Dr Reddy’s Labs to promote, distribute Sanofi paediatric, adult vaccine brands in India

Hyderabad: Dr Reddy’s Laboratories Ltd., a global pharmaceutical
company, has announced that it has entered into an exclusive partnership with Sanofi Healthcare India
Private Limited (“SHIPL”) to promote and distribute their vaccine brands across private markets in
India.

Under the arrangement, Dr. Reddy’s will have exclusive rights to promote and distribute Sanofi’s paediatric and adult vaccine brands Hexaxim, Pentaxim, Tetraxim,
Menactra, FluQuadri, Adacel and Avaxim 80U.
These brands saw combined sales of approx. Rs 426 crores (approx. USD 51 million) as per IQVIA MAT February 2024. Sanofi will continue to own,
manufacture, and import these brands to the country.
Preeti Futnani, General Manager India for Vaccines, Sanofi, said, “Vaccine confidence has reached
its highest in India in the last few years. Yet, there is much to be done for the rest of the country’s large
unvaccinated cohort. To fulfil our long-term commitment to India and expand our geographic reach, we’re
pleased to partner with Dr. Reddy’s Laboratories (Dr. Reddy’s) for exclusive distribution and promotion.
We’re confident this partnership will further bolster our promise of saving millions of lives against vaccines preventable diseases with improved vaccination coverage.”
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr.
Reddy’s, said, “We are happy to have the opportunity to leverage our strengths in promotion and
distribution to considerably expand engagement with healthcare professionals and help widen access of
Sanofi’s well-established and trusted vaccine brands in India. We continue our efforts to become the
partner of choice in bringing novel, innovative and trusted drugs to patients in India through strategic
collaborations. The portfolio now gives Dr. Reddy’s a strong presence in the vaccine segment, propelling
us to the second position among vaccines players in India. Through each product and partnership, our
aim is to serve over 1.5 billion patients by 2030.”

About the portfolio: 

Brand

Label Indication

Hexaxim

Indicated for primary and booster vaccination of infants and toddlers
from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B,
poliomyelitis and invasive diseases caused by Haemophilusinfluenzae type b
(Hib).

Pentaxim

Indicated for the active immunization of children against Diphtheria,
Pertussis, Tetanus, Polio and against invasive infections due to
Haemophilusinfluenzae type b bacterium (such as meningitis, septicaemia,
etc.) in children from the age of 2 months or according to local
recommendations. This vaccine does not protect against infections caused by
other types of Haemophilusinfluenzae nor against meningitis due to other
micro-organisms.

Tetraxim

Indicated in the joint prevention of diphtheria, tetanus, pertussis
and poliomyelitis: for primary vaccination in infants from the age of 2
months, for booster vaccination, one year after primary vaccination during
the second year of life, for booster vaccination between 5 and 13 years of
age, according to official recommendations

Menactra

Indicated for active immunization to prevent invasive meningococcal
disease caused by N. meningitidis serogroups A, C, Y, and W-135. MENACTRA® is
approved for use in individuals 9 months through 55 years of age

FluQuadri

FluQuadri is an inactivated quadrivalent influenza vaccine indicated
for the prevention of influenza disease caused by influenza types A and B
viruses contained in the vaccine. FluQuadri® is approved for use in persons 6
months of age and older.

Adacel

Indicated for active booster immunization for the prevention of
tetanus, diphtheria and pertussis (whooping cough) as a single dose in
persons aged 11 to 54 years. In accordance with local recommendations,
ADACEL® may be considered as an alternative for the fifth dose of tetanus,
diphtheria and acellular pertussis vaccine (DTaP) in children 4 to 6 years of
age, concomitantly administered with Inactivated Poliomyelitis Vaccine (IPV),
at separate sites to complete the vaccination series for this age, when indicated

Avaxim 80U

This vaccine is recommended for the prevention of the infection
caused by the Hepatitis A virus in children aged from 12 months to 15 years
inclusive

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Sympathy not ground to save admission: Gujarat HC cancels MBBS admission due to inconsistencies in caste certificate

Ahmedabad: Having scored 613 out of 720 marks in the National Eligibility cum Entrance Test Undergraduate (NEET-UG) 2022, an MBBS student whose admission was cancelled due to inconsistencies in caste certificate, has been denied conversion of his seat from the reserved category to the general category by the Gujarat High Court recently. 

