Lupin Announces Positive Results from Global Phase 3 Trial of Lucentis Biosimilar

Lupin recently announced positive results from global phase 3 clinical trials evaluating the immunogenicity, safety, and efficacy of LUBT010—Lupin’s biosimilar for Luncentis versus Lucentis (0.5 mg ranibizumab) in patients with neovascular age-related macular degeneration.

Results from the 12-month-long global phase 3 trial demonstrated that it achieved the primary endpoint of therapeutic equivalence in visual acuity improvement for wet age-related macular degeneration patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis. The trial enrolled about 600 patients from India, the US, the European Union and Russia who were randomised to receive either Lupin’s candidate LUBT010 or Lucentis 0.5 mg, as an injection once a month. Patients were followed for efficacy, safety and immunogenicity assessment. The data from this study would be part of Lupin’s application for marketing approval with the US Food and Drug Administration and the European Medicines Agency (EMA).

Approximately 600 patients from Russia, the US, India, and the European Union were included in the trial and randomly assigned to receive injections of either Lucentis 0.5 mg or Lupin’s biosimilar, LUBT010, once a month. Patients were monitored for safety, effectiveness, and immunogenicity evaluation. The 12-month phase 3 trial’s results showed that LUBT010 and Lucentis were similarly safe and immunogenic, and they also met the primary endpoint of therapeutic equivalency in terms of improving visual acuity for patients with wet age-related macular degeneration.

The findings from this study will be included in Lupin’s application to the US Food and Drug Administration and the European Medicines Agency (EMA) for marketing clearance. In addition, Lupin stated that the global phase 3 trial complied with the US Food and Drug Administration’s and the European Medicines Agency’s recommendations to compare the immunogenicity, safety, and effectiveness of LUBT010 with Lucentis in patients with neovascular age-related macular degeneration.

The global Phase 3 study marks another significant developmental milestone for Lupin’s Lucentis biosimilar, said Cyrus Karkaria, President, of Lupin Biotech. “We will be filing marketing applications for LUBT010 in all major global markets this year,” he added.

“This achievement of our biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialised four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab biosimilar into the global ophthalmic market, making a positive difference in the lives of our patients”, said Nilesh Gupta, Lupin’s Managing Director.

Since 2022, Lupin has been selling the biosimilar of ranibizumab in India under the name RaniEyes. Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment used in the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).

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Semaglutide Promotes Weight Loss and Improves HF Outcomes in Patients with Obesity-Related HFpEF: JACC

USA: Insights from the STEP-HFpEF program showed the efficacy of semaglutide in reducing N-terminal pro–B-type natriuretic peptide (NT-proBNP) in patients with obesity-related heart failure (HF) with preserved ejection fraction (HFpEF).

Participants with higher baseline NT-proBNP showed comparable weight loss. Still, they had greater reductions in heart failure-related symptoms and physical limitations with semaglutide compared to those with lower NT-proBNP levels,” the researchers reported in the Journal of the American College of Cardiology.

The findings indicate that the heart failure benefits of semaglutide are likely not solely due to mechanical unloading associated with weight loss; rather, they also encompass a range of weight loss-independent, disease-modifying effects.

Semaglutide, a glucagon-like peptide-1 receptor agonist, is reported to improve health status and reduce body weight in patients with obesity-related HFpEF in the STEP-HFpEF (Semaglutide Treatment Effect in People with Obesity and HFpEF) program. It remains unclear whether the benefits resulted from mechanical unloading or effects on heart failure pathobiology. Therefore, Barry A. Borlaug, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA, and colleagues sought to determine if semaglutide 2.4 mg reduced NT-proBNP in patients with obesity-related HFpEF and compare treatment responses by baseline NT-proBNP.

For this purpose, they conducted a prespecified secondary analysis of pooled data from 2 double-blind, placebo-controlled, randomized trials (STEP-HFpEF and STEP-HFpEF DM) testing semaglutide effects in patients with obesity-related HFpEF. A total of 1,145 patients were randomized.

