Liberal Transfusion Strategy in MI with anaemia: No benefits found

Liberal Transfusion Strategy fails to reduce risk of recurrence and death in MI patients with anemia suggests a new study published in The New England Journal of Medicine.

A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS:A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group Death occurred in 9.9% of the patients with the restrictive strategyand in 8.3% of the patients with the liberal strategy. In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded

Reference:

Jeffrey L. Carson, Maria Mori Brooks, Paul C. Hébert, Shaun G. Goodman, Marnie Bertolet, Simone A. Glynn, Bernard R. Chaitman, Tabassome Simon, Renato D. Lopes, Andrew M. Goldsweig, Andrew P. DeFilippis, J. Dawn Abbott. Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med 2023; 389:2446-2456. DOI: 10.1056/NEJMoa2307983

Keywords:

Liberal, Transfusion, Strategy, fails, reduce, risk, recurrence, death, MI patients, anemia, The New England Journal of Medicine, Jeffrey L. Carson, Maria Mori Brooks, Paul C. Hébert, Shaun G. Goodman, Marnie Bertolet, Simone A. Glynn, Bernard R. Chaitman, Tabassome Simon, Renato D. Lopes, Andrew M. Goldsweig, Andrew P. DeFilippis, J. Dawn Abbott

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Breakthrough in Gout Treatment: Combined Regimen Promising in lowering Urate levels

Gout, a form of inflammatory arthritis, often characterized by painful attacks, has long been managed through urate-lowering therapy (ULT). However, a recognized gap in care has led researchers to explore simpler ULT regimens that not only effectively target serum urate levels but also improve the overall quality of gout treatment. In a recent comparative effectiveness trial, a novel approach involving febuxostat monotherapy versus a combination of febuxostat and low-dose benzbromarone has shown promising results, especially in cases of gout with combined renal urate underexcretion and overload.

The study results were published in the journal Arthritis Care & Research. 

Also Read: Even moderate alcohol drinking raises hyperuricemia risk in men, study claims

The prospective, randomized trial enrolled participants with a specific type of hyperuricemia and an estimated glomerular filtration rate (eGFR) above 60 ml/min/1.73 m2. Individuals were randomly assigned to either a combination therapy of febuxostat and benzbromarone or febuxostat monotherapy. The primary goal was to assess the proportion of participants achieving a serum urate (SU) level below 360μmol/L after 12 weeks. The study also investigated changes in liver and kidney function, incidence of new-onset urolithiasis, and occurrences of gout flares.

Findings:

  • Out of the 250 participants initially randomized, 219 completed the 12-week treatment.
  • The findings revealed that the group receiving the combination of febuxostat and benzbromarone exhibited a significantly higher success rate in reaching the SU target compared to those on febuxostat monotherapy (75.5% vs. 47.7%).
  • The odds of success were approximately 3.37 times higher in the combination group.
  • Importantly, the safety profiles were found to be comparable between the two groups, suggesting a favorable risk-benefit profile for the combination therapy.
Also Read: Febuxostat and Allopurinol Have Similar Hepatic Safety Profiles in Gout Patients

Thus, this breakthrough could address the unmet need for simpler gout treatment strategies, potentially transforming the landscape of care for individuals dealing with this painful condition. As further research unfolds, this novel approach holds promise for becoming a viable option, offering hope for improved outcomes and a better quality of life for those navigating the challenges of gout.

Further reading: Superiority of low dose benzbromarone add-on to low dose febuxostat compared to febuxostat monotherapy in gout with combined-type hyperuricemia. doi: https://doi.org/10.1002/acr.25283

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Jagannath Shinde and Rajiv Singhal Reelected as AIOCD President and General Secretary

Indore: Through a recent press note, the All India Organization of Chemists and Druggists (AIOCD) has informed that Jagannath Shinde and Rajiv Singhal have been unanimously reelected as President and General Secretary of AIOCD.

This announcement was made during its triannual general meeting in the cleanest city in India, Indore. The meeting addressed significant issues that the pharmaceutical industry is experiencing, as well as significant decisions and resolutions that shaped the organization’s future direction.

The main agenda item was the election for the next term, where Jagannath Shinde and Rajiv Singhal secured their positions. Zonal Vice Presidents and Joint Secretaries were also elected, but the Treasurer’s post remains vacant.