Upholding the decision regarding the cancellation of his MBBS admission, the division bench of Chief Justice Sunita Agarwal and Justice Aniruddha P. Mayee said that he did not belong to the Socially and Economically Backward Class (SEBC) in the State of Gujarat and the conversion of his to general category could not take place as he had applied admission based on the reserved category.

“Once this certificate is cancelled, your admission goes automatically. No one can save your admission. Sympathy is not a ground to save admission in this kind of case. There is no question of considering you in the open category. Once someone has claimed the benefit of reservation, he has to stand by that.” observed the bench. 

Also read- MBBS Admission Cancelled Due To Inconsistencies In Caste Certificate, Student Seeks Urgent Intervention From Gujarat HC

During the hearing, the bench also asked “Why would you go to get this certificate when you knew that you do not belong to the caste in the State of Gujarat.”

According to Bar and Bench reports, the order was issued on Tuesday, two months after a single judge decided to reinstate the student’s admission, considering his family background and commending his accomplishments. This decision was challenged by the Admission Committee For Professional Medical Educational Courses.

Earlier, the student approached the High Court with a request to direct authorities to convert his seat to the general category as he was denied admission based on his reserve category certificate. 

The student scored 613 marks out of 720 with a merit rank of 600 in the NEET UG-examination 2022 in the General category and a merit rank of 154 in the SEBC category. He was eligible for admission to all 39 medical and 12 dental colleges, except three colleges, including the one where he was studying, as reported by Ahmedabad Mirror

Observing that he had got an admission based on a certificate that could not have been issued, the division bench suggested that the student could have competed in Uttar Pradesh to get admission under the reserved category since he could not get admission in Gujarat with Other Backward Class category. 

“You cannot get benefit [of reservation] in the State of Gujarat. Go back to the State of UP. You will get benefit over there. You compete in State of UP.”

In this case, the student is the son of a pani puri vendor from Meghraj in Aravalli district, who got admission to the Vadodara government medical college under the Socially and Economically Backward Classes (SEBC) category based on the caste certificate issued in 2018. He was born in Uttar Pradesh but did his schooling in Gujarat.

After his admission, when the state admission committee sent his caste documents for verification, the developing caste welfare department found his caste, mentioned as Teli, does not fall under the SEBC category in Gujarat. Following this, the Admission Committee for Professional Undergraduate and Postgraduate Medical Educational Courses (ACPUGMEC, ACPPGMEC) cancelled Rathod’s admission. 

On September 1, 2023, his admission was cancelled due to the rejection of the caste certificate he had submitted to the college by both the state government and the state admission committee.

Following this, he challenged the cancellation of admission before the High Court. 

Justice Nikhil S Kariel in a ruling on January 29 allowed his petition and said the cancellation of admission after the admission process being over with no possibility of the vacancy being filled in by an eligible candidate would result in the seat going vacant.

“Since seats in all colleges where the petitioner could have got admission are filled in and since the admission process is long over, the petitioner in spite of scoring very high marks in the NEET (UG-2022) entrance exam would not get admission in MBBS Course,” the judge had said.

Taking note of the financial condition of the candidate’s family, the single-bench judge decided to exercise extraordinary jurisdiction in the case.

“That a son of a person who is engaged in selling Panipuris having reached the stage of admission to an MBBS course on merits is in itself a commendable feat and whereas further considering this aspect from the view point of the fact that the marks secured by the petitioner were so much sufficient that except for three colleges who had been entitled to admission in all other colleges in the State of Gujarat, clearly point out to the fact that the extraordinary jurisdiction of this Court is required to be exercised in favour of the petitioner to ensure that he has a chance to complete his MBBS Course which seat otherwise would remain vacant for the entire term.”

