Liraglutide can prevent PAD progression in patients with type 2 diabetes: STARDUST trial

Italy: Compared with conventional treatment, liraglutide use over six months was associated with increased peripheral in patients with type 2 diabetes and peripheral artery disease (PAD), suggesting that it may prevent PAD’s clinical progression, a recent study has shown.

“The open-label randomized clinical trial (STARDUST) of 55 patients with T2D and PAD showed that liraglutide was associated with a significant increase in transcutaneous oxygen pressure (TcPo2) versus conventional treatment of cardiovascular (CV) risk factors,” the researchers reported in JAMA Network Open.

“An increase from baseline of at least 10% of TcPo2 was achieved by 89% of participants treated with liraglutide and 46% of the control group.”

Peripheral artery disease in diabetes may lead to diabetic foot ulcers and lower-extremities amputation. Glucagon-like peptide 1 receptor agonists have proven CV benefits in trials of patients with T2D at high CV risk. Considering this, Paola Caruso, University of Campania “Luigi Vanvitelli,” Naples, Italy, and colleagues aimed to investigate the effect of liraglutide on peripheral perfusion measured as peripheral TcPo2 in patients with type 2 diabetes and PAD.

For this purpose, the researchers conducted an open-label randomized clinical trial (RCT) between 2021 and 2022, with a final follow-up in December 2022. It included Fifty-five individuals with type 2 diabetes, PAD, and TcPo2 between 30 and 49 mm Hg.

Fifty-five participants (mean age, 67.5 years; 78% male) were randomized to receive 1.8 mg of subcutaneous liraglutide (n=27) or conventional treatment of cardiovascular risk factors (control group, n=28) for six months.

Coprimary outcomes were the change in peripheral perfusion from baseline between groups and the comparison of the proportion of individuals who reached a 10% increase of TcPo2 from baseline in each group.

The study led to the following findings:

  • Participants had a median (IQR) hemoglobin A1c level of 6.9% and a mean TcPo2 of 40.3 mm Hg.
  • Transcutaneous Po2 increased over time in both groups, with significant differences favoring the liraglutide group after 6 months (estimated treatment difference, 11.2 mm Hg).
  • The 10% increase in TcPo2 occurred in 89% of participants in the liraglutide group and 46% in the control group (relative risk, 1.91).
  • Compared with the control group, individuals in the liraglutide group had a significant reduction of C-reactive protein (−0.4 mg/dL), urinary albumin to creatinine ratio (−119.4 mg/g), and improvement of 6-minute walking distance (25.1 m).

In conclusion, the RCT of patients with type 2 diabetes and PAD, liraglutide increased peripheral perfusion detected by TcPo2 measurement during 6 months of treatment.

“These results support liraglutide use to prevent the clinical progression of PAD in individuals with type 2 diabetes,” the researchers wrote.

Reference:

Caruso P, Maiorino MI, Longo M, et al. Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial. JAMA Netw Open. 2024;7(3):e241545. doi:10.1001/jamanetworkopen.2024.1545

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Treating anxiety, depression in people with heart disease reduced ER visits, hospitalizations, finds study

Treating anxiety and depression reduced emergency room visits and rehospitalizations among people with heart disease, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association.

“For patients who had been hospitalized for coronary artery disease or heart failure and who had diagnoses of anxiety or depression, treatment with psychotherapy, pharmacotherapy or a combination of the two was associated with as much as a 75% reduction in hospitalizations or emergency room visits. In some cases, there was a reduction in death,” said lead study author Philip Binkley, M.D., M.P.H., executive vice chair of the department of internal medicine and emeritus professor of internal medicine and public health at The Ohio State University in Columbus, Ohio.

Binkley noted that anxiety and depression are common in people with heart failure, and mental health can have a significant impact on an individual’s risk of other health conditions, disability and death.

In this study, Binkley and colleagues examined the association of mental health treatment with antidepressant medication or psychotherapy, also known as talk therapy or a combination of the two in relation to, emergency room visits, hospitalizations and death in people with blocked arteries or heart failure and with a formal diagnosis of anxiety or depression before hospitalization.

The analysis found using three different statistical models that adjusted for different variables and compared to patients not receiving treatment for anxiety or depression:

  • For people who received both medication and talk therapy for anxiety or depression the risk of hospitalization was reduced by 68% to 75% the risk of being seen in the emergency department was reduced by 67% to 74%, and the risk of death from any cause was reduced by 65% to 67%.
  • Psychotherapy treatment alone was associated with a 46% to 49% reduction of risk for hospital readmission and a 48% to 53% reduction in emergency room visits.
  • Medication treatment alone reduced hospital readmission by 47% to 58% and reduced ER visits by 41% to 49%.
  • Follow-up time was variable based on the needs of each patient.

