Statin Use Linked to Higher Glaucoma Risk, Especially in Older Adults and Those with Elevated LDL-C Levels: Study

USA: The use of
statins to treat hyperlipidemia and high low-density
lipoprotein cholesterol (LDL-C) levels may increase the risk of
developing glaucoma, as revealed by a current study.

“Statin use was linked to a higher likelihood of glaucoma in the overall adult All of Us (AoU) population with hyperlipidemia, particularly in individuals with optimal or high LDL-C levels and those aged 60-69,” the researchers wrote in Ophthalmology Glaucoma. 

“Findings suggest that statin use may be an independent risk factor for glaucoma, which may be affected by one’s lipid profile and age.” 

High levels of lipids and LDL-C increase the
risk of having coronary artery disease, heart attack, and stroke. Statins are
first-line drugs given in cases of hyperlipidemia and high LDL-C levels which also pose the risk of having
glaucoma thereby damaging the optic nerve.

Against the above background, researcher
Samuel Y. Lee, David Geffen School of Medicine at UCLA, Los Angeles, CA USA, and
collogues investigated the association between statin use and glaucoma in the 2017-2022
ALL of Us research program.

From the electronic health record (EHR)
data in the AoU database, 79,742 adult participants aged ≥ 40 years with
hyperlipidemia were selected. Hyperlipidemia, glaucoma status, and statin use
were defined by diagnoses and medication information in EHR data collected by
AoU.

The association between statin use and
glaucoma likelihood was evaluated by Logistic regression analysis and also
to examine associations between glaucoma and all covariates included in the adjusted
analysis.

The severity of hyperlipidemia was assessed using serum LDL-C level. Analyses stratified by LDL-C level and
age were performed.

The study revealed
the following findings:

  • 6,365
    (8.0%) statin users were identified out of 79,742 individuals with hyperlipidemia
    in AoU.
  • Statin use was
    found to be associated with increased glaucoma prevalence when compared with
    statin non-use (adjusted odds ratio [aOR])
  • Higher serum
    levels of LDL-C were associated with increased odds of glaucoma (aOR: 1.003)
  • Significantly
    higher LDL-C levels were found in statin
    users as compared to nonusers (144.9 mg/dL versus 136.3 mg/dL)
  • Analysis
    stratified by LDL-C identified positive associations between statin use and
    prevalence of glaucoma among those with optimal (aOR = 1.39) and high LDL-C
    levels. (aOR = 1.37).
  • positive
    association between statin use and prevalence of glaucoma in individuals aged
    60-69 years (aOR = 1.28) as identified by Age-stratified analysis.

“Statins
pose an increased risk of glaucoma with potential influences from an individual’s
lipid profile and age,” said the researcher

Reference:
Lee, S. Y., Paul, M. E., Coleman, A. L.,
Kitayama, K., Yu, F., Pan, D., & Tseng, V. L. (2024). Associations between
Statin Use and Glaucoma in the All of Us Research Program. Ophthalmology
Glaucoma.

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Sebetralstat, wonder drug for Hereditary Angioedema Attacks, claims study

Sebetralstat- a wonder drug for Hereditary Angioedema Attacks

Hereditary angioedema (HAE) is a rare disease characterized by recurrent swelling of eyes, lips and other soft tissues and can be associated with life threatening respiratory distress due to laryngeal edema. All approved on-demand treatments for acute attacks of hereditary angioedema are administered parenterally, a route of administration that is associated with delays in treatment or withholding of therapy. Recently a phase 3 study of an oral drug sebetralstat for control of acute attacks of HAE was published in the New England Journal of Medicine.

This was a phase 3, double-blind, three-way crossover trial, where participants ≥ 12 years of age with type 1 or type 2 hereditary angioedema were randomly assigned to take up to two oral doses of sebetralstat (300 mg or 600 mg) or placebo for an angioedema attack. The primary end point, assessed in a time-to-event analysis, was the beginning of symptom relief, defined as a rating of “a little better” on the Patient Global Impression of Change scale (ratings range from “much worse” to “much better”) at two or more consecutive time points within 12 hours after the first administration of the trial agent. Key secondary end points, assessed in a time-to-event analysis, were a reduction in attack severity (an improved rating on the Patient Global Impression of Severity [PGI-S] scale, with ratings ranging from “none” to “very severe”) at two or more consecutive time points within 12 hours and complete attack resolution (a rating of “none” on the PGI-S scale) within 24 hours.

