Higher APOA4 Levels in Umbilical Cord Blood Linked to Maternal Depression, reports research

Researchers discovered high levels of apolipoprotein A4 (APOA4), a biomarker for depression, in umbilical cord blood of newborns whose mothers suffered with major depressive disorder (MDD). Maternal mental health in pregnancy has been known to impact neurodevelopment in the children. A recent study was published in The Journal of Obstetrics and Gynecology Research by Seiko M. and colleagues. The main aim of the study was the characterization of biochemical profiles in the umbilical cord serum of depressed mothers focusing on APOA4, a protein previously associated with lipid metabolism and inflammation.

Umbilical cord serum samples from two groups were screened: mothers with major depressive disorder (MDD) and healthy controls. Two mothers of each group were taken whose umbilical cord serum was assayed for LC–MS analysis that detected several proteins differentially expressed. Following this proteome analysis, ELISA was conducted to validate the findings. The second stage of the research consisted of a higher number of samples, 10 mothers per group; that is, MDD group: n = 10, control group: n = 10, in order to further improve the description of specific protein levels, particularly APOA4.

Important changes in proteomic profiles were evident to distinguish the two groups for MDD vs. controls, with pathways involved in the regulation of plasma lipoprotein particles and organization of synapses being one of those pathways. But most importantly, only APOA4 was elevated to statistical levels in the blood of the umbilical cord of the MDD patients.

  • APOA4 was significantly higher in the serum of the umbilical cord of MDD patients compared to controls.

  • Maternal serum APOA4 levels were also higher in mothers with MDD, but surprisingly levels in umbilical cord serum were found to be higher than those seen in maternal serum.

  • These findings indicate that the fetuses who reside within the womb of the mothers experiencing prenatal depression are exposed to high levels of APOA4 in utero that can influence their neurodevelopment and maybe even predispose them to future mental health disorders.

In umbilical cord serum, mothers suffering from MDD have significantly increased concentrations of APOA4 compared with healthy controls. Thus, fetuses of pregnant women experiencing prenatal depression are exposed to higher levels of APOA4 in utero, which may be implicated in neurodevelopment and mental health later in life. As maternal mental health is one of the crucial determinants of prenatal care, these findings focus on monitoring and treating the pregnant woman’s depression for the health of the mother and her offspring.

Reference:

Matsuo, S., Moriyama, Y., Ushida, T., Imai, K., Tano, S., Miki, R., Yoshida, K., Yokoi, A., Kajiyama, H., & Kotani, T. (2024). Elevated levels of apolipoprotein A4 in umbilical cord serum from the maternal major depressive disorder. The Journal of Obstetrics and Gynaecology Research. https://doi.org/10.1111/jog.16096

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Meta-Analysis Highlights Gestational Diabetes as Novel Risk Factor for Maternal GBS Transmission

USA: A recent systematic review and meta-analysis has suggested gestational diabetes (GDM) as a significant risk factor for maternal rectovaginal colonization with Group B Streptococcus (GBS). Conducted by a team of researchers, the meta-analysis provides critical insights into the association between GDM and GBS, highlighting implications for maternal health strategies worldwide.

This study reconciled previously conflicting findings and established that both gestational diabetes and pregestational diabetes are notable risk factors for maternal rectovaginal carriage of GBS.

“Recognizing GDM as a risk factor in clinical decisions regarding GBS screening and intrapartum antibiotic prophylaxis has the potential to reduce the global impact of GBS on maternal and perinatal health,” the researchers wrote in BMC Pregnancy and Childbirth.

Maternal rectovaginal colonization by GBS raises the risk of perinatal GBS disease that can lead to death or long-term neurological impairment. The factors contributing to rectovaginal carriage of Group B Streptococcus are not fully understood, leading to challenges in identifying GBS through risk-based clinical approaches. There remains uncertainty regarding whether GDM constitutes a risk factor for rectovaginal GBS colonization.

To fill this knowledge gap, Kathryn A. Patras, Baylor College of Medicine, One Baylor Plaza, Houston, TX, USA, and colleagues aim to address current conflicting findings and determine whether GDM should be clinically considered as a risk factor for maternal GBS colonization by conducting a systematic review and meta-analysis.

The analysis included peer-reviewed studies that provided GDM prevalence and documented GBS vaginal and/or rectal colonization in women with and without gestational diabetes. From the study’s inception to October 30, 2023, the researchers identified 6,275 relevant studies from online databases of which 19 were eligible for inclusion.

