Lucknow hospitals on high alert, 100 beds reserved to manage emergencies during Holi

Lucknow: To provide swift treatment to those getting injured in accidents on Holi, the Health Department has put all hospitals in Lucknow on alert and asked all the doctors and paramedical staff to remain on duty on March 24 and 25 respectively.   

Specifically asking the healthcare community for assistance, Deputy CM Brajesh Pathak has directed the doctors and hospital staff at all government hospitals in the emergency department to be available on duty for 48 hours. In addition, he also asked hospitals to store essential medicines. 

Alerting government hospitals to enhance their emergency services during Holi, the government have reserved collectively 100 beds at various government hospitals on Sunday and Monday to avoid any inconvenience to the patients in cases of an emergency.

Also read- PM Modi Inaugurates Gyaltsuen Jetsun Pema Wangchuk Mother And Child Hospital

The Trauma Centre at King George’s Medical University (KGMU) Lucknow, has allocated 20 beds for medical emergencies. Senior residents from each department have been assigned duties to ensure doctors from all branches remain on duty throughout Holi.

Similarly, the medical teams at Ram Manohar Lohia Institute of Medical Sciences, Civil, and BRD Mahanagar hospitals have been notified, and the civil hospitals have allocated 15 beds specifically for emergency cases.

A total of 44 ambulances (on emergency numbers 102 and 108) will be on the road throughout the day. In cases of emergency, people can dial 108 or 112 to get help to reach a medical centre.

“In Lucknow, 44 ambulances under 108 service will remain on high alert. Also, 34 ambulances under 102 service for pregnant women will also be on alert,” said TVSK Reddy, senior vice president, of Emri Green Health Services which runs 108 ambulance service in the state.

In case of an injury, individuals can seek assistance by contacting the helpline at 9118455570, where medical professionals on emergency duty will respond to the call.

Speaking to HT, Dr Manoj Agrawal, chief medical officer of Lucknow said, “All hospitals have been asked to ensure that senior consultants and para-medical staff are available to deal with any sort of medical emergency, particularly on Sunday and Monday 48 hours. This is in addition to the regular facilities available in emergency and OPD,” said Dr Manoj Agrawal, chief medical officer of Lucknow.

“Duty of senior residents from each department unit has been assigned so that doctors from all branches remain on duty during Holi. The peak starts in the afternoon. Hence, all have been asked to remain on high alert,” said Prof Sandip Tiwari, head of the Department of Trauma Surgery and chief medical superintendent of the trauma centre at KGMU.

“An eye specialist, a general surgeon, a skin specialist and an orthopaedic surgeon will be available round the clock. Our special focus is on ensuring a team of different specialists on Monday particularly as past experiences show more than usual accident cases come on the Holi day,” said Dr NB Singh, chief medical superintendent, of Balrampur Hospital.

“Beds will be reserved to deal with emergency cases during the two days of festivities. Our teams have been asked to stay on alert,” said Dr Ajai Shankar Tripathi, medical superintendent, of Lok Bandhu Hospital.

Also read- Sakra World Hospital To Set Up 500-Bed Hospital In Bengaluru For Rs 1000 Crore

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Medical Bulletin 23/ March/ 2024

Here are the top medical news for the day:

Sedentary lifestyle may affect risk of erectile dysfunction, finds study

According to a study published in the journal Andrology, a higher genetic susceptibility to leisure time may be associated with a greater risk of erectile dysfunction in men.

The prevalence of ED varies worldwide, with studies suggesting rates ranging from 5% to 25% in men aged 40 and older. Erectile dysfunction (ED) can stem from various factors, including physical conditions such as cardiovascular disease, diabetes, obesity, hormonal imbalances, and neurological disorders. Psychological factors like stress, anxiety, depression, and relationship issues can also contribute.

Leisure time can indirectly affect erectile dysfunction through its impact on overall health. Engaging in sedentary activities for a longer time can increase the risk of obesity, cardiovascular disease, and diabetes, all of which are significant contributors to ED.

