Intervention reduces likelihood of developing postpartum anxiety and depression by more than 70%

Results from a large clinical trial funded by the National Institutes of Health show that an intervention for anxiety provided to pregnant women living in Pakistan significantly reduced the likelihood of the women developing moderate-to-severe anxiety, depression, or both six weeks after birth. The unique intervention was administered by non-specialized providers who had the equivalent of a bachelor’s degree in psychology-but no clinical experience. The results suggest this intervention could be an effective way to prevent the development of postpartum mental health challenges in women living in low-resource settings.

“In low resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, M.D., Ph.D., Director of the National Institute of Mental Health, part of NIH. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period.”

Led by Pamela J. Surkan, Ph.D., Sc.D., of Johns Hopkins Bloomberg School of Public Health, Baltimore, the study was conducted in the Punjab Province of Pakistan between April 2019 and January 2022. Pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either routine pregnancy care or a cognitive behavioral therapy (CBT)-based intervention called Happy Mother-Healthy Baby. The researchers assessed the participants (380 women in the CBT group and 375 women in the routine care group) for anxiety and depression six weeks after the birth of their child.

The researchers found that 9% of women in the intervention group developed moderate-to-severe anxiety compared with 27% of women in the routine care group. Additionally, 12% percent of women in the intervention group developed depression compared with 41% of women in the routine care group.

“Postpartum depression not only harms mothers, it is also associated with poorer physical growth and delayed cognitive development in their children,” said Dr. Surkan. “The link between maternal and child health highlights the critical importance of developing effective ways to address postpartum anxiety and depression.”

The Happy Mother-Healthy Baby intervention was created using input from pregnant women in a hospital in Rawalpindi, Pakistan. Pregnant women took part in six intervention sessions where they learned to identify anxious thoughts and behaviors, such as thoughts about possible miscarriage, and to practice replacing them with helpful thoughts and behaviors. The first five sessions were conducted in early to mid-pregnancy, and the sixth session occurred in the third trimester.

Prior research suggests that up to 30% of women in the Global South, which includes South America, Africa, and most of southern Asia, report experiencing anxiety during pregnancy. Anxiety during pregnancy predicts the development of anxiety and depression after birth, making the prenatal period a prime target for intervention. However, it can be challenging for women living in low-resource settings to access trained clinical care. The findings from this study demonstrate that an intervention such as Happy Mother-Healthy Baby could be an effective way to help prevent the development of postpartum depression and anxiety in settings where specialist clinical care may be hard to access.

“In the future, we can build on these findings through implementation research. Having identified an intervention that works, the next step is to figure out the best ways to deliver effective treatment to the people who need it, bridging the gap between science and practice,” said Dr. Surkan.

Reference:

Surkan, P. J., Malik, A., Perin, J., Atif, N., Rowther, A., Zaidi, A., & Rahman, A. (2024). Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: A randomized, phase 3 trial. Nature Medicine. https://www.nature.com/articles/s41591-024-02809-x.

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Hyperlactatemia after heart transplantat tied to greater risk of mortality and veno-arterial ECMO initiation: Study

Hyperlactatemia (HL) is a prevalent complication following cardiac surgery. It is related to tissue hypoperfusion and hypoxia. The condition is tied to poor clinical outcomes.

According to a study published in the Journal of Cardiology, Severe hyperlactatemia following orthotopic heart transplant was linked to a higher likelihood of VA ECMO initiation and mortality at 30 days post-transplant.

Although HL is often observed following orthotopic heart transplantation (OHTx), the relationship between the two pertaining to outcomes is unclear. The study investigated the occurrence and consequences of HL in patients following OHTx.

