Hatchet flap versatile, effective, and safe technique for eyelid and midfacial reconstructions in select patients: Study

Hatchet flap versatile, effective, and safe technique for eyelid and midfacial reconstructions in select patients suggests a new study published in the Ophthalmic Plastic and Reconstructive Surgery.

A study was done to describe surgical variations of the hatchet flap and a large series of patients in which this procedure was used for eyelid and midfacial reconstruction. A retrospective review was performed on patients treated with a hatchet flap between March 2016 and March 2023. Patient demographics, defect characteristics, surgical techniques, and outcomes were investigated. Results: The hatchet flap was used to repair 70 defects in 69 patients, aged 41.6 to 90.0 years (mean, 66.1). Defects measured 0.6 to 23.6 cm2 (mean, 4.8) and resulted from Mohs surgery (n = 62), exenteration (n = 2), benign lesion excision (n = 3), or cicatricial ectropion/fistula repair (n = 3). The flap tail was managed with 3 techniques: V-Y plasty (n = 26), transposition (n = 34), and excision (n = 10). Ancillary procedures were often used during reconstructions (skin grafts: 29; double hatchet flap: 2; additional skin flaps: 26; tarsoconjunctival flaps: 6; and other grafts: 7). Small distal eschars healed in 7 flaps without necrosis. Four patients with subcutaneous thickening improved after steroid injections. Mild hatchet flap contracture may have contributed to postoperative cicatricial ectropion in 1 patient. There were no other flap related complications. In selected patients, the hatchet flap is a versatile technique to mobilize vascularized tissue into eyelid/midfacial defects resulting from the excision of lesions or treatment of cicatricial ectropion/fistulas. Individuals without laxity in the plane perpendicular to the flap base may not be good candidates for this procedure. The hatchet flap can be modified by advancing, transposing, or excising the flap tail. Reconstruction is often combined with other flaps/grafts. Few complications were associated with the hatchet flap.

Reference:

Custer, Philip L. M.D., F.A.C.S.; Maamari, Robi N. M.D.. The Hatchet Flap for Eyelid and Midfacial Reconstruction: Experience From 70 Cases. Ophthalmic Plastic and Reconstructive Surgery 40(1):p 43-48, January/February 2024. | DOI: 10.1097/IOP.0000000000002499

Keywords:

Hatchet flap versatile, effective, safe technique, eyelid, midfacial reconstructions, select patients, Study, Custer, Philip L. M.D., F.A.C.S.; Maamari, Robi N, Ophthalmic Plastic and Reconstructive Surgery

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CRT Defibrillator bests IC Defibrillator for increasing survival in HF patients with wide QRS complex: NEJM

USA: Long-term results of the RAFT trial showed survival benefits associated with receipt of cardiac resynchronization therapy defibrillator (CRT-D) as compared with implantable cardioverter-defibrillator (ICD) in eligible heart failure patients (HF) with a wide QRS complex.

“Survivors with nearly 14 years of follow-up continued to tilt the study’s all-cause mortality rates in favour of CRT-D (71.2% versus 76.4% with ICD),” the researchers reported in the New England Journal of Medicine. “Time until death was significantly different between the two randomly assigned therapies (acceleration factor 0.80).”

A secondary outcome, the composite of death from any cause, implantation of a ventricular assist device, or heart transplantation was also less likely with a CRT-D compared with ICD therapy (75.4% vs 77.7%, acceleration factor 0.85).

A CRT-D (or biventricular pacemaker) has electrodes going to both the right and left ventricles so that a pulse generator can signal them to pump with correct synchrony.

The RAFT (resynchronisation–defibrillation for Ambulatory Heart Failure Trial) showed a greater benefit concerning mortality at 5 years among patients who received CRT than among those who received ICDs. However, there is no clarity on the effect of CRT on long-term survival.

John L Sapp, Dalhousie University in Halifax, Nova Scotia, and colleagues included patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more). They were randomly assigned to receive either an ICD alone or a CRT defibrillator.

They assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The study’s primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, implantation of a ventricular assist device, or heart transplantation.

