WHO Adds R21/Matrix-M Malaria Vaccine to Prequalified List

Malaria inflicts a disproportionate burden on children in the African Region, taking up nearly half a million lives annually. Global statistics from 2022 reported 249 million malaria cases and 608,000 deaths across 85 countries.

In a ongoing battle against this, the World Health Organization (WHO) has added the R21/Matrix-M malaria vaccine to its list of prequalified vaccines. This decision was based on recommendations from the WHO Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Group.

This prequalification is important as it translates to broader access to the vaccine, becoming a cornerstone for vaccine procurement by UNICEF and garnering funding support for deployment from Gavi, the Vaccine Alliance. The R21 vaccine which was developed by Oxford University and manufactured by the Serum Institute of India, now stands as the second malaria vaccine to receive WHO prequalification, following the RTS,S/AS01 vaccine in July 2022.

Clinical trials affirm the safety and efficacy of both vaccines in preventing malaria in children. In conjunction with other established malaria control measures, their widespread implementation is expected to yield a significant public health impact.

Dr. Rogério Gaspar, Director of the Department of Regulation and Prequalification at WHO, underscored the importance of achieving WHO vaccine prequalification that ensures the safety and effectiveness of vaccines in targeted health systems.

The R21/Matrix-M’s prequalification is set to alleviate the limited supply of malaria vaccines, specially in African countries with high demand. With two WHO-recommended and prequalified malaria vaccines now available, the expectation is to meet the substantial demand and provide adequate vaccine doses for all children residing in malaria-prone regions. The rigorous prequalification process employed by WHO ensures ongoing safety and efficacy evaluations, reinforcing the commitment to delivering safe, effective, and quality health products for global immunization programs. This achievement marks a significant leap towards a malaria-free future, shielding countless lives from the relentless threat of this deadly disease.

Reference:

WHO prequalifies a second malaria vaccine, a significant milestone in prevention of the disease. (n.d.). Who.int. Retrieved December 22, 2023.

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Stressful events in pregnancy may increase risk of childhood asthma and wheeze

Maternal stressful life events during pregnancy may increase risk of childhood asthma and wheeze suggests a new study published in the Annals of Allergy, Asthma & Immunology.

Studies have linked prenatal maternal psychosocial stress to childhood wheeze/asthma but have rarely investigated factors that may mitigate risks.

A study was done to investigate associations between prenatal stress and childhood wheeze/asthma, examining factors that may modify stress effects.

Participants included 2056 mother-child dyads from ECHO PATHWAYS, a consortium of three prospective pregnancy cohorts (CANDLE, TIDES, and GAPPS) from six cities. Maternal stressful life events experienced during pregnancy (PSLEs) were reported using the Pregnancy Risk Assessment Monitoring System SLE questionnaire. Parents reported child wheeze/asthma outcomes at age 4-6 years using standardized questionnaires. We defined outcomes as ever asthma, current wheeze, current asthma, and strict asthma. We used modified Poisson regression with robust standard errors to estimate risk ratios (RR) and 95% confidence intervals (95%CI) per one-unit increase in PSLE, adjusting for confounders. We examined effect modification by child sex, maternal history of asthma, maternal childhood traumatic life events, neighborhood-level resources, and breastfeeding.

Results

Overall, we observed significantly elevated risk for current wheeze with increasing PSLE (RR:1.09 (95%CI:1.03,1.14)), but not for other outcomes. We observed significant effect modification by child sex for strict asthma (p-interaction=0.03), where risks were elevated in boys (RR:1.10 (95%CI:1.02,1.19)) but not girls. For all other outcomes, risks were significantly elevated in boys and not girls, although there was not statistically significant evidence of effect modification. We observed no evidence of effect modification by other factors (p-interactions>0.05).

Risk of adverse childhood respiratory outcomes is higher with increasing maternal PSLEs, particularly in boys.