In the study, researchers analysed data of more than 200,000 men and found that each 1.2 hour increase in leisure computer usage predicted 3.57-fold greater odds of erectile dysfunction. There was no evidence to suggest that watching television or driving for leisure increased the risk of erectile dysfunction. Also, computer use was not linked with depression, anxiety, or markers of blood vessel health, but it was associated with lower levels of follicle-stimulating hormone, which plays a role in sexual development and reproduction in both males and females.

The study revealed substantial evidence for a positive causal association between leisure time and the risk of erectile dysfunction. Extended computer usage for leisure raises the likelihood of developing erectile dysfunction, which may be associated to lower hormones that aid in sexual development.

The study’s findings suggested that moderate physical activity may be useful in correcting the dysfunction by improving cardiovascular health and balancing hormones.

Reference: Zhao Huangfu, Xinxin Gan, Yiren Yang, Qingyang Pang, Baohua Zhu, Xiao Zhang, Linhui Wang; A Mendelian randomization study on causal effects of leisure sedentary behavior on the risk of erectile dysfunction; Journal: Andrology; DOI:10.1111/andr.13611

Could antibiotics help fight COVID-19?

New research published in the Journal of Medical Virology indicated that antibiotics can effectively target bacteria in the gut that harbour the virus that causes COVID-19 and produce toxin-like peptides that contribute to COVID-19-related symptoms.

The bacteriophage behaviour of SARS-CoV-2 during the acute and post-COVID-19 phases appeared to be an important factor in the development of the disease. The early use of antibiotics seemed to be crucial to inhibit disease progression—to prevent viral replication in the gut microbiome, and control toxicological production from the human microbiome.

To study the impact of specific antibiotics on recovery from COVID-19 and long COVID (LC) taking into account: vaccination status and time of initiation of antibiotic therapy, researchers recruited a total of 211 COVID-19 patients in the study: of which 59 were vaccinated with mRNA vaccines against SARS-CoV-2 while 152 were unvaccinated. Patients were enrolled in three waves: from September 2020 to October 2022, corresponding to the emergence of the pre-Delta, Delta, and Omicron variants of the SARS-CoV-2 virus.

In the analysis, both vaccinated and unvaccinated groups had a median illness duration of 7 days, the median illness duration for the pre-Delta and Delta waves was 8 days, while it was shorter, 6.5 days, for Omicron.

The results showed that patients with comorbidities had a significantly longer disease duration: median 8 days compared to 7 days for those without comorbidities. Early initiation of antibiotic therapy resulted in a significantly shorter recovery time. Concomitant use of antibiotics did not reduce disease duration and in multivariate analysis prolonged the disease. A subgroup of 42 patients receiving corticosteroids for a median of 3 days had a longer recovery time compared to others.

The findings revealed a statistically significant reduction in recovery time among patients who received early antibiotic treatment. Early initiation of antibiotics played a crucial role in maintaining higher levels of blood oxygen saturation. In addition, it is worth noting that a significant number of patients who received antibiotics in the first 3 days and for a duration of 7 days, during the acute phase did not develop Long Covid.

Reference: Carlo Brogna, Luigi Montano, Maria Elisabetta Zanolin, Domenico Rocco Bisaccia, Gianluca Ciammetti, Valentina Viduto, Mark Fabrowski, Abdul M. Baig, Joachim Gerlach, Iapicca Gennaro, Elio Bignardi, Barbara Brogna, Aquilino Frongillo, Simone Cristoni, Marina Piscopo; A retrospective cohort study on early antibiotic use in vaccinated and unvaccinated COVID-19 patients; Journal: Journal of Medical Virology; DOI: 10.1002/jmv.29507

Does diet play a role in Vitiligo?

In a recent study published in the Journal of Cosmetic Dermatology, researchers combined available data to explore the impacts of diet and nutritional interventions against vitiligo.

Vitiligo is a rare autoimmune disorder characterized by the loss of skin pigmentation in patches or blotches, usually around the mouth, hair, and eyes. It is estimated to affect between 0.004% and 2.28% of the global population, and while phototherapy and pharmacological interventions can reduce symptom visibility, no cure for the condition currently exists. Heightened concentrations of reactive oxygen species (ROS) in tandem with reduced efficacy of the body’s normal antioxidant mechanisms is assumed to substantially exacerbate the disease.