“Heart disease and anxiety/depression interact such that each promotes the other,” Binkley said. “There appear to be psychologic mechanisms that link heart disease with anxiety and depression that are currently under investigation. Both heart disease and anxiety/depression are associated with activation of the sympathetic nervous system. This is part of the so-called involuntary nervous system that increases heart rate, blood pressure and can also contribute to anxiety and depression.”

Binkley considers the large number of people with heart disease and the marked reduction in hospitalizations and emergency room visits and the drop in death to be the strength of the study.

“I hope the results of our study motivate cardiologists and health care professionals to screen routinely for depression and anxiety and demonstrate that collaborative care models are essential for the management of cardiovascular and mental health. I would also hope these findings inspire additional research regarding the mechanistic connections between mental health and heart disease,” he said.

Study details and background:

  • 1,563 adults ages 22 to 64 over a three-year period were included, and all participants had a first hospital admission for blocked arteries or heart failure and had two or more health insurance claims for an anxiety disorder or depression.
  • Sixty-eight percent of participants were women, and 81% were noted as white race. All were enrolled in Ohio’s Medicaid program during the six months prior to the hospital admission. Health data was from two sources: Ohio Medicaid claims and Ohio death certificate files from July 1, 2009, to June 30, 2012.
  • Participants were followed through the end of 2014 or until death or the end of Medicaid enrollment.
  • About 23% of participants received both antidepressant medications and psychotherapy; nearly 15 percent received psychotherapy alone; 29% took antidepressants alone; and 33% received no mental health treatment.
  • About 92% of participants in the study were diagnosed with anxiety and 55.5% with depression prior to hospitalization.

The study was limited to people enrolled in Medicaid, therefore, it may not be representative of people covered by commercial health insurance plans. In addition, the majority of participants were noted as white race, therefore, these finding are not applicable to people of other races, ethnicities or communities.

Reference:

Cheryl N. Carmin, Raymond L. Ownby, Cynthia Fontanella, Danielle Steelesmith and Philip F. Binkley, Impact of Mental Health Treatment on Outcomes in Patients With Heart Failure and Ischemic Heart Disease,Journal of the American Heart Association, https://doi.org/10.1161/JAHA.123.031117.

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Add on clarithromycin to standard of care may attenuate inflammatory burden of community-acquired pneumonia: Study

Add on clarithromycin to the standard of care may attenuate the inflammatory burden of community-acquired pneumonia suggests a new study published in The Lancet Respiratory Medicine.

The addition of macrolide antibiotics to β-lactam antibiotics for the treatment of patients in hospitals with community-acquired pneumonia is based on results from observational studies and meta-analyses rather than randomised clinical trials. They investigated if the addition of the macrolide clarithromycin to treatment with a β-lactam antibiotic in this population could improve early clinical response—the new regulatory endpoint for community-acquired pneumonia—and explored the possible contribution of modulation of the inflammatory host response to that outcome. The ACCESS trial was a phase 3 prospective, double-blind, randomised controlled trial, in which adults in hospital with community-acquired pneumonia who had systemic inflammatory response syndrome, Sequential Organ Failure Assessment (SOFA) score of 2 or more, and procalcitonin 0·25 ng/mL or more were enrolled in 18 internal medicine departments of public Greek hospitals. Patients were randomly assigned (1:1) by computer-generated block randomisation to standard-of-care medication (including intravenous administration of a third-generation cephalosporin or intravenous administration of β-lactam plus β-lactamase inhibitor combination) plus either oral placebo or oral clarithromycin 500 mg twice daily for 7 days. Investigators, staff, and patients were masked to group allocation. The primary composite endpoint required that patients fulfilled both of the following conditions after 72 hours (ie, day 4 of treatment): (1) decrease in respiratory symptom severity score of 50% or more as an indicator of early clinical response and (2) decrease in SOFA score of at least 30% or favourable procalcitonin kinetics (defined as ≥80% decrease from baseline or procalcitonin <0·25 ng/mL), or both, as an indicator of early inflammatory response. Participants who were randomly assigned and received allocated treatment were included in the primary analysis population. Patients were enrolled between Jan 25, 2021, and April 11, 2023, and 278 individuals were randomly allocated to receive standard of care in combination with either clarithromycin (n=139) or placebo (n=139). 134 patients in the clarithromycin group (five withdrew consent) and 133 patients in the placebo group (six withdrew consent) were included in the analysis of the primary endpoint. The primary endpoint was met in 91 (68%) patients in the clarithromycin group and 51 (38%) patients in the placebo group. Serious treatment-emergent adverse events (TEAEs) occurred in 58 (43%) patients in the clarithromycin group and 70 (53%) patients in the placebo group. None of the serious TEAEs was judged to be related to treatment assignment. The addition of clarithromycin to the standard of care enhances early clinical response and attenuates the inflammatory burden of community-acquired pneumonia. The mechanism of benefit is associated with changes in the immune response. These findings suggest the importance of adding clarithromycin to β-lactams for the treatment of patients in hospitals with community-acquired pneumonia to achieve early clinical response and early decrease of the inflammatory burden.

