Plant-Based Diet Linked to Lower Risk of Prostate Cancer Progression: JAMA

Researchers have found that a higher intake of plant foods after a prostate cancer diagnosis is associated with a lower risk of cancer progression. The findings from a recent longitudinal observational cohort study involving 2,062 men with nonmetastatic prostate cancer suggest that postdiagnostic plant-based diet patterns can have a significant impact on reducing the risk of prostate cancer progression. This study was published in the journal JAMA Network Open by Vivian N. and colleagues.

Plant-based diets have been linked to numerous health and environmental benefits, including the prevention of various cancers. However, the impact of a plant-based diet on individuals already diagnosed with prostate cancer is less understood. This study aims to examine the association between postdiagnostic plant-based dietary patterns and the risk of prostate cancer progression and prostate cancer-specific mortality.

The study analyzed data from men with biopsy-proven nonmetastatic prostate cancer enrolled in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) between 1999 and 2018. Participants completed a comprehensive diet and lifestyle questionnaire, including a validated food frequency questionnaire (FFQ), between 2004 and 2016. Overall plant-based diet index (PDI) and healthful plant-based diet index (hPDI) scores were calculated from the FFQ.

The key findings of the study were:

  • The study included 2,062 men with a median age of 65.0 years. Most participants identified as White (95%), followed by African American (3%), Asian or Pacific Islander (<1%), Latino (1%), and American Indian or Alaska Native (<1%).

  • The median time from prostate cancer diagnosis to the completion of the FFQ was 31.3 months.

  • The median follow-up after the FFQ was 6.5 years, during which 190 progression events and 61 prostate cancer-specific mortality events were observed.

  • Men in the highest quintile of PDI had a 47% lower risk of cancer progression compared to those in the lowest quintile (HR 0.53; 95% CI 0.37-0.74; P for trend = .003).

  • While the overall hPDI was not associated with a significant risk reduction, among 680 individuals with Gleason grade 7 or higher at diagnosis, the highest hPDI quintile was associated with a 55% lower risk of progression compared to the lowest quintile (HR 0.45; 95% CI 0.25-0.81; P for trend = .01).

The study’s findings suggest that a plant-based diet may be beneficial for men with prostate cancer, particularly for those with higher Gleason grades. Higher intake of plant-based foods after a prostate cancer diagnosis could help reduce the risk of cancer progression. The results support the potential role of nutritional assessment and counseling for patients with prostate cancer to establish healthy dietary practices.

Higher intake of plant foods following a prostate cancer diagnosis was associated with a lower risk of cancer progression. Nutritional assessment and counseling may be recommended for prostate cancer patients to support overall health and well-being.

Reference:

Liu, V. N., Van Blarigan, E. L., Zhang, L., Graff, R. E., Loeb, S., Langlais, C. S., Cowan, J. E., Carroll, P. R., Chan, J. M., & Kenfield, S. A. (2024). Plant-based diets and disease progression in men with prostate cancer. JAMA Network Open, 7(5), e249053. https://doi.org/10.1001/jamanetworkopen.2024.9053

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COPD patients with smoking history face higher risk of developing ADHD but a slight reduction in Alzheimer’s disease risk: Study

China: A recent study revealed a higher risk of attention deficit hyperactivity disorder (ADHD) development in chronic obstructive pulmonary disease (COPD) patients with a history of smoking but may experience a slight reduction in Alzheimer’s disease risk.

Conversely, the researchers did not observe any causal association between COPD and psychiatric disorders among patients who never smoked. The findings were published online in the International Journal of Chronic Obstructive Pulmonary Disease.

“Never-smokers with COPD showed no causal association with psychiatric disorders. In contrast, ever-smokers with COPD experienced a higher risk of ADHD (OR: 2.303) but experienced a slight reduction in the risk of Alzheimer’s disease (OR: 0.994),” the researchers reported.

Chronic obstructive pulmonary disease is a progressive inflammatory respiratory condition characterized by symptoms like limited physical activity, dyspnea, and partially reversible airflow obstruction. Clinically, COPD patients often present with comorbidities such as hypertension, coronary heart disease, psychological disorders, cognitive impairment, and other ailments, indicating that COPD should no longer be considered exclusively as a pulmonary disorder.

Although there has been significant scientific progress in the past few years, the potential relationship between COPD and mental illness remains debatable. To shed light on the same, Qinxia Zhang, Department of Respiratory Medicine, The First People’s Hospital of Fuyang, Hangzhou, Zhejiang, People’s Republic of China, and colleagues retrieved COPD data from the genome-wide association studies (GWAS) directory and data on mental illnesses, including obsessive-compulsive disorder, schizophrenia, post-traumatic stress disorder, Alzheimer’s disease, major depressive disorder, panic disorder, ADHD, bipolar disorder, multiple disabilities, and schizophrenia, from the Psychiatric Genomics Consortium.