The eligible studies underwent analysis and rigorous evaluation for bias risk using a modified Newcastle-Ottawa Scale. This assessment included considerations of cohort representativeness, comparability, quality of reporting on GDM and GBS status, and potential bias related to other metabolic conditions. The synthesized results were analyzed using STATA 18 software and subjected to random-effects meta-analyses.

The researchers reported the following findings:

· Studies encompassed 266,706 women from 10 different countries, with study periods spanning from 1981 to 2020.

· Meta-analysis revealed that gestational diabetes is associated with a 16% increased risk of rectovaginal GBS carriage (OR 1.16).

· Subgroup analyses were also performed to assess the independent effects of pregestational vs. gestational diabetes on the risk of maternal GBS carriage.

· Pregestational diabetes (Type 1 or Type 2 diabetes mellitus) was also associated with an increased risk of 76% (pooled OR 1.76).

“An important future focus is to evaluate neonatal infection rates among women with GDM and investigate whether optimal glucose management contributes to reducing GBS-related morbidity and mortality in newborns,” the researchers concluded.

“Enhancing our understanding of other factors influencing GBS transmission to neonates will enhance screening, prevention, and treatment strategies for fetal and neonatal GBS disease.”

Reference:

Mercado-Evans, V., Zulk, J.J., Hameed, Z.A. et al. Gestational diabetes as a risk factor for GBS maternal rectovaginal colonization: a systematic review and meta-analysis. BMC Pregnancy Childbirth 24, 488 (2024). https://doi.org/10.1186/s12884-024-06694-7

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CPAP and MAD better than OMT for TMJ health preservation among Sleep apnea Patients: Study

CPAP and MAD better than OMT for TMJ health preservation among Sleep apnea Patients suggests a study published in the BMC Oral Health.

In recent years, obstructive sleep apnea (OSA) has been increasingly recognized as a significant health concern. No previous studies assessed the effect of recommended treatment modalities of patients with OSA on the temporomandibular joint (TMJ). The current study aimed to evaluate the effect of different treatment modalities of OSA, such as continuous positive airway pressure (CPAP), mandibular advancement device (MAD), and oral myofunctional therapy (OMT) on subjective symptoms, clinical, and radiographic signs of temporomandibular disorders. The institutional review board approved this hospital-based prospective randomized controlled clinical trial study and formal patient consent, 39 OSA patients, ranging in age from 19 to 56 after confirmation with full night Polysomnography (PSG) with healthy TMJ confirmed clinically and radiographically with magnetic resonance imaging (MRI) were randomly allocated into three treatment groups. Group 1: 13 patients were managed with CPAP after titration, group 2: 13 patients were managed with digitally fabricated MAD, and group 3: 13 patients were managed with OMT. The following parameters were evaluated before and 3 months after the intervention. Pain using a visual analogue scale (VAS), maximum inter-incisal opening (MIO), lateral movements, and clicking sound of TMJ. MRI was done before and 3 months after the intervention. Results: Out of the 83 patients enrolled, 39 patients completed the treatment. There were no statistically significant differences in lateral jaw movements or clicking, and no significant difference in MRI findings between the three studied groups before and after the intervention. The OMT group showed a statistically significant difference in pain (p = 0.001), and MIO (p = 0.043) where patients experienced mild pain and slight limitation in mouth opening after 3 months of follow-up in comparison to MAD and CPAP groups. CPAP and MAD are better for preserving the health of TMJ in the treatment of OSA patients. While OMT showed mild pain and slight limitation of MIO (that is still within the normal range of mouth opening) compared to CPAP and MAD.

Reference:

Attia, A.A., Awad, S.S., Mansour, M. et al. Effects of different treatments for obstructive sleep apnea on temporomandibular joint: a randomized clinical trial. BMC Oral Health 24, 931 (2024). https://doi.org/10.1186/s12903-024-04623-w

Keywords:

CPAP, MAD, OMT, TMJ, health preservation, Sleep apnea Patients, study, Attia, A.A., Awad, S.S., Mansour, M, Obstructive sleep apnea, Temporomandibular disorder, Mandibular advancement device, Continuous positive airway pressure, oral myofunctional therapy, Pain

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USFDA nod to Aurobindo Pharma for Cephalexin Tablets

Hyderabad: Aurobindo Pharma Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg and 500 mg.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and Company.

Aurobindo Pharma was granted Competitive Generic Therapy (CGT) designation for Cephalexin Tablets USP, 250 mg and 500 mg, and is eligible for 180 days of shared generic drug exclusivity.

