Which antidepressants are less likely to effect weight gain?

New evidence comparing weight gain under eight different first-line antidepressants finds that bupropion users are 15-20% less likely to gain a clinically significant amount of weight than users of sertraline, the most common medication.

The findings are published in Annals of Internal Medicine.

Antidepressants are among the most commonly prescribed medications in the U.S., with 14% of U.S. adults reporting using an antidepressant. Weight gain is a common side effect, which could affect patients’ long-term metabolic health and cause some to stop taking their prescribed treatment, leading to poor clinical outcomes. Although antidepressants overall are associated with weight gain, specific antidepressant medications may affect weight differently.

The new findings, led by investigators from the Harvard Pilgrim Health Care Institute reveal which common antidepressants are associated with the most and least weight gain following medication initiation.

“Patients and their clinicians often have several options when starting an antidepressant for the first time. This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants,” said lead author Joshua Petimar, Harvard Medical School assistant professor of population medicine at the Harvard Pilgrim Health Care Institute. “Clinicians and patients can use this information, among other factors, to help decide on the right choice for them.”

Researchers used electronic health record prescription data from eight health systems in the U.S. participating in PCORnet, the National Patient-Centered Clinical Research Network, to conduct the study using data from 183,118 adults ages 18-80 years who were new users of antidepressants. While randomized control trials are considered the most rigorous method for comparing the effects of different medications, they are prohibitively costly and time consuming. In this case, the study team emulated a randomized trial by designing their ideal, hypothetical trial and aligning the data to match that trial as closely as possible.

Study investigators compared weight at 6, 12, and 24 months after initiation of eight common antidepressants: sertraline, citalopram, escitalopram, fluoxetine, paroxetine, bupropion, duloxetine, and venlafaxine.

Results showed that bupropion users gained the least amount of weight compared to users of other antidepressants. Bupropion users were approximately 15-20% less likely to gain a clinically significant amount of weight than those taking the most common medication, sertraline. The researchers considered weight gain of 5% or more as clinically significant. Results also showed a large percentage of patients were taking a medication that led to greater weight gain than alternatives that are commonly available in the same class or subclass. For example, sertraline, escitalopram, and paroxetine are all selective serotonin reuptake inhibitors (SSRI), the most common type of antidepressant, but escitalopram and paroxetine were each associated with an approximate 15% higher risk of gaining a clinically significant amount of weight than sertraline in the first 6 months.

“Although there are several reasons why patients and their clinicians might choose one antidepressant over another, weight gain is an important side effect that often leads to patients stopping their medication,” said senior author Jason Block, a general internal medicine physician and Harvard Medical School associate professor of population medicine at the Harvard Pilgrim Health Care Institute. “Our study found that some antidepressants, like bupropion, are associated with less weight gain than others. Patients and their clinicians could consider weight gain as one reason for choosing a medication that best fits their needs.”

Reference:

Joshua Petimar,  Jessica G. Young, Han Yu, Sheryl L. Rifas-Shiman, Matthew F. Daley,William J. Heerman, David M. Janicke, Medication-Induced Weight Change Across Common Antidepressant Treatments: A Target Trial Emulation Study, Annals of Internal Medicine,  https://doi.org/10.7326/M23-2742

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Study compares Air-Q SP and PLMA Efficacy in patients undergoing elective surgery under GA

New supraglottic airway devices have been introduced with innovative capabilities.Recently published randomized controlled trial compared the performance of the Air-Q self-pressurized laryngeal airway (Air-Q SP) and the Proseal laryngeal mask airway (Proseal LMA) in 90 adult patients undergoing elective surgery under general anesthesia. The primary outcome measure was oropharyngeal leak pressure (OLP), while secondary outcomes included device insertion time, fiberoptic view of the larynx, hemodynamic and respiratory parameters, and postoperative complications.

OLP and Device Insertion Time –

All supraglottic airway devices were successfully inserted within two attempts. The mean initial OLP and OLP at 10 minutes were significantly lower in the Air-Q SP group compared to the Proseal LMA group (24.09 ± 1.66 cmH2O vs 29.62 ± 2.15 cmH2O initially, and 28.53 ± 1.66 cmH2O vs 36.73 ± 2.64 cmH2O at 10 minutes). However, the device insertion time was significantly shorter for the Air-Q SP compared to the Proseal LMA (12.29 ± 1.52 seconds vs 18.82 ± 1.43 seconds).