Refuting the single bench decision, the division bench said the student would have been eligible for being considered for admission in the open category in a majority of the medical colleges but there was no doubt he had got admission to the specific college where he was not allowed to apply based on a certificate.

“The decision to save admission of the petitioner merely by the fact that he has attained high marks in the NEET examination and could have secured admission in the open category in any of the colleges in the State of Gujarat cannot be a reason to secure his admission in the college concerned,” the Court opined.

The Court also said no fault can be attributed either to the Admission Committee or any authority of the college concerned. “The place which the respondent/original petitioner has secured in the medical college has resulted in denying the opportunity of securing admission to an otherwise eligible candidate belonging to the SEBC category in the State of Gujarat,” it added.

Noting that none of the student’s family members had an SEBC certificate in Gujarat, the court said “The caste comes from parents. You are born in a caste. You don’t acquire caste otherwise. If your parents did not have an SEBC certificate in Gujarat, you could not have got it.” 

Also read- Domicile Entitled For MBBS Seat Even If Parent Is Posted Outside State, SC Slaps Compensation On Maha Govt, Medical College

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Dispelling Myths related to Borderline Diabetes – Dr P.C Runnu

Diabetes, often known as blood sugar, is a chronic illness marked by elevated blood glucose levels. It happens when the body is unable to use the insulin that is produced, or is unable to create enough of it. The hormone insulin controls blood sugar levels and permits it to enter cells for cellular energy production. When insulin isn’t working properly, blood glucose levels rise and cause a number of health issues.

Even though having prediabetes, another name for borderline diabetes, may not appear as serious as being diagnosed with diabetes, it still needs to be monitored closely and managed proactively. Blood sugar levels that are higher than normal but not high enough to be classified as diabetes are called prediabetes. Nonetheless, prediabetes can eventually turn into type 2 diabetes if lifestyle modifications and treatments are not implemented. It’s important to understand that having borderline diabetes increases the likelihood of getting diabetes and its associated health consequences, even in people who do not yet have the disease.

Dispelling some of the common misconceptions related to diabetes, Dr. P.C. Runnu from Ranchi, Jharkhand, addresses questions about what diabetes is and why we need to worry about it. Additionally, he sheds light on the misconception that having borderline diabetes means one doesn’t need to worry.

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Debunking Myths: Non-Vegetarian Diets and Diabetes Risk – Dr Girija Subramanian

For those with diabetes, keeping HbA1c values below 7% is essential because it indicates improved long-term blood sugar control and lowers the risk of consequences from the condition, including kidney disease, nerve damage, eye issues, and cardiovascular disease. High HbA1c results on a regular basis are indicative of poorly controlled diabetes, which over time can cause major health problems. People with diabetes can reduce their risk of problems and live better lives by aiming to maintain a HbA1c below 7%.

It’s a common misconception that those who eat non-vegetarian food are immune to diabetes. Regardless of dietary habits, anyone can get diabetes. Diabetes is largely determined by genetics, lifestyle variables, and general health, even while particular dietary patterns, such as consuming an excessive amount of sugary or processed foods, may increase one’s chance of getting the condition. Hence, regardless of dietary choices, it’s critical to concentrate on keeping a balanced diet, regular physical exercise, and routine health check-ups to control and avoid diabetes.

Addressing common myths about diabetes, Dr Girija Subramanian from Sri Manakula Vinayagar Medical College, Pondicherry, explains the misconception that being a non-vegetarian prevents one from developing diabetes.

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Caplin Steriles bags USFDA approval for Ketorolac tromethamine Ophthalmic Solution

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin
Point Laboratories Limited, has been granted final
approval by the United States Food and Drug Administration (USFDA) for its Abbreviated
New Drug Application (ANDA) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye
drops).

The product is a generic therapeutic equivalent version of (RLD), ACULAR Ophthalmic Solution of
Allergan Inc.

Ketorolac tromethamine Ophthalmic Solution 0.5% is a nonsteroidal, anti- inflammatory
indicated for the treatment of inflammation following cataract surgery and for the temporary
relief of ocular itching due to seasonal allergic conjunctivitis.