The product is expected to be launched in Q3FY25.
Cephalexin Tablets USP, 250 mg and 500 mg are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms.
Aurobindo Pharma now has a total of 523 ANDA approvals (506 Final approvals and 17 tentative approvals) from USFDA.
Read also: Aurobindo Pharma to acquire balance 49 percent stake in GLS Pharma for Rs 22.5 crores

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

Read also: Aurobindo Pharma to acquire balance 49 percent stake in GLS Pharma for Rs 22.5 crores

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Epilepsy Drug sulthiame promising for dangerous obstructive sleep apnea, finds study

Patients taking sulthiame, a drug currently in use for epilepsy, experienced a reduction in their symptoms of obstructive sleep apnoea (OSA), according to results of a clinical trial presented at the European Respiratory Society(ERS) Congress in Vienna, Austria.

Patients with OSA often snore loudly, their breathing starts and stops during the night, and they may wake up several times. Not only does this cause tiredness, but it can also increase the risk of high blood pressure, stroke, heart disease and type 2 diabetes. OSA is very common, but many people do not realise they have the condition.

The new research was presented by Professor Jan Hedner from Sahlgrenska University Hospital and the University of Gothenburg in Sweden. He said: “The standard treatment for obstructive sleep apnoea is sleeping with a machine that blows air through a face mask to keep the airways open. Unfortunately, many people find these machines hard to use over the long term, so there is a need to find alternative treatments. We also a need better understanding of the underlying mechanisms in OSA to help clinicians give more personalised treatment.”

The trial was a double-blind, randomised, placebo-controlled trial – the gold-standard in medical research. It involved 298 people with OSA being treated at 28 different centres in Spain, France, Belgium, Germany and the Czech Republic. All the patients could not tolerate or refused to use continuous positive airway pressure (CPAP) machines or mouthpieces designed to keep the airways open.

The patients were assessed with polysomnography at the start of the trial, and after four weeks and 12 weeks in the study. Polysomnography measures breathing, levels of oxygen in the blood, heart rhythm, eye movements, brain and muscle activity during a night of sleep.

The patients were divided into four groups: 74 people took 100 mg of sulthiame daily, 74 took 200 mg, 75 took 300 mg and the remaining 75 took a placebo (dummy pill). Sulthiame is a drug that targets the respiratory system by inhibiting an enzyme called carbonic anhydrase and stimulating the upper airway muscles.

The people taking sulthiame had fewer pauses in their breathing and higher levels of oxygen in their blood during sleep. A measure of the frequency of respiratory pauses during sleep, called AHI3a [2], was 17.8% lower for patients taking the lowest dose, 34.8% lower for patients on the medium dose and 39.9% lower for patients on the highest dose. When researchers used another measure called AHI4, the effect of the treatment was close to a 50% reduction of respiratory pauses with more profound lowering of oxygen levels. OSA patients who had been feeling sleepy during the daytime also felt less so when they took sulthiame.

Side effects experienced by the people taking sulthiame, such pins and needles, headache, fatigue, and nausea, were generally mild or moderate.

Professor Hedner said: “People taking sulthiame in the trial had a reduction in OSA symptoms such as stopping breathing during the night and feeling sleepy during the day. Their average levels of oxygen in the blood were also improved with the treatment. This suggests that sulthiame could be an effective treatment for OSA, especially for those who find they cannot use the existing mechanical treatments.

“Although sulthiame is already available as a treatment for childhood epilepsy, we still need to carry out a phase III study to confirm the beneficial respiratory effects of this drug in a larger group of patients with OSA.”

Professor Sophia Schiza is Head of the ERS assembly on sleep disordered breathing, Professor of Respiratory and Sleep Medicine in the School of Medicine at the University of Crete, Greece, and was not involved in the research. She said: “Many of us know that we snore or that our partner snores. If snoring is accompanied by other symptoms, such as waking up often in the night, feeling fatigued and/or sleepy during the daytime, then it’s time to speak to a doctor. Because obstructive sleep apnoea increases the risk of serious health problems such as high blood pressure, heart and metabolic disease, it’s vital that we diagnose and treat the condition. Treatments are available, but because they don’t work for everyone, we need more ways to treat the disease, based on individualised diagnostic and treatment approaches.