As is the case in other chronic conditions characterized by altered ROS metabolism (some cancers and neurodegenerative conditions), diets are being explored for their potential antioxidant properties.

In the study, researchers discussed up-to-date outcomes from studies and publications exploring the association between diet and vitiligo. Two independent reviewers collected papers from online scientific repositories, while in another pilot study, the effectiveness of high-dose oral vitamin D supplementation on vitiligo repigmentation was investigated in 16 individuals with vitamin D deficiency vitiligo. Over half of the patients experienced 26%–75% repigmentation after consuming 35,000 IU daily.

The results highlighted the critical role of ROS and the body’s antioxidant mechanisms in the development and progression of vitiligo. ROS-producing heavy metals like cadmium (Cd), Mercury (Hg), and lead (Pb) are implicated as disease-causing substances. In contrast, the roles and impacts of micronutrients remain poorly understood.

Furthermore, diets and nutritional interventions rich in ROS-depleting molecules (such as vitamin C, B12, and D, polyunsaturated fatty acids (PUFAs), and antioxidants are observed to trigger beneficial vitiligo outcomes and reduce the burden of metabolism, cellular deterioration, and oxidative stress brought about by ROS.

The study concluded that while dietary interventions cannot be thought of as a standalone therapy, they still make a case for being used as adjuncts. Many food items that have antioxidants can be used in therapy for this disease, because of the pathophysiological nature of the disease.

Reference: Hadi, Z., Kaur, R., Parekh, Z., Khanna, S., Bin Khalil, A. B., Abbasi, H. Q., Ashfaque, F., Shah, D., Patel, V. J., & Hasibuzzaman, M. A. Exploring the impact of diet and nutrition on vitiligo: A systematic review of dietary factors and nutritional interventions. Journal of Cosmetic Dermatology, DOI – 10.1111/jocd.16277

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West Bengal Surgeons successfully remove glass bottle from man’s rectum through innovative approach

Midnapore: In a successful and unique operation, a team of doctors at Midnapore Medical College and Hospital surgically removed a glass bottle along with a cork from a man’s rectum by squeezing out the bottle via the rectum on Tuesday.  

The man reported to be in his 30s accidentally inserted a glass bottle inside him following which the doctors noticed through x-ray that the object had moved further upwards encouraging them to perform surgery immediately after an attempt to remove the object without surgery failed. 

The surgical team consisted of Dr Sumitava Pachal, Dr Rafi Moazzam, Dr Saurav Kanji, and Dr Aftab Alam. They effectively extracted the glass bottle and cork from his body, ensuring the integrity of the gut and the safety of the rectum throughout the procedure.

Also read- Living Recipient Receives World’s First Genetically-Edited Pig Kidney Transplant At Massachusetts General Hospital

The incident came to light when the patient visited the hospital’s emergency ward with complaints of extreme abdominal pain and problems with bowel movements. Although he had done an x-ray from a private lab, the doctors at the hospital conducted a second x-ray to determine the severity of the case. 

In the second x-ray, the doctors noticed a bottle-shaped object lodged in his pelvis in the lower abdomen region which had moved further upwards. To remove the object from his body through surgery as they failed to do it manually, the doctors took an innovative approach instead of performing laparotomy which involved cutting open the patient’s stomach and pushing the object out via the rectum.

On March 19 at midnight, the doctors’ team successfully removed the glass bottle from his rectum by squeezing out the bottle via the rectum that reduced the patient’s recovery time from four months to less than a week

Speaking to The Telegraph in detail Dr Sumitava Pachal, the lead surgeon of the operating team said, “When we asked him several times about what exactly happened, the patient told us that he accidentally inserted a glass bottle inside him and insisted that no one else had forced or manipulated him into doing this.”

“Our biggest fear was what if the glass bottle breaks amid our attempts to extract it out. The usual operating procedure entails cutting the rectum and removing the bottle, just like delivering a baby from a woman’s uterus. But, we decided to adopt an innovative approach where we had to squeeze out the bottle via the rectum, literally like a tomato ketchup sachet”, he added.

“Rectal foreign body cases are not common in a government hospital’s emergency ward, except in psychiatric patients. We will discharge him within a day after talking to the neighbours who brought him to us as he lives alone,” said Dr Pachal.

