Tirzepatide, novel agent for treating type 2 diabetes has different efficacy in Asians and non-Asians: Study

China: A recent meta-analysis published in Diabetes Therapy has shed light on the comparative safety and efficacy of tirzepatide in Asians and non-Asians with type 2 diabetes mellitus (T2DM).

Jianjun Dong, Shandong University, Jinan, Shandong, China, and colleagues revealed that tirzepatide is a novel agent for diabetes treatment and has different efficacy in Asians and non-Asians. They found that tirzepatide exhibited greater efficacy in regulating blood glucose levels among non-Asian patients versus Asian patients while demonstrating a more pronounced body weight reduction among Asian patients as opposed to non-Asian patients.

Concerning adverse events, Asian patients exhibited a higher incidence of gastrointestinal adverse events compared to non-Asian patients receiving the same dosage. Conversely, non-Asian patients showed a higher incidence of nutrition and metabolic disorders in comparison to Asian patients.

“Asians were more likely to experience gastrointestinal adverse events and weight loss, whereas non-Asians were more likely to have better glycemic control and more nutritional and metabolic disorders,” the researchers reported.

There has been an increase in the incidence of type 2 diabetes mellitus (T2DM) in recent years and displays variations in pathophysiological mechanisms between Asians and non-Asians; Asian patients constitute more than half of the global patient population.

Tirzepatide is a novel treatment that acts as a dual agonist of GIP and GLP-1 receptors. The 2023 guidelines issued by the American Diabetes Association support tirzepatide as a favourable treatment option for patients with obesity and T2DM. However, there is no clarity on the safety and efficacy of tirzepatide in Asian or non-Asian patients with T2DM.

Against the above background, the research team aimed to provide evidence on the varying safety and efficacy of tirzepatide with different dose formulations for type 2 diabetes patients, looking for possible differences in safety and efficacy in Asians, considering the significant heterogeneity observed between Asians and non-Asians in terms of age of onset, BMI, and fat distribution. In the context of the study, Asian populations were represented by patients from China, Japan, South Korea, and India.

For this purpose, the researchers conducted a literature search in online databases for clinical studies of tirzepatide for type 2 diabetes. Two authors independently performed the data extraction process.

The systematic review and meta-analysis involved 2118 patients with T2DM from 6 studies, with tirzepatide doses ranging from 5 to 15 mg administered subcutaneously once weekly.

Based on the research, the researchers reported the following findings:

  • Compared with the control/placebo, tirzepatide was more effective in decreasing fasting blood glucose (FBG) in non-Asians than in Asians, and 10 mg rather than 15 mg was the optimal dose to decrease FBG.
  • Non-Asians were more effective than Asians in improving glycated haemoglobin (HbA1c).
  • Asians were significantly more effective than non-Asians in reducing body weight and ≥ 5% weight loss.
  • In terms of adverse events, the incidence of gastrointestinal adverse events was higher in Asians than in non-Asians at the same dose, while the incidence of metabolic and nutrition disorders was higher in non-Asians than in Asians.

“This paper adds to the growing body of knowledge showing different antidiabetic drug responses in Asians and non-Asians. Such studies if confirmed by other groups, could pave the way for precision treatment of obesity and diabetes which are rapidly rising globally in Asia,” the researchers concluded.

Reference:

Cui, Y., Yao, J., Qiu, X. et al. Comparative Efficacy and Safety of Tirzepatide in Asians and Non-Asians with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Diabetes Ther (2024). https://doi.org/10.1007/s13300-024-01540-7

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Religious people coped better with the Covid-19 pandemic, research suggests

People of religious faith may have experienced lower levels of unhappiness and stress than secular people during the UK’s Covid-19 lockdowns in 2020 and 2021, according to new University of Cambridge research.

The findings follow a recently published Cambridge-led study suggesting that worsening mental health after experiencing Covid infection-either personally or in those close to you-was also somewhat ameliorated by religious belief. This study looked at the US population during early 2021.

University of Cambridge economists argue that-taken together-these studies show that religion may act as a bulwark against increased distress and reduced wellbeing during times of crisis, such as a global public health emergency.

