Tirzepatide may reduce CVD Risk in Non-Diabetic Overweight Patients

The outcomes from the SURMOUNT-1 phase 3 trial found tirzepatide to effectively manage the long-term risk of atherosclerotic cardiovascular disease (ASCVD) among individuals with obesity or overweight but with no diabetes. The findings were published in the Journal of Diabetes, Obesity and Metabolism.

The study assessed the efficacy and safety of tirzepatide in adults with a body mass index (BMI) of ≥30 or ≥27 kg/m² and at least one weight-related complication, excluding diabetes. Participants were randomly assigned to receive tirzepatide at varying doses (5/10/15 mg) or a placebo. Over 72 weeks, cardiometabolic variables were scrutinized and 10-year ASCVD risk scores were calculated using the American College of Cardiology/American Heart Association risk engine.

The tirzepatide-treated groups exhibited reductions in cardiometabolic variables throughout the study duration. In the 2461 participants without a history of ASCVD, the baseline median risk score, ranging from 1.5% to 1.6%, showed no significant differences. The relative change in ASCVD risk from baseline to week 72 was remarkably greater for the tirzepatide cohort (-23.5% to -16.4%) compared to the placebo group (12.7%; P < 0.001). This trend was found true for participants with intermediate-to-high baseline risk by showing a significantly greater relative change (P < 0.05) and underlining the potential impact of tirzepatide in this subgroup.

Tirzepatide treatment significantly reduced the 10-year predicted risk of ASCVD in individuals with obesity or overweight but without diabetes. These findings deepen our understanding of the potential of tirzepatide and also helps in addressing cardiovascular risks in a population facing the challenges of excess weight.

Reference:

Hankosky, E. R., Wang, H., Neff, L. M., Kan, H., Wang, F., Ahmad, N. N., Griffin, R., Stefanski, A., & Garvey, W. T. (2023). Tirzepatide reduces the predicted risk of atherosclerotic cardiovascular disease and improves cardiometabolic risk factors in adults with obesity or overweight: SURMOUNT‐1 post hoc analysis. In Diabetes, Obesity and Metabolism (Vol. 26, Issue 1, pp. 319–328). Wiley. https://doi.org/10.1111/dom.15318

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Weight loss with anti-obesity medications improve survival in people with knee or hip osteoarthritis: Study

China: A population-based study revealed that the slow-to-moderate, but not fast, rate of weight loss induced by antiobesity medications is linked with lower all-cause mortality in patients with obesity or overweight and knee or hip osteoarthritis (OA). The findings were published online in Arthritis & Rheumatology on December 6, 2023.

“For people overweight or with obesity who also have knee or hip osteoarthritis, a slow-to-moderate-but not fast-rate of weight loss caused by anti-obesity medications may lower their risk of premature death,” the researchers wrote.

The current guidelines recommend weight loss for overweight/obese patients with knee or hip osteoarthritis; however, there is a lack of data on the relation of weight loss to death among patients with OA. Chao Zeng, Central South University, Changsha, China, and colleagues aimed to examine the relation of the rate of weight loss induced by antiobesity medications over one year to all-cause mortality among patients with overweight or obesity and knee or hip OA.

For this purpose, the researchers identified people with obesity or overweight and hip or knee OA using the IQVIA Medical Research Database. They emulated analyses of a hypothetical target trial to evaluate the effect of slow-to-moderate (2%–10%) or fast (≥10%) weight loss induced by the initiation of antiobesity medications within one year on all-cause mortality and secondary outcomes over a follow-up of five years. 

Among 6,524 participants with knee or hip osteoarthritis who were taking orlistat, sibutramine, or rimonabant, the 5-year death rate was 5.3%, 4.0%, and 5.4% for the “weight gain/stable”, “slow-to-moderate weight loss,” and “fast weight loss” groups, respectively. Compared with the “weight gain/stable” group,” the risk of death was 28% lower for the “slow-to-moderate weight loss” group and only 1% lower for the “fast weight loss” arm.

“A slow-to-moderate rate of weight loss induced by anti-obesity medications may lower the risk of death in overweight/obese people with knee/hip osteoarthritis”, said first author Jie Wei, PhD, of Xiangya Hospital, Central South University, in China.

