Loneliness common among older informal caregivers, says report

On behalf of the Swedish Gender Equality Agency, researchers Lena Dahlberg and Mariam Kirvalidze have done a scoping review of informal caregiving and loneliness.

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Parents’ watchful eye may keep young teens from trying alcohol, drugs: Study

Teenagers are less likely to drink, smoke or use drugs when their parents keep tabs on their activities—but not necessarily because kids are more likely to be punished for substance use, suggests a new study in the Journal of Studies on Alcohol and Drugs.

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Repurposed cancer drug could treat diabetes by nudging pancreatic acinar cells to produce insulin

In 2016, University of Pittsburgh researchers Dr. Farzad Esni, Ph.D., and Jing Hu, Ph.D., did an experiment in mice where they deleted one of two copies of the gene encoding an enzyme called focal adhesion kinase (FAK). They were interested in the role of FAK in pancreatic cancer, but a surprise finding took the research in a very different direction.

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Research shows LGBTQI+ health-related content in medical school has increased

Reducing barriers to comprehensive and affirming health care for lesbian, gay, bisexual, transgender, queer and intersex (LGBTQI+) populations requires physicians to receive LGBTQI+ health content during undergraduate medical education (UME).

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Lupin bags USFDA nod for Travoprost Ophthalmic Solution

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%(Ionic Buffered Solution), to market a generic equivalent to the reference listed drug (RLD)Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc.

The product will be manufactured at Lupin’s Pithampur facility in India.

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Read also: Lupin Digital Health’s Lyfe Platform gets Class C Medical Device license from CDSCO

Medical Dialogues team had earlier reported that the Company had received approval from the U.S. FDA for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.

Read also: Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension

Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.

Travoprost Ophthalmic Solution USP, 0.004% (RLD Travatan Z), had estimated annual sales of USD 77 million in the U.S. (IQVIA MAT March 2024).

Read also: Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers.

Read also: Lupin unveils Rymti biosimilar Etanercept in Canada

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5 SRM medical college MBBS students Drown In Sea Off Kanyakumari Coast

Tiruchirappalli: In a tragic incident, 5 final year MBBS students of a private medical college in Tamil Nadu’s Trichy, who went to Nagercoil to attend a wedding, drowned in the sea off the Rajakkamangalam Lemur Beach on Monday morning.

According to the police, all five deceased medicos, two women and three men house surgeons, were final-year students of Trichy SRM Medical College Hospital and Research Centre. One of the victims was from Andhra Pradesh, and the other four were from Tamil Nadu, all in the age group of 23-24 years. The police said all bodies have been recovered.

Speaking to PTI, the police said, “Five students of a private medical college in Tiruchirappalli drowned in the sea off the coast of Kanniyakumari on Monday… A group of MBBS students doing their house surgeonship in the Tiruchirappalli college went to the Lemur Beach at Rajakkamangalam and a huge wave dragged several of them into the sea.”

“Two women and 3 men drowned,” Kanniyakumari police superintendent E Sundaravathanam said.

To a question, the police official said the students were told by local people to avoid going to the beach in view of official warnings of sudden ‘swell waves.’

The students, however, managed to reach the beach by going through a coconut grove. They arrived in Kanniyakumari district on May 5 to take part in the wedding of a student’s brother, the official said adding the bodies were being sent to the families, adds PTI.

Three students, who were part of the group, are being treated at a government hospital.

“There were high tides, and a security staff posted there had warned them. As they were close to the water, enjoying the sea, a strong wave hit them and dragged seven people. Two were rescued soon, but five students lost their lives due to drowning. One of the rescued is in critical condition and admitted to the hospital. A case has been registered, and an investigation is ongoing,” an officer informed The Indian Express.

Meanwhile, expressing grief, Tamil Nadu Chief Minister M K Stalin conveyed his condolences and sympathies to the kin of the deceased and said necessary assistance would be provided to the bereaved families after getting the Election Commission’s permission.