“Selection biases make the wellbeing effects of religion difficult to study,” said Prof Shaun Larcom from Cambridge’s Department of Land Economy, and co-author of the latest study. “People may become religious due to family backgrounds, innate traits, or to cope with new or existing struggles.”

“However, the Covid-19 pandemic was an extraordinary event affecting everyone at around the same time, so we could gauge the impact of a negative shock to wellbeing right across society. This provided a unique opportunity to measure whether religion was important for how some people deal with a crisis.”

Larcom and his Cambridge colleagues Prof Sriya Iyer and Dr Po-Wen She analysed survey data collected from 3,884 people in the UK during the first two national lockdowns, and compared it to three waves of data prior to the pandemic.

They found that while lockdowns were associated with a universal uptick in unhappiness, the average increase in feeling miserable was 29% lower for people who described themselves as belonging to a religion.*

The researchers also analysed the data by “religiosity”: the extent of an individual’s commitment to religious beliefs, and how central it is to their life. Those for whom religion makes “some or a great difference” in their lives experienced around half the increase in unhappiness seen in those for whom religion makes little or no difference.**

“The study suggests that it is not just being religious, but the intensity of religiosity that is important when coping with a crisis,” said Larcom.

Those self-identifying as religious in the UK are more likely to have certain characteristics, such as being older and female. The research team “controlled” for these statistically to try and isolate the effects caused by faith alone, and still found that the probability of religious people having an increase in depression was around 20% lower than non-religious people.

There was little overall difference between Christians, Muslims and Hindus-followers of the three biggest religions in the UK. However, the team did find that wellbeing among some religious groups appeared to suffer more than others when places of worship were closed during the first lockdown.

“The denial of weekly communal attendance appears to have been particularly affecting for Catholics and Muslims,” said Larcom. The research is published as a working paper by Cambridge’s Faculty of Economics.

For the earlier study, authored by Prof Sriya Iyer, along with colleagues Kishen Shastry, Girish Bahal and Anand Shrivastava from Australia and India, researchers used online surveys to investigate Covid-19 infections among respondents or their immediate family and friends, as well as religious beliefs, and mental health.

The study was conducted during February and March 2021, and involved 5,178 people right across the United States, with findings published in the journal European Economic Review in November 2023.

Researchers found that almost half those who reported a Covid-19 infection either in themselves or their immediate social network experienced an associated reduction in wellbeing.

Where mental health declined, it was around 60% worse on average for the non-religious compared to people of faith with typical levels of “religiosity”.

Interestingly, the positive effects of religion were not found in areas with strictest lockdowns, suggesting access to places of worship might be even more important in a US context. The study also found significant uptake of online religious services, and a 40% lower association between Covid-19 and mental health for those who used them.

“Religious beliefs may be used by some as psychological resources that can shore up self-esteem and add coping skills, combined with practices that provide social support,” said Prof Iyer, from Cambridge’s Faculty of Economics.

“The pandemic presented an opportunity to glean further evidence of this in both the United Kingdom and the United States, two nations characterised by enormous religious diversity.”

Added Larcom: “These studies show a relationship between religion and lower levels of distress during a global crisis. It may be that religious faith builds resilience, and helps people cope with adversity by providing hope, consolation and meaning in tumultuous times.”  

Reference:

Girish Bahal, Sriya Iyer, Kishen Shastry, Anand Shrivastava, Religion, Covid-19 and mental health, European Economic Review, 2023, https://doi.org/10.1016/j.euroecorev.2023.104621.

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GLP-1 receptor agonists can dial down inflammation in the brain, raising hopes for treating neurodegenerative diseases

USA: Evidence suggests that glucagon-like peptide 1 (GLP-1) receptor agonists that reduce obesity can reduce inflammation in the kidneys, liver and heart. The drugs even seem to dial down inflammation in the brain, leading researchers to hope that the compounds could be used to treat Alzheimer’s and Parkinson’s diseases, both of which are characterized by brain inflammation.

A recent review listed more than 20 clinical trials that are exploring the drugs as therapies for the two conditions.

“The next generation of drugs could be even more targeted to reduce these new inflammation pathways that we’ve identified,” says Daniel Drucker, an endocrinologist at the University of Toronto in Canada who co-authored a study investigating how the drugs dampen inflammation. “Maybe they would be more effective.”