Fiberoptic Laryngeal View and Other Parameters –

The fiberoptic laryngeal view grading was significantly better with the Air-Q SP, with more patients having a grade 3 or 4 view (vocal cords plus posterior epiglottis visible or only vocal cords visible) compared to the Proseal LMA group. There were no significant differences between the groups in terms of ease of insertion, number of manipulations required, hemodynamic parameters, respiratory parameters, or postoperative sore throat.

Conclusion and Implications

The authors concluded that while the Proseal LMA had a higher oropharyngeal leak pressure than the Air-Q SP, the Air-Q SP had a faster insertion time and better fiberoptic laryngeal view. Overall, both devices were effective for positive pressure ventilation. The authors suggest the Air-Q SP may offer advantages over the Proseal LMA, particularly the faster insertion time and superior fiberoptic view, which could make it a more attractive option in certain clinical situations.

The study was limited by the lack of blinding of the anesthesiologist performing the device insertions, as well as only including patients with expected “easy” airways. Further research would be needed to evaluate the performance of these devices in patients with more difficult airways or compromised respiratory function. Nonetheless, this study provides useful comparative data on the clinical performance of these two supraglottic airway devices in adult patients undergoing elective surgery.

Key Points –

Here are the 3 key points of the research paper:

1. The study compared the performance of the Air-Q self-pressurized laryngeal airway (Air-Q SP) and the Proseal laryngeal mask airway (Proseal LMA) in 90 adult patients undergoing elective surgery under general anesthesia. The primary outcome measure was oropharyngeal leak pressure (OLP), while secondary outcomes included device insertion time, fiberoptic view of the larynx, hemodynamic and respiratory parameters, and postoperative complications.

2. The Proseal LMA had significantly higher initial and 10-minute OLP compared to the Air-Q SP, but the Air-Q SP had a significantly shorter device insertion time. The fiberoptic laryngeal view was also significantly better with the Air-Q SP, with more patients having a grade 3 or 4 view. There were no significant differences between the groups in other secondary outcomes.

3. The authors concluded that while the Proseal LMA had higher OLP, the Air-Q SP offered advantages such as faster insertion time and superior fiberoptic view, suggesting it may be a more attractive option in certain clinical situations. However, the study was limited by lack of blinding and only including patients with expected “easy” airways, so further research is needed to evaluate the devices in patients with more difficult airways or compromised respiratory function.

Reference –

Rana S, Anand LK, Singh M, Kapoor D, Gupta D, Kaur H. Comparative evaluation of self‑pressurized Air‑Q® and ProsealTM LMA® in patients undergoing elective surgery under general anaesthesia: A randomized clinical trial. J Anaesthesiol Clin Pharmacol 2024;40:336‑43.

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Survey shows aspirin use remains high among older adults, despite risks

A survey representing about 150 million adults annually suggests that aspirin use for primary prevention of cardiovascular disease (CVD) remains prevalent among older adults, contrary to recommendations from the American College of Cardiology and the American Heart Association. According to the study authors, these findings highlight the urgent need for physicians to inquire about aspirin use and discuss the benefits and risks with older patients. The findings are published in Annals of Internal Medicine.

Researchers from Cleveland Clinic studied data from the National Health Interview Survey Sample Adult component (2012–2019 and 2021) to characterize trends in prevalence of aspirin use for CVD prevention. Participants aged 40 years or older were asked to report aspirin use and were stratified by age group and CVD status based on self-reported history of stroke, myocardial infarction, coronary artery disease, or angina.

The data showed that aspirin use declined from 2018 to 2019 after new evidence prompted the American College of Cardiology and the American Heart Association to recommend against aspirin therapy for primary prevention in older adults. Still, even after this decline, nearly a third of adults aged 60 or older without CVD were still using aspirin in 2021, and nearly 1 in 20 were using it without medical advice. Overall, 25.6 million adults reported aspirin use in the U.S, with 18.5 million adults aged 60 years or older using aspirin in 2021. The findings suggest a need to reduce inappropriate use of aspirin among older adults.

Reference:

 Mohak Gupta, Snigdha Gulati, Khurram Nasir, and Ashish Sarraju, Aspirin Use Prevalence for Cardiovascular Disease Prevention Among U.S. Adults From 2012 to 2021,Annals of Internal Medicine, https://doi.org/10.7326/M24-0427.