Reference:

Margaret A. Adgent, Erin Buth, Amanda Noroña-Zhou, Adam A. Szpiro, Christine T. Loftus, Paul E. Moore, Rosalind J. Wright, Emily S. Barrett, Kaja Z. LeWinn, Qi Zhao, Ruby Nguyen, Catherine J. Karr, Nicole R. Bush, Kecia N. Carroll. Maternal stressful life events during pregnancy and childhood asthma and wheeze,

Annals of Allergy, Asthma & Immunology,

2023, ISSN 1081-1206, https://doi.org/10.1016/j.anai.2023.12.015.

(https://www.sciencedirect.com/science/article/pii/S1081120623014989)

Keywords:

Maternal, stressful, life, events, during, pregnancy, may, increase, risk, childhood, asthma, wheeze, Annals of Allergy, Asthma & Immunology, asthma; wheeze; pediatric; prenatal; stress; DOHaD; trauma; breastfeeding; sex; maternal, Margaret A. Adgent, Erin Buth, Amanda Noroña-Zhou, Adam A. Szpiro, Christine T. Loftus, Paul E. Moore, Rosalind J. Wright, Emily S. Barrett, Kaja Z. LeWinn, Qi Zhao, Ruby Nguyen, Catherine J. Karr, Nicole R. Bush, Kecia N. Carroll

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Higher intake of vitamin B1 associated with lower risk of age-related macular degeneration

Vitamin B1, called thiamine, is a water-soluble, colourless, odourless, and slightly bitter vitamin necessary for all living organisms. It is a cofactor for various enzymes involved in metabolic processes, mainly carbohydrate and amino acid metabolism. Since humans cannot produce their own vitamin B1, it must be obtained through food sources. Deficiency in vitamin B1 has been linked to polyneuritis, Alzheimer’s disease, colon cancer, beriberi, Wernicke’s encephalopathy, paralysis, and cardiac failure.

A study published in Ophthalmic Research found a negative correlation (inverse association) between vitamin B1 intake and late age-related macular degeneration in the US. According to them, more randomized clinical trials are needed to investigate the relationship.

AMD, a leading cause of permanent blindness globally, is investigated for its correlation with vitamin B1 intake in a US representative sample as part of the current study.

The study analyzed NHANES data from 2005 to 2008, using logistic regression to assess the connection between vitamin B1 intake and late AMD.

Key findings in this study are:

  • Five thousand one hundred seven people aged 40 years old and above were included in the study.
  • There was an inverse association between Vitamin B1 intake levels and the prevalence of late AMD.
  • The OR for the crude model 1, adjusted model 2 and fully adjusted model 3 was 0.40, 0.53 and 0.55, respectively.

We found that people consuming more vitamin B1 had lower odds of being diagnosed with late AMD, they said.

This study has a few limitations. First, as it is a cross-sectional study, a causal relationship cannot be established. Second, limiting the generalizability of the findings. However, the study has some strengths, such as data collection from a diverse and representative sample to ensure generalizability to all American seniors. Additionally, this research provides an extensive investigation into the connection between vitamin B1 consumption levels and late AMD among the US population, contributing to the study’s credibility.

Reference:

Zheng Q, Shen T, Xu M, Tan L, Shen Z, Hong C. Association between dietary consumption of vitamin B1 and advanced age-related macular degeneration: a cross-sectional observational study in NHANES 2005-2008. Ophthalmic Res. 2023 Nov 3. doi: 10.1159/000534819. Epub ahead of print. PMID: 37926095.

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Maisonneuve fracture treated with novel suture-button system stabilization combined with plate and arthroscopic assistance

Maisonneuve fractures, named after Jules Germain Francois Maisonneuve, were first described in 1840.These fractures account for approximately 5% of all ankle traumas requiring surgical intervention. Diagnosis is made through radiographic imaging and clinical evaluation, including specific tests such as the Cotton test, pronation-external rotation test, squeeze test, and crossed-leg test.