The GLP-1 receptor agonists include semaglutide, which is marketed as Ozempic for diabetes and Wegovy for obesity, and tirzepatide, marketed as Zepbound for obesity and Mounjaro for diabetes. The drugs mimic a gut hormone called glucagon-like peptide 1, which acts on the brain to dampen appetite, in addition to controlling blood sugar levels. But many previous studies have showcased the ability of the hormone and its mimics to calm inflammation, caused by an onslaught of immune cells and immune-system chemicals.

In one experiment, a GLP-1 receptor agonist called liraglutide reduced liver inflammation in mice with fatty liver. A similar effect was seen in a pilot study with people. In other experiments in mice, liraglutide demonstrated anti-inflammatory potential in the heart and the kidneys. GLP-1 itself reduces inflammation in fat tissue in obese and diabetic mice.

The reductions in blood sugar and body weight that the drugs trigger probably help to control inflammation. However, some of the drugs’ anti-inflammatory effects start even before meaningful weight loss is achieved. This is why scientists think there’s a separate mechanism at play.

Drucker and his team observed a potential clue: receptors for GLP-1 are scarce in immune cells in many tissues in which the hormone and its mimics reduce inflammation, but are abundant in the brain. To test the role of the nervous system, Drucker’s team began by inducing system-wide inflammation in mice.

“Multiple GLP-1 drugs made those mice better and reduced inflammation,” Drucker says. However, when the researchers used either genetic methods or drugs to block GLP-1 receptors in the animals’ brains, the GLP-1 drugs no longer reduced inflammation in multiple tissues. The findings were published in Cell Metabolism on December 2.

The anti-inflammatory powers of the GLP-1 drugs are promising for treating neurodegenerative diseases such as Alzheimer’s and Parkinson’s. Both are characterized by neuroinflammation that is not effectively targeted by current therapies. In both disorders, pathological proteins — for example, alpha-synuclein in Parkinson’s and beta-amyloid in Alzheimer’s — interact with certain receptors in the brain to induce a cascade of events that cause inflammation.

Excessive inflammation can contribute to disease, says Nigel Greig, a pharmacologist at the National Institutes of Health in Baltimore, Maryland. But GLP-1 receptor agonists seem to have the ability to knock back inflammation in the brain so that important processes, such as the birth of new neurons, can continue to occur, he notes.

In one clinical trial, a GLP-1 receptor agonist called exenatide resulted in greater improvement in the abilities of patients with Parkinson’s than did a placebo. The medication is now being assessed in a trial involving a larger population of people with Parkinson’s and should conclude this year. At least two clinical trials are investigating semaglutide as a therapy for early-stage Alzheimer’s disease.

The drugs’ anti-inflammatory action might also help to boost their effectiveness against diabetes and obesity, says Vinicius de Frias Carvalho, a biologist at the Inflammation Laboratory at the Oswaldo Cruz Institute in Rio de Janeiro, Brazil.

Both conditions “are also inflammatory diseases”, he says. Semaglutide’s anti-inflammatory action might play a part in an effect that recently made headlines: the drug provides strong protection against cardiovascular disease in people with obesity.

The use of GLP-1 drugs to treat inflammation-related diseases could expand even further, Greig says, especially given the drugs’ lack of significant side effects. “There are so many systemic disorders where there’s an inflammatory component,” he says. It only makes sense, he says, to try the drugs against such disorders if there’s no effective treatment.

Reference:

Lenharo, M. (2024). Obesity drugs have another superpower: Taming inflammation. https://doi.org/10.1038/d41586-024-00118-4

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Handheld one-lead ECG may detect AF in outpatient setting, with high sensitivity and specificity: Study

Sweden: A recent study published in the Journal of Electrocardiology has shed light on the sensitivity and specificity of handheld one-lead ECG detecting atrial fibrillation (AF) in an outpatient clinic setting.

The researchers found that in a health-care outpatient setting, Zenicor One handheld ECG had high specificity and sensitivity for detecting atrial fibrillation compared with 12‑lead ECG.