The primary outcomes included changes in NT-proBNP at 52 weeks and alterations in the dual primary endpoints of the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and body weight based on baseline NT-proBNP levels.

The study led to the following findings:

  • Compared to a placebo, semaglutide reduced NT-proBNP at 52 weeks (estimated treatment ratio: 0.82).
  • Improvements in health status were more pronounced in those with higher vs lower baseline NT-proBNP (estimated difference: tertile 1: 4.5 points; tertile 2: 6.2 points; tertile 3: 11.9 points; baseline NT-proBNP as a continuous variable).
  • Reductions in body weight were consistent across baseline NT-proBNP levels.

In conclusion, semaglutide significantly reduced NT-proBNP levels in patients with obesity-related HFpEF in the STEP-HFpEF program. Participants with higher baseline NT-proBNP showed similar weight loss but greater reductions in heart failure-related symptoms and physical limitations compared to those with lower NT-proBNP. This suggests disease-modifying effects of semaglutide and supports the need for outcome trials of incretin-based therapies in HFpEF.

Limitations included the absence of cardiac imaging through echocardiography or cardiac magnetic resonance imaging for all participants, which would have enabled an assessment of semaglutide’s effects on cardiac structure and function. An echocardiographic substudy was conducted, with plans to report these findings. Additionally, the enrollment of non-White patients was insufficient, restricting the generalizability of the results.

Reference:

Petrie, M. C., Borlaug, B. A., Butler, J., Davies, M. J., Kitzman, D. W., Shah, S. J., Verma, S., Jensen, T. J., Einfeldt, M. N., Liisberg, K., Perna, E., Sharma, K., Ezekowitz, J. A., Fu, M., Melenovský, V., Ito, H., Lelonek, M., & Kosiborod, M. N. (2024). Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program. Journal of the American College of Cardiology, 84(1), 27-40. https://doi.org/10.1016/j.jacc.2024.04.022

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Stable HbA1c Levels Linked to Reduced Risk of Alzheimer’s Disease and Related Dementias in Older Diabetics: JAMA

USA: A recent study published in JAMA Network Open suggests that for older adults with diabetes, consistently keeping HbA1c levels within individualized target ranges over time is linked to a reduced risk of Alzheimer’s disease and related dementias (ADRD).

“In the cohort study of 374,021 older veterans with diabetes, higher HbA1c stability, indicated by more time spent within target HbA1c ranges, was linked to a reduced risk of ADRD. Additionally, when HbA1c levels fell outside the target range, spending more time below individualized HbA1c targets was associated with a higher risk of ADRD, even in individuals not on medications known to cause hypoglycemia,” the researchers reported.

Individuals with diabetes often develop Alzheimer’s disease and related dementias. Factors such as hyperglycemia, hypoglycemia, and glycemic variability are linked to a higher risk of ADRD. Traditional glycemic metrics, like average glycated hemoglobin A1c (HbA1c), might not capture the complex and dynamic factors connecting diabetes to ADRD. The HbA1c time in range (TIR), a measure of glycemic control that reflects HbA1c stability within specific ranges over time, could provide new insights into how glucose levels over time relate to the incidence of ADRD.

Against the above background, Patricia C. Underwood, William F. Connell School of Nursing, Boston College, Boston, Massachusetts, and colleagues examine the association between HbA1c TIR and the incidence of ADRD in older veterans with diabetes.

The cohort study utilized administrative and healthcare utilization data from the Veterans Health Administration and Medicare, covering the period from January 1, 2004, to December 31, 2018. It included veterans aged 65 and older with diabetes who had at least four HbA1c tests during a 3-year baseline period starting between January 1, 2005, and December 31, 2014. Data analysis took place between July and December 2023.

Hemoglobin A1c TIR was calculated as the percentage of days during the baseline period when HbA1c levels were within individualized target ranges based on clinical characteristics and life expectancy, with higher HbA1c TIR considered more favorable. The study estimated the association between HbA1c TIR and the incidence of Alzheimer’s disease and related dementias. Additional models assessed ADRD incidence in participants who mostly fell above or below their HbA1c target ranges.