Also read- Sri Sathya Sai Health And Education Trust, The Hans Foundation Collaborate For 300 Cost-Free Heart Surgeries For Children

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Novo Nordisk Awiqli recommended for approval for diabetes by European regulatory authorities

Denmark: Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults.

The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators. In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec. Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile.

“We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We are committed to driving innovation in diabetes treatment, and Awiqli has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”

Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months.

Awiqli is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection.

The ONWARDS clinical development programme comprised six phase 3a global clinical trials, which investigated the efficacy and safety of once-weekly basal insulin icodec, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.

Novo Nordisk is a global healthcare company, founded in 1923 and headquartered in Denmark. The Company markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).

Read also: Novo Nordisk hopes to launch weight loss pill Amycretin this decade

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USFDA grants full approval for Abbvie Elahere for certain ovarian cancer patients

North Chicago, Ill.: AbbVie has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.

“The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.

ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator’s choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FRα and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

“As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that,” said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.

MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator’s choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.

Based on current results:

  • OS hazard ratio (HR) was 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046), representing a 33% reduction in risk of death in the ELAHERE arm compared to the IC chemotherapy arm.
  • PFS HR was 0.65 (95% CI: 0.52, 0.81; p<0.0001), representing a 35% reduction in the risk of tumor or cancer progression in the ELAHERE arm compared to IC chemotherapy.
  • ELAHERE showed overall fewer Grade 3+ adverse events and a lower rate of discontinuations due to adverse events when compared to the IC chemotherapy control group.

Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities.

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. 

The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries.

Read also: FDA approves new dermal filler for hollows in upper face

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No need to pay requisite fee if already paid: NMC tells medical colleges on submission of annual declaration

New Delhi: Through a recent notice, the National Medical Commission (NMC) has told the medical colleges they need not pay the requisite fee for Renewal, Recognition or Continuation of Recognition for the academic year 2024-25, if they have already made the payment.

Earlier, stating that the submission of the Annual Declaration Form on the National Medical Commission’s (NMC) portal is mandatory for annual renewal of permission of undergraduate MBBS seats, the Undergraduate Medical Education Board (UGMEB) of NMC directed all medical colleges to fill their details on NMC portal.

At that time, medical colleges/institutes were notified that the requisite fee of ₹ 3,54,000(including 18% GST) must be paid online through the portal’s payment gateway along with the application for permission of admission of seats for UG courses for the academic year 2024-25, irrespective of prior payments.

Now, the NMC has told the medical colleges that have already made the payment to not pay the requisite fee again but they need to submit the details of the payment made with the NMC. The recent notice read:

“All Medical Colleges/Institutes are hereby informed that in case such Medical Colleges/Institutes have already paid the requisite fee for Renewal/Recognition/ Continuation of Recognition for the year 2024-25 need not to pay the fee again. Details of the payment made are required to be filled in the requisite column in payment gateway of the portal along with the supporting documents” 

Medical Dialogues had earlier reported that in the previous notice, the NMC further warned that no seat will be permitted if any medical college fails to submit the annual declaration within the deadline.

“All Medical Colleges/Institutes having valid Letter of Permission (LoP) for MBBS admission are hereby directed to fill the details/data of respective Institutions on NMC portal for annual declaration as required in the NMC Act, 2019 and various regulations issued by NMC from time to time. Submission of duly completed Annual Declaration Form of each College on NMC Portal is mandatory for annual renewal of permission of UG-MBBS seats. No seat shall be permitted in case the College/Institution fails to submit the Annual Declaration within the specified time period,” stated the NMC.

The Commission had said that all the medical colleges must make the payment online irrespective of whether the payment has been made earlier or not. It also mentioned that no mode of payment other than payment gateway shall be acceptable. “Payment, if any, made earlier on account of Renewal/Recognition/Continuation of Recognition shall be refunded by the Accounts Division of NMC separately,” NMC clarified in its notice.

To view the official Notice, Click here : https://medicaldialogues.in/pdf_upload/public-notice-24-234890.pdf

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PM Modi inaugurates Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital

New Delhi: Prime Minister Narendra Modi inaugurated the state-of-the-art hospital, Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital built with Indian assistance showcasing the robust development cooperation between India and Bhutan.