To explore the association between COPD and mental illnesses, a two-sample Mendelian randomization (MR) approach was applied, with subgroup analyses based on smoking history.

The key findings of the study were as follows:

  • The two-sample MR analysis revealed no causal link between overall COPD and the development of common psychiatric disorders.
  • Subgroup analyses based on smoking history showed no causal association between never-smokers with COPD and the occurrence of psychiatric disorders.
  • Ever-smokers with COPD were associated with a significantly increased risk of ADHD (OR: 2.303) and a modestly reduced risk of Alzheimer’s disease (OR: 0.994).

The findings revealed that ever-smokers with COPD face a higher risk of ADHD development but may reduce the risk of Alzheimer’s disease to some extent. In COPD patients without a smoking history, no causal association with psychiatric disorders was observed.

“Therefore, there is a need to pay attention to preventing psychiatric disorders in COPD patients with a smoking history,” the research team concluded.

Reference:

Zhang Q, Zhang H, Xu Q. Association of Chronic Obstructive Pulmonary Disease with Risk of Psychiatric Disorders: A Two-Sample Mendelian Randomization Study. Int J Chron Obstruct Pulmon Dis. 2024;19:343-351. https://doi.org/10.2147/COPD.S442725

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Exposure to TNF-α inhibitors during pregnancy not tied to reduced risk of preeclampsia: Study

Exposure to TNF-α inhibitors during pregnancy was not tied to reduced risk of preeclampsia suggests a study published in the Journal of Hypertension.

Although the clinical importance of preeclampsia is widely recognized, few treatment options are available for prevention. TNF-α inhibitors have been hypothesized to potentially prevent the disease. They aimed to examine whether exposure to TNF-α inhibitors during pregnancy reduces the risk of preeclampsia. They conducted a population-based pregnancy cohort study using nationwide samples of publicly (Medicaid data, 2000-2018) and commercially (MarketScan Research Database, 2003-2020) insured pregnant women linked to their liveborn infants. Exposure was ascertained based on a filled prescription or administration code for TNF-α inhibitors during the first and second trimester of pregnancy. The outcomes included early-onset preeclampsia, late-onset preeclampsia, and small-for-gestational age. For baseline confounding adjustment, we leveraged propensity score overlap weights to estimate risk ratios (RR). RESULTS: Among 4 315 658 pregnancies in the Medicaid and the MarketScan cohort, 2736 (0.063%) were exposed to TNF-α inhibitors during the first trimester and 1712 (0.040%) during the second trimester. After adjustment, the risk of early-onset preeclampsia was not decreased among mothers exposed during the first trimester compared with unexposed women with treatment indications [RRpooled: 1.25, 95% confidence interval (CI) 0.93-1.67]. Similarly, the risk of late-onset preeclampsia was not decreased among mothers exposed during the second trimester compared with unexposed women (RRpooled: 0.99, 95% CI 0.81-1.22). Contrary to the hypothesis, exposure to TNF-α inhibitors during pregnancy did not appear to be associated with a reduced risk of early-onset or late-onset preeclampsia. These findings do not support consideration of the use of TNF-α inhibitors for the prevention of preeclampsia.

Reference:

Adomi, Motohiko, et al. “TNF-α Inhibitor Use During Pregnancy and the Risk of Preeclampsia: Population-based Cohort Study.” Journal of Hypertension, 2024.

Keywords:

Journal of Hypertension, Adomi, Motohiko, Exposure, TNF-α inhibitors, pregnancy, reduced risk, preeclampsia

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Weight loss prior to TKA fails to modify postoperative complication rate: Study

A recent study published in The Journal of Arthroplasty found that reducing body mass index (BMI) before undergoing total knee arthroplasty (TKA) does not significantly affect postoperative complication rates in morbidly obese patients. The study could influence future surgical guidelines by suggesting that delaying surgery to achieve weight loss may not be beneficial and could potentially be harmful.

Total knee arthroplasty the commonly known knee replacement surgery is aimed to relieve pain and restore function in patients with severe knee arthritis. Traditionally, morbidly obese patients who are at high risk for complications have been encouraged to lose weight before undergoing surgery. It was believed that a lower BMI could reduce the risk of postoperative issues.