A total of 136 participants were assigned to one of six trial sequences, with 110 treating 264 attacks. The time to the beginning of symptom relief with the 300-mg dose and the 600-mg dose was faster than with placebo (P<0.001 and P=0.001 for the two comparisons, respectively), with median times of 1.61 hours (interquartile range, 0.78 to 7.04), 1.79 hours (1.02 to 3.79), and 6.72 hours (1.34 to >12), respectively. The time to reduction in the attack severity with the 300-mg dose and the 600-mg dose was faster than with placebo (P=0.004 and P=0.003), with median times of 9.27 hours (interquartile range, 1.53 to >12), 7.75 hours (2.19 to >12), and more than 12 hours (6.23 to >12). The time to complete resolution was faster with the 300-mg and 600-mg doses than with placebo (P=0.002 and P<0.001). The percentage of attacks with complete resolution within 24 hours was 42.5% with the 300-mg dose, 49.5% with the 600-mg dose, and 27.4% with placebo. Sebetralstat and placebo had similar safety profiles; no serious adverse events related to the trial agents were reported.

Sebetralstat provided faster times to the beginning of symptom relief, reduction in attack severity, and complete attack resolution than placebo in HAE. In conclusion sebetralstat could be the first oral drug to be useful in the treatment of acute attacks of HAE.

Reference– Riedl MA, Farkas H, Aygören-Pürsün E, Psarros F, Soteres DF, Staevska M, Cancian M, Hagin D, Honda D, Melamed I, Savic S, Stobiecki M, Busse PJ, Dias de Castro E, Agmon-Levin N, Gower R, Kessel A, Kurowski M, Lleonart R, Grivcheva Panovska V, Wedner HJ, Audhya PK, Hao J, Iverson M, Smith MD, Yea CM, Lumry WR, Zanichelli A, Bernstein JA, Maurer M, Cohn DM; KONFIDENT Investigators. Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks. N Engl J Med. 2024 Jul 4;391(1):32-43.

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Early weight-bearing effective for recovery and cost in ankle fracture patients: Study

A new study published in The Lancet journal found an early weight-bearing method to be both extremely likely to be cost-effective and clinically non-inferior to the present standard of treatment (delayed weight-bearing).

The patients with fractured ankles are often told not to walk for 6 weeks following surgery (delayed weight-bearing). Early weight-bearing (walking) two weeks post-surgery may be a safer and better rehabilitation approach. In order to examine the clinical and financial efficacy of an early weight-bearing method vs a delayed weight-bearing strategy, Christopher Patrick Bretherton and colleagues undertook this study.

This pragmatic, randomised, multicenter, non-inferiority trial included 561 participants (over 18 years) who underwent acute surgery in 23 NHS hospitals in the UK for an unstable ankle fracture. The participants were randomly assigned to an early weight-bearing rehabilitation strategy (n = 281) or a delayed weight-bearing rehabilitation strategy (n = 280). Excluded patients were those receiving treatment for a hindfoot nail, those without protective ankle feeling (such as peripheral neuropathy), those incapable of giving informed permission, and those unable to follow study protocols. The therapy was not concealed from either the subjects or the doctors. The Olerud and Molander Ankle Score (OMAS), which measures ankle function in the per-protocol population 4 months after randomization, was the main outcome. The intention-to-treat population underwent superiority testing in the event of non-inferiority, and the pre-specified non-inferiority OMAS margin was –6 points.

Of the 561 individuals, 480 (86%) had primary outcome data collected with the hiring period running between January 13, 2020 and October 29, 2021. 4 months post-randomization, the mean OMAS score of early weight-bearing group was 65·9, while the delayed weight-bearing group’s was 61·2. The adjusted mean difference was 4·47, favoring the early weight-bearing group. One or more problems were experienced by 46 (16%) individuals in the early weight-bearing group and 39 (14%) participants in the delayed weight-bearing group.