Reference:

Evangelos J Giamarellos-Bourboulis, Athanasios Siampanos, Amalia Bolanou, Sarantia Doulou, Nikolaos Kakavoulis, Konstantinos Tsiakos, Sokratis Katopodis, Georgios Schinas, Lamprini Skorda, Zoi Alexiou, Konstantinos Armenis, Paraskevi Katsaounou, George Chrysos, Aikaterini Masgala, Garyphalia Poulakou, Nikolaos Antonakos, Asimina Safarika, Miltiades Kyprianou, Konstantina Dakou, Styliani Gerakari, Ilias C Papanikolaou, Haralampos Milionis, Markos Marangos, George N Dalekos, Vasiliki Tzavara, Karolina Akinosoglou, Eryfilli Hatziaggelaki, Styliani Sympardi, Theano Kontopoulou, Maria Mouktaroudi, Antonios Papadopoulos, Michael S Niederman. Clarithromycin for early anti-inflammatory responses in community-acquired pneumonia in Greece (ACCESS): a randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine. 2024, ISSN 2213-2600. https://doi.org/10.1016/S2213-2600(23)00412-5. (https://www.sciencedirect.com/science/article/pii/S2213260023004125)

Keywords: Evangelos J Giamarellos-Bourboulis, Athanasios Siampanos, Amalia Bolanou, Sarantia Doulou, Nikolaos Kakavoulis, Konstantinos Tsiakos, Sokratis Katopodis, Georgios Schinas, Lamprini Skorda, Zoi Alexiou, Konstantinos Armenis, Paraskevi Katsaounou, George Chrysos, Aikaterini Masgala, Garyphalia Poulakou, Nikolaos Antonakos, Asimina Safarika, Miltiades Kyprianou, Konstantina Dakou, Styliani Gerakari, Ilias C Papanikolaou, Haralampos Milionis, Markos Marangos, George N Dalekos, Vasiliki Tzavara, Karolina Akinosoglou, Eryfilli Hatziaggelaki, Styliani Sympardi, Theano Kontopoulou, Maria Mouktaroudi, Antonios Papadopoulos, Michael S Niederman, Clarithromycin for pneumonia, community-acquired pneumonia, The Lancet Respiratory Medicine

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Gestational exposure to systemic glucocorticoids linked to incident kidney disease in childhood: Study

Gestational exposure to systemic glucocorticoids linked to incident kidney disease in childhood suggests a study published in the American Journal of Kidney Diseases.

The potential effects of antenatal glucocorticoid exposure on children’s health are unclear. We examined the association between gestational exposure to maternal systemic glucocorticoids (SG) and the risk of developing chronic kidney disease (CKD) in childhood. Cox proportional hazard models with stabilized inverse probability of treatment weighting and robust sandwich estimator were used to estimate the average association between SG and incident CKD after adjustment for offspring characteristics (aHR). Results: Among 23,363 singleton-born children, gestational SG exposure was significantly associated with a higher risk of childhood CKD (aHR, 1.69 [95% CI, 1.01-2.84]). Stratified analyses showed stronger associations between SG and childhood CKD within the strata of birth <37 weeks gestational age (aHR, 2.38 [95% CI, 1.19-4.78]), male sex (aHR, 1.89 [95% CI, 1.00-3.55]), gestational exposure in the second trimester (aHR, 6.70 [95% CI, 2.17-20.64]), and total dose >24 mg hydrocortisone equivalent (aHR, 1.91 [95% CI, 1.05-3.47). Study was limited to the Taiwan healthcare delivery system and childhood CKD events through age 10 years. The findings of this study suggest that gestational exposure to systemic glucocorticoids is associated with the occurrence of kidney disease in childhood. If these findings are confirmed, they may inform clinicians who are considering prescribing SG during pregnancy.

Reference:

Tain YL, Li LC, Kuo HC, Hsu CN. Gestational Exposure to Maternal Systemic Glucocorticoids and Childhood Risk of CKD. Am J Kidney Dis. 2024 Mar 11:S0272-6386(24)00669-3. doi: 10.1053/j.ajkd.2024.01.523. Epub ahead of print. PMID: 38479460.

