Primary splenic pregnancy: A diagnostic and Therapeutic Enigma of Ectopic Pregnancy

A recent study found that primary splenic pregnancy, which
is a rare form of ectopic pregnancy, poses significant diagnostic and
therapeutic challenges. The study results were published in the Journal of
Obstetrics and Gynecology Research.

Primary splenic pregnancy is a rare type of ectopic
pregnancy which can be life-threatening. Intra-abdominal bleeding is one of the
major causes of emergency in primary splenic pregnancy. To date, about 51 cases
have been reported globally. Hence, researchers conducted a study to identify
the fundamental steps of the diagnosis necessary to reduce the mortality rate simultaneously
evaluating the available therapeutic options.

Also Read: Multiplexed serum biomarkers may help discriminate nonviable and ectopic pregnancy: Study

Researchers presented the diagnostic-therapeutic pathway of a
22-year-old woman with primary splenic pregnancy. To identify the best
treatment for these patients, researchers reviewed various databases in English
and all available non-English literature, including historical publications. The
collected literature was classified each article by clinical onset, diagnostic
and therapeutic strategy, and histological findings, if available.

Findings:

  • About 43 cases in the English-language
    literature were reviewed (plus another paper in German).
  • The study found that 72.7% of patients presented
    in an emergency setting.
  • Seventy-five percent of patients required
    splenectomy, 6.8% received pharmacological-only therapy, and 11.3% received
    arterial embolization before definitive treatment.
  • The other ones received non-radical surgical
    treatment.
Also Read: Methotrexate useful for managing symptoms in patients with ectopic pregnancy

Primary splenic pregnancy poses significant diagnostic and
therapeutic challenges due to its rare presentation. Various treatment
approaches that are used, such as pharmacological, interventional, or surgical should
be personalized based on the clinical presentation and hemodynamic stability of
the patient. The study highlighted the necessity of developing and validating
evidence-based treatment strategies to improve clinical outcomes.

Further reading: Primary splenic ectopic pregnancy: A case
report and literature review of a rare issue. Doi: https://doi.org/10.1111/jog.16154

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Levofloxacin Lowers Tuberculosis Incidence in Trial, But Results Not Statistically Significant: Study

Australia: A recent study in Vietnam has investigated the potential of levofloxacin in preventing multidrug-resistant tuberculosis (MDR-TB) in high-risk populations. While the findings, published in The New England Journal of Medicine, suggest a lower incidence of tuberculosis in the levofloxacin group compared to a placebo, the difference was not statistically significant over the 30-month follow-up period.

Prevention of drug-resistant tuberculosis remains a global health priority, yet there is a lack of trials evaluating the effectiveness of treating Mycobacterium tuberculosis infection in contact with individuals with MDR-TB. Levofloxacin, a broad-spectrum antibiotic commonly used for various bacterial infections, has not been extensively studied for its potential in preventing MDR-TB, despite its widespread use in treating other types of infections.

This gap in research prompted Greg J. Fox, Faculty of Medicine and Health, University of Sydney, Medical Foundation Bldg. K25A, Camperdown, Australia, and colleagues to investigate whether levofloxacin could play a role in preventing TB transmission, especially among those at high risk of contracting drug-resistant strains.

For this purpose, the researchers conducted a double-blind, randomized, controlled trial to compare 6 months of daily levofloxacin (weight-based doses) with a placebo for treating M. tuberculosis infection. The trial included household contacts of individuals with bacteriologically confirmed rifampicin-resistant or multidrug-resistant (MDR) tuberculosis in Vietnam. Eligible participants were of any age and had either a positive tuberculin skin test or immunologic impairment.

The primary endpoint was the occurrence of bacteriologically confirmed tuberculosis within 30 months, while secondary endpoints included grade 3 or 4 adverse events, death from any cause, and the development of acquired drug resistance.