The study involved  a total of 1,270 patients with a preoperative BMI of over 40. These individuals were categorized into three groups based on their BMI changes in the year preceding their surgeries. The groups included patients who decreased their BMI by 5% or more, those whose BMI increased by at least 5% and those whose BMI remained stable.

These findings revealed no significant difference in the 90-day postoperative complication rates among patients who lowered their BMI when compared to the individuals whose BMI did not change. The complication rates were similar across these groups by highlighting that a preoperative reduction in BMI did not confer expected benefits.

The study illuminated a concerning trend where nearly one-fourth of the patients underwent a significant increase in BMI during the pre-surgery period. This group showed a elevated risk of complications when compared to the individuals with stable BMI that indicates the weight gain while waiting for surgery could indeed be detrimental.

These results suggest that the strategy of delaying knee replacement surgery to achieve weight loss should be reevaluated and these findings support the need for more inclusive surgical criteria that do not necessarily cling on BMI reduction for morbidly obese patients.

Also, the patient-reported outcome measures (PROMs) that assess recovery and satisfaction levels from the patient’s perspective showed no significant differences between the groups after six weeks. This further supports the point that immediate surgical intervention without mandatory BMI reduction may be justified in this high-risk population.

Source:

LaValva, S. M., Grubel, J., Ong, J., Chiu, Y.-F., Lyman, S., Mandl, L. A., Cushner, F. D., Della Valle, A. G., & Parks, M. L. (2024). Substantial Weight Loss May Not Improve Early Outcomes of Total Knee Arthroplasty in the Morbidly Obese. In The Journal of Arthroplasty. Elsevier BV. https://doi.org/10.1016/j.arth.2024.04.015

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Dr. Reddy’s Laboratories gets CDSCO Panel Nod for BA/BE study of Ketorolac Tromethamine Sustained Release Tablet

New Delhi: The drug major Dr Reddy’s Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Bioavailability/Bioequivalence studies (BA/BE study) of nonsteroidal anti-inflammatory drug Ketorolac Tromethamine Sustained Release Tablet 30 mg for export purpose only.

This came after Dr. Reddy’s Laboratories presented the proposal along with a justification of study design about the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

The primary mechanism of action responsible for ketorolac’s anti-inflammatory, antipyretic, and analgesic effects is the inhibition of prostaglandin synthesis by competitive blocking of the enzyme cyclooxygenase (COX). Ketorolac is a non-selective COX inhibitor. It is considered a first-generation nonsteroidal anti-inflammatory drug (NSAID).

At the recent SEC meeting for analgesic and rheumatology held on 2nd May 2024, the expert panel reviewed the proposal along with the justification of the study design with regard to the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the BA/BE study for export purposes only.

Also Read: Biological E Gets CDSCO Panel Nod for Continued Safety study of 14-valent pneumococcal polysaccharide conjugate vaccine

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Aurobindo Pharma subsidiary API facility gets one USFDA observation

Hyderabad: Through a recent BSE filing, Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has concluded the inspection with one observation at Unit-VII, an API manufacturing
facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at
Parwada Mandal, Anakapally District, Andhra Pradesh.

The inspection was conducted from May 5 to 10, 2024.

“The observation is of procedural in nature and will be
responded to within the stipulated time,” the Company stated.

Read also: Aurobindo Pharma arm gets 7 USFDA observations for Alwar facility

Medical Dialogues team had earlier reported that the new injectable facility of Eugia Steriles Private Limited, a 100% subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the Company, situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, has recently started the commercial operations.

Read also: Aurobindo Pharma arm gets 3 USFDA observations for AP injectable facility

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The Company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

Read also: Aurobindo Pharma receives tax demand of over Rs 13 crore, including interest, penalty

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19-year-old goes missing after giving NEET exam

Having no desire to continue medical studies anymore, a 19-year-old aspirant from Rajasthan has allegedly run away from home with Rs 8,000 in his possession a day after taking the National Eligibility-cum-Entrance Test (NEET) examination. He had conveyed his wish to be away for five years. His worried Parents have filed missing complaint.

Sending his message to his parents, the aspirant had gone missing from Kota on May 6 with a promise to call his family once a year and assure them not to worry about him as he would not take any extreme steps in life.
For more information, click on the link below:

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ICMR issues guidelines urging Indians to avoid using protein supplements

Following a study last month that uncovered inaccurate protein information in 70% of the 36 popular protein supplements tested in India, the Indian Council of Medical Research (ICMR) has issued revised Dietary Guidelines for Indians (DGIs). The new guidelines adopt a cautious approach towards protein supplements, urging Indians to refrain from their consumption, as reported by PTI.