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Online Trading Fraud: Kerala doctor duped of Rs 3.42 crore

Thiruvananthapuram: In yet another case of cyber fraud reported from the city, a 53-year-old doctor became a victim of an online trading and investment scam leading to a loss of Rs 3.42 crore following which the cyber police registered a case.   

According to the police, the sophisticated scheme is believed to have been masterminded by a gang of ten individuals who deceived the doctor into believing that he could attain immense wealth, just like the others he encountered within the fraudulent organization.

Also read- FedEx Courier Scam: Delhi Doctor Loses Rs 5 Lakh To Fraudsters

As per the TOI news report, the incident occurred when the doctor was contacted by an individual posing as a member of a leading firm’s share trading research team, promoting the potential of online trading. 

Subsequently, he was invited to join a WhatsApp group where fake profiles of purported billionaires in online trading were presented. The doctor, unaware of the deception, was lured by promises of attractive profits from small investments.

To win the trust of the doctor, the accused began giving him profits in small investments. This prompted the doctor to invest more and gain more profit. However, things took a turn when the accused asked the doctor to download an application purportedly for trading purposes.

But in reality, the app allowed the accused to access his personal information and banking credentials. With this access, they were able to transfer a substantial amount from his bank account. 

Upon realising that he had fallen into a trap, the doctor approached the cyber police and registered a case under relevant sections of the Information Technology Act and the Indian Penal Code (IPC), including sections 66(D) for cyber fraud, 419 for cheating by personation, and 420 for cheating. 

Speaking to the Daily, an officer of the cyber police department said, “We have been collecting all the available details from the victim and measures have been taken to block the accounts to which the snatched money was transferred.”

Also read- Pune Doctor Duped By Fraudsters In Drug Parcel Scam, Loses Rs 1 Crore

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Groundbreaking angiogenic gene therapy shows promise in refractory angina: EXACT Phase 2 trial

USA: Refractory angina, a debilitating condition characterized by persistent chest pain despite optimal medical therapy, poses significant challenges for patients and clinicians alike. However, a beacon of hope shines through the latest advancements in medical science. The results of the EXACT Phase 2 Trial, investigating the efficacy of angiogenic gene therapy in refractory angina patients, have been unveiled, heralding a potential breakthrough in treatment.

According to the trial, gene therapy for therapeutic angiogenesis showed promise for patients with angina who had already exhausted their options for medical therapy and coronary revascularization. The findings were published online in Circulation: Cardiovascular Interventions.

“XC001, an engineered adenovirus vector that transiently increases VEGF-A expression in the myocardium, administered via transepicardial delivery is safe and generally well tolerated,” the researchers reported. “Exploratory improvements in ischemic burden, total exercise duration, and subjective measures support a biological effect sustained to 12 months, warranting further investigation.”

XC001 is a novel adenoviral-5 vector designed to express multiple VEGF (vascular endothelial growth factor) isoforms and more safely and potently induce angiogenesis. Kenta Nakamura, Division of Cardiology, Department of Medicine, University of Washington, Seattle. (K.N.), and colleagues conducted the EXACT trial to assess the safety and preliminary efficacy of XC001 in patients with no option refractory angina.

The single-arm, multicenter, open-label trial included 32 patients with no option refractory angina who received a single treatment of XC001 (1×1011 viral particles) via transepicardial delivery.

The researchers reported the following findings:

  • There were no severe adverse events attributed to the study drug. Twenty expected severe adverse events in 13 patients were related to the surgical procedure.
  • Total exercise duration increased from a mean of 359.9 seconds at baseline to 448 (3 months), 449.2 (6 months), and 477.6 (12 months; +88.3, +84.5, and +115.5).
  • Total myocardial perfusion deficit on positron emission tomography imaging decreased by 10.2%, 14.3%, and 10.2%.
  • Angina frequency decreased from a mean of 12.2 episodes to 5.2 (3 months), 5.1 (6 months), and 2.7 (12 months), with an average decrease of 7.7, 6.6, and 8.8 episodes at 3, 6, and 12 months.
  • Angina’s class improved in 81% of participants at six months.