The study led to the following findings:

  • The study included 374 021 veterans with diabetes (mean age, 73.2 years; 99% males). During follow-up of up to 10 years, 11% developed ADRD.
  • Adjusted Cox proportional hazards regression models showed lower HbA1c TIR was associated with increased risk of incident ADRD (HbA1c TIR of 0 to <20% compared with ≥80%: hazard ratio, 1.19).
  • The direction of out-of-range HbA1c levels was associated with incident ADRD.
  • Having greater time below range (≥60%, compared with ≥60% TIR) was associated with significantly increased risk (hazard ratio, 1.23).
  • Findings remained significant after excluding individuals with baseline use of medications associated with hypoglycemia risk (ie, insulin and sulfonylureas) or with hypoglycemia events.

The findings showed that in older adults with diabetes, greater HbA1c stability within individualized target ranges was linked to a reduced risk of Alzheimer’s disease and related dementias. Conversely, lower HbA1c TIR may help identify patients at higher risk for ADRD.

“These results underscore the advantages of using personalized HbA1c target ranges tailored to age, life expectancy, and comorbidities. Clinicians should collaborate with patients to maintain HbA1c stability, which can help lower the risk of ADRD in older adults with diabetes,” the researchers concluded.

Reference:

Underwood PC, Zhang L, Mohr DC, et al. Glycated Hemoglobin A1c Time in Range and Dementia in Older Adults With Diabetes. JAMA Netw Open. 2024;7(8):e2425354. doi:10.1001/jamanetworkopen.2024.25354

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SC directs re-medical test of UPSC aspirant declared temporarily unfit in 2014

New Delhi: In a significant ruling, the Supreme Court on Friday ordered the Union Public Service Commission (UPSC) to conduct a fresh medical examination for Rakshit Shivam Prakash, who had previously been declared “temporarily unfit” for civil services due to obesity. 

The decision comes nearly a decade after Prakash, who ranked 93 in the 2014 civil services exam, was disqualified for having a Body Mass Index (BMI) of 31.75—above the acceptable limit of 30.

The Supreme Court invoked its special powers under Article 142 of the Constitution, which allows it to issue decrees or orders necessary for achieving complete justice in a case. 

According to a PTI report, the BMI of the candidate was at 31.75, which is higher than the prescribed standard of 30. He was declared “temporarily unfit” and consequently, denied employment. He could not take part in the second medical test scheduled on July 14, 2015. 

Also Read: AIIMS Giving PG Seat Preference to its Own Doctors? Plea in Supreme Court Cites Violation of Norms

Article 142 explained:

Article 142 of the Constitution empowers the top court to pass “any decree or order necessary for doing complete justice in any case or matter pending before it”.

Exercising this power, a bench comprising Justices P S Narasimha and Pankaj Mithal said, “Having considered the facts and circumstances of the case, we consider it appropriate to grant a limited relief. This will be to direct the respondents (UPSC and others including the Department of Personnel and Training) to reschedule the re-medical test that was to be conducted on July 14, 2015, which the petitioner unfortunately missed”, adds PTI.

The bench, however, rejected the plea seeking a direction to the UPSC for allocation of service to the person with all consequential benefits at par with other similarly placed candidates of the 2014 test. 

“Considering the fact that the original re-medical examination was to happen in 2015 and almost a decade has passed by, we direct that in the event the petitioner qualifies in the medical re-examination, he shall neither claim appointment in the 2014 batch nor will he be entitled to seniority in the catch in which he could be appointed,” it said.

The court also clarified that if Prakash clears the medical test, his services shall commence from the date of the appointment.

“This is an exceptional case in which we have exercised our jurisdiction under Article 142 of the Constitution of India to do complete justice and as such, the present decision shall not be treated as a precedent in any case,” it added.