This study examined 209 adult patients who underwent heart transplantation between January 2011 and December 2020. These were stratified into three groups based on peak lactate levels within the first 72 hours postoperatively: group 1 (normal to mild hyperlactatemia, <5 mmol/L, n=42), group 2 (moderate hyperlactatemia, 5-10 mmol/L, n=110), and group 3 (severe hyperlactatemia, >10 mmol/L, n=57). The primary endpoint was all-cause mortality or veno-arterial extracorporeal membrane oxygenation ( VA ECMO) initiation within 30 days, while secondary endpoints included duration of mechanical ventilation, ICU length of stay, and hospital LOS.
Key results of the study are:
  • Patients with higher postoperative peak lactate levels were more commonly transplanted from left ventricular assist device support (33.3 % vs 50.9 % vs 64.9). They had longer cardiopulmonary bypass time (127 min vs 141 min vs 153 min)
  • 8.6 % of patients (n=18) met the Composite primary endpoint. It was more common in patients with higher postoperative peak lactate levels (0.0 % vs 6.4 % vs 19.3 %).
  • Postoperative hyperlactatemia (HL) >5 mmol/L was seen in 79.9% of patients after OHTx.
  • Early postoperative HL was tied to a greater risk of mortality and or use of VA ECMO.
  • The threshold value was high, around 10 mmol/L. the sensitivity and specificity were 61.1% and 75.9%, respectively.
  • There was a 32 % increase in the risk of the primary outcome for each unit increase in lactate with OR 1.32
  • CPB time and preoperative durable LVAD were associated with postoperative severe HL.
Concluding further, they found Postoperative HL to be associated with a higher rate of death and or use of VA ECMO. Cardiopulmonary bypass time and preoperative durable left ventricular assist device were related to postoperative severe HL.
Reference:
Doi, A., Batchelor, R., Demase, K. C., Manfield, J. C., Burrell, A., Paul, E., Marasco, S., Kaye, D., & McGiffin, D. C. (2024). Impact of postoperative hyperlactatemia in Orthotopic heart transplantation. Journal of Cardiology. https://doi.org/10.1016/j.jjcc.2024.02.001

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Incidence, diagnosis, therapy, and prognosis of acute mesenteric ischaemia, AMESI Study reveals

Recently published multicentre prospective observational study was conducted to investigate the incidence, patient characteristics, diagnostic pathway, management, and outcome of acute mesenteric ischaemia (AMI). The study included adult patients with clinical suspicion of AMI admitted or transferred to 32 participating hospitals worldwide. It was found that AMI occurred in 0.038% of adult admissions in participating acute care hospitals, with a total of 705 included patients, of which 418 patients had confirmed AMI. The study revealed that occlusive arterial AMI was the most common type diagnosed, followed by venous AMI and non-occlusive AMI (NOMI).

Management and Outcome of Acute Mesenteric Ischaemia (AMI)

In 69% of cases, AMI was the primary reason for hospital admission, and in 31% of cases, AMI occurred after being admitted with another diagnosis. The median time from onset of symptoms to hospital admission was 24 hours, and the time from admission to diagnosis was 6 hours. Initial management involved surgery in 58% of patients, with 24.4% undergoing revascularization. The overall in-hospital and 90-day mortality rates for AMI were 49% and 53.3%, respectively, with the highest mortality seen in the NOMI subtype (72.7% and 74.5%).

Variability and Need for Standardization in Management of Acute Mesenteric Ischaemia (AMI)

The study also highlighted the variability between participating sites for most variables studied, indicating a lack of standardized management internationally. Furthermore, the findings suggest a need for greater awareness of AMI, better guidance in diagnosis and management, and emphasize the importance of computed tomography angiography and immediate surgical treatment in patients with suspected AMI. The study provided valuable insights into the incidence, characteristics, diagnostic pathways, management, and outcomes of AMI, but also highlighted the need for further research and consensus processes to improve the understanding and management of this condition.

Reference –

Reintam Blaser, A., Mändul, M., Björck, M. et al. Incidence, diagnosis, management and outcome of acute mesenteric ischaemia: a prospective, multicentre observational study (AMESI Study). Crit Care 28, 32 (2024). https://doi.org/10.1186/s13054-024-04807-4

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Gastric bypass surgery bests sleeve gastrectomy for continued remission of diabetes, finds study

Roux-en-Y gastric bypass (RYGB) is known for its high rates of type-2 diabetes mellitus (T2DM) remission, believed to be primarily driven by weight loss. However, recent research suggests that RYGB may offer metabolic benefits beyond weight reduction, especially compared to sleeve gastrectomy (SG).