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To regenerate the kidney, please don’t pass the salt, suggests study

A loss of salt and body fluid can stimulate kidney regeneration and repair in mice, according to a NIH-funded study led by USC Stem Cell scientist Janos Peti-Peterdi and published in The Journal of Clinical Investigation. This innate regenerative response relies on a small population of kidney cells in a region known as the macula densa (MD), which senses salt and exerts control over filtration, hormone secretion, and other key functions of this vital organ.

“Our personal and professional mission is to find a cure for kidney disease, a growing global epidemic affecting one out of seven adults, which translates to 850 million people worldwide or about 2 million in the Los Angeles area,” said Peti-Peterdi, a professor of physiology, neuroscience and medicine at the Keck School of Medicine of USC. “Currently, there is no cure for this silent disease. By the time kidney disease is diagnosed, the kidneys are irreversibly damaged and ultimately need replacement therapies, such as dialysis or transplantation.”

To address this growing epidemic, Peti-Peterdi, first author Georgina Gyarmati, and their colleagues took a highly non-traditional approach. As opposed to studying how diseased kidneys fail to regenerate, the scientists focused on how healthy kidneys originally evolved.

“From an evolutionary biology perspective, the primitive kidney structure of the fish turned into more complicated and more efficiently working kidneys to absorb more salt and water,” said Peti-Peterdi, who also directs the Multi-Photon Microscopy Core at the Zilkha Neurogenetic Institute (ZNI). “This was necessary for adaptation to the dry land environment when the animal species moved from the salt-rich seawater. And that’s why birds and mammals have developed MD cells and this beautiful, bigger, and more efficient kidney structure to maintain themselves and functionally adapt to survive. These are the mechanisms that we are targeting and trying to mimic in our research approach.”

With this evolutionary history in mind, the research team fed lab mice a very low salt diet, along with a commonly prescribed drug called an ACE inhibitor that furthered lowered salt and fluid levels. The mice followed this regimen for up to two weeks, since extremely low salt diets can trigger serious health problems if continued long term.

In the region of the MD, the scientists observed regenerative activity, which they could block by administering drugs that interfered with signals sent by the MD. This underscored the MD’s key role in orchestrating regeneration.

When the scientists furthered analyzed mouse MD cells, they identified both genetic and structural characteristics that were surprisingly similar to nerve cells. This is an interesting finding, because nerve cells play a key role in regulating the regeneration of other organs such as the skin.

In the mouse MD cells, the scientists also identified specific signals from certain genes, including Wnt, NGFR, and CCN1, which could be enhanced by a low-salt diet to regenerate kidney structure and function. In keeping with these findings in mice, the activity of CCN1 was found to be greatly reduced in patients with chronic kidney disease (CKD).

To test the therapeutic potential of these discoveries, the scientists administered CCN1 to mice with a type of CKD known as focal segmental glomerulosclerosis. They also treated these mice with MD cells grown in low-salt conditions. Both approaches were successful, with the MD cell treatment producing the biggest improvements in kidney structure and function. This might be due to the MD cells secreting not only CCN1, but also additional unknown factors that promote kidney regeneration.

“We feel very strongly about the importance of this new way of thinking about kidney repair and regeneration,” said Peti-Peterdi. “And we are fully convinced that this will hopefully end up soon in a very powerful and new therapeutic approach.”

Reference:

Georgina Gyarmati, Urvi Nikhil Shroff, Anne Riquier-Brison, Dorinne Desposito, Wenjun Ju, Sean D. Stocker, Audrey Izuhara, Sachin Deepak, Alejandra Becerra Calderon, James L. Burford, Hiroyuki Kadoya, Ju-Young Moon, Yibu Chen, Neuronally differentiated macula densa cells regulate tissue remodeling and regeneration in the kidney, Journal of Clinical Investigation, DOI:10.1172/JCI174558.

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Prolonged Antibiotic Use in Very Preterm Infants Linked to Increased Mortality Risk: JAMA

A new study published in the Journal of the American Medical Association found that very preterm infants (VPIs) who were at low risk for early-onset sepsis (EOS) and exposed to prolonged or broad-spectrum antibiotics were more likely to develop moderate to severe bronchopulmonary dysplasia (BPD).

Antibiotic overuse in preterm newborns with low risk of early-onset sepsis is linked to higher death and morbidity rates. Thereby, Wei Shi and colleagues undertook this study to assess the relationship between varied durations and kinds of early antibiotic exposure and the occurrence of BPD in VPIs at a low-risk of EOS.