The trial enrolled 1798 patients, of whom 1050 were in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years, and the median duration of follow-up for those who survived was 13.9 years.

Key findings of the study:

  • Death occurred in 76.4% assigned to the ICD group and in 71.2% assigned to the CRT-D group.
  • The time until death appeared to be longer for those assigned to receive a CRT-D than those assigned to receive an ICD (acceleration factor, 0.80).
  • A secondary outcome event occurred in 77.7% of patients in the ICD group and 75.4% in the CRT-D group.

The limitations included a lack of accounting for crossovers between groups and the low representation of women and different races.

“Because CRT offers remarkable improvements in quality of life, functional capacity, and survival, the principles of providing earlier treatment for HF might now include CRT, particularly with improvement in technology,” Lynne Warner Stevenson and Jay Montgomery both of Vanderbilt University Medical Center in Nashville, wrote in an accompanying editorial.

The study authors cautioned that since the completion of the initial trial, there has been an advancement in pharmacologic therapy for heart failure, with the introduction of neprilysin inhibitors and SGLT2 inhibitors. CRT improves cardiac performance without increasing cardiac work and would be anticipated to have a complementary effect to pharmacotherapy; however, the impact of CRT on survival for patients treated with newer drugs is uncertain.

Reference:

Sapp JL, Sivakumaran S, Redpath CJ, Khan H, Parkash R, Exner DV, Healey JS, Thibault B, Sterns LD, Lam NHN, Manlucu J, Mokhtar A, Sumner G, McKinlay S, Kimber S, Mondesert B, Talajic M, Rouleau J, McCarron CE, Wells G, Tang ASL; RAFT Long-Term Study Team. Long-Term Outcomes of Resynchronization-Defibrillation for Heart Failure. N Engl J Med. 2024 Jan 18;390(3):212-220. doi: 10.1056/NEJMoa2304542. PMID: 38231622.

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FDA Approves First Treatment for Patients with Liver scarring Due to NASH

The U.S. Food and Drug Administration has approved Rezdiffra (resmetirom) for treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.

“Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, M.D., acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”

NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction. NASH is often associated with other health problems such as high blood pressure and type 2 diabetes. By at least one estimate, approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring, with that number expected to increase. Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.

The safety and efficacy of Rezdiffra was evaluated based on an analysis of a surrogate endpoint at month 12 in a 54-month, randomized, double-blind placebo-controlled trial. The surrogate endpoint measured the extent of liver inflammation and scarring. The sponsor is required to conduct a postapproval study to verify and describe Rezdiffra’s clinical benefit, which will be done through completing the same 54-month study, which is still ongoing. To enroll in the trial, patients needed to have a liver biopsy showing inflammation due to NASH with moderate or advanced liver scarring. In the trial, 888 subjects were randomly assigned to receive one of the following: placebo (294 subjects); 80 milligrams of Rezdiffra (298 subjects); or 100 milligrams of Rezdiffra (296 subjects); once daily, in addition to standard care for NASH, which includes counseling for healthy diet and exercise.

At 12 months, liver biopsies showed that a greater proportion of subjects who were treated with Rezdiffra achieved NASH resolution or an improvement in liver scarring as compared with those who received the placebo. A total of 26% to 27% of subjects who received 80 milligrams of Rezdiffra and 24% to 36% of subjects who received 100 milligrams of Rezdiffra experienced NASH resolution and no worsening of liver scarring, compared to 9% to 13% of those who received placebo and counseling on diet and exercise. The range of responses reflects different pathologists’ readings. In addition, a total of 23% of subjects who received 80 milligrams of Rezdiffra and 24% to 28% of subjects who received 100 milligrams of Rezdiffra experienced an improvement in liver scarring and no worsening of NASH, compared to 13% to 15% of those who received placebo, depending on each pathologist’s readings. Demonstration of these changes in a proportion of patients after just one year of treatment is notable, as the disease typically progresses slowly with a majority of patients taking years or even decades to show progression.

The most common side effects of Rezdiffra included diarrhea and nausea. Rezdiffra comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects.