Reference:

Jie Wei, David Hunter, Nancy E. Lane, Jing Wu, Chao Zeng, Guanghua Lei, Yuqing Zhang, Weight Loss Induced by Antiobesity Medications and All-Cause Mortality Among Patients With Knee or Hip Osteoarthritis,https://doi.org/10.1002/art.42754.

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More than 4 hours of daily smartphone use associated with health risks for adolescents

In a new study of more than 50,000 Korean adolescents, those who used a smartphone for more than 4 hours per day had higher rates of adverse mental health and substance use. Jin-Hwa Moon and Jong Ho Cha of Hanyang University Medical Center, Korea, and colleagues present these findings in the open-access journal PLOS ONE on December 6, 2023.

Prior research has shown that smartphone use among adolescents has increased in recent years, and that this usage may be associated with higher risk of adverse health-such as psychiatric disorders, sleep issues, eye-related problems, and musculoskeletal disorders. However, growing evidence suggests that at least some daily internet usage may be associated with better physical and mental health for adolescents.

To deepen understanding of the relationship between adolescents’ use of smartphones and health, Moon, Cha and colleagues analyzed data on more than 50,000 adolescent participants in the ongoing Korea Youth Risk Behavior Web-based Survey collected in 2017 and in 2020. The data included the approximate number of daily hours each participant spent on a smartphone as well as various health measures. The statistical analysis employed propensity score matching to help account for other factors that could be linked to health outcomes, such as age, sex, and socioeconomic status.

The researchers found that in 2020, the percentage of adolescents in the study who used a smartphone more than 2 hours per day was 85.7 percent-up from 64.3 percent in 2017. Adolescents who used a smartphone for more than 4 hours per day had higher rates of stress, thoughts of suicide, and substance use than those with usage below 4 hours per day. However, adolescents that used a smartphone 1-2 hours per day encountered fewer problems than adolescents who did not use a smartphone at all.

The authors note that this study does not confirm a causal relationship between smartphone use and adverse health outcomes. Nonetheless, the findings could help inform usage guidelines for adolescents-especially if daily usage continues to rise.

The authors add: “This research shows the impact of using smart devices for more than 4 hours a day on adolescent health.”

Reference:

Jong Ho Cha,Young-Jin Choi,Soorack Ryu,Jin-Hwa Moon, Association between smartphone usage and health outcomes of adolescents: A propensity analysis using the Korea youth risk behavior survey, https://doi.org/10.1371/journal.pone.0294553. 

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Study finds no Direct Association Between Cholesterol Intake and Chronic Kidney Disease Risk

A recent investigation exploring the link between cholesterol intake and the risk of chronic kidney disease (CKD) has yielded intriguing insights, suggesting a nuanced relationship between dietary cholesterol and CKD risk. This study was published in the journal of Nutrition Metabolism and Cardiovascular Diseases by Haekyung Lee and colleagues.

The study, utilizing data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2019-2021 and the Korean Genome and Epidemiology Study (KoGES), aimed to examine the potential association between cholesterol intake and CKD risk. Cholesterol intake was assessed through a 24-hour recall food frequency questionnaire, and participants were categorized based on their cholesterol intake levels.

Results from the KNHANES revealed a modest association between higher cholesterol intake and increased serum levels of total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol. However, despite this link between cholesterol intake and altered serum cholesterol levels, the study did not find a significant association between cholesterol intake and the prevalence of CKD in the KNHANES dataset, regardless of participants having a history of hypercholesterolemia.

In the KoGES dataset, which included a median follow-up of 11.4 years, researchers found that cholesterol intake was not significantly associated with the incidence of CKD. This held true for individuals both with and without hypercholesterolemia. Egg consumption, often a source of dietary cholesterol, also showed no significant association with the risk of incident CKD.

The study’s findings challenge the conventional notion of a direct correlation between cholesterol intake and CKD risk. Despite observing an association between cholesterol intake and altered serum cholesterol levels, researchers did not find a direct link between dietary cholesterol and the prevalence or incidence of CKD. These results suggest that solely reducing cholesterol intake may not suffice in preventing CKD development.

The study’s outcomes signal the need for a more comprehensive understanding of the multifaceted factors contributing to CKD risk. While dyslipidemia remains a known risk factor for CKD, this study suggests that focusing solely on dietary cholesterol intake might not effectively mitigate CKD risk. Further research is warranted to explore additional dietary, lifestyle, and physiological factors contributing to CKD development.