While further research is warranted to validate these findings and optimize treatment protocols, the results of the EXACT Phase 2 Trial signify a paradigm shift in the approach to refractory angina management. With continued advancements in gene therapy technology, the prospect of personalized, targeted treatments for ischemic heart disease looms on the horizon, promising renewed hope for patients facing this challenging condition.

Reference:

Nakamura K, Henry TD, Traverse JH, Latter DA, Mokadam NA, Answini GA, Williams AR, Sun BC, Burke CR, Bakaeen FG, DiCarli MF, Chaitman BR, Peterson MW, Byrnes DG, Ohman EM, Pepine CJ, Crystal RG, Rosengart TK, Kowalewski E, Koch GG, Dittrich HC, Povsic TJ; EXACT Trial Investigators. Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial. Circ Cardiovasc Interv. 2024 May 2:e014054. doi: 10.1161/CIRCINTERVENTIONS.124.014054. Epub ahead of print. PMID: 38696284.

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Empagliflozin Shows Promise for Alleviating Peripheral Diabetic Neuropathy in Type 2 Diabetes Patients: Study

Egypt: In a significant development for type 2 diabetes mellitus (T2DM) management, a recent study has uncovered promising evidence regarding the potential of empagliflozin in mitigating peripheral diabetic neuropathy among patients. The findings, published in Medicina Clínica, shed light on a new avenue for addressing the debilitating effects of neuropathy in individuals living with diabetes.

The researchers revealed that empagliflozin may be a promising therapeutic and neuroprotective agent for diabetic peripheral neuropathy (DPN).

Peripheral diabetic neuropathy, a common complication of diabetes, affects the nerves in the extremities, leading to symptoms such as numbness, tingling, and pain. It burdens patients’ quality of life considerably and is often challenging to manage effectively with existing treatments.

The study, conducted by Maha Khalifa, Clinical Pharmacy Department, Tanta Universal Teaching Hospital, Tanta University, Tanta, Egypt, and colleagues aimed to assess the probable protective effect of empagliflozin in type 2 diabetics who are suffering from DPN.

For this purpose, the researchers recruited fifty eligible type 2 diabetes mellitus (T2DM) cases with diabetic peripheral neuropathy. They were classified into two groups: Group I (control group; n=25) received placebo tablets once daily. Group II (empagliflozin group; n=25) received empagliflozin 25 mg once daily for three months.

The efficacy of empagliflozin was evaluated using HbA1c levels, and electrophysiological studies, the diabetic neuropathy symptom (DNS) score, the brief pain inventory short-form item (BPI-SF) score, the atherosclerotic cardiovascular disease (ASCVD) risk score, and the serum levels of malondialdehyde (MDA), neuron-specific enolase (NSE), and calprotectin (Calpro), lipid profile, and random blood glucose level (RBG).

The study led to the following findings:

  • After three months, comparing the results of the empagliflozin arm to the control arm showed a significant improvement in the electrophysiological studies and a substantial decrease in the BPI-SF score and the mean serum levels of NSE and MDA.
  • No significant difference was determined in HbA1c, Calpro, lipid profile, and RBG levels.
  • The DNS and ASCVD risk scores were not significantly different.
  • The NSE and MDA levels significantly negatively correlated with the electrophysiological parameters.
  • The BPI-SF score showed a non-significant difference.

According to the authors, the study can be considered the first prospective clinical trial to investigate empagliflozin’s effect in T2DM patients with DPN who were not on SGLT2 inhibitor treatment. Preclinical studies have proven that SGLT2 inhibitors improve nerve conduction with neuropathic pain amelioration in DM rats, so this study agreed with this preclinical study.