Seasonal allergic conjunctivitis is an allergic reaction that affects the eyes, triggered by airborne allergens such as pollen, mold spores, and pet dander during specific seasons.

According to IQVIA (IMS
Health), Ketorolac tromethamine Ophthalmic Solution 0.5% had US sales of approximately
$36 million for the 12-month period ending December 2023.

Read also: Low BP treatment: Caplin Steriles bags USFDA nod for Norepinephrine Bitartrate Injection

Caplin Point Laboratories Limited is a pharmaceutical company with a end to end business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms.

Read also: Caplin Point Labs reappoints Dr C K Gariyali as Independent director

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such
as US FDA, EU-GMP, INVIMA and ANVISA. Caplin Steriles Limited, has developed and filed 39
ANDAs in USA on its own and with partners, with 26 approvals so far. The Company is also
working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it
intends to file over the next 4 years. The company also has multiple products filed with several
approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.

Read also: Caplin Steriles gets USFDA nod for Ofloxacin Otic Solution


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Delhi AIIMS unveils groundbreaking initiatives to revolutionize neurosurgical education

New Delhi: In a groundbreaking move aimed at revolutionizing neurosurgical education and practice, the All India Institute of Medical Sciences (AIIMS) Delhi has unveiled a series of innovative initiatives. These initiatives, spearheaded by the Department of Neurosurgery, are designed to elevate standards in medical practice, enhance patient outcomes, and improve accessibility to advanced services.

With innovative training modules and technologies, Department of Neurosurgery of AIIMS, Delhi aims to equip neurosurgeons with new techniques and foster a culture of continuous medical education, officials said.

The Department of Neurosurgery at AIIMS Delhi has introduced a visionary approach to surgical training, hosting a range of innovative workshops featuring leading international and national experts.

Also Read:First: Delhi AIIMS performs dual kidney transplant on 51-year-old patient

According to ANI, “These workshops serve as dynamic platforms where doctors immerse themselves in the latest methodologies aimed at honing surgical proficiency. Leading international and national experts are invited to teach neurosurgical skills,” an official statement said on Wednesday.

This year, for the first time in India, the department utilised some of UpSurgeOn’s hyper-realistic surgical simulation models, it said.

One of the most notable advancements this year is the utilization of hyper-realistic surgical simulation models from UpSurgeOn, marking a first in India. These Italian models boast intricate layers and a realistic tissue feel, augmented with advanced, cadaver-free training through augmented reality applications.

In a bid to democratize neurosurgical education, the department has developed low-cost training modules. Notable among these is a simple ultrasound training module crafted from everyday materials. This ingenious model allows neurosurgeons to practice biopsies and localize deep brain lesions in a remarkably realistic environment.

This ingenious model, crafted from everyday materials transcends traditional boundaries to offer an immersive, hands-on learning experience.

“By utilising agar or jelly set within a glass jar to simulate the brain interface, and strategically placing berries to mimic brain lesions, trainees are offered a remarkably realistic environment to refine their skills. This affordable and easily accessible training module plays a crucial role in enhancing neurosurgeons’ ability to localise lesions,” the statement read.

Moreover, AIIMS Delhi has pioneered the development of novel solutions, including a low-cost endoscopic spine surgery simulator and a device for practicing micro-suturing, both constructed from readily available materials.

“These DIY devices, made from items such as mobile phones, optical cables, and cardboard boxes, provide surgeons with hands-on training at a fraction of the cost of foreign-made alternatives, costing less than 2000 rupees,” it said, adding that beyond their affordability, these simulators provide comprehensive training, from honing micro suturing skills to mastering endoscopic techniques, empowering surgeons with critical surgical proficiency, news agency ANI reported.

The ingenious integration of mobile phones can also allow experts to remotely provide telementoring to young surgeons, offering invaluable guidance and support previously unavailable.

Furthermore, the department has embraced collaboration with industry leaders like Microsoft and apoQlar to leverage mixed reality devices, such as the HoloLens 2. This technology facilitates a deeper understanding of complex surgical anatomy, particularly in high cervical surgeries.