Atrial fibrillation is a major cause of mortality and morbidity worldwide, The prevalence of AF in adults is estimated to be thirty-seven million individuals globally. Atrial fibrillation is estimated to cause 10–12% of all ischemic strokes. Since many patients have unspecific or no symptoms (silent AF), and as the risk of stroke can be reduced effectively by anticoagulation, there is a need to consider screening for AF in high-risk populations and patients with suspected arrhythmias.

As handheld and wearable ECG devices are gaining popularity and availability for atrial fibrillation screening, the researchers stress the importance of assessing the diagnostic quality of such devices.

Against the above background, Johan Malmqvist, Dept of Clinical Physiology, Danderyd University Hospital, Stockholm, Sweden, and colleagues aimed to validate the specificity and sensitivity of the Zenicor One handheld ECG device for detection of atrial fibrillation in an outpatient clinical setting.

For this purpose, the researchers examined patients attending outpatient clinics at Danderyd Hospital (n = 220) with one lead handheld ECG immediately after standard care 12‑lead ECG recording. Twelve recordings were excluded (atrial flutter or pacing) or missing.

Two senior cardiologists dichotomously categorized the recordings as “atrial fibrillation” or “not atrial fibrillation”. In cases of diverging interpretations, a third senior cardiologist had the deciding vote. Specificity and sensitivity in diagnosing atrial fibrillation were calculated with 12‑lead ECG as the gold standard.

The researchers found that specificity and sensitivity for the diagnosis of atrial fibrillation with one-lead handheld ECG and 12‑lead ECG as the gold standard were 99% and 98%, respectively.

The study showed high sensitivity and specificity of Zenicor One handheld ECG in a health-care outpatient setting for detection of atrial fibrillation when compared with 12‑lead ECG.

“We report high diagnostic performance of the Zenicor One handheld one‑lead ECG device compared to 12‑lead ECG in an outpatient setting. The arrhythmia analysed against sinus rhythm was atrial fibrillation, the arrhythmia most relevant for large-scale arrhythmia screening,” the researchers wrote.

Reference:

Malmqvist, J., Engdahl, J., Sjölund, G., & Doliwa, P. (2024). Sensitivity and specificity of handheld one lead ECG detecting atrial fibrillation in an outpatient clinic setting. Journal of Electrocardiology. https://doi.org/10.1016/j.jelectrocard.2024.02.001

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Thiamine may be effective and safe option for treatment of patients with septic shock: Study

Thiamine may be effective and safe in the treatment of patients with septic shock suggests a new study published in critical care.

This is a post hoc analysis of combined cohorts from two previous Phase II clinical trials to assess the effect of thiamine administration on kidney protection and mortality in patients with septic shock. Patient-level data from the Thiamine in Septic Shock Trial (NCT01070810) and the Thiamine for Renal Protection in Septic Shock Trial (NCT03550794) were combined in this analysis. The primary outcome of the current study was survival without the receipt of renal replacement therapy (RRT). Analyses were performed on the overall cohort and the thiamine-deficient cohort (thiamine < 8 nmol/L).

Results: A total, 158 patients were included. Overall, thiamine administration was associated with higher odds of being alive and RRT-free (adjusted odds ratio [aOR]: 2.05 [95% confidence interval (CI) 1.08–3.90]) and not needing RRT (aOR: 2.59 [95% CI 1.01–6.62]). In the thiamine-deficient group, thiamine administration was associated with higher odds of being alive and RRT-free (aOR: 8.17 [95% CI 1.79–37.22]) and surviving to hospital discharge (aOR: 6.84 [95% CI 1.54–30.36]). There was a significant effect modification by baseline thiamine deficiency for alive and RRT-free (interaction, p = 0.016) and surviving to hospital discharge (p = 0.019). In the combined analysis of two previous randomized trials, thiamine administration was associated with higher odds of being alive and RRT-free at hospital discharge in patients with septic shock. This signal was stronger in patients with thiamine deficiency.