Puddu et al conducted a study to evaluate the short-to medium-term clinical and radiological outcomes of patients with Maisonneuve fractures treated with a suture-button system stabilization combined with plate and arthroscopic assistance (SBPAA).

The study included 13 patients treated from January 2018 to June2022. Specific radiographical follow-up and periodic checks were performed in a short -to-medium term period, to evaluate syndesmosis evolution and tibiofibular overlap with medial clear space (MCS). In addition, fracture Angle, shortening, and displacement were evaluated.

The surgical technique consists of two stages: an open one and a subsequent arthroscopic. A 4-hole 1/3 tubular plate is selected and positioned according to the biometric criteria for syndesmosis stabilization with a posteroanterior inclination of 20◦ and an application proximal to the tibiotarsal joint. Subsequently stabilization via two “button and suture” traction is performed.

For arthroscopic surgery two different accesses are made in anteromedial and anterolateral region in order to diagnose visible injuries and evaluate the degree of syndesmosis’s instability .The two-traction system are tensioned under arthroscopic guidance to evaluate the correct tibiofibular alignment and restore the overlap sign. Once the syndesmosis has been stabilized, the deltoid ligament can be arthroscopically reinserted using anchors or treated with mini-open suturing.

Key findings of the study were:

• The study included 13 patients, 9 males and 4 females, treated at our surgical department between January 2018 and June 2022.

• Patients were aged between 35 and 63 years old.

• Mean AOFAS score showed significant increase from 86.7 ± 5.2 s dev at 6 months to 94.2 ± 3.3 at 12 months.

• Progressive recovery and improvement were observed during follow-up from both radiographic and clinical perspective.

• Data showed that patients were able to return to full weight-bearing walking around the 9th week and to sport activities in 7.5 months.

• Long-term complications associated with residual joint stiffness, complex regional pain syndrome, or wound complications were observed in three patients.

The authors concluded that – “Intraoperative arthroscopy represent a valid diagnostic tool to better recognize and evaluate osteochondral lesions in case of syndesmosys. The study demonstrates the importance of intraoperative arthroscopy for recognizing and treating associated osteochondral lesions with proper syndesmosis evaluation. Plate associated to double TightRope represent valid solution to functionally fix and reduce fractures. Additionally, it imitates the normal syndesmosis’s anatomy and provides elasticity and robustness, guaranteeing a rapid return to sporting activity. Data and casuistry support these findings.”

Further reading:

Maisonneuve fracture treated with suture-button system stabilization combined with plate and arthroscopic assistance (SBPAA): Clinical and radiological evaluation in short-medium period

L. Puddu , F. Cortese et al

Journal of Orthopaedics 46 (2023) 12–17

https://doi.org/10.1016/j.jor.2023.10.007

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Hypochloremia may increase in-hospital mortality and hospital stay in critically ill patients with HF

Hypochloremia may increase in-hospital mortality and hospital stay in critically ill patients with HF suggests a new study published in the International Journal of Cardiology.

A study was done to assess whether serum chloride predicts risk of death in intensive care unit (ICU) patients with heart failure (HF) and the effect of bicarbonate on the efficacy of serum chloride in predicting risk of death in ICU patients.

Methods: A total of 9364 HF patients hospitalized in the ICU were enrolled. Patients were divided into hypochloremia (< 96 mEq/L), normal chloride (96–108 mEq/L), and hyperchloremia (> 108 mEq/L) groups. Similarly, we divided the serum bicarbonate level into three groups: low bicarbonate (< 22 mEq/L), medium bicarbonate (22–26 mEq/L), and high bicarbonate (> 26 mEq/L). The outcome of this study was in-hospital mortality. Then, we analyzed the association between abnormal serum chloride and mortality according to the category of serum bicarbonate and assessed the interaction effect. Restricted cubic spline (RCS) was used to show possible nonlinear associations.