The following were the key findings of the study:

  • 3948 individuals were screened for eligibility, with 61 (1.5%) having coprevalent tuberculosis and 2041 proceeding to randomization.
  • Of the 2041 participants, 97.7% completed 30 months of follow-up, had a primary endpoint event or died.
  • Confirmed tuberculosis occurred in 0.6% of participants in the levofloxacin group and 1.1% in the placebo group, with an incidence rate ratio of 0.55, but the difference was not significant.
  • Grade 3 or 4 adverse events were similar between the two groups, with a risk difference of 1.0 percentage points.
  • Adverse events of any grade were in 31.9% of participants in the levofloxacin group and 13.0% in the placebo group, with a risk difference of 18.9 percentage points.
  • There was no acquired fluoroquinolone resistance.

The researchers concluded that, although the incidence of tuberculosis was lower in participants receiving levofloxacin for treating M. tuberculosis infection than those on placebo, the difference was not statistically significant. Levofloxacin was not linked to a notably higher incidence of grade 3 or 4 adverse events, though lower-grade adverse events were more frequently reported in the levofloxacin group.

The researchers suggested that these findings should be considered alongside data from other settings to gain further insights into the potential role of levofloxacin in tuberculosis prevention.

Reference:

Fox GJ, Nhung NV, Cam Binh N, Hoa NB, Garden FL, Benedetti A, Ngoc Yen P, Cuong NK, MacLean EL, Yapa HM, Dowdy DW, Lan NH, Guevara-Rattray E, Duc Cuong P, Solomon O, Behr MA, Marais BJ, Graham SM, Menzies D, Thu Anh N, Marks GB. Levofloxacin for the Prevention of Multidrug-Resistant Tuberculosis in Vietnam. N Engl J Med. 2024 Dec 19;391(24):2304-2314. doi: 10.1056/NEJMoa2314325. PMID: 39693541.

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Study Confirms Strong Link Between Celiac Disease and Alopecia Areata

USA: A recent multicenter case-control study published in the Journal of the American Academy of Dermatology has provided robust evidence supporting a significant association between celiac disease (CD) and alopecia areata (AA). Leveraging a large sample size, the research strengthens a connection that has been long suspected but previously underexplored due to limited data.

“The strong association identified, despite potential inaccuracies in large, automatically compiled databases, reinforces the long-held suspicion of a link between celiac disease and an increased risk of alopecia areata,” the researchers wrote.

Celiac disease, an autoimmune condition triggered by gluten, affects the small intestine and often presents with gastrointestinal and systemic symptoms. Alopecia areata, another autoimmune disorder, leads to patchy hair loss and, in some cases, complete baldness. While the coexistence of these two conditions has been anecdotally observed, Rashwan Alameddine, MS. Texas A&M University College Station, Bryan, Texas UNITED STATES, and colleagues seek to explore the possible connection between celiac disease and the occurrence of alopecia areata following its initial diagnosis.

For this purpose, the researchers conducted a case-control study using TriNetX to analyze data from 509,910 patients with celiac disease and 622,747 control participants, comparing their risk outcomes for alopecia areata.

Based on the study, the researchers reported the following findings:

  • The analysis included 495,211 patients with celiac disease and 495,112 controls.
  • Patients with CD were found to have an increased risk of developing alopecia areata.
  • The odds ratio for developing alopecia areata in CD patients was 1.25.
  • The association was statistically significant with a p-value of <0.0001.

This study has several limitations, including its focus on the United States population, potential errors in charting, misdiagnoses, and inaccuracies in assigning ICD codes to patient records, as TriNetX relies on AI to extract patient data.

“Despite these limitations, the large sample size used in this study strengthens the evidence for a previously suggested association but not well established. The significant degree of association observed, even with the potential errors inherent in large, automatically compiled databases, reinforces the long-held suspicion of a link between celiac disease and an increased risk of alopecia areata,’ the researchers concluded.

Reference:

Alameddine R, Ahmad N, Alam Z, Pacha O. Celiac Disease Associated with Alopecia Areata: A multicenter case control study. J Am Acad Dermatol. 2024 Nov 20:S0190-9622(24)03227-4. doi: 10.1016/j.jaad.2024.11.023. Epub ahead of print. PMID: 39577700.

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New drug atogepant to prevent migraine may start working right away, reports research

 A drug recently approved to prevent migraine may start working right away, according to a study published in the December 23, 2024, online issue of Neurology®. The study looked at the drug atogepant, which is a calcitonin gene-related peptide (CGRP) receptor antagonist taken by mouth.