This nationwide multicenter cohort research used data from the Chinese Neonatal Network (CHNN) that gathered data prospectively from January 1, 2019 to December 31, 2021.The cohort included VPIs less than 32 weeks of gestational age or with a birth weight of less than 1500 grams. These infants were further categorized as low risk for EOS based on criteria such as cesarean delivery, absence of labor or rupture of membranes, and no clinical evidence of chorioamnionitis.

The key findings of this study were:

  • Of the 27,176 VPIs included in the CHNN throughout the research period, a total of 6510 were classed as low risk for EOS.
  • Among them, 1324 (20.3%) faced no antibiotic exposure, 1134 (17.4%) had 1 to 4 days of antibiotic treatment and 4052 (62.2%) received 5 to 7 days of antibiotic therapy.
  • Of the 5186 VPIs who got antibiotics, 4098 (79.0%) infants got broad-spectrum antibiotics, 888 (17.1%) infants got narrow-spectrum antibiotics and 200 (3.9%) infants were given antifungals or other antibiotics.
  • Prolonged exposure (5-7 days) was related with an increased risk of moderate to severe BPD or mortality. The use of broad-spectrum antibiotics (1-7 days) was also linked to an elevated risk of moderate to severe BPD and mortality.

Overall, this analysis of VPIs at low risk for EOS, extended or broad-spectrum antibiotic use was linked to an elevated chance of acquiring moderate to severe BPD or mortality. These findings indicate that VPIs who were exposed to extended or broad-spectrum antibiotics early in infancy should be monitored for the potential complications.

Source:

Shi, W., Chen, Z., Shi, L., Jiang, S., Zhou, J., Gu, X., Lei, X., Xiao, T., Zhu, Y., Qian, A., Zhou, W., Lee, S. K., Du, L., Yang, J., Ma, X., Hu, L., Chen, C., Cao, Y., … Chen, X. (2024). Early Antibiotic Exposure and Bronchopulmonary Dysplasia in Very Preterm Infants at Low Risk of Early-Onset Sepsis. In JAMA Network Open (Vol. 7, Issue 6, p. e2418831). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2024.18831

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Fezolinetant therapy effective for women with menopausal vasomotor symptoms: Study

A recent study published in the Menopause journal found promising outcomes for women who undergo moderate-to-severe vasomotor symptoms (VMS) due to menopause. The research further characterize the efficacy of fezolinetant in treating these symptoms by focusing on whether the treatment resulted in clinically meaningful changes for patients without adjusting for placebo effects.

The analysis was based on pooled data from two phase 3, randomized, double-blind, placebo-controlled studies, known as SKYLIGHT 1 and 2. These studies involved a detailed responder analysis to measure the effectiveness of fezolinetant. The participants were considered responders if they underwent reductions in VMS frequency by 50%, 75%, 90% or 100% from baseline to weeks 4 and 12.

To evaluate the efficacy of fezolinetant, the study utilized patient-reported outcome (PRO) measures. They assessed clinically meaningful changes at week 4 and week 12 when compared to baseline. These measures included the frequency of VMS, the Patient-Reported Outcomes Measurement Information System Sleep Disturbance–Short Form 8b Total Score (PROMIS SD SF 8b), the Menopause-Specific Quality of Life (MENQoL) Total Score and the MENQoL VMS Domain Score.

The study also conducted double and triple responder analyses. These analyses combined VMS frequency with one or more PRO measures to further substantiate the effectiveness of fezolinetant. Also, the Patient Global Impression of Change VMS was used as an anchor measure to assess meaningful within-patient change in VMS frequency. 

The outcomes demonstrated a significant difference in the proportion of responders between the fezolinetant-treated groups and the placebo-treated groups. The participants receiving fezolinetant showed greater reductions in VMS frequency across all responder thresholds (50%, 75%, 90% and 100%) at both week 4 and week 12.

At week 12, a higher proportion of responders was observed in the fezolinetant groups for all four single responder analyses when compared to the placebo groups. The double and triple responder analyses further supported the beneficial effects of fezolinetant, with favorable odds ratios indicating its efficacy over placebo.

The study concluded that fezolinetant is associated with significantly higher within-patient clinically meaningful improvements in several important patient-reported outcomes. These include VMS frequency, sleep disturbance scores, overall quality of life, and menopause-specific quality of life domains.

The findings from this study illuminated the potential of fezolinetant as an effective treatment option for women with menopausal vasomotor symptoms by providing substantial relief and improving their overall quality of life. This finding could lead to improved management of menopause symptoms and a better quality of life for many women. This data indicates that fezolinetant reduces the frequency of VMS and leads to meaningful improvements in related quality of life measures for the individuals affected by menopausal symptoms.