“At the outset, we reject the prayer (allocation of service) made by the petitioner for allocation of service and consequential benefits against Civil Services Examination, 2014,” Justice Narasimha said in the judgement, news agency PTI reported.

Also Read: More than 4 Lakh NEET candidates May Lose 5 Marks as SC Directs NTA to Re-Tally Results over ‘Ambiguous’ Physics Question

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BFUHS Invites Applications For Round 2 BSc Para Medical Counselling 2024, Schedule released

Punjab- Baba Farid University of Health Sciences (BFUHS) is inviting fresh online applications for the 2nd round of online counselling for admission to the BSc Para Medical Course for the session 2024. On this, BFUHS has released the complete schedule and important information for the candidates participating in the said counselling.

As per the schedule, the last date for submission of the online admission application form, correction in the online application form and submission of the online application form for the NRI quota is also August 12, 2024. There will be no opportunity for correction in the online application form after the last date of application, after which the application will be automatically locked and no changes can be made to it. The online admission application form should be submitted through the official website of BUFHS.

The application fee is Rs. 3000/- + 18% GST (Rs. 3540/-) and the SC candidates have to pay a fee of Rs. 1500 + 18% GST (Rs. 1770/-). The last date for submission of the application fee through the online payment gateway is 13 August 2024.

Moreover, upto August 16, 2024, the university will display the provisional merit list. Thereafter, if candidates have any objection to the Provisional Merit List then they can submit their objections through email only till 05:00 PM on 16 August 2024. Later, the final merit list will be displayed after considering the objections on 19th August 2024.

Meanwhile, to fill the choices for the 2nd round of online counselling, candidates are required to submit their online preferences of colleges/categories through the BUFHS official website. However, the date for choice filling for the 2nd round of online counselling will be displayed later.

Further, candidates applying under the sports category are required to submit the printed/hard copy of the online submitted application form along with self-attested photocopies of 10+1 & 10+2 DMC, Sports Graduation Certificate issued by the Director Sports, Punjab and other supporting certificates/documents in person to the University by 13th August 2024. Below is the complete schedule-

SCHEDULE

S.NO

EVENTS

DATES

1

Availability of Prospectus on University website.

05.08.2024

2

Last date for submission of online admission application form through the University website. Application Fee: Rs. 3000/- + 18 % GST (Rs. 3540/-). SC candidates will deposit a fee of Rs. 1500+18% GST (Rs. 1770/-).

12.08.2024

3

Last date of correction in online submitted Application Form. Thereafter, the application will be automatically locked and no change can be made.

4

FOR NRI CANDIDATES

Last Date for submitting the admission application form for NRI Quota (The application form for getting the Eligibility certificate and admission application form for NRI candidates is separately available on the University website)

5

Last date for deposition of application fee through online payment gateway.

13.08.2024

6

FOR SPORTS CATEGORY CANDIDATES

The candidates applying under the Sports category have to submit printed / hard copies of the online submitted application form personally (by hand) in the University along with self-attested photocopies of 10+1 & 10+2 DMC’s, Sports Gradation Certificate issued by the Director, Sports, Punjab and other supporting certificates/documents.

13.08.2024

7

Display of Provisional Merit List(s).

Upto 16.08.2024

8

Last date for submission of objections on the Provisional Merit list through email only.

Upto 16.08.2024 (till 05:00 PM)

9

Display of Merit List after considering objections.

19.08.2024

10

CHOICE FILLING FOR THE 2nd ROUND OF ONLINE COUNSELING

candidates will submit online preferences of colleges/categories through the University website.

Will be displayed later on

To view the schedule, click the link below

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Patanjali Misleading Ads Case: SC asks IMA President to publish apology in all newspapers from his funds

New Delhi: Expressing unhappiness over the nature of the apology tendered by Indian Medical Association (IMA) President RV Asokan, the Supreme Court on Tuesday refused to accept his apology and asked why he tendered his apology to only its e-newspaper and a news agency. 

Stating that the apology was supposed to be published in all the newspapers that carried his interview, the court asked Asokan to publish apologies in all prominent newspapers that carried his interview over his controversial remarks regarding the hearing on misleading advertisements in the top court.