The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital is a state-of-the-art 150-bedded facility that has been built with the assistance of the Government of India in Thimphu. 

“A boost to partnership in healthcare. PM @narendramodi together with PM @tsheringtobgay of Bhutan inaugurated the Gyaltsuen Jetsun Pema Mother and Child Hospital in Thimphu. The state-of-the-art hospital is a shining example of India-Bhutan development cooperation,” External Affairs Ministry Spokesperson Randhir Jaiswal said in a post on X.

Also Read:PM Modi inaugurates 960-bed AIIMS Kalyani, IPD services open for patients

India’s support for the hospital’s development spanned two phases, with the first phase operational since 2019, constructed at a cost of Rs 22 crore. The second phase, initiated in 2019 as part of the 12th Five Year Plan and completed recently at a cost of Rs 119 crore, further enhances the hospital’s capabilities.

The new facility promises to elevate the quality of mother and child health services in Bhutan, boasting state-of-the-art departments for Pediatrics, Gynecology and Obstetrics, Anesthesiology, Operation Theatre, Neonatal Intensive Care, and Pediatric Intensive Care.

According to PTI, “The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital stands as a shining example of India-Bhutan partnership in health care,” it added.

“Bhutan has been receiving a lot of support from India, especially in the health sector, starting from the three referral hospitals and also other health facilities,” Bhutan Health Minister Tandin Wangchuk told PTI Videos.

“It is an honour for us to have Shri Narendra Modi here, inaugurating the Gyaltsuen Jetsun Pema Mother and Child Hospital,” he said, adding that this hospital is purely dedicated to the mothers and the children of Bhutan.

He added that there is a proposal for a cancer hospital which will come up on this campus only. “We are referring all the cancer patients to India. So after the completion of the cancer hospital, I think this will also enhance the tertiary care of health services in Bhutan,” he added.

According to PTI reports, Modi, who arrived in Bhutan on Friday for a two-day State visit to further cement India’s unique relations with the Himalayan nation, called on the King of Bhutan, Jigme Khesar Namgyel Wangchuck and held talks with Prime Minister Tobgay on Friday.

Modi also announced India’s commitment to provide Rs 10,000 crore in support to Bhutan over the next five years.

Bhutan’s King Wangchuck conferred the ‘Order of the Druk Glyalpo’ to Prime Minister Modi at a public ceremony here on Friday, making him the first foreign Head of the Government to receive the honour.

 The award recognizes Modi’s efforts in bolstering India-Bhutan friendship and his people-centric leadership.

“It is with great humility that I accept the Order of the Druk Gyalpo. I am grateful to HM the King of Bhutan for presenting the Award. I dedicate it to the 140 crore people of India. I am also confident that India-Bhutan relations will keep growing and benefit our citizens,” Modi wrote in a post on X on Friday night.

India and Bhutan established diplomatic relations in 1968.

The basic framework of India- Bhutan relations has been the Treaty of Friendship and Cooperation signed in 1949 between the two countries, which was revised in February 2007.

Also Read:PM Modi inaugurates 300-bed PGI satellite centre in Sangrur

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Research reveals link between menstrual cycles, emotions, and sleep patterns in women

Women experience disruptions in their sleep patterns and report heightened feelings of anger in the days leading up to their period, according to new research.

The study sheds new light on the intricate relationship between women’s menstrual cycles, emotions, and sleep patterns.

Co-author Dr Jo Bower, of the University of East Anglia’s School of Psychology, said: “Our research provides valuable insights into the complex interplay between menstrual cycles, emotions, and sleep and the impact of hormonal fluctuations on women’s well-being.

“By understanding how these factors interact, we can better address the unique needs of women in terms of sleep health and emotional well-being.”

The study analysed data from 51 healthy women aged between 18 and 35, who had regular periods and were not taking hormonal contraception.

Utilising ecological momentary assessment (EMA) methodology, reproductive-aged women completed daily self-reports on their sleep and emotion measures and wore actiwatches (a sleep/wake tracking watch) to track sleep across two menstrual months.

