Diabetic Retinopathy and Nephropathy May Not Progress Together in Type 2 Diabetes, Reveals Study

USA: A recent study published in Frontiers in Endocrinology has shed light on a critical finding: diabetic retinopathy (DR) and diabetic nephropathy (DN)—two major microvascular complications in type 2 diabetes—do not always progress in parallel. Conducted by Dr. Ashley Fitzgerald and colleagues from the Department of Ophthalmology and Visual Sciences, University of New Mexico School of Medicine, the cross-sectional case-control study aimed to evaluate the degree of concordance between the severity of DR and DN in a New Mexican diabetic population.     

To explore this relationship, researchers analyzed data from two distinct patient groups—one with end-stage renal disease (ESRD, Stage 5, on dialysis) and the other with early-stage DN (Stage 1 or 2). The ESRD group included 164 individuals with severely reduced kidney function (eGFR <15 mL/min), while the mild DN group comprised 165 patients with relatively preserved kidney function (eGFR >60 mL/min). Retinal status was evaluated through dilated fundus examinations, and systemic clinical parameters were extracted from retrospective chart reviews.

The following were the key findings of the study:

  • 65% of patients with end-stage renal disease (ESRD) exhibited proliferative diabetic retinopathy (PDR), the most advanced stage of DR.
  • 18% of patients in the ESRD group had either mild or no signs of diabetic retinopathy.
  • In the mild diabetic nephropathy (DN) group, 38% of individuals already showed signs of PDR.
  • These findings highlight a lack of consistent overlap between the progression of diabetic kidney disease and eye complications.
  • Higher systolic and diastolic blood pressure were significantly associated with the presence of PDR, particularly among ESRD patients.
  • Elevated LDL cholesterol levels were linked to an increased risk of PDR.
  • Increased levels of albuminuria and serum creatinine were also significantly associated with PDR.
  • HbA1c levels, a marker of glycemic control, showed no significant correlation with PDR severity.
  • Younger age was a contributing factor to the development of PDR.

Despite its findings, the study acknowledges several limitations, including its retrospective nature and missing data from patient records, which may introduce selection bias. Some patients had irregular follow-ups, making it difficult to capture the full progression of complications. Additionally, race and ethnicity were self-reported and inconsistently recorded, potentially affecting statistical interpretations.

The researchers concluded that while DR and DN share several modifiable risk factors, their progression is not necessarily synchronous. Relying solely on glycemic control is inadequate for predicting the severity of either condition. Therefore, both complications should be assessed independently, taking into account individual clinical profiles and risk markers. The team also hypothesized that genetic variability may play a role in the discordant progression patterns, with some individuals being genetically predisposed to more aggressive forms of one complication over the other.

“The study emphasizes the importance of individualized assessment and the need for further longitudinal research to better understand the mechanisms underlying the divergence between diabetic eye and kidney disease progression,” the researchers wrote.

Reference:

Fitzgerald, A., Das, R., Moezzi, C. J., Salazar, S. R., Mankad, R., Qualls, C. R., Cabrera, A., Kathuria, A., Monickaraj, F., Tzamaloukas, A., & Das, A. (2025). Discordance of diabetic retinopathy severity in a cohort of diabetic nephropathy patients: A cross-sectional case-control study in a new Mexican population of type 2 diabetes. Frontiers in Endocrinology, 16, 1638415. https://doi.org/10.3389/fendo.2025.1638415

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Fresh hope for type 1 diabetes as daily pill that slows onset confirms promise at 2-year follow-up

In 2023, the groundbreaking Australian BANDIT (Baricitinib in New Onset Type 1 Diabetes) trial reported that a daily pill of baricitinib, commonly prescribed for rheumatoid arthritis and alopecia, could safely preserve the body’s own insulin production and slow the progression of type 1 diabetes (T1D) in people recently diagnosed with the condition.

Now the follow-up of the blinded BANDIT trial, being presented at this year’s Annual Meeting of The European Association for the Study of Diabetes (EASD), Vienna (15-19 Sept), reveals that once baricitinib treatment was stopped, participants’ diabetes progressed-they produced less insulin and had less stable blood sugar levels, that were not significantly different to those on placebo.

“Among the promising agents shown to preserve beta cell function in T1D, baricitinib stands out because it can be taken orally, is well tolerated, including by young children, and is clearly efficacious”, said author Dr Michalea Waibel from St Vincent’s Institute of Medical Research, Fitzroy, Australia.