“This is one of the first studies to suggest that a drug treatment could help some patients, and the results are promising. We need to continue testing sulthiame and other treatments to understand their long-term effects, including any side effects. For example, we’d like to see whether treatment can help with lowering blood pressure and preventing cardiovascular disease for people with OSA.”

Reference:

Drug treatment shows promise for dangerous snoring condition, obstructive sleep apnea, European Respiratory Society, Meeting: European Respiratory Society Congress 2024.

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Donidalorsen- a new drug for Hereditary Angioedema

Donidalorsen- a new drug for Hereditary Angioedema

Hereditary angioedema is a unusual dermatological disorder which presents with by episodic, potentially life-threatening swelling of mucocutaneous system. Kallikrein–kinin dysregulation plays a major role in the pathogenesis of this disease. Long-term prophylaxis can stabilize this system but options are limited. Recently phase 3 study of a new drug Donidalorsen in hereditary angioedema was published in New England Journal of Medicine.

This was a phase 3, double-blind, randomized trial, where patients with hereditary angioedema were randomized to receive donidalorsen (80 mg subcutaneously) or placebo once every 4 or 8 weeks. The primary end point was the time-normalized number of investigator-confirmed hereditary angioedema attacks per 4 weeks (attack rate) from week 1 to week 25.

A total of 90 patients received donidalorsen every 4 weeks (45 patients), donidalorsen every 8 weeks (23 patients), or placebo (22 patients). The least-squares mean time-normalized attack rate was 0.44 (95% CI, 0.27 to 0.73) in the 4-week group, 1.02 (95% CI, 0.65 to 1.59) in the 8-week group, and 2.26 (95% CI, 1.66 to 3.09) in the placebo group. The mean attack rate from week 1 to week 25 was 81% lower (95% CI, 65 to 89) in the 4-week group than in the placebo group (P<0.001) and 55% lower (95% CI, 22 to 74) in the 8-week group than in the placebo group (P=0.004). The median reduction in the attack rate from baseline was 90% in the 4-week group, 83% in the 8-week group, and 16% in the placebo group. The mean attack rate during weeks 5 to 25 was 87% lower (95% CI, 72 to 94) in the 4-week group than in the placebo group (P<0.001) and 60% lower (95% CI, 25 to 79) in the 8-week group than in the placebo group.

Donidalorsen is a ligand conjugated antisense oligonucleotide which specifically reduces prekallikrein expression. When administered every 4 weeks it resulted in an improvement in the least-squares mean total score for the change at week 25 on the Angioedema Quality-of-Life Questionnaire (scores range from 0 to 100, with a score of 100 indicating the worst possible quality of life) that was 18.6 points (95% CI, 9.5 to 27.7) better than that with placebo (P<0.001). The most common adverse events were erythema at the injection site, headache, and nasopharyngitis; 98% of adverse events were mild or moderate in severity.

To conclude donidalorsen treatment reduced the hereditary angioedema attack rate, making it a potential drug for long-term prophylaxis of hereditary angioedema.

Reference– Riedl MA, Tachdjian R, Lumry WR, Craig T, Karakaya G, Gelincik A, Stobiecki M, Jacobs JS, Gokmen NM, Reshef A, Gompels MM, Manning ME, Bordone L, Newman KB, Treadwell S, Wang S, Yarlas A, Cohn DM; OASIS-HAE Team. Efficacy and Safety of Donidalorsen for Hereditary Angioedema. N Engl J Med. 2024 Jul 4;391(1):21-31.

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Crigler lacrimal sac massage may improve resolution of congenital nasolacrimal duct obstruction in young kids: Study

Crigler lacrimal sac massage may improve the resolution of congenital nasolacrimal duct obstruction in young kids suggests a study published in the Paediatric ophthalmology.

Congenital nasolacrimal duct obstruction (CNLDO) is the most common cause of epiphora and mucous discharge in the newborn. We conducted a multicentre randomised controlled trial to determine whether Crigler massage promotes the resolution of CNLDO in infants under 1 year of age. A total of 102 infants aged 3–11 months with unilateral CNLDO were enrolled in the study. Patients were randomly assigned to the massage and non-massage groups (n=51/group). As an allocation adjustment factor, the patients were divided into age groups of 3–5, 6–8 and 9–11 months. In the massage group, the guardian performed 10 strokes two times per day for each day until resolution or 1 month. The primary endpoint was a comparison of the 1-month resolution rate in the massage and non-massage groups. Results: This study included 49 male and 53 female patients with a mean age of 6.4±2.4 months. Overall, in this study, the resolution rate was not significantly different between the massage and non-massage groups (31.4% and 33.3%, respectively). However, the resolution rate was higher in the massage group in the 3–5 months age group among the protocol-compliant patients after excluding those with insufficient massage frequency (the massage group, 68.8% and the non-massage group, 28.6%, p=0.022). There was no increase in the resolution rate after 1 month of lacrimal sac massage in patients 3–11 months old with unilateral CNLDO. However, in protocol-compliant younger age groups, Crigler massage may be effective.