Use of Rezdiffra should be avoided in patients with decompensated cirrhosis. Patients should stop using Rezdiffra if they develop signs or symptoms of worsening liver function while on Rezdiffra treatment.

Using Rezdiffra at the same time as certain other drugs, in particular statins for lowering cholesterol, may result in potentially significant drug interactions. Health care providers should refer to the full prescribing information for additional information on these potentially significant drug interactions with Rezdiffra, recommended dosage and administration modifications.

The FDA approved Rezdiffra under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The required aforementioned 54-month study, which is ongoing, will assess clinical benefit after 54 months of Rezdiffra treatment.

Rezdiffra received Breakthrough Therapy, Fast Track and Priority Review designations for this indication.

The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals.

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Red light can reduce blood glucose levels, says study

The researchers found that 670 nanometres (nm) of red light stimulated energy production within mitochondria, the tiny powerhouses within cells, leading to increased consumption of glucose. In particular, it led to a 27.7% reduction in blood glucose levels following glucose intake, and it reduced maximum glucose spiking by 7.5%.

While the study was conducted in healthy individuals, the non-invasive, non-pharmacological technique has the potential to have an impact on diabetes control after meals, as it can reduce damaging fluctuations of blood glucose in the body that contribute to ageing.

The study also highlights the significant long-term consequences for human health, including the potential dysregulation of blood sugars posed by lengthy exposure to blue light. Given the prominence of LED lighting and the fact that LEDs emit towards the blue end of the spectrum with very little red, the authors suggest that this may be a potential public health issue. The research has been published in the Journal of Biophotonics.

Mitochondria provide energy for vital cellular processes, using oxygen and glucose to produce the energy-rich nucleoside adenosine triphosphate (ATP). Previous research has established that long-wavelength light between approximately 650-900 nm (spanning the visible through to the near-infrared range) can increase mitochondrial production of ATP which reduces blood glucose and also improves health/lifespan in animals.

The authors Dr Michael Powner, Senior Lecturer in Neurobiology in the School of Health & Psychological Sciences at City, and Professor Glen Jeffery, Professor of Neuroscience in the UCL Institute of Ophthalmology, also say that this improvement in ATP production can cause signalling changes that are transmitted throughout the body.

They suggest that it may be mediating the abscopal effect, which refers to the phenomenon in cancer treatment where specific irradiation of a primary tumour can result in shrinkage of secondary tumours located in a different part of the body. Likewise, 670 nm light shone selectively on to the backs of mice in previous studies has been shown to result in improvements in ATP that improve symptoms in both a model of Parkinson’s disease and a model of diabetic retinopathy.

To explore the impact of 670 nm red light on blood glucose, the researchers recruited 30 healthy participants, who were then randomised into two groups: 15 in the 670 nm red light group, and 15 in the placebo (no light) group. They had no known metabolic conditions and were not taking medication.

Participants were then asked to do an oral glucose tolerance test and record their blood glucose levels every 15 minutes over the next two hours. People who received red light exposure 45 minutes prior to drinking glucose exhibited a reduced peak blood glucose level and reduced total blood glucose during the two hours.

Dr Powner, who was the lead author of the study, said:

“It is clear that light affects the way mitochondria function and this impacts our bodies at a cellular and physiological level. Our study has shown that we can use a single, 15-minute exposure to red light to reduce blood sugar levels after eating.

“While this has only been done in healthy individuals in this paper, it has the potential to impact diabetes control going forward, as it could help to reduce potentially damaging glucose spikes in the body after meals.”

Professor Jeffery said:

“Sunlight has a balance between red and blue, but we now live in a world where blue light is dominant because although we do not see it, LED lights are dominant in blue and have almost no red in them. This reduces mitochondrial function and ATP production. Hence our internal environments are red-starved. Long-term exposure to blue light is potentially toxic without red. Blue light on its own impacts badly on physiology and can drive disrupted blood sugars that may in the long run contribute to diabetes and undermine health spans.

“Pre-1990, we all had incandescent lighting which was OK because it had the balance of blue and red similar to sunlight, but there is a potential health span time bomb in the change to LEDs in an ageing population. This can partly be corrected by spending more time in sunlight.”

