninety-four patients with collected samples were randomly assigned to POC-PCR (n = 148, 50.4%) or SCO (n = 146, 49.6%). The study used logistic regression and Huber–White clustered standard errors for the prescription of antibiotic treatment. The study included intention-to-treat and per-protocol analysis.

Key findings from the study are:

  • Loss to follow-up comprises three patients in the POC-PCR and none in the SCO group.
  • There was no difference in the primary outcome of prescriptions of no or narrow-spectrum antibiotics four hours after admission for the POC-PCR and SCO.
  • The prescriptions were more targeted at four h (OR 5.68) and 48 h (OR 4.20)and more adequate at 48 h (OR 2.11) and on day 5 in the POC-PCR group (OR 1.40).
  • There was no difference between the groups about intensive care unit (ICU) admissions, readmission within 30 days, length of stay, 30-day mortality and in-hospital mortality.

· The POC-group patients showed a non-statistically significant shortening of hospital stay by approximately one day.

· The POC group treated more patients with targeted antibiotics within 48 hours and five days after admission.

Antimicrobial resistance is low in Denmark, and most Haemophilus influenzae and Streptococcus pneumoniae are susceptible to benzylpenicillin. Danish guidelines recommend narrow-spectrum penicillin for milder CAP cases and broad-spectrum antibiotics for severe cases. CAP diagnosis is based on clinical symptoms and unspecific diagnostic tools like auscultation, chest radiography, blood tests, and microbiological analysis of sputum samples.

They said that in a setting with limited antibiotic use, point-of-care – polymerase chain reaction (POC-PCR) did not increase the number of patients treated with narrow-spectrum or without antibiotics. However, it showed potential for more targeted and appropriate antibiotic use. A study limitation was the COVID-19 pandemic, which led to low respiratory virus transmission.

Reference:

: Cartuliares MB et al. Evaluation of point-of-care multiplex polymerase chain reaction in guiding antibiotic treatment of patients acutely admitted with suspected community-acquired pneumonia in Denmark: A multicentre randomized controlled trial. PLoS Med 20(11): e1004314. https://doi.org/10.1371/journal.pmed.1004314

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Statin Initiation Linked to Reduced Mortality in Chronic Kidney Disease among Older Veterans

In a breakthrough study focusing on older veterans with chronic kidney disease (CKD), researchers have discovered a potential game-changer in the form of statin initiation. The study, employing a target trial emulation design, aimed to investigate the impact of statin use on all-cause mortality and major adverse cardiovascular events (MACE) in veterans aged over 65 with CKD stages 3 to 4. The study found that Statin initiation in US veterans over 65 with CKD stages 3 to 4 and no prior atherosclerotic cardiovascular disease (ASCVD) was associated with a lower risk of all-cause mortality but did not significantly impact the occurrence of MACE

The study results were published in the journal JAMA Network Open. 

Also Read: Novel hypolipidemic bempedoic acid safe in diabetics, may overcome shortcomings of statins: Lancet

Atherosclerotic cardiovascular disease is the leading cause of death among adults with chronic kidney disease. Some evidence supports the use of statins for the primary prevention of ASCVD in older patients with CKD. While statins are widely known for their efficacy in preventing cardiovascular events, their utility in individuals with CKD has been a subject of limited data and exploration. Due to uncertainty in the evidence researchers from Massachusetts conducted a study to evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4

The study was conducted as a cohort study, by utilizing a target trial emulation design and involving veterans diagnosed with moderate CKD between 2005 and 2015. Participants were aged over 65, within 5 years of CKD diagnosis, without prior atherosclerotic cardiovascular disease (ASCVD) or statin use, and had at least 1 clinical visit in the year before the trial baseline. Propensity weighting was applied for a meticulous analysis of the outcomes.

Findings:

  • The comprehensive analysis included 14,828 veterans, with a mean age of 76.9 years at CKD diagnosis.
  • The results, after propensity score adjustment, were striking.
  • Statin initiators exhibited a significantly lower risk of all-cause mortality (hazard ratio 0.91, 95% CI 0.85-0.97) compared to noninitiators.
  • This finding suggests a noteworthy association between statin initiation and a reduced risk of mortality in this specific population.
  • However, the study did not find a significant impact on the occurrence of major adverse cardiovascular events (MACE) with statin use.
  • The hazard ratio for MACE was 0.96 (95% CI 0.91-1.02), indicating that statin initiation did not result in a statistically significant reduction in MACE.

These findings carry significant implications for the management of CKD in older veterans. While statin initiation demonstrated a clear association with lower all-cause mortality, the lack of a substantial impact on MACE suggests a need for further research.

Also Read: Statin Use and lowering of Cholesterol may reduce Breast Cancer Mortality

The study underscores the importance of considering statin therapy in the care plan for older veterans with CKD, emphasizing the potential for mortality reduction. However, the researchers emphasize the necessity for confirmation through randomized clinical trials to establish a robust evidence base and inform clinical guidelines.

Further reading: Barayev O, Hawley CE, Wellman H, et al. Statins, Mortality, and Major Adverse Cardiovascular Events Among US Veterans With Chronic Kidney Disease. JAMA Netw Open. 2023;6(12):e2346373. doi:10.1001/jamanetworkopen.2023.46373

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