The researchers discovered compelling associations between menstrual phases, emotional states, and sleep quality.

Key findings from the study include:

• Women experience disruptions in their sleep patterns in the days leading up to and during their period (peri-menstrual phase), spending more time awake at night, with a lower proportion of time spent in bed that is asleep (lower sleep efficiency).

• During the peri-menstrual phase, women report heightened feelings of anger compared to other phases of their menstrual cycle.

• Sleep disturbances during the peri-menstrual phase correlate with reduced positive emotions such as calmness, happiness, and enthusiasm.

This contributes to a growing body of evidence suggesting that menstrual cycles may play a significant role in women’s vulnerability to insomnia and mental health issues.

Dr Bower added: “The findings underscore the importance of considering hormonal fluctuations when addressing sleep disorders and emotional distress in women.

“The implications of this research reach further than just the controlled setting, providing potential pathways for interventions and treatments aimed at enhancing sleep quality and emotional resilience in women.”

Although the study had unique strengths, such as the use of both objective and subjective prospective data across two menstrual cycles, the researchers said the findings must be interpreted within the context of several limitations.

For example, the data was collected between May 2020 and January 2021, and precisely how the Covid-19 pandemic impacted outcomes cannot be fully known.

Although the researchers did not find strong effects for pandemic stress on outcome variables, they cannot discount the fact that the pandemic likely impacted participants’ emotional experiences and sleep-wake behaviours.

Reference:

Jessica M. Meers, Joanne Bower, Sara Nowakowski, Candice Alfano, Interaction of sleep and emotion across the menstrual cycle, Journal of Sleep Research, https://doi.org/10.1111/jsr.14185.

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JnJ gets USFDA nod for Opsynvi for chronic treatment of adults with pulmonary arterial hypertension

Raritan: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. 

OPSYNVI may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.

PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure. An estimated 500 to 1,000 new cases of PAH are diagnosed each year in the U.S., classifying the disease as a rare condition.

The 2022 European Society of Cardiology (ESC) / European Respiratory Society (ERS) clinical guidelines recommend initial combination therapy of an ERA and a PDE5 inhibitor for patients with idiopathic PAH, heritable drug-associated PAH, or PAH-associated with connective tissue disease without cardiopulmonary comorbidities at low or intermediate risk.

“Clinical guidelines recommend treating patients with initial and sequential dual-combination therapy, regardless of risk at initial diagnosis and follow-up. Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available,” said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.* “As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, the introduction of a single tablet combining both is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation for the appropriate patients.”

The FDA’s approval of OPSYNVI is based on the results from the pivotal Phase 3 A DUE study, in which OPSYNVI demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy. OPSYNVI has a Boxed Warning due to the risk of embryo-fetal toxicity and requires female patients to enroll in the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS) program.

With the approval, Johnson & Johnson now offers a PAH portfolio addressing all three foundational and guideline-recommended pathways – nitric oxide, endothelin, and prostacyclin.

“People with PAH often live with the burden of taking many pills each day, which can pose challenges,” said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson. “We’re thrilled to bring this single tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment.”

Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.

The A DUE study was a double-blind, randomized, active-controlled, multi-center, adaptive, parallel-group study designed to compare the efficacy and safety of OPSYNVI to macitentan and tadalafil monotherapies in adult patients with PAH (WHO FC II or III). The three-arm trial enrolled patients from across 76 sites in 16 countries/territories worldwide who were treatment-naïve or on a stable dose of an endothelin receptor antagonist (ERA), or a phosphodiesterase 5 (PDE5) inhibitor, for at least three months. The primary endpoint was change from baseline in PVR at the end of double-blind treatment at 16 weeks and was considered met if macitentan and tadalafil fixed-dose combination (FDC) treatment was superior to both monotherapies. Following the treatment period, patients transitioned to the open-label treatment period for 24 months.

Read also: USFDA nod to Johnson and Johnson EDURANT PED for certain pediatric patients living with HIV-1

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New classification of tuberculosis to support efforts to eliminate the disease

A new way to classify tuberculosis (TB) that aims to improve focus on the early stages of the disease has been presented by an international team involving researchers at UCL.

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