She added, “These latest data support our previous clinical trial data by showing that the therapeutic effect is lost when baricitinib is stopped and justify further trials to determine if treatment benefit can be sustained over many years on treatment and if treating earlier stages of disease can prevent or delay clinical diagnosis.”

T1D is caused by the immune system mistakenly attacking the insulin-producing cells in the pancreas. Over time, this leads to the need for lifelong insulin injections to manage blood sugar levels.

Baricitinib, a Janus kinase (JAK) inhibitor, works by blocking signals in the body that lead to overactivity of the immune system, and helps to protect the remaining insulin-producing cells in people who are newly diagnosed with T1D, thus delaying progression of full-blown symptoms. It is already prescribed to treat several autoimmune diseases, including rheumatoid arthritis, ulcerative colitis, and alopecia.

The BANDIT trial enrolled 91 people aged between 10 and 30 years old who had been diagnosed with T1D in the previous 100 days. Participants were either given a baricitinib pill (4mg) or a placebo, once daily for 48 weeks.

At the beginning of the trial and at weeks 12, 24 and 48, researchers measured participants’ C-peptide levels (a marker of insulin secretion) to find out how much insulin participants could make themselves. They also used continuous glucose monitoring and HbA1c (a marker of longer-term blood sugar levels) to assess the need for injected insulin and how well blood sugar levels were managed.

The findings revealed that takingly a daily pill of baricitinib for 48 weeks preserved insulin-producing beta cell function, decreased blood glucose fluctuations, and reduced the need for insulin in people with newly diagnosed T1D. The researchers also found that baricitinib was safe, with no side effects attributed to the drug.

In this study, researchers report the findings from the off-drug follow-up period, with assessments done at weeks 72 and 96.

At 48 weeks the C-peptide level was 0.65 in the baricitinib group and 0.43 in the placebo group. After treatment was stopped, C-peptide levels fell to 0.49 in the baricitinib group and 0.36 in the placebo group at 72 weeks, and then to 0.37 and 0.26, respectively, at 96 weeks, demonstrating reduced insulin production.

The fall in insulin-producing beta cell function after baricitinib treatment was stopped resulted in the need for more insulin treatment, with insulin requirements at weeks 72 and 96 that were not significantly different between the groups.

Baricitinib cessation also led to a deterioration in glucose control, with differences in the time spent in the safe glucose range and blood glucose fluctuations between the groups in the first 48 weeks, no longer statistically significant at weeks 72 and 96.

Further analyses were unable to identify any characteristic at the start of the trial that predicted treatment response, including age, specific immune system genes known as human leukocyte antigens (HLA), body mass index (BMI), or number of autoantibodies. Moreover, drug adherence (at least 80% of study drug taken) did not distinguish responders from non-responders. Overall, around two-thirds of participants taking baricitinib met the criteria for response.

Notably, there was no additional safety concerns raised in the follow-up period.

“This is a really exciting step forward. For the first time, we have an oral disease-modifying treatment that can intervene early enough to allow people with T1D to be significantly less dependent on insulin treatment and provide time free from the demands of the disease’s daily management, and which could also lower rates of long-term complications,” said Dr Waibel.

She added, “If we can identify people at high risk of developing type 1 diabetes with genetic tests and blood markers, they could be offered treatment even earlier to prevent the disease taking hold in the first place. We are hopeful that larger phase III trials with baricitinib are going to commence soon, in people with recently diagnosed T1D as well as in earlier stages to delay insulin dependence. If these trials are successful, the drug could be approved for T1D treatment within 5 years.”

Reference:

Fresh hope for type 1 diabetes as daily pill that slows onset confirms promise at 2-year follow-up, European Association for the Study of Diabetes, Meeting: Annual Meeting of the European Association for the Study of Diabetes (EASD).

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Timely pain treatment linked to reduced hospitalizations for children with sickle cell disease: Study

A new study has found that prompt administration of opioid pain relief in emergency departments reduces the likelihood of hospitalization for children with sickle cell disease, according to findings published in JAMA Pediatrics.

Sickle cell disease (SCD) is a genetic blood disorder that can cause severe episodes of intense pain due to blocked blood flow. While national guidelines recommend prompt opioid treatment, this study is among the first to quantify the impact of timing on hospitalization rates, said Elizabeth Alpern, MD, MSCE, the George M. Eisenberg Professor and Vice Chair in the Department of Pediatrics at Northwestern University Feinberg School of Medicine, who was a co-author of the study.