“With many current drugs to prevent migraine, it takes time to find the right dosage for the individual and it can take weeks or even months for it to be most effective,” said study author Richard B. Lipton, MD, of Albert Einstein College of Medicine in the Bronx, New York, and a Fellow of the American Academy of Neurology. “Some people give up and stop taking the drugs before they reach this point. Plus, many people experience side effects with current treatments. Developing a drug that works both effectively and quickly is critical.”

In the study, people taking the drug atogepant were less likely to have a migraine on the first day of taking the drug compared to those taking a placebo. They also had fewer migraines per week during each of the first four weeks of the study and fewer migraines during the study overall than those taking a placebo.

For this study, researchers looked at the data from three trials on the safety and effectiveness of atogepant over 12 weeks to focus on how rapidly improvements appeared. The ADVANCE trial, which enrolled people with episodic migraine, had 222 people taking the drug and 214 taking placebo. The ELEVATE trial, which enrolled people with episodic migraine who had previously not responded well to other oral preventive treatments, had 151 on the drug and 154 on placebo. The PROGRESS trial, which enrolled people with chronic migraine, had 256 on the drug and 246 on placebo.

People with episodic migraine experience up to 14 migraine days per month. People with chronic migraine experience at least 15 days with headache per month, with at least eight days being characteristic of migraine.

On the first day of the study, 12% of those taking the drug in the first trial, the ADVANCE trial had a migraine, compared to 25% of those taking placebo. In the second trial, the ELEVATE trial, the numbers were 15% and 26%. For the third trial, the PROGRESS trial, the numbers were 51% and 61%.

When researchers adjusted for other factors that could affect the rate of migraine, they found that people taking the drug were 61% less likely to have a migraine in the first trial, 47% less likely in the second trial, and 37% less likely in the third trial.

For the first two trials, the people taking atogepant had an average of one fewer day with migraine per week, compared to an average of less than one-half day fewer per week for those taking the placebo. For the third trial, average migraine days per week declined by about 1.5 days for those taking the drug compared to about one day for those taking the placebo.

The people taking atogepant also showed improvement on assessments of how much migraine impaired their activities and their overall quality of life compared to people taking the placebo.

“Migraine is the second-leading cause of disability in the overall population and the leading cause of disability in young women, with people reporting negative effects on their relationships, parenting, career and finances,” Lipton said. “Having a treatment that can act quickly and effectively addresses a key need.”

A limitation of the study is that it involved mostly female and white participants, so the results may not apply to the overall population.

Reference:

Richard B. Lipton, Early Improvements With Atogepant for the Preventive Treatment of Migraine Results From 3 Randomized Phase 3 Trials, Neurology, https://doi.org/10.1212/WNL.0000000000210212.

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Male fertility restoration: in vivo and in vitro stem cell–based strategies using cryopreserved testis tissue

Childhood cancer survival rates have increased substantially
in the past few decades, with over 80% of survivors reaching adulthood thanks
to modern treatment regimens. Many prepubertal patients with cancer are facing
gonadotoxic treatments such as chemotherapy or gonadal radiation, which poses a
significant threat to their future fertility. Prepubertal males have no option
to preserve fertility by traditional sperm cryopreservation; for these
patients, the only fertility preservation strategy is cryopreservation of immature
testis tissue (ITT). Fertility restoration is increasingly becoming a concern,
with the focus shifting toward continuation of care after successful cancer
treatment and securing quality of life for childhood cancer survivors who wish
to become biologic parents in adulthood. Some centers also offer testis tissue
cryopreservation for selected young boys with cryptorchidism who have a high
risk of infertility. A growing number of centers worldwide now offer routine
cryopreservation of ITT with the aim of advancing spermatogonial stem cell
(SSC)–based treatments to a clinical stage to provide opportunities for
fertility restoration.