Led by the health research body the National Institute of Nutrition (NIN) in Hyderabad, these guidelines stem from a meticulous process involving extensive research. According to PTI, “The DGIs have been drafted by a multi-disciplinary committee of experts led by Dr Hemalatha R, Director, ICMR-NIN and have undergone several scientific reviews. Seventeen guidelines have been listed in it.”

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Health bulletin 10/ May/ 2024

Here are the top health news for the day:

ICMR issues guidelines urging Indians to avoid using protein supplements

Following a study last month that uncovered inaccurate protein information in 70% of the 36 popular protein supplements tested in India, the Indian Council of Medical Research (ICMR) has issued revised Dietary Guidelines for Indians (DGIs). The new guidelines adopt a cautious approach towards protein supplements, urging Indians to refrain from their consumption, as reported by PTI.

Led by the health research body the National Institute of Nutrition (NIN) in Hyderabad, these guidelines stem from a meticulous process involving extensive research. According to PTI, “The DGIs have been drafted by a multi-disciplinary committee of experts led by Dr Hemalatha R, Director, ICMR-NIN and have undergone several scientific reviews. Seventeen guidelines have been listed in it.”

Medical aspirant runs away from Kota after NEET: ‘Will return after 5 years’
Having no desire to continue medical studies anymore, a 19-year-old aspirant from Rajasthan has allegedly run away from home with Rs 8,000 in his possession a day after taking the National Eligibility-cum-Entrance Test (NEET) examination. He had conveyed his wish to be away for five years. His worried Parents have filed missing complaint.
Sending his message to his parents, the aspirant had gone missing from Kota on May 6 with a promise to call his family once a year and assure them not to worry about him as he would not take any extreme steps in life.
For more information, click on the link below:

High levels of ultra-processed foods linked with early death, brain issues
Limiting the consumption of ultra-processed foods may be crucial for reducing the risk of premature death, suggests a large-scale study involving 115,000 participants. Published in the BMJ, the research highlights a connection between high intake of ultra-processed foods—such as processed meats, sugary breakfast items, and artificially sweetened beverages—and increased mortality rates. These foods, characterized by their industrial formulations and low nutritional value, are designed to trigger cravings and are often lacking in essential nutrients like fiber and vitamins.
The study uncovered associations between heavy consumption of ultra-processed foods and a heightened risk of dying prematurely, particularly from neurodegenerative diseases like multiple sclerosis and dementia. Notably, certain items within the ultra-processed category, such as processed meats and sugary snacks, were linked to greater harm. However, the findings underscored that these associations do not imply causation, as individuals with high ultra-processed food intake often exhibit other unhealthy behaviors like smoking and sedentary lifestyles.
Telangana doctor attacked & suspended! Medical fraternity boycott duties demanding suspension revocation, action against culprits
The medical fraternity in Telangana is vehemently opposing the recent incident of violence against doctors at Korutla Area Hospital, demanding immediate action against the culprits who attacked the medical personnel and vandalized the hospital on Sunday night.
Doctors are also upset over the fact that after being assaulted by the relatives of a patient, who was declared dead, the doctor was also suspended by the Commissionerate of Telangana Vaidya Vidhana Parishad.
For more information, click on the link below:
Telangana Doctor Attacked & Suspended! Medical Fraternity Boycott Duties Demanding Suspension Revocation, Action Against Culprits

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Strides Pharma Science arm gets USFDA nod for Hypocalcemia drug Sevelamer Carbonate

Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for
Sevelamer Carbonate Tablets, 800 mg, from the United States Food & Drug Administration (USFDA).


The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela Tablets, 800 mg, of Genzyme.

Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia
(low levels of calcium in the body) caused by elevated phosphorus. Sevelamer Carbonate is a medication used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease. When consumed after a meal, the medication binds to dietary phosphate and prevents its absorption thereby managing overall phosphate levels in the blood.


Sevelamer Carbonate Tablets, 800 mg has a market size of ~US$ 181 Mn as per IMS. This approval further
strengthens the Company’s presence in the Sevelamer portfolio, complementing the existing approval of
Sevelamer Carbonate Powder for Oral Suspension, which has a market size of US$23 Mn.

The Sevelamer
tablets will be manufactured at the company’s facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at
Chestnut Ridge) with USFDA, of which 245+ ANDAs have been approved. The company has set a target to
launch ~ 60 new products over three years in the US.

Read also: Strides Pharma Science Singapore arm gets USFDA nod for Major Depressive Disorder drug Fluoxetine

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor‐ funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).

Read also: Strides Pharma Science arm secures USFDA nod for Gabapentin tablets for neuropathic pain treatment

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