A bench of Justices Hima Kohli and Sandeep Mehta also made it clear that Asokan will bear the expanses for the same from his own pocket and not to be done on the IMA’s behalf.  

Also read- Misleading Ads Case: IMA chief tenders apology to Supreme Court

As per the PTI report, the top court was hearing a plea filed in 2022 by the IMA alleging a smear campaign by Patanjali against the COVID-19 vaccination drive and modern systems of medicine. On July 9, Asokan had told the apex court that his unconditional apology to the court was published in various publications.

The IMA’s counsel had said that Asokan’s unconditional apology was published in the association’s monthly publication, on the IMA website, as well as by PTI. During the hearing on Tuesday, a bench of Justices Hima Kohli and Sandeep Mehta told the IMA’s counsel that the apology should have been published in all those newspapers where Asokan’s interview was carried.

“Was it published in all those newspapers where your interview was published,” the bench asked, adding that the IMA president was inviting trouble. 

Senior advocate P S Patwalia, appearing for the IMA, told the bench that Asokan would take appropriate steps to purge himself of the contempt. The bench has posted the matter for further hearing on August 27.

Earlier Asokan’s lawyer apprised the court that an apology for his controversial remarks regarding the Patanjali hearing has been published in the various media platforms and its website too. When the IMA website is opened, there is a pop-up of this apology. He also apprised the court that the IMA President expressed regret and furnished an unconditional apology for such statements.

On the website, the apology was published by Dr R V Asokan National President, IMA who said that he expressed regret to the Supreme Court and has also submitted his affidavit to the Court for tendering my unconditional apology. The lawyer had also said that he never had any intention to lower the majesty or dignity of the Supreme Court.

In the interview with PTI, where he had answered queries about Patanjali Ayurved Ltd’s misleading advertisements case, Asokan said it was “unfortunate” that the Supreme Court criticised the association and also some of the practices of private doctors. The court also observed that the apology needs to be published in the newspapers by Asokan personally and not from the funds of the IMA.

Asokan was replying to a query about the Supreme Court’s observations during a hearing on April 23, when it had said while it was pointing one finger at Patanjali, the remaining four fingers were pointed towards IMA. 

During the hearing on May 14, the bench had posed some tough questions to Asokan over his “damaging” statements against the court in the interview and said, “You cannot sit on a couch giving an interview to the press and lampooning the court.” The court had then made it clear that it would not accept his affidavit tendering apology at that stage.

The court expressed its dissatisfaction with Asokan’s remarks made just one day prior to the scheduled hearing of the case. It requested his response regarding an application submitted by Patanjali Ayurved Ltd, which had asked the court to acknowledge the statements he made.

Also read- SC refuses to accept IMA president’s Apology, Reserves verdict on Patanjali Misleading Ads case

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Metformin Significantly Reduces Risk of Renal Function Deterioration in Type 2 Diabetes: Study

Researchers have found that metformin is associated with substantially reducing the risk of decline in renal function in type 2 diabetics. Diabetic kidney disease (DKD) remains a significant challenge in the clinical management of diabetes. The reno-protective effects of metformin remain controversial. This research work was published in The Journal of Clinical Endocrinology and Metabolism by Hsi-Hao Wang and colleagues. The objective was to clarify the impact of metformin on renal outcomes among these patients.

The study was a retrospective observational study among 316,693 multicenter cohorts with type 2 diabetes across seven hospitals. Propensity score matching was performed to calibrate age, gender, medical year, baseline estimated glomerular filtration rate, urine protein by dipstick, and glycated hemoglobin for creating a balanced comparison. Finally, 13,096 metformin users were compared to 13,096 non-metformin users. The adverse key endpoints measured included a doubling of serum creatinine, eGFR ≤ 15 mL/min/1.73 m², and ESKD.

Results

The metformin group demonstrated significantly better renal outcomes than the non-metformin group:

  • Doubling of Serum Creatinine: Metformin users had a lower incidence (HR 0.71; 95% CI 0.65-0.77).