In the early and delayed weight-bearing groups, the mean costs to the NHS and personal social services were £725 and £785, respectively. Also, more than 80% of people believed that early weight-bearing was cost-effective. Overall, this study found that an early weight-bearing technique is not inferior to delayed weight-bearing following ankle fracture repair and is very likely to be cost-effective.

Reference: 

Bretherton, C. P., Achten, J., Jogarah, V., Petrou, S., Peckham, N., Achana, F., Appelbe, D., Kearney, R., Claireux, H., Bell, P., Griffin, X. L., McAndrew, A., Jacobs, N., Forder, J., Hester, T., Cross, C., Bateman, T., Kieffer, W., Barton, T., … White, T. (2024). Early versus delayed weight-bearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomised controlled trial. In The Lancet (Vol. 403, Issue 10446, pp. 2787–2797). Elsevier BV. https://doi.org/10.1016/s0140-6736(24)00710-4

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AI integration with point-of-care ultrasonography tied to reliable gestational age assessment in low resource settings: JAMA

Researchers in a recent study showed that it is possible for a deep learning AI model to accurately estimate the gestational age solely based on blinded ultrasonography sweeps by means of a low-cost, battery-powered device. This is a probably generalizable way for assessing gestational age (GA) in low-resource settings that could be a game changer in obstetrical care worldwide. The findings were published in JAMA by Jeffrey S. A. and colleagues.

Accurate assessment of gestation is paramount in the provision of appropriate care in pregnancy and for guiding interventions and monitoring fetal development. Traditionally, this mandates high-specification ultrasonography that most likely may not exist in a low-resource setting. In this study, an AI-enabled ultrasonography tool will be created for use by novice users who have no prior training in sonography.

This was a prospective diagnostic accuracy study that involved 400 women with viable, singleton, nonanomalous, first-trimester pregnancies from Lusaka, Zambia, and Chapel Hill, North Carolina. GA was determined by experienced sonographers with transvaginal crown-rump length measurements. At random follow-up visits spanning the window of the primary evaluation from 14 to 27 weeks of gestation, novice users obtained blinded sweeps of the maternal abdomen with an AI-enabled device. Comparative fetal biometry was performed on a high-specification machine by experienced sonographers.

The primary outcome was the mean absolute error of the AI-enabled device compared with the study standard. The accuracy of the device was considered equivalent if the difference in MAE fell within a prespecified margin of ±2 days. The percentage of assessments within 7 days of ground truth GA was measured secondarily.

Results

  • In the primary evaluation window, the AI-enabled device demonstrated equivalence to the study standard with an MAE of 3.2 days (SE 0.1) versus 3.0 days (SE 0.1) for the standard method (difference, 0.2 days [95% CI, −0.1 to 0.5]).

  • The percentage of assessments within 7 days of the ground truth GA was 90.7% for the AI device and 92.5% for the study standard.

  • The AI tool’s performance was consistent across various subgroups, including different geographical locations and body mass index categories.

The study epitomizes how AI technology can bridge this gap in prenatal care within low-resource settings. With the aid of an AI-enabled device, this brings novice users closer to the same level of GA estimation accuracy attained by credentialed sonographers using high-specification equipment. This is most relevant where access to advanced medical technology is limited and thus serves a universal access aim of the World Health Organization for GA estimation during pregnancy.

Novice operators who had never received ultrasonography training estimated GA for dates between 14 and 27 weeks of gestation as accurately with this low-cost, AI-enabled device as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, and on a global scale, they have advanced global health initiatives and improved pregnancy outcomes.

Reference:

Stringer, J. S. A., Pokaprakarn, T., Prieto, J. C., Vwalika, B., Chari, S. V., Sindano, N., Freeman, B. L., Sikapande, B., Davis, N. M., Sebastião, Y. V., Mandona, N. M., Stringer, E. M., Benabdelkader, C., Mungole, M., Kapilya, F. M., Almnini, N., Diaz, A. N., Fecteau, B. A., Kosorok, M. R., … Kasaro, M. P. (2024). Diagnostic accuracy of an integrated AI tool to estimate gestational age from blind ultrasound sweeps. JAMA: The Journal of the American Medical Association. https://doi.org/10.1001/jama.2024.10770

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TATA AIG-Avanti Fellows Scholarship launched for female MBBS aspirants

New Delhi: TATA AIG-Avanti has announced a Fellows Scholarship programme for female MBBS aspirants. The programme is also for engineering students.