Keywords:

Gestational exposure, systemic glucocorticoids, incident, kidney disease , childhood, Tain YL, Li LC, Kuo HC, Hsu CN, American Journal of Kidney Diseases, adolescents; antenatal; children; chronic kidney disease; gestational timing; pregnancy; systemic glucocorticoids.

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Merck gets CDSCO Panel Nod To study anti-cancer drug Avelumab

New Delhi: The drug major Merck has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a non-interventional study (NIS) of Avelumab concentrate for solution for infusion (Intravenous Infusion) in India.

This came after the drug maker Merck presented the proposal to conduct an interventional Study (NIS) on the Bavencio (Avelumab concentrate for solution for infusion (Intravenous Infusion) in India vide protocol No. MS100070_0133, version 2.0 dated 08 Nov 2022.

Avelumab is an anti-PD-L1 monoclonal antibody used to treat metastatic merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. PD-L1 blockade removes the suppression of T-cell activity, resulting in T-cell-mediated, adaptive antitumor immune responses.

At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the proposal to conduct an interventional Study (NIS) on the Bavencio (Avelumab concentrate for solution for infusion (Intravenous Infusion) in India vide protocol No. MS100070_0133, version 2.0 dated 08 Nov 2022.

After detailed deliberation, the committee recommended the firm conduct the study as per the presented protocol.

Also Read: Synokem Pharma Gets CDSCO Panel Nod To Study Antidiabetic FDC

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UP doctor duped of Rs 40 lakh in digital arrest scam

Lucknow: A shocking incident of cyber fraud has come to light as a woman doctor a professor at a government medical university in Uttar Pradesh, fell victim to a ‘digital arrest’ scam and was duped of Rs 40 lakh.  

The cybercrime, known as ‘digital arrest,’ involves cybercriminals posing as law enforcement or investigative authorities to coerce individuals into transferring money under false pretenses.

According to the woman’s statement, she received a call on March 11, purportedly from Maharashtra, reports IANS.

The caller accused her of involvement in illegal activities using a phone number issued under her ID in July 2023. The call was then transferred to someone claiming to be from the Maharashtra police headquarters, who accused her of fraudulent activities, including money laundering through a fictitious account in Canara Bank, Mumbai. The caller threatened her with an arrest warrant and claimed to have blocked her financial cards, PAN, and Aadhaar.

Also Read:Hyderabad: Man poses as doctor on matrimonial website dupes woman of Rs 6 lakh

According to IANS,“An arrest warrant has been issued in your name. All your financial accounts will be frozen and they will be investigated. Till then you are put under ‘digital arrest’. After that they called me on Skype and showed me many documents which included my phone number, Aadhaar number and which also included my arrest warrant,” she said.

“A staggering amount of Rs 31.31 lakh was transferred by her on March 11, followed by Rs 9 lakh from another account the next day,” police said.  

Furthermore, the scammers instructed the woman to maintain constant communication, provide personal information and refrain from contacting anyone else, citing national security concerns and the purported involvement of police and bank officials in the scam, police said. 

Upon realizing she had been deceived, the professor promptly reported the incident to the cybercrime police station and filed a formal complaint, leading to the registration of an FIR. 

The victim, a widow, had saved the money for her children’s education and her future, making the loss particularly devastating.

Former SP in Cyber Cell and cyber expert, Triveni Singh said that people should be aware that no legitimate agency will request presence on a Skype call for matters of investigation or arrest. There is nothing like a ‘digital arrest’. 

Also Read:Delhi doctor becomes victim of sextortion scam, loses Rs 8.6 Lakh

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Research visualizes ‘demonic’ face distortions in a case of prosopometamorphopsia

Imagine if every time you saw a face, it appeared distorted. Well, for those who have a very rare condition known as prosopometamorphopsia (PMO), which causes facial features to appear distorted, that is reality.

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Scientists using novel hydrogel to create ‘lollipops’ for mouth cancer diagnostic

Researchers from the University of Birmingham, U.K., are creating a new ‘lollipop’ diagnostic for mouth cancer using a novel smart hydrogel.

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Research reveals link between menstrual cycles, emotions and sleep patterns in women

Women experience disruptions in their sleep patterns and report heightened feelings of anger in the days leading up to their period, according to new research.

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Breast cancer patients can safely avoid extensive removal of lymph nodes if they respond well to systemic treatment

Patients with breast cancer that has started to spread to the lymph nodes in the armpit can safely avoid extensive removal of the lymph nodes if their treatment is tailored to their response to cancer-killing therapies such as chemotherapy before surgery.

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