Enhanced learning experiences using mixed reality devices like HoloLens 2, help students visualise complex anatomical structures in 3D, interactively explore medical scenarios, and gain practical insights. HoloLens 2, developed by Microsoft, is a mixed-reality headset that allows users to interact with holograms, overlaying digital information onto the physical world.

AIIMS, Delhi, has also invested in new digital surgery technology from Immersive Touch, a leading medical technology company building the digital surgery metaverse. Its Immersive View 5.0® VR (virtual reality) platform gives surgeons the ability to virtually plan and simulate each patient’s unique anatomy in 3D, before entering the operating room. This VR platform converts 2D data into a digital twin of the patient, providing surgeons with unobstructed views of the target anatomy from every angle and access to surgical planning tools with high fidelity with precise accuracy. More than 100 cases have been performed using the technology, which has helped both the surgeons and residents to virtually transport into the middle of an operating room for procedural rehearsal, enhancement of clinical performance, and training.

These simulators serve as invaluable tools for teaching various surgical techniques, paving the way for enhanced patient care nationwide.

Prof. Vivek Tandon, Professor of Neurosurgery, said that these simulators provide a secure environment for trainees to practice surgical techniques without risking patient safety.

“Offering repetitive practice, they boost confidence, muscle memory, and proficiency. The simulators’ realism ensures skills transfer seamlessly to real surgeries, resulting in better patient outcomes. Additionally, this cost-effective training decreases the need for cadaveric or live surgery sessions,” Dr Tandon said.

Prof. Shashank Kale, Head of the Department of Neurosurgery at AIIMS, Delhi, said that the department is committed to empowering neurosurgeons with skills and knowledge to provide exceptional patient care

“Our commitment to excellence in neurosurgical education and patient care is unwavering. Through our innovative training initiatives and strategic collaborations, we aim to empower the next generation of neurosurgeons. As the pioneers in the field of neurosurgery in India, we are proud to lead the charge in revolutionising surgical education and skill sets through our innovative initiatives. Through our low-cost simulators, our department is committed to empowering neurosurgeons with the skills and knowledge to provide exceptional patient care,” he added.

Also Read:Delhi AIIMS signs MoA with CAPFIMS, Cabinet nod to funding of Rs 2207.50 crore

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Lupin bags USFDA nod for Eslicarbazepine Acetate Tablets for partial-onset seizures

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, to market a generic equivalent of Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc.

Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.

Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Partial-onset seizures, also known as focal seizures, are a type of seizure that originates in one specific area of the brain. These seizures can cause a variety of symptoms depending on the part of the brain affected and the extent of the seizure activity.

Eslicarbazepine Acetate Tablets (RLD Aptiom) had estimated annual sales of USD 354 million in the U.S. (IQVIA MAT January 2024).

Read also: Lupin gets USFDA nod to market a generic drug to treat bacterial infections

Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin schizophrenia drug Aripiprazole gets USFDA okay

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Dr Kamakshi Memorial Hospital opens 80-bed Multispecialty Facility at Siruseri

Chennai: Dr Kamakshi Memorial Hospital, known for its unwavering commitment to superior healthcare, has announced the grand opening of its latest branch near Siruseri on OMR opposite SIPCOT. 

At the grand inauguration ceremony, Mr. Suresh Raman, Vice President and Regional Head (Chennai) of Tata Consultancy Services (TCS), was the Guest of Honour. Esteemed dignitaries were present at the event, including Mr Anwar Hussain, Chairman of Madharsha; Ms Niroopa Paulson, Chennai Branch Safety Head, TCS; Mr Venkataraman, Deputy HR Head, TCS; Mr Aravind, Operations Head (BFSI/APAC), TCS; Col. Ashok Subramanian, Chennai Admin Head, TCS; and Mr C.R. Raju, the Chief Architect of the building.

Their presence underscored the significance of this milestone in Dr. Kamakshi Memorial Hospital’s journey so far. According to the press release, this 80-bed hospital offers comprehensive healthcare solutions.  