Reference:

Lee, H., Park, J., Kwon, S. H., Jeon, J. S., Noh, H., & Kim, H. Dietary cholesterol intake is not associated with the development of chronic kidney disease: results from two Korean cohort studies. Nutrition, Metabolism, and Cardiovascular Diseases: NMCD,2023. https://doi.org/10.1016/j.numecd.2023.12.011

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Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem Pharmaceutical to modify the Phase IV clinical trial protocol of the fixed-dose combination (FDC) drug Amoxicillin plus Clavulanate Potassium oral suspension in accordance with the Inclusion criteria, dose of the Potassium Clavulanate, sites of study.

This came after the firm presented the Phase IV clinical trial protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 10.09.2021.

In line with the inclusion criteria, the expert panel suggested that inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.

Furthermore, the committee stated that participants should be enrolled in thousands, and North Indian sites should be included to represent pan-Indian representation.

In addition, the committee noted that the dose of Potassium Clavulanate should be corrected.

Amoxicillin/clavulanic acid is a combination of penicillin-type antibiotics used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
Amoxicillin belongs to the group of medicines known as penicillin antibiotics. Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin-binding proteins. Penicillin-binding proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin-binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.
It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It’s often prescribed for children, to treat ear infections and chest infections.
Clavulanate potassium (the potassium salt of clavulanic acid) is a β-lactamase inhibitor that is added to amoxicillin to prevent inactivation by bacterial enzymes. β-Lactamase inhibitors (clavulanate, sulbactam, tazobactam) irreversibly bind to β-lactamase.
At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the Phase IV clinical trial protocol of FDC Amoxicillin plus Clavulanate Potassium Oral Suspension.
After detailed deliberation, the committee recommended the following modification in the Phase IV clinical trial Protocol:
1. As it is presented as a phase IV clinical study, participants should be enrolled in thousands.
2. Inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.
3. Dose of the Potassium Clavulanate should be corrected.
4. North Indian sites should be included to represent pan-Indian representation.

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Submit Justification and Rational: CDSCO Panel tells Pfizer on protocol amendment proposal for Palbociclib

New Delhi: In response to the proposal presented by the drug major Pfizer for the protocol amendment, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit the justification and rationale for the proposed amendment of the anti-cancer drug Palbociclib.

This came after the firm presented Protocol Amendment 7.0 dated 31 May 2023, Protocol no. A5481092.
Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
Palbociclib is an oral medicine that is used to treat specific types of breast cancer in adults. It is used in combination with other cancer treatments, either aromatase inhibitor or fulvestrant depending on clinical factors.
At the recent SEC meeting for Oncology and Hematology held on the 29th and 30th of November 2023, the expert panel reviewed the proposal presented by the drug major Pfizer for the protocol Amendment of the anti-cancer drug (Palbociclib).
After detailed deliberation, the committee recommended that the justification and rationale for the proposed amendment need to be submitted for further review by the committee.

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Sanofi India names Himanshu Bakshi as General Manager for Consumer Healthcare Business

Sanofi India Limited (SIL) has announced the appointment of Himanshu Bakshi as General Manager for its Consumer Healthcare (CHC) business, effective 15th January 2024.

SIL earlier this year had announced that the Company’s Consumer Healthcare business will be demerged into its wholly owned subsidiary, Sanofi Consumer Healthcare India Limited (SCHIL), subject to necessary approvals and sanction by the National Company Law Tribunal, Mumbai.

For more details, check out the link given below:

Sanofi India Ropes In Himanshu Bakshi As General Manager For Consumer Healthcare Business

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Breaking News: Home Minister Amit Shah Promises to Decriminalize Medical Negligence

New Delhi: In an unprecedented move, Union Home Minister Amit Shah has promised in the Parliament to decriminalise medical negligence by doctors, drawing a big cheer from the entire medical fraternity.

Addressing the Lok Sabha, the Home Minister stated, “Currently, if there is a death due to negligence of a doctor, it is also treated as criminal negligence, almost akin to murder. Hence, I will bring an official amendment now to free the doctors from this criminal negligence.”