Reference:

Vine, J., Lee, J.H., Kravitz, M.S. et al. Thiamine administration in septic shock: a post hoc analysis of two randomized trials. Crit Care 28, 41 (2024). https://doi.org/10.1186/s13054-024-04818-1

Keywords:

Thiamine, effective, safe, treatment, patients, septic shock, critical care, medicine, Vine, J., Lee, J.H., Kravitz, M.S, Sepsis, Shock, Thiamine, Kidney injury, Renal protective

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EULAR releases guidelines on imaging use in the clinical management of crystal-induced arthropathies

Austria: The European Alliance of Associations for Rheumatology (EULAR) has released recommendations on imaging for diagnosing and managing crystal-induced arthropathies (CiAs) in clinical practice.

The purpose of these guidelines, published in Annals of the Rheumatic Diseases, is to help clinicians when applying imaging techniques for all common CiAs and include the full spectrum of imaging in clinical practice, including monitoring disease activity, diagnosis, treatment response, and the prediction of outcome. These guidelines are also useful for healthcare providers when making decisions regarding management in terms of imagining this patient population.

“These are the first recommendations that encompass the major forms of CiA and guide the use of common imaging modalities in the clinical management of this disease group,” wrote an international team comprising 25 rheumatologists, radiologists, methodologists, healthcare professionals, and patient research partners from 11 countries.

During the development of these guidelines, the team considered the heterogeneous clinical phenotype of these diseases. Five overarching principles and 10 recommendations were developed encompassing the role of imaging in various aspects of patient management: making a CiA diagnosis, monitoring inflammation and damage, predicting outcomes, response to treatment, guided interventions and patient education. Overall, the LoA for the recommendations was high.

Five statements are as follows:

  • Imaging in CiAs provides useful information on crystal deposition, inflammation, and structural damage.
  • The presence of imaging abnormalities, particularly those related to crystal deposition, may not always be related to clinical manifestations.
  • CiAs are typically characterized by intermittent, acute episodes of inflammation. However, they may also exhibit a persistent disease course with or without superimposed flares.
  • Imaging in CiAs should be performed and interpreted by trained healthcare professionals.
  • Patient information, including medical history, physical and laboratory examination, synovial fluid and tissue analysis, should be taken into account when considering imaging in CiAs.

The following recommendations were developed:

  • When conducting imaging in CiAs, both symptomatic areas and disease-specific target sites, such as first metatarsophalangeal in gout, knee and wrist in calcium pyrophosphate deposition (CPPD), shoulder in basic calcium phosphate deposition (BCPD), should be considered.
  • During the diagnostic assessment of gout, ultrasound and dual-energy computed tomography (DECT) are recommended imaging modalities.
  • When characteristic features of monosodium urate (MSU) crystal deposition on ultrasound, such as double-contour sign or tophi, or on DECT are identified, synovial fluid analysis is not needed to confirm a diagnosis of gout.
  • During the diagnostic assessment of CPPD, conventional radiography (CR) and ultrasound (or CT if axial involvement is suspected) are recommended imaging modalities.
  • During the diagnostic assessment of BCPD, imaging is necessary. CR or ultrasound is the recommended modality.
  • In CPPD and BCPD, serial imaging is not recommended unless there is an unexpected change in clinical characteristics.
  • In gout, ultrasound and DECT can be used to monitor crystal deposition and in the case of ultrasound, also inflammation. Both modalities provide additional information in addition to clinical and biochemical assessment. CR can be used to assess structural damage due to gout when ultrasound/DECT is unavailable. The decision on when to repeat imaging depends on the clinical circumstances.
  • If synovial fluid analysis is required in CiAs assessment, ultrasound guidance should be used in cases where aspiration based on anatomical landmarks is challenging.
  • In gout, assessing the amount of MSU crystal deposition by ultrasound or DECT may be used to predict future flares.
  • Showing and explaining imaging findings of CiAs to people with such conditions may help them understand their condition and improve treatment adherence in gout.

The authors encourage future research to investigate which imaging techniques provide the best early and accurate CiAs diagnosis and determine the utility of ultrasound and DECT in monitoring crystal deposition and inflammation.

They are also interested in the diagnostic performance of emerging advanced imaging techniques in this patient population and want to assess the utility of presenting and discussing imaging findings with patients with crystal-induced arthropathy concerning disease management.