Fertility has a profound impact on our quality of life. Male
fertility restoration is currently a dynamically evolving field including a
broad range of strategies such as surgical and in vitro approaches to achieve
restoration of fertility from prepubertally cryopreserved testis tissue.
Meanwhile, the current evidence for fertility restoration strategies has not yet
been systematically synthesized, leading to a potential lack of structured
research cooperation across different disciplines. Thus, this topic lends
itself to a scoping approach to map and assess the extent of the evolving
heterogeneous literature and identify gaps in knowledge. This review aimed to
examine the current evidence and clinical applicability of the different
strategies for fertility restoration using ITT as well as identify future
research questions that will accelerate the expected implementation of therapy
options in clinical medicine. Furthermore, potential barriers in the
development of clinically relevant therapies are identified.

The review was conducted after the Preferred Reporting Items
for Systematic Reviews and Meta-Analyses extension for Scoping Reviews criteria
and previously published guidelines and examined studies using human testis
tissue of prepubertal boys or healthy male adults. A literature search in
PubMed was conducted, and 72 relevant studies were identified, including in
vivo and in vitro approaches.

In vivo strategies, such as testis tissue engraftment and
spermatogonial stem cell transplantation, hold promise for promoting cell
survival and differentiation. Yet, complete spermatogenesis has not been
achieved. In vitro approaches focus on the generation of male germ cells from
direct germ cell maturation in various culture systems, alongside human induced
pluripotent stem cells and embryonic stem cells. These approaches mark
significant advancements in understanding and promoting spermatogenesis, but
achieving fully functional spermatozoa in vitro remains a challenge. Barriers
to clinical implementation include the risk of reintroducing malignant cells
and introduction of epigenetic changes.

Male fertility restoration is a rapidly transforming field
with new evolving technologies and a recent substantial advancement with the
first proof-of-principle study of testis tissue engraftment in a human male. A
broad range of studies on in vitro and in vivo stem cell–based strategies for
male fertility restoration demonstrated significant advancements. However, lack
of standardized outcomes and reporting tools, heterogeneous source tissue
material, risk of reintroduction of malignant cells, and unresolved challenge
of definite identification of SSCs in vitro are still challenging clinical
implementation. After assessment of the currently available reports, autologous
engraftment of cryopreserved and thawed testis tissue appears to be the most
promising strategy for male fertility restoration and is likely close to the
first human experimental clinical trials. Testis tissue has been cryopreserved
from >3,000 boys aged <18 years worldwide, and it is now a collective
task to team up, improve interdisciplinary efforts, and share knowledge across
countries for establishing evidence-based robust guidelines for clinical male
fertility preservation and restoration.

Source: Elena von Rohden, M.D.,a,b,h Christian Fuglesang S.
Jensen, M.D., Ph.D.,a Claus Yding Andersen; Fertil Steril® Vol. 122, No. 5,
November 2024 0015-0282

https://doi.org/10.1016/j.fertnstert.2024.07.010

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Compared to non hypertensives, Patients of Hypertension have higher Decayed, Missing, and Filled Teeth scores: Study

Compared to non-hypertensives, Patients of Hypertension have higher Decayed, Missing, and Filled Teeth scores suggests a study published in the BMC Oral Health.

This study investigated the association between hypertension and oral health status, as measured by the Decayed, Missing, and Filled Teeth (DMFT) index, using data from the PERSIAN Guilan Cohort Study (PGCS). A cross-sectional analysis was conducted on 10,520 participants aged 35–70 from Guilan Province, Northern Iran. Blood pressure measurements, oral examinations, and comprehensive data collection on demographic, lifestyle, and clinical factors were performed. The DMFT index was used to assess oral health status. Statistical analyses included Pearson correlation, t-tests, and multiple linear regression. Results: The mean DMFT score was significantly higher in hypertensive participants than in non-hypertensive individuals (15.80 vs. 13.62, p < 0.001). Factors associated with increased DMFT scores in both hypertensive and non-hypertensive groups included older age, lower education levels, lower BMI, not flossing, smoking, alcohol use, and infrequent tooth brushing. In the hypertensive group, urban residency was additionally associated with higher DMFT scores. For non-hypertensive participants, hookah use, not using mouthwash, and lower socioeconomic status were also linked to increased DMFT scores. A significant negative correlation was found between blood triglyceride levels and DMFT scores in individuals with hypertension (p = 0.037). This study establishes a significant association between hypertension and poor oral health, as evidenced by elevated DMFT scores. The findings highlight the importance of integrated healthcare approaches that consider cardiovascular and oral health.