Also Read:Dr Kamakshi Memorial Hospital sets up Parkinson’s Support Group for Holistic Patient Care

It provides round-the-clock multispecialty services using the latest technological advancements. Patients can avail of an extensive array of services, including consultations across multiple specialities, advanced diagnostic imaging (MRI, X-ray, USG, CT, ECG, ECHO, TMT, PFT), Cathlab, Clinical laboratory analyses, Pharmacy services, Physiotherapy, Endoscopy, and swift ambulance assistance, available 24/7.

Dr Kamakshi Memorial Hospitals offers an impressive spectrum of specialities, spanning Cardiology, Orthopedics, Obstetrics & Gynecology, Pediatrics, ENT, Infertility, Psychiatry, Neurology, Oncology, Preventive Medicine, Urology, Gastroenterology, Dermatology, Ophthalmology, and various other super and surgical specialities.

In the words of the company spokesperson, “Our Hospital’s integrated approach to healthcare encompasses prevention, diagnosis, treatment, and rehabilitation, empowering patients to live the healthiest life possible.

We are committed to delivering the ultimate quality of health care with the utmost excellence and personal care. The opening of this centre at Siruseri is yet another milestone in this mission.”

Dr TG Govindarajan, Founder and Chairman of Dr. Kamakshi Memorial Hospitals, addressed the gathering. He reiterated the hospital’s commitment to fostering an environment of inclusivity and compassion. “Beyond our clinical expertise lies a dedication to providing unwavering support and care to our patients and their families. From our cutting-edge facilities to our compassionate staff, we are dedicated to surpassing expectations and setting new benchmarks in healthcare excellence,” he affirmed.

Dr TG Govindarajan concluded by saying, “The opening of the Dr. Kamakshi Memorial Hospital branch at Siruseri heralds a new chapter in the saga of healthcare excellence, promising a future where innovation and compassion intertwine to sculpt healthier, happier lives.”

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Could Delirium be a strong factor for dementia?

A study published in the journal The BMJ found that delirium is a strong risk factor for dementia and death among older people and has a strong independent effect in this clinical population.

Delirium is a sudden change in a person’s usual mental state. Symptoms include agitation, confusion or being unable to stay focused when awake. Delirium is much more common in hospital patients and older people. Previous observational studies have suggested an association between delirium and subsequent dementia, but the relationship remains unclear.

For the study, researchers in Australia analysed data from 626,467 patients aged 65 years and older with no dementia diagnosis who were admitted to hospitals between January 2009 and December 2014. Of these patients, 55,211 had at least one recorded episode of delirium and were matched to another 55,211 patients without delirium by age, sex, frailty, reason for being in hospital, length of stay in hospital and length of stay in the intensive care unit. These 110,422 patients (average age 83) were then followed up for five years to see how many of them were diagnosed with dementia. Collectively, 58% of patients died and 17% had a newly reported dementia diagnosis over the follow-up period.

The results revealed that patients with delirium had a 39% higher risk of death and three times the risk of being diagnosed with dementia than patients without delirium. The relationship between delirium and dementia was stronger in men than women and each additional episode of delirium was associated with a 20% increased risk of developing dementia (a dose-response relationship).

The researchers discovered that among hospital patients with at least one episode of delirium, the risk of receiving a new dementia diagnosis was three times higher than for patients without delirium and each additional episode of delirium increased that risk by 20%.

“While our results are consistent with the hypothesis that delirium plays a causative part in dementia, they are not conclusive owing to the fundamental limitations of observational studies in determining causality. Nevertheless, the results of this study provide valuable insights because prospective randomised controlled trials are unlikely to be conducted,” concluded the researchers.

Reference: Emily H Gordon, senior lecturer, David D Ward, research fellow, Hao Xiong, research fellow, Shlomo Berkovsky, professor of medical artificial intelligence, Ruth E Hubbard, professor of geriatric medicine; Delirium and incident dementia in hospital patients in New South Wales, Australia: retrospective cohort study; Journal: The BMJ; DOI: 10.1136/bmj-2023-077634

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Eggs may not be bad for your heart after all, reveals research

Researchers have found in a prospective, controlled trial that over a four-month period cholesterol levels were similar among people who ate fortified eggs most days of the week compared with those who didn’t eat eggs. The research was presented at the American College of Cardiology’s Annual Scientific Session.