Reference:

Nappi, R. E., Johnson, K. A., Stute, P., Blogg, M., English, M., Morga, A., Scrine, L., Siddiqui, E., & Ottery, F. D. (2024). Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2). In Menopause (Vol. 31, Issue 6, pp. 512–521). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/gme.0000000000002354

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MPDME Releases Tentative Schedule for NEET MDS 2024 Round 1 Counselling, details

Madhya Pradesh- The Madhya Pradesh Directorate of Medical Education (MPDME) has released a tentative schedule for MP State Combined NEET MDS Counselling 2024.

As per the schedule, the registrations begin from tomorrow.

The tentative schedule are as follows-

S.NO

ACTIVITY

DATE

NO. OF DAYS

1

Registration by eligible candidates of NEET MDS 2024.

03-07-2024 to 10-07-2024 (12:00 Midnight)

8 Days

2

Publication of Vacancies.

05-07-2024

1 Day

3

Invitation of Objection Against Vacancies.

06-07-2024 to 07-07-2024.

2 Days

4

Disposal of Objection.

08-07-2024.

1 Day

5

Publication of Final Vacancies.

09-07-2024.

1 Day

6

Publication of Merit list of registered candidates.

11-07-2024.

1 Day

7

Choice filling and choice locking for the first round.

12-07-2024 to 15-07-2024 (12:00 Midnight).

4 Days

8

First-Round Allotment Result.

19-07-2024.

9

Reporting at allotted college in person for document verifications and admission.

20-07-2024 to 25-07-2024 (06:00 PM).

6 Days

10

Willingness for upgradation for the second round by admitted candidates through the candidate’s login.

20-07-2024 to 25-07-2024 (12:00 Midnight).

6 Days

11

Online Resignation/Cancellation of admission at college level.

20-07-2024 to 25-07-2024 (07:00 PM).

6 Days

To view the schedule, click the link below

https://medicaldialogues.in/pdf_upload/mpdme-releases-tentative-schedule-for-neet-pg-2024-round-1-counselling-for-mds-course-242821.pdf
The MCC had earlier released the state counselling schedule for MDS Admissions this year. 

S.NO

SCHEDULE FOR ADMISSION

ALL INDIA QUOTA/DEEMED & CENTRAL UNIVERSITIES

SHARING OF JOINED CANDIDATE’S DATA BY MCC

STATE COUNSELLING

SHARING OF JOINED CANDIDATE’S DATA BY STATES

1

Ist Round of Counselling.

1st July, 2024 to 10th July, 2024.

19th July, 2024.

10th July to 20th July, 2024.

26th July to 27th July, 2024.

2

Last date of Joining.

The last date of Joining is 17th July 2024.

–

25th July, 2024.

–

3

2nd round of Counselling.

7 th Aug, 2024

–

12th Aug, 2024.

–

4

Round-3.

12th Aug to 21st Aug, 2024.

29th Aug., 2024.

21st Aug 2024 to 26th Aug, 2024.

31st Aug.,2024.

5

Last date of joining.

28th Aug., 2024.

–

30th Aug., 2024.

–

6

Stray Vacancy.

2nd Sept., 2024 to 7th Sept., 2024.

–

5th Sept., 2024 to 10th Sept., 2024.

–

7

Last date of joining.

14th Sept., 2024.

–

14th Sept., 2024.

–

It is to be noted that, to ensure faithful obedience of the time schedule and also keeping in view the limited time available for conducting counselling, all participating institutes/colleges are directed to treat all Saturdays/ Sundays and Gazetted Holidays as working days.

Also Read: CPS Mumbai announces schedule for PG medical admissions 2023-24 academic year through NEET PG 2023 merit, all details here

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BFUHS Invites Applications for NEET MDS 2024 admissions, details

Punjab- Baba Farid University of Health Sciences (BFUHS) is inviting online applications from eligible candidates on the basis of National Eligibility-Entrance Test-Master of Dental Surgery (NEET-MDS) for 2024 for admission to MDS courses in government/private colleges, private universities and minority institutions in the state of Punjab.

The registration for admission to MDS courses in government/private colleges, private universities, and minority institutions in Punjab has already been started from yesterday i.e. 01 July 2024 and will be valid till 05 July 2024 till 12:00 noon. The eligible candidates can register themselves through the official website of BFUHS. 

With this, candidates should note that the last date for depositing the registration fee through the online payment gateway is also 05 July 2024, the official notice in this regard informed.