The results were announced by Shri Vaijanath Jagushte, with ARO Shri Dinesh Madan and K. Shanmugam in attendance. Sandeep Nangia, Organizing Secretary, A K Jeevan Dypt. Organizing Secretaries and Jaswant Singh Patel PRO were appointed.

In addition to the above, the summit discovers that despite High Court orders, the Central Government authorities are hesitant to take visible action when it comes to online pharmacies that are functioning illegally.

However, concerning the above, Health Minister Shri. Mansukh Mandaviya has assured AIOCD of protecting its 12 lakh members’ interests and preventing corporate involvement in online medicine sales.

Furthermore, regarding the aforementioned, J S Shinde proposed, “AIOCD would wait for the time allowed by the Hon. Delhi HC before initiating a nationwide protest, the “Halla Bol ANDOLAN,” in the future. A committee empowered under the President will make suitable decisions.”

Furthermore, the summit observed that a crucial unanimous decision by AIOCD is the objection to the “National Pharmacy Commission” draft, which neglects the input of community pharmacists and threatens the autonomy of State Pharmacy Councils.

The proposed draft raised concerns during the conference since, if passed, it may erode democratic processes and result in a bureaucratic department. AIOCD has already filed objections within the stipulated time.

The Madhya Pradesh Chemists Association team, under the leadership of Shri Gautam Chand Dhing, Rajiv Singhal along with Ramesh Gupta, Arvind Gupta Team of Maharashtra MSCDA were engaged in a three-day successful mega event.

Also Read:Rocky Road to E-Pharmacy Regulations

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How can Early-Onset Dementia be prevented?

In the quest to understand and combat young-onset dementia (YOD), a groundbreaking study has delved into previously unexplored territory, shedding light on modifiable risk factors that could revolutionize preventive initiatives. In a groundbreaking prospective cohort study utilizing data from the UK Biobank, researchers sought to unravel the factors associated with the incidence of YOD in individuals younger than 65 years without a dementia diagnosis at baseline. The study found many modifiable factors that were associated with young-onset dementia.

The study results were published in the journal JAMA Neurology.

Exploring the landscape of young-onset dementia (YOD) has been hindered by a lack of comprehensive information on modifiable risk factors. Hence, researchers conducted a prospective cohort study using data from the UK Biobank to examine factors that are associated with the incidence of YOD.

The study, conducted between 2006 and 2010 with follow-up until March 2021 in England and Scotland and until February 2018 in Wales, excluded participants aged 65 and older and those with dementia at baseline. A total of 39 potential risk factors were examined, categorized into domains such as sociodemographic, genetic, lifestyle, environmental, blood marker, cardiometabolic, psychiatric, and other factors. The association between the risk factors and the incidence of YOD was assessed using the Multivariable Cox proportional hazards regression analysis.

Findings:

  • Among the extensive cohort of 356,052 participants included in the study, 197,036 (55.3%) were women, and the baseline mean age stood at 54.6 (with a standard deviation of 7.0) years.
  • Throughout the extensive follow-up period encompassing 2,891,409 person-years, researchers observed 485 incident cases of young-onset dementia (YOD), with 251 of these cases occurring in men, representing 51.8% of the male population.
  • This translated to an incidence rate of 16.8 per 100,000 person-years, with a 95% confidence interval ranging from 15.4 to 18.3.
  • In the conclusive model, a profound exploration of factors revealed 15 variables significantly associated with an elevated risk of YOD.
  • These factors encompassed a spectrum of influences, including lower levels of formal education, diminished socioeconomic status, possession of two apolipoprotein ε4 alleles, abstinence from alcohol use, the presence of alcohol use disorder, experiences of social isolation, vitamin D deficiency, elevated C-reactive protein levels, reduced handgrip strength, hearing impairment, orthostatic hypotension, a history of stroke, diabetes, heart disease, and the presence of depression.
  • Each of these elements contributed distinctly to the heightened risk of young-onset dementia, forming a comprehensive understanding of the multifaceted factors implicated in the onset of this condition.