Reference:

Michael B. Powner, Glen Jeffery, Light stimulation of mitochondria reduces blood glucose levels, Journal of Biophotonics, https://doi.org/10.1002/jbio.202300521.

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Study Links Parkinson’s Disease with Periodontal Inflammation

Parkinson’s disease (PA) affects approximately 1% of the global population aged 60 and above, with its pathogenesis involving severe neuroinflammation impacting both systemic and local inflammatory changes. Recent study suggests a compelling association between Parkinson’s disease and heightened periodontal inflammatory burden, characterized by increased bleeding upon probing and elevated levels of inflammatory markers.

This study was published in the Journal Of Periodontology by Melis Y. and colleagues. The study aimed to investigate the association between Parkinson’s disease and periodontal tissue inflammation, hypothesizing that periodontitis may contribute to a greater systemic inflammatory burden in individuals with Parkinson’s disease.

The study included 60 patients diagnosed with Stage III, Grade B periodontitis, categorized into two groups: those with Parkinson’s disease (P+PA) and those without (P-alone), with 20 participants in each group. Additionally, a control group comprised systemically and periodontally healthy individuals. Clinical periodontal parameters were meticulously recorded, and samples of serum, saliva, and gingival crevicular fluid (GCF) were collected to measure inflammatory and neurodegenerative markers.

Key findings of the study were:

  • Parkinson’s patients displayed mild to moderate motor dysfunctions but maintained optimal oral hygiene control.

  • Periodontal parameters and GCF volume were significantly higher in both the P-alone and P+PA groups compared to the control group.

  • Parkinson’s disease was linked to increased bleeding on probing (BOP) compared to periodontitis alone, indicating an elevated periodontal inflammatory burden in individuals with Parkinson’s.

  • YKL-40 levels in saliva and serum were notably higher in the P+PA group compared to both P-alone and the control group.

  • GCF neurofilament light chain (NfL) levels from shallow sites were significantly elevated in the P+PA group compared to controls.

  • GCF S100B levels from deep sites were higher in the P+PA group than in healthy individuals.

This parallel increase in neuroinflammation and periodontal inflammation sheds light on potential interconnected pathways between oral health and Parkinson’s disease.

Reference:

Yilmaz, M., Yay, E., Balci, N., Toygar, H., Kılıc, B. B., Zirh, A., Rivas, C. A., & Kantarci, A. Parkinson’s disease is positively associated with periodontal inflammation. Journal of Periodontology,2023;94(12):1425–1435. https://doi.org/10.1002/jper.23-0274

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Study reveals high prevalence of radiation-induced cataracts among radiation workers of interventional cardiology

Indonesia: A recent study published in the Journal of Clinical Interventional Radiology has shed light on the effects of ionizing radiation exposure on cataracts among radiation workers of interventional cardiology in Indonesia.

The study showed that the prevalence rate of radiation-induced cataracts among radiation workers of interventional cardiology was 16.7%.

The researchers identified a significant relationship between the estimated cumulative radiation dose, the risk of radiation-induced cataracts, and lens density. They revealed an association between increased cumulative radiation dose and increasing risk of radiation-induced cataracts and lens density. A significant relationship was also found between radiation protection use, the risk of radiation-induced cataracts, and lens density.

“Responsive use of ceiling-suspended shields and protective eyewear will lead to reduced risk of radiation-induced cataracts and lens density,” Wida Setiawati, Department of Ophthalmology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia, and colleagues wrote in their study.

A cataract is a haziness of the lens structure with multifactorial aetiology, including diabetes mellitus, age, genetics, use of steroid drugs, trauma, free radicals, and radiation exposure. The lens is one of the most radiosensitive tissues in the human body. Lens structure can be disrupted due to radiation exposure, especially ionizing radiation. Cataract is classified as a deterministic effect of radiation, which only appears when the radiation exposure dose limit is exceeded.