Reference:

Mandl P, D’Agostino MA, Navarro-Compán V, et al2023 EULAR recommendations on imaging in diagnosis and management of crystal-induced arthropathies in clinical practiceAnnals of the Rheumatic Diseases Published Online First: 06 February 2024. doi: 10.1136/ard-2023-224771

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Bariatric surgery may induce weight loss and improve Thyroid Functions: Study

In a groundbreaking study, researchers have uncovered the
intricate relationship between bariatric surgery, thyroid function, and
postoperative weight loss. This study, conducted on euthyroid patients with
obesity offers unprecedented insights into the dynamics of this relationship. The
study results were published in the journal Frontiers in Endocrinology.

Also Read: Bariatric surgery most effective for long-term BP control among obese people

Bariatric surgery, renowned for its effectiveness in weight
reduction, has long been associated with potential alterations in
thyroid-stimulating hormone (TSH) and thyroid hormones. Hence researchers
conducted a study to understand the relationship between thyroid function and
bariatric surgery on euthyroid obese patients who underwent sleeve gastrectomy
and Roux-en-Y gastric bypass between 2017 and 2022.

The primary focus of the investigation was the
assessment of alterations in key thyroid hormones, namely free thyroxine (FT4),
free triiodothyronine (FT3), total thyroxine (TT4), total triiodothyronine
(TT3), and thyroid-stimulating hormone (TSH). These assessments were conducted one-year
post-surgery to discern any notable changes in thyroid function resulting from
the weight loss interventions.


Findings:


  • The research, involving 256 patients, revealed a remarkable mean
    total weight loss (%TWL) of 28.29% one year after surgery.

  • Strikingly, postoperative analyses demonstrated significant
    decreases in TSH, free triiodothyronine (FT3), free thyroxine (FT4), total
    triiodothyronine (TT3), and total thyroxine (TT4).

    Interestingly, the study categorized %TWL into three groups for
    a more nuanced analysis—%TWL ≤ 25%, 25% < %TWL ≤ 35%, and %TWL > 35%.

  • Pearson correlation analysis established a substantial
    association between the percentage of total weight loss and the change in TSH
    (ΔTSH), revealing that as weight loss increased, TSH levels decreased.

  • Further validating this connection, multivariable linear
    regression demonstrated that %TWL was independently linked to ΔTSH.


  • The results remained consistent, confirming that %TWL
    independently predicted ΔTSH even after accounting for various covariates.
Also Read: Perioperative Risks Not deciding Factor for Choosing between two methods of primary bariatric surgery: JAMA

In conclusion, this study sheds light on the transformative
effects of bariatric surgery, not only as a powerful weight-loss tool but also
as a modulator of thyroid function. The observed declines in TSH, FT4, FT3,
TT4, and TT3 signify a complex interplay, with weight loss emerging as a key
determinant. These findings not only contribute to our understanding of the
post-bariatric surgery landscape but also pave the way for personalized
approaches to weight loss with considerations for thyroid function. The implications
of this research stretch beyond the realm of obesity management, offering hope
for those navigating the intricate relationship between weight loss, thyroid
health, and surgical interventions.

Further reading: Total weight loss induces the alteration in thyroid function after bariatric surgery. Doi:  https://doi.org/10.3389/fendo.2024.1333033

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New digital therapy reduces anxiety and depression in people living with long-term physical health conditions

A therapist-guided digital cognitive behavioural therapy reduced distress in 89 per cent of participants living with long-term physical health conditions, a new King’s College London study finds.

Researchers at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London found that people living with long-term conditions who received the therapist-guided digital programme called COMPASS showed a significant reduction in psychological distress (a combined score of anxiety and depression) 12-weeks after starting the study.

194 patients were recruited via long-term condition charities, including Crohn’s & Colitis UK, Kidney Care UK, MS Society, Shift.ms and Psoriasis Association in the UK. Half of the participants received the COMPASS programme and the other half did not. Both groups continued to access their usual charity support.

Overall, 89 per cent of participants who received COMPASS showed a clinically significant improvement in distress, compared to 45 per cent of those who did not have access to the programme. Alongside improvements in anxiety and depression, COMPASS was also associated with improved ability to undertake daily activities, reduction in illness-specific distress and better quality of life.