Reference:

Samami, M., Joukar, F., Hassanipour, S. et al. Hypertension and DMFT: insights from the PERSIAN Guilan Cohort Study. BMC Oral Health 24, 1456 (2024). https://doi.org/10.1186/s12903-024-05236-z

Keywords:

Compared, non-hypertensives, Patients, Hypertension, higher, Decayed, Missing, Filled, Teeth scores, study, BMC Oral Health, Samami, M., Joukar, F., Hassanipour, S, Hypertension, Oral health, DMF Index, Cohort studies, Cardiovascular diseases, Blood pressure, Dental Caries

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Healthy prenatal diet associated with proper infant growth and reduced risk factors associated with obesity: JAMA

Extreme birth sizes and different post-birth growth rates are connected to obesity in the future. Investigating how maternal diet quality during pregnancy influences infant growth could provide valuable information for preventing obesity. Recent research paper focused on the impact of prenatal diet quality on infant growth from birth to 24 months of age, with a specific emphasis on the associations of being born small for gestational age (SGA) or large for gestational age (LGA) and experiencing rapid or slow growth after birth with later-life obesity. The study aimed to evaluate the relationships between prenatal dietary quality according to the Healthy Eating Index (HEI) and the Empirical Dietary Inflammatory Pattern (EDIP) with infant size at birth and growth patterns during infancy.

The findings of the study, which included 2854 birthing parent-child dyads, revealed that a high HEI score (>80), indicative of a healthier diet, was associated with lower odds of LGA and rapid growth from birth to 6 and 24 months, as well as slow growth from birth to 6, 12, and 24 months. On the other hand, a low EDIP score (indicating a less inflammatory diet) was associated with higher odds of LGA and rapid infant growth from birth to 12 months but lower odds of rapid growth to 6 months, although there was no association with SGA.

Major Highlights

The study highlighted that a prenatal diet aligning with the US Dietary Guidelines was linked to reduced patterns of rapid and slow infant growth, both known risk factors for obesity. The research pointed out the need for further investigations to determine if interventions to improve prenatal diet could also positively impact the growth trajectory in children. Overall, the study provided valuable insights into the importance of prenatal diet quality in shaping infant growth patterns, emphasizing the relevance of adhering to healthy dietary guidelines during pregnancy to promote healthy birth weight and infant growth in the first 2 years of life.

Methodology and Limitations-

The research paper employed a rigorous methodology, including a prospective cohort study design with diverse cohorts from different regions in the US, making the findings generalizable. However, the study also had limitations, such as harmonization of dietary data from different tools and lack of information on infant feeding practices. The study contributed valuable knowledge to the field of nutrition and obesity research, emphasizing the significance of prenatal diet in shaping infant growth outcomes and later-life obesity risk.

Key Points

– The research paper explored the impact of prenatal diet quality on infant growth from birth to 24 months of age, focusing on associations with being born small for gestational age (SGA) or large for gestational age (LGA) and experiencing rapid or slow growth after birth on later-life obesity risk.

– Findings from the study of 2854 parent-child dyads indicated that a high Healthy Eating Index (HEI) score (>80) was related to lower odds of LGA and rapid growth from birth to 6 and 24 months, as well as slow growth from birth to 6, 12, and 24 months. Conversely, a low Empirical Dietary Inflammatory Pattern (EDIP) score was associated with higher odds of LGA and rapid growth from birth to 12 months but lower odds of rapid growth to 6 months, with no association with SGA noted.

– The study emphasized that adhering to a prenatal diet in line with US Dietary Guidelines was linked to reduced instances of rapid and slow infant growth, known risk factors for obesity, underscoring the importance of addressing prenatal diet for healthy birth weight and infant growth during the first 2 years of life.

– Methodologically, the research used a prospective cohort study design with diverse cohorts from various US regions, enhancing the generalizability of the findings. Limitations included challenges in harmonizing dietary data from different tools and a lack of information on infant feeding practices.

