Bedaquiline-based regimen improves outcomes in drug resistant tuberculosis, suggests study

A new study published in the Journal of Clinical Tuberculosis and Other Mycobacterial Diseases showed that two bedaquiline-containing regiments maintained effectiveness and safety beyond 132 weeks, marking a significant advancement in the treatment of RR-TB.

Roughly 25% of people on the planet are thought to have come into contact with TB bacterium. In the world, tuberculosis (TB) is the thirteenth leading cause of death. It is also the second leading infectious agent (after COVID-19) that causes death, more often than HIV and AIDS combined. Treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are complex and costly, posing a serious threat to public health and raising concerns about health security. The unsatisfactory treatment results for MDR-TB are demonstrated by the about 50% success rate among patients undertaking therapy.

A relatively new medication called bedaquiline has shown promise in treating MDR-TB. The substance in issue is a unique therapeutic agent with a distinct mode of action when compared to currently known anti-tuberculosis treatments. Thus, the study by Obaid Ur Rehman and colleagues set out to evaluate the effectiveness and safety profile of bedaquiline-based therapy regimens by a meta-analysis and systematic review of the literature.

To locate pertinent material for this investigation, an electronic search was conducted on PubMed, ScienceDirect, and the Cochrane library starting in March 2021. A p-value of less than 0.05 indicated publication bias, and the pooled treatment success rate and 95% confidence intervals were evaluated using a random-effects model.

Database search yielded a total of 543 publications, of which 12 new research satisfied the inclusion requirements. There were 41 publications in all, which comprised 5 experimental and 36 observational studies, that were included in the review. In the observational research, the pooled treatment success rate was 76.9%, whereas in the experimental investigations, it was 81.7%. On the basis of treatment plans including bedaquiline alone and plans comprising both bedaquiline and delamanid, further subgroup analysis was carried out. In trials where patients received therapy with regimens including bedaquiline alone, the pooled treatment success rate was 78.4%. In studies where patients received treatment with regimens containing both bedaquiline and delamanid, it was 73.6%.

Overall, high rates of culture conversion and treatment effectiveness are seen in patients with drug-resistant TB who are receiving therapy with a bedaquiline-based regimen and have extremely resistant strains of Mycobacterium tuberculosis.

Source:

Ur Rehman, O., Fatima, E., Ali, A., Akram, U., Nashwan, A., & Yunus, F. (2024). Efficacy and safety of bedaquiline containing regimens in patients of drug-resistant tuberculosis: An updated systematic review and meta-analysis. In Journal of Clinical Tuberculosis and Other Mycobacterial Diseases (Vol. 34, p. 100405). Elsevier BV. https://doi.org/10.1016/j.jctube.2023.100405

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Measure of body roundness may help to predict risk of cardiovascular disease, suggests study

Having a high body roundness index (BRI) over a 6-year period was associated with an increased risk of developing cardiovascular disease for adults older than age 45, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association. Previous research has indicated that BRI, a measure to reflect abdominal fat and body shape, may be helpful to predict CVD risk.

Cardiovascular disease is the leading cause of death worldwide, with almost 20 million deaths annually, according to the American Heart Association’s Heart Disease and Stroke Statistics 2024 Update. Obesity is a significant modifiable risk factor for cardiovascular disease, and previous research has indicated that abdominal obesity may be a stronger risk factor for cardiovascular disease than general obesity.

BRI is an abdominal obesity-related index that combines waist circumference and height, reflecting the proportion of abdominal and visceral fat. In contrast, body mass index (BMI) only measures weight in relationship to height. Previous research has suggested that BRI is a valuable predictor of cardiovascular disease risk, and BRI may help determine the presence of insulin resistance and metabolic syndrome.

In this study, researchers evaluated the association of BRI with cardiovascular disease among participants in the China Health and Retirement Longitudinal Study(CHARLS), a nationally representative study of middle-aged and older adults in China.

“This is the first large study to evaluate BRI over time and how it may be associated with the incidence of cardiovascular disease among middle-aged and older Chinese adults,” said senior study author Yun Qian, M.D., Ph.D., a researcher in the department of chronic non-communicable disease control at Nanjing Medical University’s Wuxi Center for Disease Control and Prevention in Nanjing, China.

Researchers analyzed BRI measurements from 2011 to 2016 and detailed the trajectory of BRI levels of the study participants. Rather than relying on a single measurement of the body roundness index, they analyzed trajectories of change in BRI over time, providing a comprehensive understanding of how the levels fluctuated in the study participants. Individuals who shared similar BRI trajectories were assigned to groups. Researchers then compared BRI trajectories for three groups: the low-stable BRI trajectory group, the moderate-stable BRI trajectory group and the high-stable BRI trajectory group.