  • eGFR ≤ 15 mL/min/1.73 m²: The risk was significantly reduced (HR 0.61; 95% CI 0.53-0.71).

  • End-Stage Kidney Disease (ESKD): Metformin users had a reduced risk (HR 0.55; 95% CI 0.47-0.66).

Subgroup Analyses

  • The renoprotective effect of metformin was consistent across a wide array considering the radically wide variations in patient subgroups in terms of age, sex, comorbidities, and medications used concomitantly.

  • The metformin group witnessed slower deterioration in renal function in nearly all subgroups than the non-metformin group.

The study stresses further that, as compared to other antihyperglycemic agents, metformin might be useful in the management of renal function in patients with T2D. Prior to this, there had been a lot of controversies hovering around the findings, but these results support very strongly metformin’s role in slowing down progression in DKD. This meta-analysis connected metformin use with a significantly reduced rate for the incidence of severe renal outcomes, especially with regard to doubling in serum creatinine and in those patients with extremely low levels of eGFR/ESKD.

The results clearly emerge that, in patients with T2D, clinicians should not consider metformin for glycemic control alone but also for renoprotection. The study suggested that metformin may be one of the effective tools in delaying the progression of DKD, improving overall patient outcomes.

Metformin significantly lowers the risk of decline in renal function among subjects with T2DM. This current study thus supports metformin therapy in T2DM patients in reducing DKD progression and hence adds more support to administration beyond simple glucose control.

Reference:

Wang, H.-H., Lin, S.-H., Hung, S.-Y., Chiou, Y.-Y., Hsu, W.-C., Chang, C.-M., Liou, H.-H., Chang, M.-Y., Ho, L.-C., Wu, C.-F., & Lee, Y.-C. (2024). Renal protective effect of metformin in type 2 diabetes patients. The Journal of Clinical Endocrinology and Metabolism, dgae477. https://doi.org/10.1210/clinem/dgae477

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At risk of high cholesterol, Can fish oil help?

Fish oil supplements are a multi-billion dollar industry in the U.S. and abroad, with about two out of every 25 people popping the popular omega-3 pills.

And a new study from the University of Georgia might encourage a new population to start looking into the supplements as well: people with a genetic predisposition to high cholesterol.

Using genetic data from more than 441,000 participants, the researchers calculated a score to predict the genetic likelihood of high levels of total cholesterol, high LDL cholesterol (which is often referred to as “bad” cholesterol), triglycerides and HDL cholesterol (or “good” cholesterol).

“Recent advances in genetic studies have allowed us to predict someone’s genetic risk of high cholesterol,” said Yitang Sun, a recent doctoral graduate from UGA’s Department of Genetics. “But the current prediction has room for improvement because it does not consider individual differences in lifestyles, such as taking fish oil supplements.”

The researchers found that participants who reported taking fish oil supplements have lower blood lipid levels than predicted, especially for total cholesterol, LDL cholesterol and triglycerides.

“Our study shows that considering lifestyles will improve genetic prediction,” said Kaixiong Ye, corresponding author of the study and an assistant professor of genetics in UGA’s Franklin College of Arts and Sciences. “Our findings also support that fish oil supplements may counteract the genetic predisposition to high cholesterol.”

Fish oil counters effect of family history of high cholesterol

It’s no secret that high cholesterol is bad for the body. Arteries start to harden, and the risk of heart attack or stroke increases.

While a healthy diet and exercise can help prevent it, the Centers for Disease Control and Prevention estimates that more than 86 million American adults-or about one in four-have high cholesterol.

Millions more are at risk of developing high cholesterol due to a variety of factors including one they can’t control: genetics.

For people whose families have a history of high cholesterol, the study’s findings offer another possibility to help safeguard their health.

“Taking fish oil is associated with a shift toward a healthy lipid profile,” Ye said.