Reference

Asano M, Takeuchi M, Ohno T, et alLacrimal sac massage for congenital nasolacrimal duct obstruction: a multicentre randomised controlled trialBritish Journal of Ophthalmology 2024;108:1281-1285.

Keywords:

Crigler, lacrimal, sac, massage, may, improve, resolution, congenital, nasolacrimal, duct, obstruction, young kids, Study, Paediatric ophthalmology, Asano M, Takeuchi M, Ohno T

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Pitt study identifies potential new treatment for liver fibrosis

New research from the University of Pittsburgh School of Pharmacy sheds light on the processes that lead to liver fibrosis and suggests a novel treatment approach for this common and serious condition.

Led by senior author Wen Xie, M.D., Ph.D., professor and Joseph Koslow endowed chair of the Department of Pharmaceutical Sciences and co-first authors Hung-Chun Tung, graduate student, and Jong-Won Kim, Ph.D., postdoctoral fellow, the study published today in Science Translational Medicine.

In this Q&A, Xie elaborates on the study’s findings and explains why new diagnostic tools and treatment options for liver fibrosis are greatly needed.

What is liver fibrosis and who is at risk?

Liver fibrosis is the formation of tissue scars in the liver due to chronic inflammation and injury. Over time, fibrosis can impair liver function and may lead to cirrhosis or even liver cancer. Those at risk include individuals with chronic viral hepatitis, obesity, diabetes and excessive alcohol use. Early detection and intervention are crucial to prevent progression to more severe liver disease.

What are the current treatments for liver fibrosis?

Currently there are no FDA-approved drugs that specifically treat liver fibrosis. The only treatment option is to treat diseases that cause liver fibrosis in the first place, such as hepatitis, obesity, type 2 diabetes and alcoholic liver disease. Preventive measures include avoiding excessive alcohol, maintaining a healthy body weight and early screening for liver diseases to prevent fibrosis from advancing to cirrhosis or liver failure.

What are hepatic stellate cells (HSCs), and how do they contribute to liver fibrosis?

HSCs are a unique cell type in the liver. When the liver is injured or inflamed, HSCs become activated and produce excess collagen and other extracellular matrix proteins. The accumulation of collagen and other extracellular matrix proteins leads to scar tissue formation and liver fibrosis.

What were the main findings of this study?

This study identified the enzyme CYP1B1 as a biomarker and predictor of HSC activation and liver fibrosis in both patients and mice. Inhibition of CYP1B1 led to the accumulation of a sugar called trehalose, which we showed for the first time that trehalose has anti-fibrotic activity. Moreover, treatment of mice with trehalose, its analog lactotrehalose or CYP1B1 inhibitor protected mice from getting liver fibrosis.

It was surprising to identify a liver function of CYP1B1, an enzyme traditionally known for its functions outside the liver. Although the concentration of CYP1B1 in the whole liver is not high, this enzyme is uniquely and abundantly present in HSCs and thus plays an important role in HSC activation and liver fibrosis.

What are the clinical implications of these findings?

Liver fibrosis is a common, potentially deadly and costly liver disease that lacks FDA-approved drugs. Our findings are clinically important because we identified CYP1B1 as a predictor of HSC and liver fibrosis in patients, which may help with the early diagnosis of this disease. More importantly, we found that trehalose and lactotrehalose are potential novel drugs that could be used to treat liver fibrosis in the future.

What’s next for this research?

Future and more comprehensive human studies are needed to confirm the role of CYP1B1 in human liver fibrosis. The utility of trehalose or lactotrehalose in the treatment of human liver fibrosis also warrants future studies. 

Reference:

Hung-Chun Tung et al. ,Inhibition of heme-thiolate monooxygenase CYP1B1 prevents hepatic stellate cell activation and liver fibrosis by accumulating trehalose.Sci. Transl. Med.16,eadk8446(2024).DOI:10.1126/scitranslmed.adk8446

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Success rate of PRP injections better than steroid injections for Sacroiliac joint pain, claims study

The most effective injective treatment approach for sacroiliac joint (SIJ) pain remains unclear. Ruflli et al conducted a study to quantify the safety and effectiveness of the available injective strategies to address SIJ pain.