Also Read: BSc Nursing admissions 2024: BFUHS Releases Revised schedule, check details

NEET-MDS is an eligibility-and-ranking examination prescribed as a single entrance examination for admission to various MDS courses. No other entrance examination in the state or institution level will be valid for admission to MDS courses. Candidates have to qualify the NEET-MDS for admission to MDS courses under various universities/institutions in the country.

Candidates have to score the minimum cutoff to qualify the NEET-MDS exam, although the qualifying marks differ for different categories. The NEET MDS cutoff percentile is 50 for General and EWS, 45 for UR PWD category candidates, and 40 for the SC. ST, OBC (including PWD of SC/ST/OBC) category candidates.

Also Read: BFUHS Releases Revised Schedule for BSc Paramedical Courses 2024 Registration, Online Counseling

NEET-MDS 2024 was conducted by the National Board of Examination in Medical Sciences (NBEMS) on March 18, 2024. The examination was conducted on a single day and in a single session through a computer-based platform at various examination centres across the country. The result of NEET-MDS has been declared on the official website of NBE on 3rd April.

Baba Farid University of Health Sciences was established in July 1998 by Punjab Act No. 18. It is named after Baba Farid, a 12th-century Punjabi Sufi headquartered in Faridkot. The mission of the University is to create an intellectual, academic, and physical environment conducive to the free flow of ideas and exchange of information between various faculties of the University and between this University and other Universities of Health Sciences in the country and abroad.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/neet-mds-2024-bfuhs-invites-applications-for-mds-admissions-via-neet-mds-2024-242816.pdf

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Novo Nordisk Gets CDSCO Panel Nod To Import, Market Insulin Icodec to treat diabetes mellitus in adults

New Delhi: The drug major Novo Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market the Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml for the indication of treatment of diabetes mellitus in adults.

However, this approval is subject to the condition that the drug major, Novo Nordisk, conduct an active post-market surveillance (PMS) study.

Furthermore, the expert panel stated that the drug shall be prescribed only by a registered endocrinologist or physician with a postgraduate qualification in medicine.

This came after the firm presented the product approval from the NRA of the country of origin, i.e., the EMA for grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml.

Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. It is currently under investigation for the treatment of type 1 and 2 diabetes in the phase 3 ONWARDS programme.

Insulin remains the cornerstone of diabetes treatment. However, initiation of insulin therapy in type 2 diabetes is often delayed, despite uncontrolled blood sugar levels, leading to an increased risk of diabetes-related complications.

The insulin icodec molecule has been engineered by modifying human insulin to give it a prolonged half-life of approximately 7 days. Three amino acid substitutions have been introduced to provide molecular stability, minimise the enzymatic breakdown of insulin icodec, and reduce receptor-mediated clearance.

Insulin icodec is formulated at 700 units/mL to ensure that the injection volume is similar to that of once-daily basal insulin. It is designed to be injected subcutaneously once a week with an easy-to-use pen and optional digital support for personalized automated dose guidance.

At the recent SEC meeting for endocrinology and metabolism held on June 19, 2024, the expert panel reviewed the product approval from NRA of country of origin, i.e. EMA for grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, 2100 U/3ml.

After detailed deliberation, the committee recommended the grant of permission to import and market Insulin Icodec 700 U/ml, 1050 U/1.5 ml, and 2100 U/3 ml for the indication of treatment of diabetes mellitus in adults with the following conditions:

1) The firm should conduct an active PMS study.
2) The drug shall be prescribed only by a registered endocrinologist or physician with a graduate qualification in medicine.

Accordingly, the expert panel suggested that the firm submit an active PMS study protocol within three months of the grant of marketing authorization permission and a revised PI of the product to CDSCO for approval.

Also Read:CDSCO Panel Approves AstraZeneca pharma’s Protocol Amendment proposal to study Anifrolumab

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38-week pregnant woman, unborn child dies at Govt Hospital, probe on

The medical staff at a government-run Pandit Madan Mohan Malviya Hospital in Malviya Nagar are facing accusations of medical negligence following the tragic death of a 38-week pregnant woman and her unborn child on Saturday.

According to reports, Singh the husband of the deceased alleged that the hospital staff failed to provide her with adequate treatment. He further claimed that no senior doctors attended her when she was experiencing complications at the hospital.

For more information, click on the link below:

Alleged Delay In Treatment: Pregnant Woman Dies At Delhi Govt Hospital, Probe On

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