The analysis determined that higher BRI trajectories were significantly associated with the risk of cardiovascular disease, and with increasing and persistently higher BRI measurements, a higher risk of developing cardiovascular disease, stroke or cardiac events was evident, independent of the participants’ age, sex or other variables. During the last four years of the follow-up period, from 2017 to 2020, there were 3,052 cardiovascular events recorded and 894 cardiovascular deaths.

The researchers found:

  • Compared to participants in the low-stable BRI level group, the risk of cardiovascular disease in the moderate-stable BRI level group increased by 61%, and the risk in the high-stable BRI level group increased by 163%.
  • When researchers accounted for demographic variables, medical history and cardiac medication history, significant differences in CVD were still observed in the moderate-stable BRI and high-stable BRI groups when compared to the low-stable BRI group.
  • After further accounting for health measures, including blood pressure, blood glucose and cholesterol levels, the participants in the moderate-stable BRI group and the high-stable BRI group still had a higher risk of CVD diagnosis during the study period.
  • The incidence of stroke and cardiac events was also significantly higher among participants in the moderate-stable and high-stable BRI level groups.

“Our findings indicate that 6 years of moderate-to-high stable BRI appeared to increase the risk of cardiovascular disease, suggesting that BRI measurements may potentially be used as a predictive factor for cardiovascular disease incidence,” Qian said. “This could be explained by the correlation between obesity and hypertension, high cholesterol and Type 2 diabetes, all of which are risk factors for cardiovascular disease. Obesity has also been shown to lead to inflammation and other mechanisms in the body that can affect the heart and cardiac functioning. More research is needed to confirm and fully understand how these results might be used to prevent cardiovascular disease.”

Study design, background and details:

  • The study analyzed the health data for more than 9,935 adults living in China, ages 45 years and older, with an average age of 58 years at the beginning of the study. 53% of participants self-identified as men and 47% as women. All participants in the study analysis group had not reported a physician diagnosis of cardiovascular disease from 2011 to 2015.
  • Participants were located in 150 counties across 28 provinces, and the sample used the lowest level of government organization – administrative villages in rural areas and neighborhoods in urban areas – as primary sampling units.
  • Participants’ waist circumference and height were measured by medical staff from the Chinese Center for Disease Control and Prevention at their households when they enrolled in the study. Follow-up measurements were taken every two years by medical staff. The body roundness index of each participant was calculated using a standard formula factoring in waist circumference and height.
  • Blood samples from participants were also collected at enrollment, which was in 2011-2012, and again in 2013-2014. This study used blood samples from 2011-2012.
  • Blood pressure measurements were taken by medical staff with an electronic blood pressure monitor after five minutes of rest in the sitting position. The analysis used the average of three measurements taken at each visit; there were two visits in 2011-2012 and in 2013-2014.
  • Staff also recorded participants’ health history and demographic information, including the presence of chronic disease and lifestyle risk factors.
  • The participants were asked to self-report throughout the study follow-up period if they had been diagnosed by a health professional with a heart attack, stroke, angina, coronary heart disease, heart failure or other heart conditions.

The study had some limitations, including that it was specific to adults living in China, meaning the results may not be generalizable to people living in other countries. The follow-up period of the study was six years, which may be too brief to assess changes in BRI measurements. Additionally, the diagnosis of cardiovascular disease was based upon information from participants rather than medical records, which may have included information bias or errors.

Reference:

Yang M, Liu J, Shen Q, Chen H, Liu Y, Wang N, Yang Z, Zhu X, Zhang S, Li X, Qian Y. Body Roundness Index Trajectories and the Incidence of Cardiovascular Disease: Evidence From the China Health and Retirement Longitudinal Study. J Am Heart Assoc. 2024 Sep 25:e034768. doi: 10.1161/JAHA.124.034768.

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RIMS Ranchi Medico falls to death from third floor of hostel building

In a tragic incident, a second-year postgraduate student in the orthopaedics department and his female friend allegedly fell from the third floor of a hostel building on the campus of Rajendra Institute of Medical Sciences (RIMS) Ranchi. The student lost his life, while his female-injured friend is currently receiving treatment and is out of danger.
According to police, prima facie it appears to be a suicide case, however, more details will be ascertained after an investigation. As per a TOI news report, the doctor sustained serious injuries after falling from the third floor. He was spotted lying on the ground floor by the security guards, indicating that he reportedly fell from the third floor.