Thus, These factors, many of which are modifiable, provide crucial insights into potential avenues for dementia prevention initiatives. The study emphasizes the importance of addressing lifestyle, environmental, and health-related factors to mitigate the risk of YOD. The identification of modifiable risks opens new possibilities for therapeutic interventions and strengthens the foundation for comprehensive dementia prevention strategies tailored to a younger demographic.

As we delve deeper into the complexities of dementia, understanding and addressing modifiable risk factors not only enriches our knowledge but also paves the way for targeted interventions that can make a significant impact on the incidence of YOD.

Further reading: Hendriks S, Ranson JM, Peetoom K, et al. Risk Factors for Young-Onset Dementia in the UK Biobank. JAMA Neurol. Published online December 26, 2023. doi: 10.1001/jamaneurol.2023.4929

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INI SS January 2024 Session: Round 2 Counselling To Begin From 3rd January

Delhi: INI SS January 2024 Round 2 counselling by All India Institute of Medical Sciences (AIIMS) is going to begin on 3rd January 2023. 

As per the schedule, the announcement of the institute allocation of 2nd round will be done on 3rd January 2024. The online acceptance of the allocated institute from 4th January 2024, 11.00 am to 9th January 2023, up to 05.00 pm. Reporting & submission of documents/security deposit can be done from 4th January 2024, 11.00 am to 9th January 2023 up to 05.00 pm.

If the round 1 allotted candidates participate in round 2 and they are allocated another Institute as per their choice in 2nd round, then they will have to join the Institute allocated during 2nd round. The Institute allocated in the first round shall be considered vacated, and the same shall be automatically allocated to other candidates in order of merit. Failure to join the upgraded Institute shall lead to impositions of penalty of Rs. 3.00 Lakh.

Also Read:100 BAMS Seats Still Vacant in Maharashtra

All the candidates who are allocated Institute are mandatorily required to report in person (for reporting and/or joining to allocated Institute within the date and times specified.

For those who have not been allocated any Institute in the first round of Institute allocation, the allocation will be done in the second round of Institute allocation as per their choice in order of merit if they follow the guidelines given in the Information brochure of 2nd Round of Institute Allocation.

The entrance test for admission into DM/MCh/MD Hospital Administration Courses at Institutes of National Importance (INI) for Medical Education, namely, AIIMS-New Delhi and all new AIIMS, JIPMER-Puducherry, PGIMER-Chandigarh, NIMHANS-Bengaluru and Sree Chitra Tirunal Institute for Medical Sciences & Technology- Thiruvananthapuram is held twice in a year for January and July session of respective year. The common entrance test is known as the Institute of National Importance Super-Specialty Entrance Test (INI-SS).

Also Read:CPS admissions in Gujarat: Round 1 Choice Filling Process Begins, details

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CDSCO Panel Grants Novartis Protocol Amendment For Ofatumumab

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis protocol amendment request for Ofatumumab study.

This came after the firm presented protocol amendment version 03 dated 13 April 2023, Protocol no. COMB157G2399.

The study is an Open-label, single-arm, Multi-center Extension Study Evaluating the Long-term Safety, Tolerability, and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis.

The purpose of this study is to collect long-term safety, tolerability, effectiveness, and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical Multiple Sclerosis (MS) study.

Ofatumumab, a recombinant human anti-CD20 monoclonal immunoglobulin G1 antibody, was initially approved for the treatment of chronic lymphocytic leukemia and is now approved as a subcutaneous (SC) injection in several countries (including the USA , those in the EU and Japan) for the treatment of relapsing forms of MS.

At the recent SEC meeting for Neurology held on the 12th and 13th of December 2023, the expert panel reviewed the protocol amendment version 03 dated 13 April 2023, Protocol no. COMB157G2399, presented by the drug major Novartis.

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

Also Read: Synokem Pharmaceutical Gets CDSCO Panel Nod To study Antidiabetic FDC Drug

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Modify eGFR value as per standard guidelines: CDSCO Panel Tells Hetero Lab on Antidiabetic FDC Drug

New Delhi: Reviewing the drug major Hetero Lab’s revised Phase III clinical trial protocol of fixed-dose combination antidiabetic drug Sitagliptin plus Metformin plus Voglibose, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested that in the exclusion criteria, estimated glomerular filtration rate (eGFR) value should be modified as per the standard guidelines.