“There hasn’t been prior work that shows if timely pain relief can impact important patient-centered outcomes like admission to the hospital,” said Alpern, who is also head of the Division of Emergency Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago. “If we can stabilize and treat patients’ pain, they won’t need to be admitted to the hospital, where they would miss school, their families would miss work, and it’s disruptive to their lives.”

In the study, investigators analyzed data from the Pediatric Emergency Care Applied Research Network Registry, reviewing over 9,000 emergency department (ED) visits by 2,538 children under the age of 19 between 2019 and 2021. The findings offer compelling evidence that faster pain management can lead to better outcomes for pediatric patients with SCD, said Jacqueline Corboy, MD, Assistant Professor of Pediatrics in the Division of  Emergency Medicine at Northwestern University Feinberg School of Medicine, who was also a co-author of the study.

“We were able to statistically show that if patients receive a timely first dose of opioid medications and a timely second dose of opioid medications, we could drastically reduce the number of hospital admissions within this population,” said Corboy, who is Director Of Quality in the Division of Emergency Medicine at Lurie Children’s. “This is the first study that shows concrete evidence, so this is really important.”

The study focused on two key time intervals: the time from ED arrival to the first opioid dose, and the time between the first and second doses. Children who received their first dose within 60 minutes of arrival were less likely to be hospitalized. The odds of hospitalization dropped even further when the second dose was administered within 30 minutes of the first.

The combination of a first dose within one hour and a second dose within 30 minutes was associated with a reduction in hospitalization odds compared to less timely treatment, according to the study. Even when the second dose was delayed up to 60 minutes, timely first-dose administration still showed a protective effect.

Alpern and Corboy said they hope the results will inform future clinical guidelines and improve care standards for children with SCD nationwide.

“Our next steps are to continue to improve the processes that we have through the ED and work collaboratively with our inpatient partners, nurses and paramedics. We want to ensure that everybody’s included as we implement these quality initiatives to improve care for our patients,” Corboy said.

The study was a collaborative effort among 12 pediatric hospitals, Alpern said, and data collected will be studied further as part of the Pediatric Emergency Care Applied Research Network.

“We’ve utilized electronic health record data that’s centralized and harmonized to see how this impacts operations and outcomes,” said Alpern, who is Principal Investigator of the PECARN Registry. “The information that we have as a result helps us understand, in a much larger setting, how we can be effective.” 

Reference:

Gwarzo I, Coleman KD, McKinley K, et al. Opioid Timeliness in the Emergency Department and Hospitalizations for Acute Sickle Cell Pain. JAMA Pediatr. Published online September 02, 2025. doi:10.1001/jamapediatrics.2025.2967

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Zydus Lifesciences Slapped Rs 3.35 Crore Tax Demand Over CENVAT Credit

New Delhi: Zydus Lifesciences Limited has informed the stock exchanges that the Commissioner of Central Goods and Services Tax (CGST), Ahmedabad, has confirmed a demand of Rs 33.50 million along with applicable interest and penalty, relating to alleged wrongful availment of CENVAT credit on sales commission paid to foreign entities.

The order, dated September 19, 2025, was communicated to the company on September 24, 2025.

The case traces back to multiple show cause notices issued by the Central Excise and Service Tax Authorities, covering the period from March 2008 to June 2017. These notices initially raised a demand of ₹392.47 million for alleged irregular availment of CENVAT credit on input services. After reviewing Zydus Lifesciences’ detailed oral and written submissions, the authorities dropped the bulk of the demand amounting to ₹358.97 million.

However, they confirmed the remaining ₹33.50 million with interest and penalty, specifically concerning CENVAT credit claimed on sales commission payments made to foreign entities.

Also Read: Zydus Lifesciences Gets CDSCO Panel Nod for Bioavailability Study of Antimalarial Candidate ZY-19489

The order was passed under Rule 14 of the CENVAT Credit Rules, 2004, read with Section 11A of the Central Excise Act, 1944. The disputed amount pertains to the classification of sales commission paid to foreign parties as Business Auxiliary Services, which the tax authorities held ineligible for CENVAT credit during the period under scrutiny.