The researchers also analyzed the effects of fish oil on HDL cholesterol and found the supplements are beneficial in raising the so-called “good” cholesterol.

Reference:

Yitang Sun, Tryggvi McDonald, Abigail Baur, Huifang Xu, Naveen Brahman Bateman, Ye Shen, Changwei Li, Kaixiong Ye, Fish oil supplementation modifies the associations between genetically predicted and observed concentrations of blood lipids: a cross-sectional gene-diet interaction study in UK Biobank, The American Journal of Clinical Nutrition, 2024, https://doi.org/10.1016/j.ajcnut.2024.07.009.

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Deep Learning Model Matches Radiologists in Detecting Significant Prostate Cancer on MRI: Study

USA: A retrospective study suggested that a deep learning model matched the performance of radiologists in detecting clinically significant prostate cancer using multiparametric MRI. The findings were published online in Radiology Journal. 

In an internal test set of 400 exams, the researchers found that the deep learning model demonstrated performance comparable to experienced radiologists in detecting clinically significant prostate cancer, with both achieving an area under the receiver operating characteristic curve (AUC) of 0.89.  

Prostate cancer is cancer
that occurs in the prostate. The prostate is a small walnut-shaped gland in
males that produces the seminal fluid that nourishes and transports sperm. Prostate
cancer is one of the most common types of cancer. Multiparametric MRI of the prostate is a standard imaging
method used to diagnose clinically significant prostate cancer (csPCa) and
assist in targeting lesions during a biopsy. Considering this Jason C. Cai, et
al conducted a study to create a deep learning model using patient-level labels
to predict the presence of clinically significant prostate cancer (csPCa)
without information on tumor location and to compare its performance with that
of radiologists.

To achieve this, the
research team included 5,735 patients in the study, of whom 5,215 were male.
Out of these, 1,514 examinations (involving 1,454 patients) revealed clinically
significant prostate cancer (csPCa) and were conducted between January 2017 and
December 2019. For the internal test set, radiology reports were utilized,
while PI-RADS ratings were used for the external ProstateX test set. The study
compared performance using areas under the receiver operating characteristic
curves (AUCs) and the DeLong test and employed gradient-weighted class
activation maps (Grad-CAMs) to illustrate tumor localization.

They found the following
results: –

·
In the internal test set, which included 400
examinations, both the deep learning (DL) classifier and radiologists achieved
an AUC of 0.89. In the external test set, consisting of 204 examinations, the
DL classifier had an AUC of 0.86, while radiologists had an AUC of 0.84.

·
The combination of the DL classifier
and radiologists achieved an AUC of 0.89.

·
Grad-CAMs showed activation over the csPCa
lesions in 35 out of 38 true-positive cases in the internal test set and in 56
out of 58 true-positive cases in the external test set.

“The
deep learning model is expected to enhance the detection of prostate cancer and
improve the diagnostic accuracy of radiologists”, the researchers concluded.

Reference

Cai,
J. C., Nakai, H., Kuanar, S., Froemming, A. T., Bolan, C. W., Kawashima, A.,
Takahashi, H., Mynderse, L. A., Dora, C. D., Humphreys, M. R., Korfiatis, P.,
Rouzrokh, P., Bratt, A. K., Conte, G. M., Erickson, B. J., & Takahashi, N.
(2024). Fully Automated Deep Learning Model to Detect Clinically Significant
Prostate Cancer at MRI. Radiology, 312(2), e232635.
https://doi.org/10.1148/radiol.232635

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COVID-19 tied to myalgias, referred pain, and widespread hyperalgesia exacerbating preexisting chronic pain conditions: Study

Recently published paper explores the impact of the COVID-19 pandemic on the management of chronic pain in patients. The study, conducted on 150 patients with chronic pain conditions for more than three months, revealed that the pandemic had significant effects on the physical and mental well-being of the patients. Majority of the patients were females, with the mean age of 50 ± 13 years, and the most common sites of pain being low back, knee, and neck. The pandemic led to a significant increase in the intensity and frequency of pain, which also affected sleep, working capacity, and mental health of the individuals. It was observed that more than half of the interventional pain procedures were delayed due to the fear of contracting infection, leading to decreased follow-up in the outpatient department.