Among the most frequent fluoroscopy users in the medical profession are radiation workers of interventional cardiology. Consequently, they are vulnerable to radiation-induced cataracts. The researchers aimed to determine the prevalence of radiation-induced cataracts and its correlation with radiation exposure dose and radiation protection equipment use among radiation workers of interventional cardiology.

For this purpose, they conducted a cross-sectional and retrospective case–control study comprising 180 subjects. The prevalence of radiation-induced cataracts was assessed using Scheimpflug analysis on the Pentacam-Oculus device. Questionnaires and personal dosimeters were used to identify individual cumulative radiation exposure dose and radiation protection equipment use.

The study led to the following findings:

  • The prevalence of radiation-induced cataracts was 16.7%.
  • The median cumulative radiation dose was 0.8 Gy.
  • There was a positive correlation between cumulative radiation dose and lens density (R Spearman = 0.64).
  • 83.9% of subjects used ceiling-suspended shields for 71 to 100% of their working period.
  • Most subjects (40.6%) did not wear protective eyewear.
  • There was a statistically significant increasing risk of radiation-induced cataracts and unresponsive use of radiation protection equipment.
  • Subjects using ceiling-suspended shields in only 31 to 50% of their working period increased their cataract risk by 10.8 times.
  • Subjects using protective eyewear in only 51 to 70% of their working period increased their cataract risk by 8.64 times.
  • Subjects who did not wear protective eyewear had an odd ratio of 164.3 compared to those who did.

“The findings showed that radiation-induced cataracts among radiation workers of interventional cardiology are dependent on the radiation exposure dose and the use of radiation protection equipment,” the researchers concluded.

Reference:

The study titled, “Effects of Ionizing Radiation Exposure on Cataract among Radiation Workers of Interventional Cardiology in Indonesia,” was published online in the Journal of Clinical Interventional Radiology. DOI: 10.1055/s-0043-1775854

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BD Vacutainer® UltraTouch™ Push Button Blood Collection Set reduces pediatric fear, anxiety

    According to a recent study seen in the Wadia Journal of Women and Child Health published by Scientific Scholar, an upcoming venepuncture technique for paediatric patients is focussing at less painful sample collection.

The UltraTouch Push Button Blood Collection Set is deemed to be the appropriate blood collection device for the paediatric population due to design elements contributing to less painful experience.

Children are scared of injections whether pricked or not, venipuncture and intravenous (IV) cannula insertions frequently cause pain and anxiety in pediatric patients. A previous study revealed that both fear and anxiety during the blood collection process diminished patient cooperation, resulting in multiple pricks.

The study reports that UltraTouch Push Button Blood Collection Set (UTPBBCS) is deemed to be the appropriate blood collection device for the paediatric population due to design elements contributing to less painful experience.

Researchers in the current study included 33 paediatric individuals. Venepuncture was performed with UltraTouch Push Button Blood Collection Set and after the procedure feedback was collected. Pain perception feedback was gathered using a categorical scale ranging from 0 to 5, also known as the “verbal pain intensity scale”.

The current study found that pain intensity was significantly lower with UltraTouch Push Button Blood Collection Set, and the overall experience was less traumatic.

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Prioritizing Sleep Equity for Global Well-being, Insights by Dr Prashant Makhija on World Sleep Day

World Sleep Day is an annual event organized by the World Sleep Society, aimed at raising awareness about the importance of sleep and the prevention and management of sleep disorders. This year it is marked on15th March.

The focus of this year’s World Sleep Day revolves around “Sleep Equity for Global Health.” While sleep is crucial for overall well-being, noticeable variations in sleep quality persist among different populations worldwide, exacerbating existing health disparities and reinforcing inequities

It is a known fact that sleep plays a crucial role in many ways. It helps in maintaining optimal cognitive function and emotional well-being. It is essential for memory consolidation, learning, problem-solving, any decision-making process does need a healthy sleep.