Zydus Lifesciences has clarified in its disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, that the company intends to file an appeal against the order. The pharmaceutical major further emphasized that the confirmed demand does not have any material financial impact on its operations or overall financials.

Also Read: Zydus Foundation Vice Chairperson Meha Patel appointed as Member of CII National Committee on Art & Culture for 2025-26

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Surat Businessman Arrested in Rs 8.5 Crore Pharma Fraud, Probe on Accomplices

Ahmedabad: A massive Rs 8.5 crore fraud involving pharmaceutical raw materials has come to light, with Surat-based businessman Vikas Sharma accused of duping a long-time trading partner.

The Ahmedabad City Economic Offences Wing (EOW) has arrested Sharma following a complaint by Sagar Desai, who alleged that Sharma defaulted on payments and deliberately stopped cheques after receiving consignments.

According to ACP (EOW) Manoj Chavda, Sharma had been dealing with Desai for two to three years. Initially, he made timely payments, winning Desai’s trust. But after placing bulk orders worth crores, Sharma allegedly began halting the cheques he issued.

“Despite repeated reminders and assurances, the accused failed to clear the dues and resorted to stopping the cheques he had given,” Chavda stated.

Also Read: Chennai Pharma Firm Under ED Net in Rs 637 Crore Bank Fraud Case

Investigators found that Sharma already had a criminal record, with four cases registered in Maharashtra and one with Ahmedabad EOW. At the time of his latest arrest, he was in judicial custody at the Central Jail for earlier offences.

Officials confirmed Sharma will be produced before a local court for remand. The probe is now focused on tracing the diverted funds and determining whether he had accomplices in the scam reports the Gujarat Samachar.

Also Read: Pharmacist Duped of Rs 70 Lakh in Hospital Project Scam, Doctor Couple Booked

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Relief Sought for Small Retailers as GST 2.0 Sparks Losses in Pharma Trade

New Delhi: Noting the fact that the reduction in GST rates (18% to 5%, 12% to 0%, 12% to 5%) has benefited consumers, but it has severely impacted the financial position of small traders, the All India Organisation of Chemists & Druggists (AIOCD), representing over 12.5 lakh chemists and distributors across the country, has appealed to the Union Finance Minister Nirmala Sitharaman for urgent relief measures to protect small retailers during the transition to GST 2.0.

Highlighting the practical difficulties and financial losses faced by small traders, the AIOCD President J. S. Shinde and General Secretary Rajiv Singhal stated:

• The reduction in GST rates (18% to 5%, 12% to 0%, 12% to 5%) has benefited consumers, but it has severely impacted the financial position of small traders.

• Stock purchased by unregistered and composite dealers at higher GST rates now has to be sold at lower prices, leading to unavoidable losses, especially when drug margins are regulated by NPPA.

• Most small traders are either not registered under GST or are composite dealers who cannot claim Input Tax Credit (ITC).

In view of the above, the AIOCD has requested the Government to allow small traders to sell their existing stock at the old MRP for a period of three months. If necessary, a special relief package should be announced, and during this transition period, no harassment or penal action should be taken against small retailers.

Also Read: Chemist Body Seeks Transition Period, GST Input Adjustment After Tax Cut, Writes to CM

In a letter to the Union Finance Minister Nirmala Sitharaman, the key concerns raised by AIOCD:

• Across the country, pricing adjustments are being made in line with the new GST rates, but the plight of small retailers is being completely ignored.

• Small chemists( URD and Composite ), particularly those in rural and semi-urban areas, are already operating on very thin margins.

• The reduction of 18% to 5%, 12% to 0%, and 12% to 5% has created a situation where pipeline stock purchased at higher tax rates must now be sold at lower prices. As you know, the margin on medicines is fixed by NPPA.

• These retailers are at a total loss since they cannot recover the tax difference. Many are not registered under GST and hence cannot claim Input Tax Credit (ITC).

• At several places, the survival of these small traders is under severe threat.

In addition, it stated that adding to their distress:

• We are observing that many political leaders, senior officers, and GSTN officials are actively moving in the market highlighting that the GST relief has reached consumers.

• While the government has already taken its full GST on goods sold before 21st September from small URD and composite retailers, nobody is addressing their present plight.

• Instead, these traders are being compelled to sell at a loss, which is highly unfair and unsustainable.