Researchers have found in a new study that Roux-en-Y gastric bypass was superior to sleeve gastrectomy (SG) in managing T2DM in obese patients.

This study was published in the Journal Of The American College Of Surgeons by Ghanem and colleagues.

This study aimed to investigate the continued diabetes remission (CDR) rates despite weight recurrence (WR) after Roux-en-Y gastric bypass compared to SG. A retrospective review was conducted on patients who underwent RYGB or SG with a BMI ≥ 35 kg/m2 and a preoperative diagnosis of T2DM. Patients with less than five years of follow-up, absence of WR, or lack of T2DM remission at nadir weight were excluded. CDR rates were stratified into WR quartiles and compared between RYGB and SG cohorts.

The key findings of the study were:

  • 224 RYGB and 46 SG patients were analyzed.

  • Overall CDR rate was significantly higher in the RYGB group (75%) compared to the SG group (34.8%).

  • Odds of T2DM recurrence were 5.5 times higher after SG compared to RYGB.

  • Rates of CDR were stratified into WR quartiles: 85.5% (<25% WR), 81.7% (25-44.9% WR), 63.2% (45-74.9% WR), and 60% (>75% WR).

  • Baseline insulin use, higher preoperative HbA1c, and longer preoperative duration of T2DM were associated with T2DM recurrence, whereas WR was not.

Roux-en-Y gastric bypass demonstrates continued diabetes remission rates despite weight recurrence, suggesting a weight-loss independent metabolic benefit, likely facilitated by bypassing the proximal small-intestine. These findings underscore the potential superiority of RYGB over SG in managing T2DM in obese patients.

Reference:

Ghanem, O. M., Abi Mosleh, K., Kerbage, A., Lu, L., Hage, K., & Abu Dayyeh, B. K. Continued diabetes remission despite weight recurrence: Gastric bypass long-term metabolic benefit. Journal of the American College of Surgeons,2024 10.1097/XCS.0000000000000934. https://doi.org/10.1097/xcs.0000000000000934

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Recent trends in epidemiology of dyslipidemias in India: Key takeaways

India: A recent study published in the Indian Heart Journal has shed light on the trends in the epidemiology of dyslipidemias in India.

Dyslipidemia is the most important risk factor for coronary artery disease (CAD). High total cholesterol and its principal subtypes: low-density lipoprotein (LDL) cholesterol and non-high-density lipoprotein (NHDL) cholesterol are the most important. The article does not cover the epidemiology of lipoprotein(a), an emerging risk factor.

Epidemiological and Mendelian randomization studies have confirmed the role of raised triglycerides and lipoprotein(a). Prospective Urban Rural Epidemiology (PURE) study identified raised NHDL cholesterol as the most important risk factor. Regional and multisite epidemiological studies in India have reported increasing population levels of total-, LDL-, and NHDL cholesterol and triglycerides. INTERHEART study showed a significant association of raised ApoB/ApoA1, total-, LDL-, and NHDL-cholesterol in South Asians.

India Heart Watch reported a higher prevalence of total and LDL cholesterol in northern and western Indian cities. ICMR-INDIAB study reported regional variations in hypercholesterolemia (≥200 mg/dl) from 4.6 % to 50.3 %, with greater prevalence in northern states, Kerala, Goa, and West Bengal.

Non-Communicable Disease Risk Factor Collaboration and Global Burden of Diseases Studies have reported increasing LDL- and NHDL-cholesterol in India. Studies among emigrant Indians in the UK and USA have reported higher triglycerides compared to Caucasians.