“Indian Medical Association had asked us to look into the matter. And hence we have decided to free the doctors from the culpability of criminal negligence,” the Minister said while addressing the Lok Sabha.

Criminal Negligence is a very bothersome and painful point for the medical fraternity. Currently, criminal negligence is dealt under IPC 304 A, which is causing death due to negligence.

As per IPC 304 A, whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.

However, the problem for doctors in reality does not end there, as many of the doctors are tried in the IPC 304 rather than IPC 304 A. While 304 A deals with charges of causing death due to negligence, IPC 304 deals with charges of Culpable homicide not amounting to murder.

Accused, who are charged under IPC 304 are punished with life imprisonment or imprisonment for up to ten years, and they may also be fined, depending on whether the act was done with the intention of causing death or with the knowledge that is is likely to cause death.

There has been a long-standing demand from the medical fraternity, that death due to to negligence of doctors should not be treated as criminal negligence.

Medical Dialogues in 2022 reported the story and the unfortunate death of Dr. Archana Sharma, a gynecologist, who had committed suicide after being booked for alleged medical negligence. 

Also Read: Booked for murder after patient death, distressed Gynecologist Commits Suicide in Rajasthan

Her patient had died due to postpartum hemorrhage (PPH) post-delivery. However, the family of the patient created a ruckus at the hospital and lodged an FIR against the late gynecologist and her husband. Holding negligence against both of the doctors, the family of the patient demanded that the two should be booked under IPC section 302 (which prescribes the punishment to murder).

Based on the allegations of the family, the police registered an FIR under IPC section 302 (Murder). Unable to face the harassment, the doctor took the extreme step of ending her life.

Amidst this, Union Home Minister’s announcement to decriminalise medical negligence by doctors has been welcomed by the medical fraternity. The announcement by the Home Minister comes after the Indian Medical Association (IMA) wrote to him raising the issue.

In a letter dated 22.11.2023, IMA requested the Government of India and the Union Home Ministry to exempt professional medical practice from criminal prosecution and to consider medical negligence only under the Law of TORTS. “The prime component of a crime mens rea is absent between a doctor and the patient during any treatment. We trust that the above appeal of the medical profession of India is under your active consideration. We had also submitted to define medical accident in the new Bharatiya Nyaya Sanhita 2023,” the association had mentioned in the letter.

“However, we understand that the new Law has not taken cognition of the representation of the medical profession. Moreover, as the Bill stands today doctors will not only be prosecuted but will be sentenced up to 7 years instead of the current 2 years. We humbly put up to you that the medical profession is greatly disturbed on this count. If the Government is considering our appeal, we expect a good gesture of atleast not raising the punishable years,” the association had further mentioned.

In the letter, IMA had urged the Minister to treat doctors differently and the association had also placed reliance on the Supreme Court order in the case of Jacob Mathew Vs State of Punjab 2005, to highlight that the Apex Court “had reiterated that such a consideration for doctors and the medical profession is entirely justified.”

Also Read: Mens rea as intent not necessary in Medical negligence cases, Following Established procedure is: Supreme Court

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State hospitals to face complete shutdown of Health services from December 29, says Haryana doctor’s body

The Haryana Civil Medical Service (HCMS) association has issued a stark ultimatum, warning of a potential disruption in medical services if the state authorities fail to promptly address their concerns. Scheduled for December 27, doctors in the state are prepared to suspend Outpatient Department (OPD) services, with a complete shutdown of all services looming from December 29 onwards if their demands remain unmet.

In a display of discontent on Tuesday, doctors statewide donned black badges and submitted a memorandum outlining their grievances to MLAs, ministers, and deputy commissioners.

For more news & updates, check out the link given below:

https://medicaldialogues.in/

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NMC warns medical colleges to ensure 75 percent faculty attendance or lose recognition

Few days after issuing show-cause notices to over 350 medical colleges after finding a deficiency in attendance and failure to meet required faculty requirements (Minimum Standard Requirements 2020), the National Medical Commission (NMC) has now issued a warning for the institutions directing them to strictly follow UG-MSR 2023 and MSMER 2023 otherwise their applications will not be considered and they will lose on approvals/recognition.

For more details, check out the link given below:

Ensure 75 Percent Faculty Attendance Or Lose Recognition: NMC Warns Medical Colleges

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