In this initiative, the girl MBBS aspirants who have cleared NEET will be eligible to apply. The students must have passed Class 12 from a Jawahar Navodaya Vidyalaya (JNV) / State Government School / Kendriya Vidyalaya, anywhere in India. 

Along with career guidance, the support will continue till the end of the course completion (provided the scholars maintain the required percentage / GPA in the semester exams and are able to progress in their academic journey).

The last date to register for the TATA AIG-Avanti Fellows Scholarship programme is August 31st 2024.

Below is the detailed eligibility criteria and benefits of the scholarship programme:

Eligibility Criteria:

a. Gender: Only for Girl students

b. School: Should have passed Class 12 from a Jawahar Navodaya Vidyalaya (JNV) / State Government School / Kendriya Vidyalaya, anywhere in India

c. Category: SC / ST / Gen-EWS / PwD students are eligible to apply

d. State: Should belong to any of the following states / UT: Arunachal Pradesh / Assam / Bihar / Jammu & Kashmir / Jharkhand / Manipur / Meghalaya / Mizoram / Nagaland / Odisha / Punjab / Sikkim / Tripura / Uttar Pradesh

e. Entrance Exam: Should have cleared JEE (Mains / Advanced) or NEET exam in 2024 and should be able to secure admission in a college for a UG program in 2024

f. Colleges: Should be able to secure admission in any of the following institutions: IIT / NIT / IIIT / IISc / AIIMS / Government Medical Colleges (MBBS) / Top 200 ranked Engineering Colleges (NIRF ranking). Girl Students seeking admission into any of the above-mentioned institutes in the academic year 2024-25 are eligible (Only 1st-year students)

g. UG Courses: Engineering / Medicine (MBBS only)

Benefits of the scholarship:

1. Coverage of the following expenses: Tuition fees, Mess fees, Hostel fees, Admission fees, Exam fees, Expenses for buying academic books

2. The support will continue till the end of the course completion (provided the scholars maintain the required percentage / GPA in the semester exams and are able to progress in their academic journey)

3. One time gift: A brand new laptop for Engineering students / a brand new tablet (iPad) for Medical students

4. Additional support: Career guidance sessions, Placement related training programs, internship opportunities, mental health support, counseling sessions and many more

5. Opportunity to join the Avanti Alumni Network who can support, guide and mentor the scholars

Last Date to register: 31-August-2024

Also Read:IIHMR University Announces More than Rs 2 Crore Scholarships for MBA Admissions 2024

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Patient Denied Admission, Discharged With Incomplete Treatment: 6 Doctors, 13 Healthcare Workers at RML Lucknow Suspended

Lucknow: Altogether 6 doctors and 13 healthcare workers of Dr. Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) were suspended recently in connection to a case of medical negligence. 

Uttar Pradesh Deputy Chief Minister Brajesh Pathak ordered the suspension of these doctors and health workers after a patient was denied admission and was discharged from the Emergency Department with incomplete treatment.

These 13 healthcare workers include two emergency officers, four resident doctors, two PROs, and five staff members, IANS has reported

The incident came to light when the news of the incomplete treatment and discharge of a patient at Lohia’s Emergency Department in Lucknow went viral in the media reports.

Subsequently, the Deputy CM responded, issuing orders for an investigation and mandating the institute administration to take action against those responsible.

Also Read: Alleged involvement of another MS orthopaedics medico at Sassoon Hospital in abandoning disabled patient, suspended

Deputy CM Brajesh Pathak emphasised that negligence towards patient care will not be tolerated and reiterated the government’s commitment to providing convenient treatment for all patients. He assured that continuous efforts are being made to improve the medical system.

He said that discharging a patient with incomplete treatment is a serious matter, and an investigation is underway and assured that strict action will be taken against those found guilty.

The Deputy CM also stressed Chief Minister Yogi Adityanath’s directive that serious patients should receive immediate and comprehensive treatment in hospitals.