The key takeaways from the study are as follows:

  • Dyslipidemia prevalence varies with age, gender, residence region, and socioeconomic status. There are geographic variations in the prevalence of various dyslipidemias in India. India Heart Watch study in 11 cities across India reported variable prevalence of various dyslipidaemias in different geographic regions.
  • While the prevalence of raised total and LDL-C was higher in northern and western Indian cities that of raised triglycerides was higher in eastern and southern states. Cities with better human development index had higher total and LDL-C, while those with lower development index had more hypertriglyceridemia.
  • Significant state-level variation in various dyslipidemias has been reported by the ICMR-INDIAB study. This study shows that the highest prevalence of raised total and LDL cholesterol is in more developed states of the country (Kerala, Goa, Delhi, etc.) while hypertriglyceridemia and low HDL are widely prevalent.
  • Dietary factors could be important but need more studies.
  • Adherence to well-structured population-based and individual-level interventions to reduce dyslipidemia, as suggested by the World Heart Federation, shall result in a decrease in cardiovascular mortality and morbidity in our country.

“Identification of regional variations and trends in dyslipidemias needs more nationwide surveys,” the researchers wrote. “Prospective studies are needed to assess the quantum of risk with the incidence of coronary artery disease.”

Reference:

Sharma, S., Gaur, K., & Gupta, R. (2024). Trends in epidemiology of dyslipidemias in India. Indian Heart Journal.. https://doi.org/10.1016/j.ihj.2023.11.266

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AIIMS NORCET 6 Exam 2024 registration begins, All details here, Apply Now

New Delhi- All India Institute of Medical Sciences (AIIMS) has invited online applications for the Nursing Officer Recruitment Common Eligibility Test (NORCET-6) for recruitment to Nursing Officer posts at Level 07.

As per the notice, Online (CBT) for stage I for NORCET Preliminary will be held on Sunday, April 14, 2024 and the Online (CBT) for stage II for NORCET Mains is scheduled to be held on Sunday, May 5th, 2024.

Interested applicants can submit their application through online mode only. Online applications can be made through the official website of AIIMS from 26 February to 17 March 2024 till 5:00 pm.

ESSENTIAL QUALIFICATION

1 B.Sc. (Hons.) Nursing / B.Sc. Nursing from an Indian Nursing Council/state Nursing council recognized Institute or UniversityOR BSc. (Post-Certificate) / Post-Basic B.Sc. Nursing from an Indian Nursing Council/State Nursing council recognized Institute/ University.

2 Registered as Nurses & Midwife with State / Indian Nursing Council

3 Diploma in General Nursing Midwifery from an Indian Nursing Council/State Nursing council recognized Institute / Board or Council.

4 Registered as Nurses & Midwife in State / Indian Nursing Council.

5 Two Years’ Experience in a minimum 50 bedded Hospital after acquiring the educational qualification mentioned above as applicable for all Participating AIIMS.

It is to be noted that candidates must have two years of valid experience. The experience shall be acquired after obtaining Essential Qualification, i.e. after completing the residency period of the course, declaration of result & registration with the State/Indian Nursing Council.

APPLICATION FEE

A General/OBC Candidates- Rs.3000/- (Rupees Three Thousand only) B) SC/ST.

B Candidates/EWS- Rs.2400/- (Rupees Twenty-Four Hundred only) .

C Persons with Disabilities- Exempted.

IMPORTANT POINTS

1 The candidate can pay the prescribed application fee through DEBIT CARD/CREDIT CARD/ NETBANKING. Transaction / Processing fee, if any, as applicable, will be payable to the bank by the candidate.

2 Application fee, once remitted, shall not be refunded under any circumstances.

3 Applications without the prescribed fee would not be considered and summarily rejected.

4 Application Fees of SC/ST candidates who appear in the Examination will be refunded after the declaration of results in due course of time after verification of SC/ST certificate to be uploaded at a later stage.

DOCUMENTS

1 Candidates applying under any of the reserved category i.e. SC/ST/OBC will be considered subject to submission of valid Caste certificate on a prescribed format issued by the competent authority.

2 For Persons with Disability, Disability Certificate issued by duly constituted and authorised Medical Board in the proforma prescribed by the Department of Personnel & Training Vide O.M. No. 36035/3/2004-Estt. (Res.) dated 29.12.2005.

3 Educational qualification certificates/Category Certificates etc. must be submitted as and when required by AIIMS New Delhi or by the respective Institute and also on the day of document verification, failing which candidature will be canceled.