– The study contributes valuable insights to nutrition and obesity research, highlighting the crucial role of prenatal diet in shaping infant growth outcomes and influencing the risk of later-life obesity. It suggests the necessity for further investigations to ascertain if enhancing prenatal diet quality could positively impact children’s growth trajectories.

– Overall, the research underscores the significance of prenatal dietary quality in influencing infant growth patterns, advocating for healthy dietary practices during pregnancy to support optimal birth weight and infant growth in the early years.

Reference –

M. Hedderson et al. (2024). Prenatal Diet And Infant Growth From Birth To Age 24 Months. *JAMA Network Open*, 7. https://doi.org/10.1001/jamanetworkopen.2024.45771

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CDSCO Panel Approves Eli Lilly’s Protocol Amendment Proposal for Antidiabetic Drug Retatrutide study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Eli Lilly’s protocol amendment proposal for the antidiabetic Drug Retatrutide (LY3437943) study.

This came after the firm presented protocol amendment(d) dated 27 August 2024 and protocol addendum 2 dated 01 October 2024 protocol no. J1I-MC-GZBJ. This is a study of Retatrutide (LY3437943) in participants who have obesity or are overweight.

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol), including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1).

Retatrutide (LY3437943) is an investigational agent that combines agonism with three key hormones that influence eating and metabolism into a single molecule. It is an agonist of the glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and glucagon receptors.

At the recent SEC meeting for endocrinology and metabolism held on 11th December 2024, the expert panel reviewed the protocol amendment (d) dated 27 August 2024 and protocol addendum 2 dated 01 October 2024 protocol no. J1I-MC-GZBJ.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: Intas Pharmaceutical gets CDSCO Panel nod to study Aflibercept Solution for Injection 40 mg/ml in Vial

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Submit justification for dose assumption and animal toxicity data: CDSCO Panel Tells Lupin on Rizatriptan nasal spray

New Delhi: Regarding the proposed bioavailability study protocol for Rizatriptan nasal spray (2.5 mg/spray, 5 mg/spray, 7.5 mg/spray), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Lupin to submit more elaborated justification for dose assumption and animal toxicity data generated on sufficient number of experimental animals.

This came after the drug maker Lupin presented the protocol no. LBC-P-039-24 Version no.00 Dt 15-4-2024 for bioavailability study for export purposes only.

Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine Rizatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light).

At the recent SEC meeting for neurology and psychiatry held on 12th December 2024, the expert panel reviewed the protocol no. LBC-P-039-24 Version no.00 Dt 15-4-2024 for bioavailability study for export purposes only.

After detailed deliberation, the committee opined that the firm is required to submit the following documents:

(1) More elaborated justification for dose assumption

(2) Animal toxicity data generated on a sufficient number of experimental animals, as the submitted toxicity data had a very less sample size.

Accordingly, the expert panel suggested that the firm submit the above information and data for re-deliberation in the SEC.

Also Read: AstraZeneca Gets CDSCO Panel Nod To study Anti-Cancer Drug Rilvegostomig

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CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal To Study antihypertensive drug Baxdrostat

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the pharmaceutical major AstraZeneca protocol amendment proposal to study Baxdrostat Tablets 1 mg/2 mg.

This came after the firm presented protocol amendment version 2.0 dated 26 April 2024 protocol no. D6970C00008. This is a study to investigate the efficacy and safety of baxdrostat in participants with uncontrolled hypertension on two or more medications, including participants with resistant hypertension.

Baxdrostat is a drug that’s being developed to treat conditions like hypertension, chronic kidney disease, and primary aldosteronism. It’s an oral, small-molecule inhibitor of aldosterone synthase, an enzyme that produces aldosterone in the adrenal gland. Baxdrostat is a selective inhibitor of aldosterone synthase, which reduces the production of aldosterone. Aldosterone levels that are too high can lead to inflammation, organ fibrosis, and systemic hypertension, which can contribute to cardiovascular events.

At the recent SEC meeting for Cardiovascular held on 11th December 2024, the expert panel reviewed the protocol amendment version 2.0 dated 26 April 2024 protocol no. D6970C00008.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: MSD Pharmaceutical Gets CDSCO Panel Nod To study MK-1084

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