Medical Dialogues had earlier reported that recently in a shocking incident, an on-duty doctor at Koylibeda Hospital in the Kanker district of Chhattisgarh was suspended for being intoxicated while on duty and reportedly declining to treat a 10-year-old boy, who subsequently passed away without receiving medical treatment.

According to the family members, the child died on the way to a district hospital after the doctor allegedly refused to treat him. They alleged that when they approached the doctor, he was in a highly intoxicated state. Even after persuading the doctor, he remained adamant and allegedly used demeaning foul language against them and their relatives.

Also Read: Denied treatment at Chhattisgarh Hospital, 10-year-old boy dies; Drunk doctor faces suspension

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Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan

New Delhi: In response to the justification presented by the drug major Lupin on the rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit more justification on the proposed dose and its rationality for further evaluation.

This came after the drug maker Lupin presented justification for the proposed dose and its rationality, along with the Phase III clinical trial protocol, before the committee.

Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Sacubitril is a prodrug that is activated to sacubitrilat by de-ethylation via esterases. Sacubitrilat inhibits the enzyme neprilysin, which is responsible for the degradation of atrial and brain natriuretic peptides, two blood pressure–lowering peptides that work mainly by reducing blood volume.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

The FDC of Sacubitril and valsartan is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization. This medicine is also used to treat children with symptomatic heart failure. Valsartan is an angiotensin II receptor blocker (ARB).

Earlier, the Medical Dialogue Team had reported that Lupin had presented its proposal along with justification for bioequivalence (BE) waiver and Phase-III clinical trials (CT) waiver before the committee at the SEC meeting for cardiovascular held on January 9, 2024, where the expert panel suggested the firm submit more justification on the proposed dose and rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25 mg.

In continuation, at the recent SEC meeting for cardiovascular held on July 18, 2024, the expert panel reviewed the justification of the proposed dose and its rationality along with the Phase III clinical trial protocol presented by drug maker Lupin.

After detailed deliberation, the committee reiterated its earlier recommendations to submit more justification on the proposed dose and its rationality to CDSCO for further review by the committee.

Also Read: Submit clinical study data conducted in adults: CDSCO Panel Tells Sanofi on atopic dermatitis drug

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More than 3 crore people screened for sickle cell anaemia under National Mission: MoS Health

Over 3 crore population in the 17 identified states in the country have been screened for sickle cell anaemia disease till June 30, 2024, the Union Minister of State for Health Shri Prataprao Jadhav informed the Lok Sabha last week.
The Minister informed that Sickle cell disease is a genetic blood disease that affects the whole life of the patient. It is more common in the tribal population of India but occurs in non-tribals too. It not only causes anaemia but also pain crisis, reduces growth and affects many organs like the lungs, heart, kidneys, eyes, bones and the brain.
For more information, click on the link below:

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Patient died due to medical negligence during blood transfusion: Hospital, 3 doctors directed to pay Rs 20 lakh as compensation

The District Consumer Disputes Redressal Commission (DCDRC), Coimbatore recently directed a hospital and three doctors to pay Rs 20 lakh as compensation to a man, whose wife died due to medical negligence during a blood transfusion.
While considering the matter, the consumer court observed that proper informed consent was not obtained and required tests were not conducted before the transfusion and even though the patient complained of body pain, the transfusion was not immediately stopped. Following the transfusion, the patient developed TRALI (Transfusion-Related Acute Lung Injury) and consequently died.
For more information, click on the link below:

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NEET MDS Admissions 2024: AFMS announces availability of 1 Periodontology seat for Priority-III, IV, V candidates in upcoming MCC round

Through a notice, Armed Forces Medical Services (AFMS) has informed that 01 seat in a postgraduate subject i.e. Periodontology at AFMC, Pune is available for Priority-III, IV & V candidates in the next round of MCC counselling. As per the MCC counselling schedule, the next round is to be held from August 12, 2024.
Notice has been released for Priority-IV candidates and Dental Officers sponsored by Military Organisations and other Organisations of the Government of India for admission to Post Graduate Courses (Master of Dental Surgery-MDS) through the National Eligibility and Entrance Test (NEET MDS) Exam 2024 in AFMS Institutions for the academic year 2024.
For more information, click on the link below:

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