An estimated 15.4 million people in England have one or more long-term physical health conditions. 30 per cent of these individuals also have a co-occurring mental health condition. The study, published in Psychological Medicine, is the first randomised controlled trial to measure the effectiveness of COMPASS for managing anxiety and depression related to living with a long-term condition.

The research was part-funded by the National Institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre.

Dr Federica Picariello, post-doctoral health psychology research associate at King’s IoPPN and joint first author of the study, said: “Currently, the main treatments for anxiety and depression in people with long-term physical health conditions are psychotherapies, such as cognitive behavioural therapy, combined with medication. However, growing evidence shows that NHS Talking Therapies services are less effective for people with long-term physical health conditions. This may be because the challenges of living with the long-term physical health condition are often not central to the treatment approach. Our study shows that COMPASS offers an effective and potentially scalable intervention for people whose long-term physical health condition is, in fact, the key driver for their anxiety and/or depression.”

Developed with the support of the Mind and Body Programme at King’s Health Partners, COMPASS adapted standard cognitive behavioural therapy (CBT) protocols to integrate mental and physical health needs and specifically address the challenges of living with a long-term health condition. Using interactive pathways tailored to the individual’s needs, the programme helps people manage their symptoms of anxiety and depression alongside building strategies to manage stressors associated with living with a long-term condition, such as relapses or unpleasant treatments.

Dr Katrin Hulme, post-doctoral health psychology research associate at King’s IoPPN, and joint first author of the study, said: “This trial is the culmination of several years of work, starting in 2018; throughout the project, we developed the COMPASS programme and training for therapists, conducted user testing, got regulatory approval, launched in healthcare clinics and conducted this trial. The valuable insights of our patient and clinician representatives helped us create an online programme specifically tailored to help people manage the challenges that can come with living with a long-term health condition, and support healthcare services in addressing this unmet need.”

After 12 weeks, during which participants could complete any of the 11 interactive digital COMPASS sessions as home and receive up to five 30-minute support calls with their therapist, patients who received COMPASS reported greater improvements in most outcomes compared to those who did not have access to the programme.

Simon Brodie, a participant in the study said: “As a person with Multiple Sclerosis, my life had changed significantly as a direct result of my diagnosis. Due to thankfully being part of the COMPASS trial, I feel empowered and confident to deal with changes and emotions that life throws at you as a person with a long-term condition. COMPASS directs you to areas of your life you’d like to improve and explore by enabling skills, providing supported tools to guide you with along your journey. I highly recommend to those in the MS community as a best practice.”

As the treatment can be administered remotely, the study authors suggest an efficient delivery pathway could be through a national hub linked to self-referral through charities or the NHS, rather than setting up within each regional primary or secondary health service with limited resources. This delivery pathway could alleviate the demand on charities who already provide some essential support services and enable them to facilitate access to further specialised treatment.

The findings highlight that the use of digital interventions, such as COMPASS, which place the long-term physical health condition at the centre of treatment for anxiety and depression, are effective, scalable, and can be delivered with minimal therapist time.

Senior author, Professor Rona Moss-Morris, Digital Therapies theme lead at NIHR Maudsley BRC and Professor Psychology as Applied to Medicine at King’s College London, said: “Accessing psychological therapies which are tailored to the needs of people with long-term conditions is challenging for both the patient (due to time, travel, and/or mobility) and healthcare providers (due to treatment costs and availability of adequately trained therapists). As a CE-marked digital therapy with minimal therapist input, COMPASS offers a potential solution to overcome some of these challenges, whilst being an effective intervention to reduce psychological distress.”

Reference:

Picariello F, Hulme K, Seaton N, et al. A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition. Psychological Medicine. Published online 2024:1-14. doi:10.1017/S0033291723003756.

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Female reproductive factors influence chronic obstructive pulmonary disease risk

A recent study published in the BMJ Thorax Journal highlight the potential link between female reproductive factors and the development of Chronic Obstructive Pulmonary Disease (COPD). The study utilized multiple cohorts to investigate how various factors such as age at menarche, number of children, infertility, miscarriage, stillbirth and age at natural menopause might impact COPD risk.