On this World Sleep Day, Medical Dialogues team interacted with Dr Prashant Makhija, a neurologist at Wockhardt Hospitals in Mumbai Central. Dr Makhija has an experience of more than 10years. He specializes in treating various neurological disorders. He has special interest in sleep and epilepsy and has a post doctoral fellowship In epilepsy and sleep medicine. He also has a certification from World Sleep Society as International sleep disorders specialist.
Dr Makhija addressed the following-
1. How the recommended amount of sleep varies across different age groups, from infants to older adults?
2. What are the potential health consequences of sleep deprivation or inadequate sleep for individuals of different age groups?
3. How does sleep quality and duration affect mental health outcomes, such as mood disorders, anxiety, and depression?
4. What strategies or lifestyle changes can individuals adopt to improve sleep hygiene and promote better sleep?
5. How do environmental factors, such as technology use, light exposure, and work schedules, influence sleep patterns and quality?
6. Recommendations for parents to establish healthy sleep habits and routines for children, considering developmental stages and specific challenges?

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Oral Iptacopan monotherapy improves outcomes in patients with paroxysmal nocturnal hemoglobinuria: NEJM

France: A recent study has shown improved clinical and hematologic outcomes with iptacopan treatment in anti–C5–treated patients with persistent anemia, in whom iptacopan showed superiority to anti-C5 therapy, and in patients who had not received complement inhibitors.

The study was published online in the New England Journal of Medicine on March 14, 2024.

A lack of oral treatments and persistent hemolytic anemia are challenges for patients with paroxysmal nocturnal hemoglobinuria who have received anti-C5 therapy or have not received complement inhibitors. Iptacopan is a first-in-class oral factor B inhibitor shown to improve hemoglobin levels in these patients.

Against the above background, Régis Peffault de Latour, Université de Paris (R.P.L.), Paris, France, and colleagues assessed iptacopan monotherapy over 24 weeks in patients with hemoglobin levels of less than 10 g per deciliter in two phase 3 trials.

In the first trial, anti–C5–treated patients were randomly assigned to switch to iptacopan or to continue anti-C5 therapy. In the second, single-group trial, patients who had not received complement inhibitors and had lactate dehydrogenase (LDH) levels more than 1.5 times the upper limit of the normal range received iptacopan.

In the first trial, the two primary endpoints were a rise in the hemoglobin level of at least 2 g per deciliter from baseline and a hemoglobin level of at least 12 g per deciliter, each without red-cell transfusion. The primary endpoint for the second trial was an increase in hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion.

The researchers reported the following findings:

  • In the first trial, 51 of the 60 patients who received iptacopan had an increase in the hemoglobin level of at least 2 g per deciliter from baseline, and 42 had a hemoglobin level of at least 12 g per deciliter, each without transfusion; none of the 35 anti-C5–treated patients attained the end-point levels.
  • In the second trial, 31 of 33 patients had an increase in the hemoglobin level of at least 2 g per deciliter from baseline without red-cell transfusion.
  • In the first trial, 59 of the 62 patients who received iptacopan and 14 of the 35 anti–C5–treated patients did not require or receive transfusion; in the second trial, no patients required or received transfusion.
  • Treatment with iptacopan increased hemoglobin levels, reduced fatigue, reduced reticulocyte and bilirubin levels, and resulted in mean LDH levels less than 1.5 times the upper limit of the normal range. Headache was the most frequent adverse event with iptacopan.

“Iptacopan treatment improved clinical and hematologic outcomes in anti-C5-treated patients with persistent anemia – in whom iptacopan showed superiority to anti-C5 therapy – and in patients who had not received complement inhibitors,” the researchers wrote.

Reference:

Peffault de Latour R, Röth A, Kulasekararaj AG, Han B, Scheinberg P, Maciejewski JP, Ueda Y, de Castro CM, Di Bona E, Fu R, Zhang L, Griffin M, Langemeijer SMC, Panse J, Schrezenmeier H, Barcellini W, Mauad VAQ, Schafhausen P, Tavitian S, Beggiato E, Chew LP, Gaya A, Huang WH, Jang JH, Kitawaki T, Kutlar A, Notaro R, Pullarkat V, Schubert J, Terriou L, Uchiyama M, Wong Lee Lee L, Yap ES, Sicre de Fontbrune F, Marano L, Alashkar F, Gandhi S, Trikha R, Yang C, Liu H, Kelly RJ, Höchsmann B, Kerloeguen C, Banerjee P, Levitch R, Kumar R, Wang Z, Thorburn C, Maitra S, Li S, Verles A, Dahlke M, Risitano AM. Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2024 Mar 14;390(11):994-1008. doi: 10.1056/NEJMoa2308695. PMID: 38477987.