Results: In the overall study population, hypochloremia was associated with a higher risk of in-hospital mortality than normal chloride (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.26–1.86, P < 0.001), hyperchloremia was not significantly related to in-hospital mortality (OR 1.00, 95% CI 0.85–1.19, P = 0.962). However, a linear association between serum chloride and in-hospital mortality was found in the low and normal bicarbonate groups (all P for nonlinear >0.05).

Hypochloremia is associated with in-hospital mortality and longer hospital stay in critically ill patients with HF. In addition, risk of death in the low and medium serum bicarbonate groups decreased with increasing serum chloride level.

Reference:

The association between serum chloride and mortality in ICU patients with heart failure: The impact of bicarbonate. Zhaochong Tan, M.D. Yang Liu, Kui Hong. Open AccessPublished:December 21, 2023DOI:https://doi.org/10.1016/j.ijcard.2023.131672

Keywords:

Hypochloremia, may, increase, in-hospital, mortality, hospital, stay , critically, ill, patients, HF, International Journal of Cardiology

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Intranasal Epinephrine Spray Outperforms Autoinjectors for treatment of anaphylaxis

The recent updates to the acute anaphylaxis guideline have highlighted the need for improved therapeutic options to address existing gaps in care as a top priority.

According to a study published in The Journal of Allergy and Clinical Immunology: Global, researchers have concluded that NDS1C offers a needle-free, user-friendly solution for self-administering epinephrine. This is better than the 0.3 mg autoinjector to address unmet medical and patient needs.

This study compares the pharmacokinetic, pharmacodynamic, safety, and tolerability profiles of intranasal and intramuscular epinephrine. One hundred sixteen healthy adults received 13.2 mg intranasal epinephrine, 0.3 mg autoinjector, or 0.5 mg manual syringe intramuscular epinephrine. Participants with 50, 100, and 200 pg/mL epinephrine concentrations were evaluated at 10-, 20-, 30-, and 60 minutes post-dose.

The results of this study could be summarised as follows:

· PK parameters for the 13.2 mg IN dose exceeded those of the 0.3 mg autoinjector with a rapid and higher Cmax and greater systemic exposure.

· The maximum concentration of epinephrine for intranasal spray was 429.4 pg/mL, and for autoinjector was 328.6 pg/mL

· PK parameters for opposite and same nostril dosing were higher than both intramuscular doses except Tmax, which was between the two intramuscular doses (20 min for intranasal, 14.9 min for autoinjector, and 45 min for manual syringe).

· Of the 54 participants, 27 achieved the same epinephrine levels as the autoinjector after opposite-nostril administration in approximately 8.2 minutes, while 33 of the 49 participants with same-nostril administration reached the same levels in 6.2 minutes.

· No severe or unexpected adverse events were reported, confirming the safety and tolerability of intranasal epinephrine.

NDS1C, a nasal spray developed by Bryn Pharmaceutics, delivers epinephrine without requiring a needle. Its compact size makes it easily portable and can be used without specialized medical training. This product aims to provide the allergy community a treatment option similar to the EpiPen autoinjector, currently the preferred treatment for outpatients.

Reference:

Dworaczyk, et al. 13.2 mg Intranasal Epinephrine Spray Demonstrates Comparable Pharmacokinetics, Pharmacodynamics, and Safety to 0.3 mg Epinephrine Autoinjector. Journal of Allergy and Clinical Immunology: Global, 100200.

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Revise BE study Protocol: CDSCO Panel Tells Akum Pharma on Chlorthalidone, Cilnidipine, Bisoprolol FDC

New Delhi: Citing that individual and innovators products should be taken as a reference product in the proposed bioequivalence (BE) study protocol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akums Drugs and Pharmaceuticals to revise the BE study protocol of the fixed-dose combination drug Chlorthalidone plus Cilnidipine plus Bisoprolol Fumarate film-coated tablet.