Findings and discussion on the impact of COVID-19 on chronic pain patients

The findings revealed that chronic pain patients developed coping strategies to manage the pain, and those with comorbidities were the hardest hit. Additionally, the pandemic adversely affected sleep, daily activities, working capacity, and emotional/mental health in individuals with chronic pain. The study also highlighted the association of COVID-19 with myalgias, referred pain, and widespread hyperalgesia, leading to worsening of chronic pain due to exacerbation of preexisting conditions. The paper discussed the impact of COVID-19 on the health of chronic pain patients, in particular, the effects on pain frequency, intensity, and quality, along with the challenges in accessing medical care, including delays in interventional pain procedures and follow-up appointments.

Recommendations and conclusion for chronic pain management during a pandemic

The study emphasized the urgent need to develop training programs for healthcare providers and patients to ensure uninterrupted and safe treatment services for chronic pain patients during a pandemic. The pandemic also brought to light the importance of utilizing digital resources and widening the spectrum of management and coping strategies for chronic pain patients. The paper concluded that it is imperative to ensure continuous treatment for chronic pain patients during and after a pandemic, emphasizing the need for comprehensive strategies to address the challenges faced by chronic pain patients during such health crises. The study acknowledges some limitations, such as being a single-centric, subjective, and questionnaire-based study, and calls for further epidemiologic studies to focus on chronic pain management in the post-pandemic era.

Key Points

1. Impact of COVID-19 on Chronic Pain Management: The study focused on the impact of the COVID-19 pandemic on chronic pain management in 150 patients with chronic pain conditions lasting more than three months. It was found that the pandemic resulted in a significant increase in the intensity and frequency of pain, leading to adverse effects on sleep, working capacity, and mental health of the individuals. The fear of contracting infection led to delays in interventional pain procedures and decreased follow-up in the outpatient department.

2. Effects on Chronic Pain Patients: The findings highlighted that chronic pain patients developed coping strategies to manage their pain during the pandemic, with those having comorbidities being the most affected. The pandemic also adversely affected sleep, daily activities, working capacity, and emotional/mental health. The study discussed the association of COVID-19 with myalgias, referred pain, and widespread hyperalgesia, which exacerbated preexisting chronic pain conditions.

3. Impact of COVID-19 on Health of Chronic Pain Patients: The paper discussed the impact of the pandemic on the health of chronic pain patients, specifically focusing on pain frequency, intensity, and quality. It also highlighted the challenges in accessing medical care, including delays in interventional pain procedures and follow-up appointments, which further worsened the condition of chronic pain patients.

4. Recommendations for Chronic Pain Management During a Pandemic: The study emphasized the urgent need to develop training programs for healthcare providers and patients to ensure uninterrupted and safe treatment services for chronic pain patients during a pandemic. It also stressed the importance of utilizing digital resources and widening the spectrum of management and coping strategies for chronic pain patients, both during and after a pandemic.

5. Conclusion and Implications: The paper concluded that it is essential to ensure continuous treatment for chronic pain patients during and after a pandemic, and comprehensive strategies are needed to address the challenges faced by chronic pain patients during health crises. The study acknowledged its limitations, such as being a single-centric, subjective, and questionnaire-based study, and called for further epidemiologic studies in the post-pandemic era.

6. Key Findings: Overall, the study highlighted the significant impact of the COVID-19 pandemic on chronic pain management, focusing on the physical and mental well-being of patients, the challenges in accessing medical care, and the importance of developing comprehensive strategies to address the needs of chronic pain patients during and after a pandemic.

Reference –

Malhotra N, Charan N, Budhwar D, Kumar A, Sinha N,Phogat V. Effects of COVID‑19 pandemic on management of patients with chronic pain. J Anaesthesiol Clin Pharmacol 2024, DOI: 10.4103/joacp.joacp_43_24

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