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Supreme Court Requests Expert Opinion on Eligibility of 88 per cent Muscular Dystrophy Candidate for MBBS

While considering the plea by an MBBS aspirant with 88% muscular dystrophy, the Supreme Court recently observed that there were no specific guidelines available to assess disability with assistive devices in terms of the guidelines issued by the Government of India.
Therefore, to ascertain whether the candidate suffering from 88% muscular dystrophy is eligible for the MBBS admission, which was beyond the permissible limit of 80%, the top court bench of CJI DY Chandrachud and Justices JB Pardiwala and Manoj Misra have sought an expert opinion in this regard.

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Mankind Pharma CALDIKIND-P gets Delhi HC protection from lookalike CALIKA-P

New Delhi: In relief to Mankind Pharma, the Delhi High Court has prohibited Sanshiv Health Tech from marketing its product CALIKA-P as it found the pharmaceutical manufacturer guilty of blatantly adopting and using the impugned trade dress and design of Mankind Pharma’s CALDIKIND-P syrup. The court highlighted the urgent need for protection against consumer confusion, especially given the potential risks posed by pharmaceutical products intended for children.

Justice Saurabh Banerjee was deliberating a case, wherein, Mankind alleged trademark infringement and unfair trade practices, asserting that the packaging of “CALIKA-P” closely mimics that of its own “CALDIKIND-P” syrup.

Mankind Pharma Limited filed a lawsuit against Sanshiv Health Tech Private Limited, alleging copyright infringement, trademark violation, and unfair trade practices. The drug maker sought to stop Sanshiv from selling a product called “CALIKA-P,” claiming its packaging closely resembles Mankind’s “CALDIKIND-P” syrup.

Mankind alleged that key elements of its product’s trade dress, such as the color scheme and flowing milk design, have been imitated. This, they argued, could confuse consumers, especially as both products target the same market, with potential risks due to the pharmaceutical nature of the goods, specifically formulated for children.

Mankind adopted the trademark ‘CALDIKIND’ for pharmaceutical and medical preparation under Class 5 for its calcitriol, calcium and zinc capsules in the year 2007. Since then, it has been continuously and extensively using trademark ‘CALDIKIND’ in relation to its pharmaceutical products.

Subsequently in the year 2017, the petitioner also introduced another variant of ‘CALDIKIND’ specifically for children, in order to improve calcium absorption in their body and strengthen their bones. The said variant was launched under the trademark ‘CALDIKIND-P’, which includes calcium, phosphorus, magnesium, D-mannose, zinc and vitamin D3 suspension.

As the product ‘CALDIKIND-P’ was created for children and their needs, Mankind created and adopted an original and distinctive trade dress/ label for its product ‘CALDIKIND-P’ having a bright yellow-light colour scheme and a unique arrangement of selected elements such as the mango device and milk being poured down at the bottom part of the packaging designed the trade dress/ label of ‘CALDIKIND-P’ in the year 2017

The drug maker had applied for and obtained registrations over the trademark ‘CALDIKIND’ in Class 5 on July 16, 2007 having registration no. 1578946. Such registration is renewed, valid and subsisting. Mankind also holds both the trademark and copyright over this design.

Mankind in its submission had said that the sales figures of CALDKIND-P have grown from Rs 9.006 crores in the first financial year to Rs 12.33 crores in the most recent year.

Mankind alleged that Sanshiv’s product “CALIKA-P” mimics key elements of their trade dress, including ingredient placement and the milk depiction, to unlawfully associate their product with Mankind’s, thereby gaining an unfair advantage in the market. They submitted that such imitation, especially for pharmaceutical products formulated for children, could confuse consumers, potentially leading to harmful consequences. Both companies operate within the same trade channels, further increasing the likelihood of confusion.

Mankind contended that greater protection is necessary in cases involving pharmaceuticals due to the potential for confusion and its serious implications. It submitted;

“Since, as per settled law confusion of source or product between pharmaceutical goods may produce physically harmful results to purchasers, therefore a greater protection is required than in the ordinary case to avoid any possibility of confusion, more so, since in the present case pharmaceutical goods are specifically formulated for children.”

The Court heard the submissions advanced by the learned senior counsel for the complainant and went through the pleadings as also perused the documents on record. It drew a comparative analysis of the competing products of the parties.