This came after the drug major Akums Drugs and Pharmaceuticals presented the proposal along with the BE study protocol before the committee.

Chlorthalidone is a diuretic used to treat hypertension or edema caused by heart failure, renal failure, hepatic cirrhosis, estrogen therapy, and other conditions. Chlorthalidone is a thiazide-like diuretic used for the treatment of hypertension and the management of edema caused by conditions such as heart failure or renal impairment. Chlorthalidone improves blood pressure and swelling by preventing water absorption from the kidneys through inhibition of the Na+/Cl− symporter in the distal convoluted tubule cells in the kidney.

Chlorthalidone prevents the reabsorption of sodium and chloride through inhibition of the Na+/Cl- symporter in the cortical diluting segment of the ascending limb of the loop of Henle. Reduction of sodium reabsorption subsequently reduces extracellular fluid and plasma volume via an osmotic, sodium-driven diuresis. By increasing the delivery of sodium to the distal renal tubule, Chlorthalidone indirectly increases potassium excretion via the sodium-potassium exchange mechanism.

Cilnidipine is a dihydropyridine calcium channel blocker with action on both N- and L-type calcium channels used to treat hypertension.

Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure. Cilnidipine also works on the N-type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

Bisoprolol is a beta-1 adrenergic blocking agent used to prevent myocardial infarction and heart failure and to treat mild to moderate hypertension.

Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long half-life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs.

At the recent SEC meeting for cardiovascular and renal held on 6th and 7th December 2023, the expert panel reviewed the proposal along with the BE study protocol of the Chlorthalidone plus Cilnidipine plus Bisoprolol Fumarate coated tablet presented by Akums Drugs and Pharmaceuticals.
After detailed deliberation, the committee recommended that the BE protocol should be revised.
Furthermore, the expert panel stated, “Individual and innovators products should be taken as the reference product in the proposed BE study protocol.”
Accordingly, the committee suggested that the revised BE study protocol should be submitted to CDSCO for review by the committee.

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ICMR Announces 5th National NICPR-ECHO Online Certificate Course On Cervical Cancer Screening For Pathologists, details

Delhi: The Indian Council for Medical Research (ICMR) has announced the conduction of the 5th National NICPR-ECHO online certificate course on Cervical Cancer Screening for Pathologists.

The course will be from 17th January 2024 – 1st March 2024, twice a week, 2.30 – 4.30 PM. The candidates need to register for the course. The registration process will be carried out till 31st December 2023. The registration fee of Rs 1000 needs to be paid. The candidates must confirm their seats by paying the registration fee and applying online by completing the Google form. The link to the Google form is enclosed in the notice below.

WHO’s global call for action to eliminate cervical cancer includes screening as one of its pillars. Cytology-based cervical cancer screening has contributed to a reduction in morbidity and mortality. However, the paucity of trained cytopathologists is a deterrent to the effective implementation of cervical cancer screening programs in developing nations.

The Division of Cytopathology, ICMR-NICPR, is conducting the 5th National NICPRECHO Online Certificate Course on Cervical Cancer Screening for Pathologists under the aegis of the Indian Academy of Cytologists. The course shall be conducted solely on the online ECHO platform between 2:30 PM to 4.30 PM on Wednesdays and Fridays. It includes talks by eminent experts on topics pertaining to various aspects of cervical cancer, including epidemiology, screening strategies, and recommendations for cervical cancer screening, with a major focus on cytology-based screening. The didactic deliberations shall be amply supplemented by interactive virtual slide sessions.

Also Read:ICMR Invites Applications For ICMR-IITKGP MedTech Biodesign CLiMB Fellowship Program

Eligibility – This training program is designed only for healthcare professionals who are pursuing or have completed an MD/ DNB in Pathology of possess a Diploma in Clinical Pathology (DCP).