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High folic acid concentration during early pregnancy risk factor for gestational diabetes: Study

China: A recent retrospective cohort study published in Nutrition has shed light on the association of serum folic acid (FA) levels in response to fasting blood glucose (FBG) in early pregnancy with the risk of gestational diabetes mellitus (GDM).

Hefeng Huang, Shanghai Jiao Tong University, Shanghai, China, and colleagues found that higher serum folic acid levels were significantly correlated with elevated fasting blood glucose concentration in the first trimester and subsequent risk of GDM diagnosed later in pregnancy.

The findings underscore the importance of maintaining an inadequate FA concentration for preserving a reduced risk of gestational diabetes, particularly in women with women with relatively higher blood glucose in early pregnancy. Furthermore, folic acid concentration > 32.5 nmol/L could be a risk factor for GDM.

‘This research indicates that folic acid levels should be monitored during the first trimester from the first prenatal checkup to prevent negative effects of excessive folic acid intake,” the researchers wrote.

There has been an increasing prevalence of folic acid consumption in early pregnancy, concerns have been raised about its potentially negative effect on maternal metabolism. Recent findings on folic acid levels and the first trimester and GDM risk have been inconclusive. Therefore, the research team aimed to examine the association of FA status in early pregnancy with GDM and to examine whether glucose levels can be modulated by folic acid status during the same first trimester.

For this purpose, the researcher performed a retrospective cohort study based on 27,128 Chinese pregnant women who registered during the first prenatal visit from 2015 to 2019. During the 9th to 13th gestational weeks, serum folic acid and FBG concentrations were measured.

Binary logistic regression was applied to estimate odds ratios of GDM by using the serum FA levels quartiles with adjustment for major confounders. To investigate the potential effect of modifying key risk factors for gestational diabetes, the investigators established subgroups, in which analyses were stratified by prepregnancy body mass index (< 18.5, 18.5–23.9, and ≥ 24 kg/m2), age (<25, 25–29, 30–34, and ≥35 y), parity (nulliparous and parous), and family history of diabetes (yes and no).

The study revealed the following findings:

  • A positive association was observed between maternal folate concentrations and fasting blood glucose: the risk for hyperglycemia was higher in those in the middle (Q3) and higher (Q4) quartiles compared with those in Q1 and Q2.
  • A higher risk for gestational diabetes was found in hyperglycemia of early pregnant women with high folate concentrations (Q3: odds ratio = 5.63, and Q4: odds ratio = 5.57) compared with normal fasting glucose mothers with folate concentrations in Q1 and Q2 after accounting for multiple covariables. Similar patterns were observed for different subgroups.
  • Restricted cubic spline plots had a positive correlation of serum folic acid level with fasting blood glucose concentration and the risk of gestational diabetes mellitus in a nonlinear pattern, with 32.5 nmol/L as the cutoff point for folic acid level.

In conclusion, serum FA in early pregnancy is positively linked with early pregnant fasting blood glucose. GDM prevalence is significantly higher in pregnant women with folic acid levels > 32.5 nmol/L compared with < 32.5 nmol/L. For women with FBG ≥ 5.1 mmol/L, FA is significantly positively associated with GDM.

“Therefore, it is suggested that folic acid levels should be monitored during the first trimester from the first prenatal checkup to prevent adverse effects of excessive FA intake,” the researchers wrote.

Reference:

Zhang, C., Liu, Z., Sun, K., Zhao, J., Huang, H., & Zhang, C. (2024). Association of serum folic acid levels in response to fasting blood glucose in early pregnancy with the risk of gestational diabetes mellitus: A retrospective cohort study. Nutrition, 122, 112383. https://doi.org/10.1016/j.nut.2024.112383

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