The court observed;

“This seems to be a clear case of the defendants trying to come as near as possible to the plaintiff since there is no reason or occasion for them to have adopted the very same trade dress/ label/ artwork/ trade mark for their product ‘CALIKA-P’ syrup lest they want the members of the general public to believe that they and their products are emanating from the house of the plaintiff.”

“The defendants are clearly attempting to ride upon the goodwill and reputation of the plaintiff’s product by using the impugned trade dress and impugned trade mark for identical product.”

“Visually, there is no iota of difference inter se the trade dress/ label/ artwork/ trade mark for defendants’ ‘CALIKA-P’ syrup from that of the plaintiff. Therefore, the likelihood of confusion is more since the defendants are also dealing in the same products through the same trade channels and are targeting the same set of customers, in the present case, it is for the children. As the competing products are pharmaceutical preparations, it would be in interest of the general public if proactive steps are taken for restraining the defendants.”

“As the facts are pertaining to pharmaceutical products, in view of what is held in Cadila Health Care v. Cadila Pharmaceuticals Ltd AIR 2001 SC 1952, Heinz Italia & Anr. v. Dabur India Ltd. (2007) 6 SCC 1, Brihan Karan Sugar Syndicate Private Limited vs. Yashwantrao Mohite Krushna Sahakari Sakhar Karkhana (2024) 2 SCC 577 and Brittania Industries Ltd. v. ITC India Ltd. (2021) SCC OnLine Del 1489, this Court is to be more cautious and stringent while dealing with matters relating to such pharmaceutical products since there is a likelihood of confusion arising in the minds of general public, if the competing trade dress, trade mark and design of the defendants are allowed to subsist and/ or continue.”

“Therefore, exercising such due diligence and circumspection as per the settled law and in view of the factual matrix involved, especially as the defendants are guilty of blatantly adopting and using the impugned trade dress and design, the rights and interest of the plaintiff needs protection.”

It further noted;

“The plaintiff has, thus, been able to make out a prima facie case with the balance of convenience for grant of an ad interim ex-parte injunction in their favour and against the defendants. In case the defendants are not restrained by way of an ad interim ex-parte injunction, there is a likelihood of the plaintiff suffering irreparable harm, loss, injury and prejudice which cannot be compensated for in terms of money.”

Subsequently, the court held;

“Accordingly, till the next date of hearing, the defendants, their proprietors, partners or directors, as the case may be, their principal officers, servants, distributors, dealers and agents, and all others acting for and on behalf of the defendants are restrained from selling, offering for sale, advertising, directly or indirectly dealing with the goods and services under the impugned trade dress/ label and the impugned trade mark ‘CALIKA – P’ or any other trade dress/ label or trade mark which may be identical to or deceptively similar to the plaintiff’s trade dress/ label and trade mark ‘CALDIKIND’.”

The case has been adjourned until January 27, 2025.

Besides, the court also granted the Mankind’s request to appoint Local Commissioners to visit the defendants’ premises to inspect and seize infringing materials related to the plaintiff’s trademark. The defendants were suspected of stocking counterfeit products. The court directed the commissioners to seize and seal the products, take necessary documentation, and report back within two weeks. The order also allowed video recording of the proceedings and granted commissioners police assistance if needed. The defendants were required to preserve the sealed products for future court orders.

To view the original judgement, click on the link below:

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Study uncovers true burden of asthma in African schools and highlights need for better access to diagnosis and care

Asthma is the second most common cause of chronic respiratory deaths in the overall population of sub-Saharan Africa. The study led by researchers at Queen Mary and published in The Lancet Child and Adolescent Health, is the first of its kind to determine the true prevalence and severity of asthma in undiagnosed, yet symptomatic young people in sub-Saharan Africa.

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Walking pneumonia cases spike among young kids

Walking pneumonia cases are surging among young children in the United States, federal health officials warn.

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Updated colorectal cancer screening effective for adults 45–50, study suggests

The updated national colorectal cancer screening guidelines that recommend screening begin at age 45—rather than 50—can benefit younger adults, a new Kaiser Permanente study found.

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Flesh-eating bacteria cases rise in Florida in wake of storms

Following the devastation of hurricanes Helene and Milton, a new health danger has emerged in Florida: A spike in cases of flesh-eating bacteria.

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Study finds reduced sensitivity in low-dose CT scans for pediatric lung nodules

Two lung-nodule computer-aided detection (CAD) systems have demonstrated reduced sensitivity on low- versus standard-dose computed tomography (CT) scans for small nodules in pediatric patients, according to a study published online Oct. 9 in the American Journal of Roentgenology.

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