This study included data from over 283,000 women and revealed many significant findings, of which one notable discovery which was the U-shaped association between age at menarche and the risk of COPD. The women who experienced menarche either very early (≤11) or late (≥16) were found to be at a higher risk of developing COPD when compared to the individuals who menstruated at age 13.

Also, this study unveiled that women with three or more children, multiple miscarriages or a history of stillbirth were also at an increased risk of COPD. Among postmenopausal women, an earlier age at natural menopause was associated with increased COPD risk that suggests a potential role of hormonal changes in respiratory health.

These findings underscore the complex interplay between female reproductive factors and respiratory health outcomes. While previous research has primarily focused on the impact of smoking and environmental factors on COPD risk, this research emphasize the importance of considering gender-specific factors in understanding the disease.

The outcomes suggest that female reproductive factors may play a critical role in shaping COPD risk. As COPD continues to pose a significant global health issue, further research could help plan more targeted interventions and improved outcomes for the individuals who suffer. Overall, this study provides crucial insights into the relationship between female reproductive factors and COPD risk by highlighting the importance of considering gender-specific factors in understanding and addressing respiratory diseases.

Reference:

Liang, C., Chung, H.-F., Dobson, A., Sandin, S., Weiderpass, E., & Mishra, G. D. (2024). Female reproductive histories and the risk of chronic obstructive pulmonary disease. Thorax. https://doi.org/10.1136/thorax-2023-220388

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Benralizumab as effective as mepolizumab for inducing remission in patients with eosinophilic granulomatosis with polyangiitis: NEJM

Researchers have shown that the drug benralizumab is as effective and safe as mepolizumab for inducing remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA) according to a study published today in The New England Journal of Medicine. The results of the non-inferiority study were presented at the American Academy of Allergy, Asthma & Immunology annual meeting in Washington, D.C., by Michael Wechsler, M.D., pulmonologist, director of The Cohen Family Asthma Institute at National Jewish Health and lead author of the paper.

EGPA is a rare form of vasculitis, characterized by inflammation in the small blood vessels. This inflammation causes restriction of blood flow, which can cause organ damage if left untreated. The cause of the disease is unknown, and it affects people differently depending on which organs are impacted. It is estimated that 50,000 individuals suffer from EGPA.

Oral glucocorticoids and medications that suppress the immune system have been the standard treatment for EGPA, but they can come with damaging side effects. Targeting inflammation caused by eosinophils (a type of white blood cell) is another well-recognized treatment for EGPA, and mepolizumab became the first FDA-approved treatment for EGPA in 2017. Benralizumab is currently approved for the treatment of severe eosinophilic asthma, suggesting it might also be a treatment for EGPA.

“By showing that benralizumab has comparable results to mepolizumab in the safe treatment of EGPA, we have added another potential option in the arsenal to help patients of this rare disease,” said Dr. Wechsler. “While both drugs showed similar disease remission, relapse and safety impacts, we observed benralizumab did a better job in reducing the need of oral glucocorticoids and lower blood eosinophil counts. This was achieved using fewer injections of benralizumab, which also could be a benefit to the patient.”

The study randomized 140 patients who received either one 30 mg injection of benralizumab or three 100 mg injections of mepolizumab every four weeks for 52 weeks. The primary analysis was to evaluate the non-inferiority of benralizumab versus mepolizumab. The results suggest that targeting eosinophils as a therapeutic strategy in EGPA can lead to a higher number of patients achieving remission, and a lower number experiencing relapse. Achieving these results while seeing substantial reductions in oral glucocorticoids use provides further evidence of the role of eosinophils in EGPA.

“Though further studies are needed, our results indicate that eliminating oral glucocorticoids may now be an achievable treatment goal while using eosinophil-targeted drugs for EGPA,” said Dr. Wechsler.

Reference:

Michael E. Wechsler, Parameswaran Nair, Benjamin Terrier, Bastian Walz,  Arnaud Bourdin, David R.W. Jayne, David J. Jackson, Florence Roufosse, Lena Börjesson Sjö, Ying Fan, Maria Jison, Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis, New England Journal of Medicine, DOI: 10.1056/NEJMoa2311155.

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