A minimum of one short case presentation and attendance in 10 of 13 sessions is mandatory to qualify for the grant of an e-certificate at the completion of the course. The participants would be required to complete the pre-training and post-training online questionnaire-based evaluation with at least a 70% score in the post-training evaluation.

In case of cancellation of registration or registration by a non-eligible candidate, no refund shall be made. The link to virtual microscopic slides shall be shared with the participants before the course. The participants must ensure a stable internet connection, preferably on a large-screen device.

Case presentations by the participants shall be held at the end of each session. The schedule for the presentations shall be shared with the participants before the start of the course.

Scientific program –

17th January 2023 –

Introduction to the virtual course: learning objectives Epidemiology of cervical cancer, magnitude of the problem, screening strategies & recommendations Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi Dr. Ruchika Gupta, ICMR-NICPR

Epidemiology of cervical cancer, the magnitude of the problem, screening strategies & recommendations Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi Dr. Ruchika Gupta, ICMR-NICPR 17 JAN 19 JAN 24 JAN 31 JAN WED FRI WED Benign cellular changes and specific infections in cervical smear Virtual interactive slide session Dr. Sanjay Gupta, Ex-Sci G, ICMR-NICPR Dr. Shalini Singh, Director, ICMRNICPR

19th January 2023 –

Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi

24th January 2023 –

Benign cellular changes and specific infections in cervical smear Virtual interactive slide session Dr. Sanjay Gupta, Ex-Sci G, ICMR-NICPR

31st January 2023 –

Cervical Cancer Pathogenesis: HPV and beyond Dr. Radhika Srinivasan, PGIMER, Chandigarh

2nd February 2023 –

Atypical Squamous Cells ( ‘ASC’) & ‘Low grade squamous intraepithelial lesions’: patterns & pitfalls Virtual interactive slide session Dr. Sanjay Gupta

7th February 2023 –

Cytology of ‘High-grade squamous lesions of the cervix’ (ASC-H, HSIL, and SCC): patterns and pitfalls Virtual interactive slide session Dr. Sanjay Gupta

9th February 2023 –

Glandular lesions of the cervix: cytomorphologic spectrum and discussion of interesting cases Dr. Neeta Kumar, New Delhi

14th February 2023 –

Liquid-based cytology in cervical pathology – specific infections and epithelial abnormalities Prof. Nalini Gupta, PGIMER, Chandigarh

16th February 2023 –

Grossing techniques relevant to cervical pathology. Histopathologic panorama of cervical precancerous lesions and carcinoma Dr. Sonal Sharma, UCMS & GTB Hospital, Delhi

21st February 2023 –

Cyto-histological correlation in cervical pathology: The ASC guidelines Dr. Ruchika Gupta, ICMR-NICPR

23rd February 2023 –

HPV & other biomarkers in cervical cancer prevention Dr. Pooja Bakshi, Sir Ganga Ram Hospital, New Delhi

28th February 2023 –

Artificial Intelligence in Cervical Cytology Dr. Ruchika Gupta

Medicolegal aspects in cervical smear reporting Dr. Shamsuz Zaman, ICMR-NICPR

1st March 2023 –

Concluding session – participants’ feedback. Dr. Ruchika Gupta, Dr. Shamsuz Zaman

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/5thcoursebrochure-228115.pdf

Also Read:MCC NEET SS Counselling Round 2 Begins Today, Register now

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Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan

New Delhi: In response to the proposal for bioequivalence (BE) study and Phase III clinical trial (CT) waiver for Sacubitril 12mg plus Valsartan 13mg film-coated tablets presented by the drug major Alkem Laboratories, the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit more justification on the proposed dose and rationality of the fixed-dose combination of Sacubitril plus valsartan.

This came after Alkem Laboratories presented their proposal along with justification for the BE waiver and Phase III CT waiver before the committee.

Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Sacubitril’s active metabolite, LBQ657 inhibits neprilysin, a neutral endopeptidase that would typically cleave natriuretic peptides, which includes: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP). ANP and BNP are released under atrial and ventricle stress, which activate downstream receptors leading to vasodilation, natriuresis, and diuresis. Under normal conditions, neprilysin breaks down other vasodilating peptides and vasoconstrictors such as angiotensin I and II, endothelin-1, and peptide amyloid beta-protein. Therefore, the inhibition of neprilysin leads to reduced breakdown and increased concentration of endogenous natriuretic peptides in addition to increased levels of vasoconstricting hormones such as angiotensin II.

Valsartan is an angiotensin-receptor blocker used to manage hypertension alone or in combination with other antihypertensive agents and to manage heart failure in patients who are intolerant to ACE inhibitors.

Valsartan belongs to the angiotensin II receptor blocker (ARB) family of drugs, which selectively bind to angiotensin receptor 1 (AT1) and prevent angiotensin II from binding and exerting its hypertensive effects.

At the recent SEC meeting for cardiovascular and renal held on 6th and 7th December 2023, the expert panel reviewed the proposal along with justification for BE waiver and Phase III CT waiver of the FDC Sacubitril plus Valartan presented by Alkem Laboratories.
After detailed deliberation, the committee opined, “More justification on the proposed dose and its rationality should be submitted for further review by the committee.”

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Intrarectal Botox Injections Promising for Treatment of Faecal Incontinence

A recent randomized, double-blind, placebo-controlled study has revealed compelling evidence supporting the efficacy of intrarectal injections of botulinum toxin type A (BoNTA) in treating urge faecal incontinence. This five-year study, conducted by a team from eight specialized French hospitals, aimed to evaluate the effectiveness of BoNTA injections compared to a placebo in adult patients experiencing at least one weekly episode of urgency or faecal incontinence for a minimum of three months, despite prior conservative or surgical treatments. The study was published in the Lancet Gastroenterology and Hepatology journal.

Between November 2015 and November 2020, 200 patients were randomly assigned to receive either BoNTA (n=100) or a placebo (n=100). Following withdrawals before injections, 96 patients received BoNTA, and 95 patients received the placebo. The primary endpoint was the number of faecal incontinence and urgency episodes per day, assessed using 21-day patient bowel diaries three months after treatment.

The findings revealed a significant decrease in the mean number of episodes in the BoNTA group from 1.9 at baseline to 0.8 at 3 months post-injections, compared to a decrease from 1.4 to 1.0 in the placebo group. The adjusted mean group difference at 3 months was estimated at -0.51 (95% CI -0.80 to -0.21, p=0.0008), highlighting the remarkable effectiveness of BoNTA injections.

The study demonstrated no serious treatment-related adverse events. Constipation was the most frequently reported non-serious adverse event, observed in 40% of patients receiving both BoNTA and placebo injections.

Lead researcher Anne-Marie Leroi, PhD, highlighted the significance of BoNTA injections as an efficacious treatment for urge faecal incontinence. Despite these promising results, further research is warranted to optimize selection criteria, dosage, injection site, frequency of re-injection, and long-term outcomes.

These findings mark a significant advancement in the treatment landscape for faecal incontinence, offering hope to individuals who have faced challenges with existing treatment options. The study’s success in significantly reducing episodes of faecal incontinence and urgency with minimal adverse effects positions BoNTA injections as a potential breakthrough therapy in this field.

The study’s results could pave the way for further research aiming to refine treatment protocols and assess the sustained effectiveness of BoNTA injections in managing urge faecal incontinence, ultimately improving the quality of life for affected individuals.

Reference:

Leroi, A.-M., Queralto, M., Zerbib, F., Siproudhis, L., Vitton, V., Amarenco, G., Etienney, I., Mion, F., Bridoux, V., Philip, J., Brochard, C., Damon, H., Lacroix, E., Gillibert, A., & Gourcerol, G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. The Lancet. Gastroenterology & Hepatology,2023. https://doi.org/10.1016/s2468-1253(23)00332-1

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