It is generally held that eggs whether consumed as sunny-side up, hard boiled or scrambled may raise cholesterol levels and be bad for heart health.

A total of 140 patients with or at high risk for cardiovascular disease were enrolled in the PROSPERITY trial, which aimed to assess the effects of eating 12 or more fortified eggs a week versus a non-egg diet (consuming less than two eggs a week) on HDL- and LDL-cholesterol, as well as other key markers of cardiovascular health over a four-month study period.

“We know that cardiovascular disease is, to some extent, mediated through risk factors like high blood pressure, high cholesterol and increased BMI and diabetes. Dietary patterns and habits can have a notable influence on these and there’s been a lot of conflicting information about whether or not eggs are safe to eat, especially for people who have or are at risk for heart disease,” said Nina Nouhravesh, MD, a research fellow at the Duke Clinical Research Institute in Durham, North Carolina, and the study’s lead author. “This is a small study, but it gives us reassurance that eating fortified eggs is OK with regard to lipid effects over four months, even among a more high-risk population.”

Eggs are a common and relatively inexpensive source of protein and dietary cholesterol. Nouhravesh and her team wanted to look specifically at fortified eggs as they contain less saturated fat and additional vitamins and minerals, such as iodine, vitamin D, selenium, vitamin B2, 5 and 12, and omega-3 fatty acids.

For this study, patients were randomly assigned to eat 12 fortified eggs a week (cooked in whatever manner they chose) or to eat fewer than two eggs of any kind (fortified or not) per week. All patients were 50 years of age or older (the average age was 66 years), half were female and 27% were Black. All patients had experienced one prior cardiovascular event or had two cardiovascular risk factors, such as high blood pressure, high cholesterol, increased BMI or diabetes. The co-primary endpoint was LDL and HDL cholesterol at four months. Secondary endpoints included lipid, cardiometabolic and inflammatory biomarkers and levels of vitamin and minerals.

Patients had in-person clinic visits at the start of the study and visits at one and four months to take vital signs and have bloodwork done. Phone check-ins occurred at two and three months and patients in the fortified egg group were asked about their weekly egg consumption. Those with low adherence were provided additional education materials.

Results showed a -0.64 mg/dL and a -3.14 mg/dL reduction in HDL-cholesterol (“good” cholesterol) and LDL cholesterol (“bad” cholesterol), respectively, in the fortified egg group. While these differences weren’t statistically significant, the researchers said the differences suggest that eating 12 fortified eggs each week had no adverse effect on blood cholesterol. In terms of secondary endpoints, researchers observed a numerical reduction in total cholesterol, LDL particle number, another lipid biomarker called apoB, high-sensitivity troponin (a marker of heart damage), and insulin resistance scores in the fortified egg group, while vitamin B increased.

“While this is a neutral study, we did not observe adverse effects on biomarkers of cardiovascular health and there were signals of potential benefits of eating fortified eggs that warrant further investigation in larger studies as they are more hypothesis generating here,” Nouhravesh said, explaining that subgroup analyses revealed numerical increases in HDL cholesterol and reductions in LDL cholesterol in patients 65 years or older and those with diabetes in the fortified egg group compared with those eating fewer than two eggs.

So why have eggs gotten a bad rap? Some of the confusion stems from the fact that egg yolks contain cholesterol. Experts said a more important consideration, especially in the context of these findings, might be what people are eating alongside their eggs, such as buttered toast, bacon and other processed meats, which are not heart healthy choices. As always, Nouhravesh said it’s a good idea for people with heart disease to talk with their doctor about a heart healthy diet.

This single-center study is limited by its small size and reliance on patients’ self-reporting of their egg consumption and other dietary patterns. It was also an unblinded study, which means patients knew what study group they were in, which can influence their health behaviors.

Reference:

Eggs may not be bad for your heart after all, American College of Cardiology, Meeting: American College of Cardiology’s Annual Scientific Session.

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