4 Those who are in employment with state/Central Govt/PSU, must submit a “NO OBJECTION CERTIFICATE” from the employer at the time of verification of documents or as asked to upload.

AGE LIMIT

For AIIMS, the candidates must be between 18-30 Years. It has been instructed that the age will be counted on the last date of closing of the application form.

PAY SCALE

As per the notice, the pay matrix pre-revised pay band -2 is Rs. 9300-34800 with grade pay Rs. 4600/-, as per the vacancies available in Group-B respective institutions for AIIMS New Delhi and other AIIMS.

Lastly, it is clearly directed that if any person is found guilty of misconduct for any reason then legal and disciplinary action will be initiated by AIIMS, New Delhi.

To view the official notice, click the link below

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Elobixibat Shows Promise in Treating Chronic Constipation in Parkinson’s Disease

Chronic constipation is a common gastrointestinal issue among individuals with Parkinson’s disease (PD), significantly impacting their quality of life. Elobixibat, an ileal bile acid transporter inhibitor, has shown potential in improving bowel movements and stool consistency in patients with chronic constipation.

However, its efficacy specifically in PD patients with constipation has not been extensively studied. A recent double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of elobixibat in PD patients with chronic constipation. This study was published in the journal Of International Parkinson and Movement Disorder Society by Taku H. and colleagues.

The study consisted of a 2-week observation/washout period followed by a 4-week treatment period. Patients were assessed for spontaneous bowel movements (SBM) frequency, stool form, quality of life (QOL) parameters, and adverse events. The study included 38 patients in the elobixibat group and 39 in the placebo group, with 37 patients completing the study in each group.

The key findings of the study were:

  • The elobixibat group showed a significant increase in SBM frequency per week from baseline (4.2 ± 2.6) to Week 4 (5.9 ± 3.2) (P = 0.0079).

  • Whereas the placebo group did not show a significant increase (4.5 ± 2.7 to 5.3 ± 3.5; P = 0.0889).

  • Although the primary endpoint of between-group difference in frequency changes at Week 4 was not significant after adjustment, a significant difference was observed at Week 1.

  • Additionally, elobixibat improved stool form and scores related to satisfaction and stigma.

Elobixibat demonstrated improvement in SBM frequency and QOL parameters, suggesting its potential therapeutic benefits in PD patients with chronic constipation. Further research is warranted to explore the long-term efficacy and safety of elobixibat in this patient population.

Reference:

Hatano, T., Oyama, G., Shimo, Y., Ogaki, K., Nishikawa, N., Nakamura, R., Tsunemi, T., Ogawa, T., Eguchi, H., Daida, K., Kurita, N., Ueno, S.-I., Fukae, J., Sako, W., Shiina, K., Nakajima, S., Oji, Y., Wakamori, R., Saiki, S., … Hattori, N. Efficacy and safety of elobixibat in Parkinson’s disease with chronic constipation: CONST‐PD study. Movement Disorders Clinical Practice,2024. https://doi.org/10.1002/mdc3.13972

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Health bulletin 27/ February/ 2024

Here are the top health stories for the day:

Delhi man swallows 39 coins, 37 magnets for ‘body-building’

A 26-year-old man underwent surgery at Sir Ganga Ram Hospital in Delhi after experiencing persistent vomiting and abdominal pain for over 20 days. The surgery revealed an astonishing cause: the patient had ingested 39 coins and 37 magnets, believing the zinc in the coins would aid his bodybuilding efforts. This unusual behavior was noted against a backdrop of psychiatric illness, with the patient having a history of consuming such objects in recent weeks. Initial X-rays and a subsequent CT scan disclosed a significant accumulation of these items in his intestine, causing a blockage that necessitated urgent surgical intervention.

PM inaugurates Rs 491-crore JIPMER-Karaikal campus in Puducherry

Prime Minister Narendra Modi recently inaugurated the Karaikal campus of the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) through a virtual event. This new extension of JIPMER in Karaikal has been developed at a cost of Rs 491 crore. The campus initially started operating in August 2016, accommodating an annual intake of 50 MBBS students in temporary facilities. To establish a permanent campus, the Puducherry government allocated two plots spanning over 67.33 acres, planning the development in two phases.