In conclusion, the study was conducted to detect if empagliflozin has a neuroprotective effect in T2DM and those with DPN, in addition to its impact on glycemic control. The drug ameliorated systemic oxidative stress and neuropathy with minimal to no side effects. Therefore, empagliflozin has improved DPN and the patient’s QOL.

“After more studies support this concept, empagliflozin may be considered a first-line of treatment in DN cases,” the researchers wrote. 

Reference:

El-Haggar, S. M., Hafez, Y. M., El Sharkawy, A. M., & Khalifa, M. (2024). Effect of empagliflozin in peripheral diabetic neuropathy of patients with type 2 diabetes mellitus. Medicina ClíNica. https://doi.org/10.1016/j.medcli.2024.01.027

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Sacubitril/valsartan exhibits CV and kidney protective benefits across the spectrum of kidney risk in heart failure patients: JACC

USA: A recent study sheds light on the efficacy and safety of sacubitril/valsartan, a novel therapy for heart failure, across varying degrees of renal impairment. Heart failure is a significant health concern globally, affecting millions of individuals and presenting a considerable burden on healthcare systems.

Patients with heart failure often experience renal dysfunction, complicating their treatment and prognosis. Sacubitril/valsartan, a combination angiotensin receptor-neprilysin inhibitor (ARNI), has emerged as a promising therapy for heart failure with reduced ejection fraction (HFrEF), but its effects on patients with renal impairment have been less understood until now.

The study, published in the renowned medical journal Journal of the American College of Cardiology, classified one in four patients with HFrEF as at least high Kidney Disease Improving Global Outcomes (KDIGO) kidney risk; these individuals faced concordantly the highest risks of cardiovascular (CV) events.

“Sacubitril/valsartan exhibited consistent kidney and CV protective benefits and safety across the spectrum of baseline kidney risk,” the researchers wrote. “These data further support sacubitril/valsartan initiation in HFrEF across a broad range of kidney risks.”

The KDIGO classification integrates both estimated glomerular filtration rate (eGFR) and urine-albumin-creatinine-ratio (UACR) to stratify risk more comprehensively in chronic kidney disease patients. Data assessing whether this classification system is associated with treatment response and prognosis in heart failure populations is limited.

PARADIGM-HF was a global randomized controlled trial (RCT) evaluating sacubitril/valsartan versus enalapril in HFrEF patients. Patients were categorized according to low, moderate, and high/very high KDIGO risk.

Treatment responses were evaluated as per the baseline KDIGO risk. The study’s primary outcome was a composite of HF hospitalization or CV death. A renal composite outcome was defined as end-stage kidney disease or a sustained decline in eGFR by ≥40%.

The study led to the following findings:

  • Among 1,910 (23%) participants with available data, 42%, 32%, and 26% were classified as low, moderate, and high/very high KDIGO risk, respectively.
  • Patients in the highest KDIGO risk categories experienced the highest rates of the primary composite outcome (7.6, 9.4, 14.9 per 100py).
  • Sacubitril/valsartan had a similar safety profile and similarly reduced the risk of both the primary outcome and the renal composite outcome across the spectrum of KDIGO risk.

In conclusion, the study demonstrates the safety and efficacy of sacubitril/valsartan across the spectrum of renal impairment in patients with heart failure. These findings provide valuable insights for clinicians and underscore the importance of personalized treatment strategies in optimizing outcomes for patients with heart failure and renal dysfunction.

Reference:

Chatur, S., Neuen, B. L., Claggett, B. L., Beldhuis, I. E., Mc Causland, F. R., Desai, A. S., Rouleau, J. L., Zile, M. R., Lefkowitz, M. P., Packer, M., McMurray, J. J., Solomon, S. D., & Vaduganathan, M. (2024). Effects of Sacubitril/Valsartan Across the Spectrum of Renal Impairment in Patients With Heart Failure. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2024.03.392

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