Furthermore, the expert panel suggested the firm submit the revised Phase III clinical trial protocol along with the bioequivalence (BE) report to the committee.

This came after Hetero Lab presented its proposal along with the revised Phase III clinical trial protocol before the committee.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar

Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.Metformin’s mechanisms of action are unique from other classes of oral antihyperglycemic drugs. Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization

Voglibose is an alpha-glucosidase inhibitor indicated in the management of postprandial blood glucose in patients with type II diabetes. Voglibose is used to reduce high post-meal glucose levels in diabetes mellitus in patients who have been using other diabetic medications. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Voglibose is an anti-diabetic medicine.

The hypoglycaemic action of voglibose results from a reversible inhibition of membrane-bound intestines α glycosidase hydrolase enzymes which hydrolize oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine.

At the recent SEC meeting endocrinology and metabolism held on 23 November 2023, the expert panel reviewed the proposal along with the revised Phase III clinical trial protocol of the antidiabetic drug Sitagliptin phosphate monohydrate plus Metformin HCl plus Voglibose film-coated tablet, presented by Hetero Lab.

After detailed deliberation, the committee recommended that in the exclusion criteria, the eGFR value should be modified as per the standard guidelines.

Accordingly, the expert panel suggested that the revised Phase III clinical trial protocol along with BE study reports should be presented before the SEC.

Also Read: Submit Justification to study Tocilizumab in patients with giant cell arteritis: CDSCO Panel Tells Cipla

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Over 5 crore ABHA accounts created at Ayushman Bhav Campaign

New Delhi: In a significant milestone, more than 5 crore ABHA accounts have been created during the ongoing Ayushman Bhava campaign. In addition, a total of 4,44,92,564 Ayushman cards have been generated and 1,15,923 Ayushman Sabha organized.

This is reflective of data up to 28.12.2023.

Under the ongoing Ayushman Bhav campaign, the cumulative footfall of Ayushman Arogya Mandir Melas and Community Health Centre Melas has reached 11,30,98,010 in 13,84,309 health melas till 28.12.2023.

Also Read:1.5 lakh patients get ABHA-based Scan and Share service at Noida’s DGCH hospital

The following activities are being carried out in the Health Melas:

Ayushman Arogya Mandir Melas: Ayushman Arogya Mandir have successfully organized and conducted 13,49,356 with a footfall of 9,76,56,060. The Melas included 9,21,783 wellness, yoga, meditations with 1,02,90,345 Tele consultations conducted. 6,41,70,297 people received free drugs and 5,10,48,644 people received free diagnostics services. 74,04,356 people received Ayush services and 10,99,63,891 were counselled for lifestyle activities. 45,43,705 Pregnant mothers registered in the first trimester and completed the first Absolute Neutrophil Count (ANC) Checkup and Immunization was provided to 29,83,565 mothers and 49,44,359 children. 7 types of screening (TB, Hypertension, diabetes, Oral Cancer, Breast Cancer, Cervical Cancer and Cataract) were conducted for 18,94,71,490 people. This data is reflected up to 28.12.2023.

Community Health Centre Melas (CHC): Community Health Centre Melas witnessed a registration of 1,54,41,950 people in 37,664 melas. 1,10,05,931 patients consulted general OPD while 49,67,675 patients consulted specialist OPD. 38,309 major surgeries and 1,30,760 minor surgeries have been conducted. This data is reflected up to 28.12.2023.

Also Read:761 hospital admissions worth Rs 1.12 crore approved under PMJAY for transgender beneficiaries: MoS Health Bhagel

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CDSCO Panel grants AstraZeneca’s Protocol Amendment Proposal for Sodium zirconium cyclosilicate

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment request presented by drug major AstraZeneca Sodium zirconium cyclosilicate.

This came after the firm presented Protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001. The study is to evaluate the effect of Sodium Zirconium Cyclosilicate on Arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

Sodium zirconium cyclosilicate is a potassium binder used to treat hyperkalemia.

Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death.

Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.

At the recent SEC meeting for the Cardiovascular and Renal held on 28 November 2023, the expert panel reviewed the protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001

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

Also Read:Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet

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