In line with the above concerns, in order to safeguard small retailers and chemists, the AIOCD has urged the government:

1. The government should permit the sale of pipeline medicine stock on old MRP for at least the next three months, so that existing inventory purchased at higher GST rates can be exhausted without causing further losses.

2. If this is not possible, a special relief mechanism should be announced for small traders and chemists to offset the unavoidable financial hit.

3. Till this transition period of three months is over, we also request that no harassment or coercive action be taken against small retailers, as they are already facing unprecedented hardship.

The association issued a warning, saying that neglecting the problems faced by small pharmacies could endanger the supply of necessary medications at the local level.

“If immediate relief is not provided, many small chemists may be forced to shut down their shops, which will certainly affect the availability of medicines in rural and remote areas — a responsibility that will fall upon the Government. The Organisation has urged the Government to act swiftly to safeguard the backbone of India’s retail drug trade, which is being overlooked during this historic reform.” AIOCD said in its statement

Also Read: Chemists’ Body Seeks Input Tax Credit Refund, Protection Period Amid GST 2.0 Rollout

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MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Oral Solution

New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN Laboratories to conduct a Phase IV clinical trial of Tofacitinib Oral Solution 1 mg/ml.

However, the nod is subject to the condition that the dosing regimen shall be stratified across at least two distinct age groups and accordingly, statistical evaluation shall be performed to assess agespecific responses and dosing appropriateness.

Furthermore, it added, that in exclusion criteria, Latent Tuberculosis Infection (LTBI) shall be incorporated as part of the clinical protocol.

This came after MSN Laboratories presented the proposal for grant of permission to conduct Phase IV Clinical Trial Protocol vide protocol No. 010/TFCB-OS/MSN/2025, Version 1.0 dated 23.Apr.2025 before the Committee.

Also Read: MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat

Tofacitinib is a Janus kinase (JAK) inhibitor used to treat rheumatic conditions, such as rheumatoid arthritis and ankylosing spondylitis, and ulcerative colitis.

Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway.

Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response.

At the recent SEC meeting for Analgesic and Rheumatology, the expert panel reviewed the proposal presented by MSN Laboratories for a grant of permission to conduct Phase IV Clinical Trial Protocol vide protocol No. 010/TFCB-OS/MSN/2025, Version 1.0 dated 23.Apr.2025.

After detailed deliberation, the committee recommended for approval to conduct the Phase IV trial as per the protocol presented by the firm, subject to the condition that the Phase IV clinical trial protocol shall be revised to incorporate the following:

i. The dosing regimen shall be stratified across at least two distinct age groups, and accordingly, statistical evaluation shall be performed to assess age-specific responses and dosing appropriateness.

ii. In exclusion criteria, Latent Tuberculosis Infection (LTBI) shall be incorporated as part of the clinical protocol.

In line with the above, the expert panel suggested that the firm shall submit a revised Phase IV clinical trial protocol to CDSCO.

Also Read: MSN Labs Gets SEC Nod to Conduct Phase III Trial of Semaglutide

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Health Ministry Bans 34 Key Antibiotics, Antivirals for Animal Use, See List

New Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare has notified a ban on the import, manufacture, sale, and distribution of several classes of antimicrobials for animal use, including 15 antibiotics such as carbapenems, ceftobiprole, ceftaroline, glycopeptides and oxazolidinones, 18 antivirals such as favipiravir, molnupiravir, oseltamivir, ribavirin and zanamivir and others and one antiprotozoal, nitazoxanide.

The decision, published in the Gazette of India (S.O. 4338(E)), was taken under sections 10A and 26A of the Drugs and Cosmetics Act, 1940.

The move follows a draft notification issued on May 22, 2025, which invited objections and suggestions from stakeholders. As no objections were received and safer veterinary alternatives are available, the government finalized the prohibition in consultation with the Drugs Technical Advisory Board.

Also Read: DTAB Recommends Ban on 34 Antimicrobials for Animal Use, Seeks Report on 3 Exceptions

According to Section 10A of the Act, “Power of Central Government to prohibit import of drugs and cosmetics in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.”

Similarly, Section 26A of the Act states, “Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.—Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.”

Relying on these provisions, and noting that “no objections and suggestions were received from the public on the said rules” and “safer alternatives to the said drugs for animal use are available,” the Centre concluded that it was in public interest to prohibit the use of several categories of antimicrobials for animals.