A systematic review and meta-analysis of the literature was conducted on PubMed, Scopus, and Embase databases from inception until January 2023. Inclusion criteria were studies written in English, comparative and non-comparative studies regardless of the minimum follow-up, and case series on SIJ injections. Safety and efficacy of the different injection therapies for the SIJ were quantified. A meta-analysis was conducted on the available data of the documented injective therapies. The “Checklist for Measuring Quality” by Downs and Black was used to assess the risk of bias and the quality of papers.

The key findings of the analysis:

• The literature search retrieved 43 papers (2431 patients): 16 retrospective case series, 2 retrospective comparative studies, 17 prospective case series, 3 prospective comparative studies, and 5 randomized controlled trials.

• The number of studies per year increased over time with 50% of the studies published since 2018.

• Most of the studies were conducted in the USA including 51% of the patients, followed by Japan (9%), Egypt (9%), and Turkey (6%).

• Of the selected studies, 63% examined the effect of steroid injections, 16% of PRP injections, while 21% reported other heterogeneous treatments.

• The number of patients retrieved in the systematic review was 2431 (1237 women, 679 men, not reported in the remaining cases), 1425 with steroids, 306 treated with PRP, 700 with other treatments, while 3 studies did not specify the number of patients while only reporting the number of SIJ treated.

• The mean age of patients treated with steroid injection was 50.4±15.7 years and the mean BMI was 30.2, the mean age of patients treated with PRP was 47.0±15.9 years and the mean BMI was 27.0.

• The most common guidance used for injection was fluoroscopy (30 studies), followed by computer tomography (CT) (5 studies), ultrasound (4 studies), and anatomical landmarks (2 studies).

• The failure rate was 26% in steroid injections and 14% in PRP injections.

• The meta-analysis showed a statistically significant reduction in pain with the VAS score for both steroids and PRP: steroids improvement at mid-term 3.4 points (p < 0.05), at long-term 3.0 (p < 0.05), PRP improvement at mid-term 2.2 (p = 0.007), at long-term 2.3 points of the VAS pain scale (p = 0.02).

The authors concluded – “Steroids are the most documented injective approach, with studies showing an overall safety and effectiveness. Still, the high number of failures underlined by some studies suggest the need for alternative procedures. Early PRP data showed promise, but the limitations of the current literature do not allow to clearly define the most suitable injective approach, and further studies are needed to identify the best injective treatment for SIJ patients.”

Further reading:

Injective Treatments for Sacroiliac Joint Pain: A Systematic Review and Meta analysis

A. Ruflli, T. Cerasoli et al

Indian Journal of Orthopaedics (2024) 58:637–649

https://doi.org/10.1007/s43465-024-01164-w

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Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Recombinant Human Follicle Stimulating Hormone

New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I clinical trial of the Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection.

However, this approval is subject to the condition that the firm should have tied up with an IVF center in case of an emergency.

This came after the firm presented the protocol to conduct a Phase I clinical study of Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection titled ” An open label, Phase-I, balanced, randomized, two-treatment, two-period, two-sequence, single subcutaneous dose administration, crossover, bioequivalence study of r-h-FSH (recombinant human follicle stimulating hormone injection), solution for injection of Intas Pharmaceuticals Limited, India with Gonal-f, recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection of Merck serono Ltd. in pituitary down-regulated normal, healthy, adult, human female subjects under fasting conditions.” vide Protocol no. 0501-23, Version: 2.0 dated 27-May-2024.

Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection belongs to a group of medicines called Gonadotropins. It is used to treat infertility in women (oligo-anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure) and to stimulate sperm production in men.

At the recent SEC meeting for reproductive medicine, held on September 18, 2024, the expert panel reviewed the protocol for conducting a Phase I clinical study of recombinant human follicle-stimulating hormone 300 IU Solution for Injection presented by the drug major Intas Pharmaceuticals.

After detailed deliberation, the committee recommended the conduct of the proposed Phase I study with the condition that the firm should have tied up with an IVF center in case of an emergency.

Accordingly, the expert panel suggested that the firm should submit a revised protocol to CDSCO for further evaluation.

Also Read: Present difference of approved and proposed formulation: CDSCO tells Novo Nordisk’s Semaglutide tablet

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