New USC Study Reveals Diet That Reverses Aging in Humans
A groundbreaking study from the University of Southern California (USC) has revealed significant health benefits of a diet mimicking fasting, showing potential in reducing insulin resistance, cutting down liver fat, boosting the immune system, and curbing biological aging. Conducted by the USC Leonard Davis School of Gerontology, this research underscores the advantages of periodic adherence to a fasting-mimicking diet (FMD).

Published in Nature Communications, the study highlights the FMD’s role in lessening aging indicators within the immune system, alongside diminishing insulin resistance and liver fat levels, thereby contributing to a younger biological age in clinical trial participants.

The FMD, formulated by img 15 Valter Longo of the USC Leonard Davis School, is a plant-based diet lasting image 16 five days, rich in unsaturated fats and low in calories, proteins, and carbohydrates, aiming to emulate the benefits of water-only fasting while still providing essential nutrients. This makes the diet more feasible for individuals to maintain.

Refrence: Brandhorst, S., Levine, M.E., Wei, M. et al. Fasting-mimicking diet causes hepatic and blood markers changes indicating reduced biological age and disease risk. Nat Commun 15, 1309 (2024). https://doi.org/10.1038/s41467-024-45260-9

 

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Why this kolaveri di? 3 nurses suspended for making reels in Hospital OT

Raipur: Three nurses were dismissed from service for allegedly filming reels in the operation theatre of a Dau Kalyan Singh PG Institute and Research Centre in Raipur in Chhattisgarh and sharing them on social media. 

The services of Pushpa Sahu, Tripti Dasar and Tej Kumari, who were daily wage staff nurses at Dau Kalyan Singh PG Institute and Research Centre Raipur, were terminated on February 23 after a complaint was received against them, said facility deputy superintendent Dr Hemant Sharma. 

Also Read:Wrong blood transfusion on pregnant woman: Two doctors terminated, staff nurse suspended

On February 5, reels shot by the trio inside the operation theatre of the burn and plastic surgery unit came to the notice of the Assistant Nursing Superintendent following which higher authorities were informed, he said.

“Clicking pictures and making reels inside operation theatres is against rules. The nurses are also seen wearing shoes and sandals that they usually wear outside the OT. They allegedly misbehaved with the ward incharge when she objected to their act,” he said.

In one of the two reels shared by the hospital management, the three nurses, wearing green dresses used in operation theatres, are seen dancing holding surgical items to songs like ‘first rahu mai dar badar’ and ‘why this kolaveri di’.

Speaking to media persons, Hemant Sharma posted as the deputy superintendent of the hospital said that as soon the video went viral, a complaint was lodged against them, and they were terminated soon after, reports HT.

 Also Read:3 doctors served notices, Nurse suspended over swapping of newborn bodies at Indore Hospital

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Synokem Pharma Gets CDSCO Panel Nod To Study Antidiabetic FDC

New Delhi: The drug major Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate plus Metformin Hydrochloride.

However, the approval is subject to the condition that the doctor (MD Medicine) should be present during the study.

This came after the drug maker Synokem Pharmaceutical presented its proposal for the BE study protocol and Phase III clinical trial protocol before the committee.

Empagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose. The glucose-lowering effect of the drug is independent of insulin.

Sitagliptin belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control which is demonstrated by reduced glycosylated hemoglobin (HbA1c).

Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose absorbed from food and the amount of glucose made by the liver.

At the recent SEC meeting for endocrinology and metabolism held on 24th January 2023, the expert panel reviewed the proposal presented with the BE study protocol and Phase III clinical trial protocol of the FDC antidiabetic drug.

After detailed deliberation, the committee recommended the grant of permission to conduct the BE study with the condition that a doctor (MD Medicine) should be present during the study.

Accordingly, the expert panel suggested that the firm should submit a BE study report for review by the committee to make further decisions on the Phase III clinical trial protocol.

Also Read:Submit Safety Data From Phase I CT : CDSCO Panel Tells Novo Nordisk on CagriSema

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