The Gazette notification finally declared:

“The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the import, manufacture, sale, and distribution of any antimicrobial medicinal products for animal use as specified in this notification;
Now, therefore in exercise of the powers conferred by sections 10A & 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, the Central Government hereby prohibit the import, manufacture, sale and distribution of the following antimicrobials and group of such antimicrobials and their formulations for animal use namely: –
1. Antibiotics
i. Ureidopenicillins
ii. Ceftobiprole
iii. Ceftaroline
iv. Siderophore cephalosporins
v. Carbapenems
vi. Penems
vii. Monobactams
viii. Glycopeptides
ix. Lipopeptides
x. Oxazolidinones
xi. Fidaxomicin
xii. Plazomicin
xiii. Glycylcyclines
xiv. Eravacycline
xv. Omadacycline
2. Antivirals
i. Amantadine
ii. Baloxavir marboxil
iii. Celgosivir
iv. Favipiravir
v. Galidesivir
vi. Lactimidomycin
vii. Laninamivir
viii. Methisazone/ Metisazone
ix. Molnupiravir
x. Nitazoxanide
xi. Oseltamivir
xii. Peramivir
xiii. Ribavirin
xiv. Rimantadine
xv. Tizoxanide
xvi. Triazavirin
xvii. Umifenovir
xviii. Zanamivir
3. Antiprotozoals
Nitazoxanide

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/20250923so-4338e-302594.pdf
Also Read: Health Authorities Crack Down on OTC Sale of Antibiotics, NRx Drugs in Visakhapatnam

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TyG-BMI may predict Adverse Pregnancy Outcomes in IVF, suggests research

Researchers have found in a new study that higher triglyceride-glucose body mass index (TyG-BMI) was associated with increased miscarriage rates in both fresh and frozen embryo transfer (FET) cycles, along with reduced live birth rates in FET and cumulative live birth outcomes. TyG-BMI may serve as a practical marker to identify patients at higher metabolic risk before in vitro fertilization (IVF) treatment.

Assisted reproductive technologies have transformed infertility care, but pregnancy outcomes remain highly variable due to both clinical and metabolic factors. Traditional predictors such as age, ovarian reserve, and body mass index (BMI) provide only partial insight into reproductive prognosis. TyG-BMI, which integrates lipid and glucose metabolism with body mass assessment, has recently emerged as a potential surrogate marker for insulin resistance, a well-known contributor to suboptimal fertility outcomes. In this study, researchers analyzed IVF outcomes across women stratified by TyG-BMI levels. Results showed that patients with higher TyG-BMI not only had a significantly greater risk of miscarriage in both fresh and frozen embryo transfer cycles but also experienced lower rates of live birth in frozen transfers and reduced cumulative live birth rates. These findings highlight the potential of TyG-BMI as a simple, cost-effective, and non-invasive tool to screen for metabolic risk in women undergoing IVF. The study underscores the importance of preconception metabolic assessment in reproductive medicine. By incorporating TyG-BMI into baseline evaluations, clinicians may be able to identify patients at risk for adverse pregnancy outcomes and provide targeted lifestyle, nutritional, or pharmacological interventions to optimize metabolic health before treatment. This could improve overall pregnancy success rates and reduce the emotional and financial burden associated with repeated IVF cycles. However, the authors cautioned that larger multicenter trials are necessary to validate TyG-BMI as a reliable predictive marker across diverse populations. They also noted that future studies should explore whether interventions aimed at lowering TyG-BMI can directly improve reproductive outcomes.

Keywords: TyG-BMI, in vitro fertilization, IVF outcomes, miscarriage risk, frozen embryo transfer, live birth rate, metabolic risk, insulin resistance

Reference:
Zhang X, et al. Association of triglyceride-glucose body mass index with pregnancy outcomes in in vitro fertilization cycles. Fertility and Sterility. 2025. doi:10.1016/j.fertnstert.2025.09.012

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Women’s Childbirth Experiences in the WILL Randomised Trial: A Mixed Methods Analysis

Chronic or gestational hypertension complicates 7% of
pregnancies, half of which will reach 37 weeks’ gestation. Observational data
suggest that early term birth (at 37 to 38 weeks) may reduce maternal
complications (e.g., preeclampsia), Caesareans, stillbirth and costs of
maternal fetal surveillance; however, early term birth may increase neonatal
morbidity. There are no high-quality data on which to base timing of birth for
this high-risk population.

The WILL trial (When to Induce Labour to Limit risk in pregnancy
hypertension) aimed to address the optimal timing of birth for women with
chronic or gestational hypertension at term gestational age, when women remain
well and there is no evidence of pre-eclampsia. WILL was a multicentre
randomised trial of 403 women with chronic or gestational hypertension, who
were randomised at 37+0–6 weeks’ gestational age to either ‘planned early term
birth at 38+0–3 weeks’ gestation’ (N = 201, intervention group) or ‘usual care
at term’ (N = 202, control group); the trial was stopped early by the funder
due to slower-than-anticipated recruitment during the COVID-19 pandemic. The
clinical outcomes and costs favoured the intervention group. While in the
intervention (vs. control) group, there was no difference in the co-primary
outcomes of ‘poor maternal outcome’ (severe hypertension, maternal death, or
maternal morbidity; 27, 13% vs. 24, 12%, respectively) or ‘neonatal unit
admission for ≥4 h’ (14, 7% vs. 14, 7%, respectively), or Caesarean births (58,
29% vs. 72, 36%, respectively), there was a significant reduction in
pre-eclampsia (56, 27.9% vs. 76, 37.6%, respectively) and costs for tests of
maternal or fetal wellbeing (102.84, 95% CI −136.65 to −67.78).

In addition to clinical outcomes and costs, patients’
experiences were evaluated in the WILL trial. As with all health policy, it is
important that timing of birth recommendations be associated with positive
psychosocial outcomes for women, particularly as dissatisfaction with the
childbirth experience has been associated with negative consequences, such as
on breastfeeding, infant bonding and postpartum mental health. In this article,
authors described the experiences of women in the WILL trial, as evaluated by
the Childbirth Experience Questionnaire (CEQ) and their associated free-text
comments.

In intervention (vs. control) groups, the CEQ was completed
by 177/202, 88.1% (vs. 180/202, 89.1%) participants, and 378 free-text comments
were made by 93/177, 52.5% (vs. 98/180, 54.4%) participants. There was no
significant difference in CEQ scores overall (3.1±0.4 vs. 3.1±0.4,
respectively) or by domain (‘Own capacity’ [2.8±0.5 vs. 2.7±0.5, respectively];
‘Professional support’ [3.7±0.5 vs. 3.7±0.6, respectively]; ‘Perceived safety’
[3.2±0.6 vs. 3.1±0.6, respectively]; and ‘Participation’ [2.6±0.7 vs.
2.7±0.6]). Most comments were positive (222/378, 58.7%), and about ‘Relational
care and care interactions’ (CEQ ‘Professional support’). Neither the number
nor positivity of comments appeared to differ between groups.

In this trial of 403 high-risk women with chronic or
gestational hypertension, randomisation to planned early term birth at 38+0–3
weeks (vs. usual care at term) resulted in a similar childbirth experience
overall, by CEQ domain, and whether labour induction or adverse outcomes had
occurred. Just over half of women who responded to the CEQ provided free-text
comments, and most were positive, particularly regarding ‘Relational care and
care interactions’ (CEQ ‘Professional support’ domain). Also, most comments
endorsed the ‘Conceptualising safety’ theme, even when labour induction did not
go as planned. However, it was clear that labour induction was not always
viewed positively, in both arms and across themes of ‘Capacity for autonomy
over care’, ‘Experiences of labour and birth’, and the less frequently-endorsed
themes of ‘Lack of shared decision-making’ and ‘Experience of participating in
research’. Repeatedly, women described logistical issues related to initiation
of labour induction, lack of information, the process not going as they had
expected, uncontrolled pain, and not always being listened to.

For women with chronic or gestational hypertension who
remain well at term gestational age, authors found no difference in childbirth
experience between women randomised to planned early term birth at 38+0–3
weeks’ gestation, compared with usual care at term. This was true regardless of
initiation of birth, mode of birth, or pregnancy outcome, and in directed
content analysis of free-text comments. Based on these findings, shared
decisions about the timing of birth may be more influenced by differences in
clinical outcomes and costs. Additionally, labour induction experiences may be
improved with good information sharing and preparation, to facilitate a sense
of ownership and control of labour.

Source: Sue Tohill, Katie Kirkham,
Eleni Gkini; BJOG: An International Journal of Obstetrics &
Gynaecology, 2025; 0:1–12 https://doi.org/10.1111/1471-0528.18257

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