Open access
Open access
Powered by Google Translator Translator

Endocrinology (all articles)

Pragmatic Cluster-Randomised Trial: Efficacy of a Fixed-Dose Polypill in Reducing Cardiovascular Disease Risk in Rural Iran

21 Apr, 2024 | 21:05h | UTC

Study Design and Population: The PolyPars Study was structured as a two-arm pragmatic cluster-randomised trial within the larger PARS cohort study. It targeted residents aged over 50 in a district in southern Iran, dividing 91 villages into two groups: one receiving a once-daily polypill (containing two antihypertensives, a statin, and aspirin) alongside non-pharmacological interventions, and the other receiving only the non-pharmacological interventions. The trial included 4,415 participants aged 50-75 years, with the primary endpoint being the first occurrence of major cardiovascular events.

Main Findings: Over a median follow-up of 4.6 years, adherence to the polypill was high at 86%. The intervention arm showed a significant reduction in the incidence of the primary outcome, with only 4.0% (88 participants) experiencing major cardiovascular events compared to 8.0% (176 participants) in the control arm. This translates to a hazard ratio of 0.50, indicating a 50% reduction in risk, and an absolute risk reduction of 4.0%.

Implications for Practice: The study demonstrates the significant potential of fixed-dose combination therapy with the polypill to halve the risk of major cardiovascular diseases in a population-level intervention. This finding supports the polypill as a safe and effective strategy for both primary and secondary prevention of cardiovascular diseases, particularly in settings where access to individual medications and consistent medical supervision might be limited.

Reference: Fatemeh Malekzadeh et al. (2024). Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars). Heart, heartjnl-2023-323614. DOI: 10.1136/heartjnl-2023-323614.


PCI vs. CABG in left main coronary disease patients with and without diabetes—a pooled analysis of 4 trials

22 Mar, 2024 | 11:41h | UTC

Study Design and Population: This research pooled individual patient data from four randomized clinical trials (SYNTAX, PRECOMBAT, NOBLE, and EXCEL), comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in 4393 patients with left main coronary artery disease. The trials included both patients with and without diabetes, allowing for a comparative analysis of outcomes based on the revascularization method and the presence of diabetes.

Main Findings: Patients with diabetes exhibited higher rates of 5-year mortality, spontaneous myocardial infarction (MI), and repeat revascularization compared to those without diabetes. However, mortality rates following PCI vs. CABG were similar in diabetic (15.3% vs. 14.1%, respectively) and non-diabetic patients (9.7% vs. 8.9%, respectively). PCI was associated with a lower risk of stroke within the first year post-operation across all patients. Notably, diabetic patients underwent higher rates of spontaneous MI and repeat revascularization after PCI compared to CABG, with a more significant absolute excess risk observed beyond the first year compared to non-diabetic patients.

Implications for Practice: For patients with left main disease deemed suitable for either PCI or CABG, diabetes status significantly influences long-term outcomes, including death and cardiovascular events. While PCI offers a lower early risk of stroke, it is associated with increased risks of spontaneous MI and repeat revascularization, particularly in diabetic patients. These findings underscore the importance of considering patient-specific factors, such as diabetes status, in choosing between PCI and CABG for left main coronary artery disease revascularization.

Reference

Prakriti Gaba et al. (2024). Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With or Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation, 0. DOI: 10.1161/CIRCULATIONAHA.123.065571. Access the study here: Link


M-A: Cardiovascular benefits of SGLT2 inhibitors in patients without diabetes

22 Mar, 2024 | 11:07h | UTC

Study Design and Population: This meta-analysis investigated the cardiovascular (CV) outcomes associated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients without diabetes mellitus (DM). By systematically reviewing online databases, the authors identified and included six randomized controlled trials (RCTs) in their analysis. These trials compared SGLT2i with placebo/control in a total of 12,984 participants, who were followed for an average duration of 17.7 months. The study population comprised mainly patients with heart failure (HF), chronic kidney disease, or myocardial infarction, with a mean age of 64 years, where 72% were men and the mean hemoglobin A1C level was 5.7%.

Main Findings: The use of SGLT2i was associated with a significant reduction in composite CV death or hospitalization for HF, with an odds ratio (OR) of 0.77 (95% confidence interval [CI], 0.68 to 0.87, p < 0.0001), primarily due to a decrease in hospitalization for HF (OR 0.70, 95% CI 0.60 to 0.81, p < 0.00001). No significant differences were observed in CV death, all-cause death, or major adverse CV events when comparing SGLT2i to placebo. Notably, serious adverse events were lower with the use of empagliflozin compared to placebo.

Implications for Practice: This meta-analysis highlights the significant CV benefits of SGLT2i treatment in reducing CV death or hospitalization for HF in patients without DM, compared with placebo. These findings suggest the potential for broader use of SGLT2i in populations without diabetes to improve cardiovascular outcomes.

Reference: Sahib Singh et al. (2024). Cardiovascular Outcomes With Empagliflozin and Dapagliflozin in Patients Without Diabetes. The American Journal of Cardiology, Published: February 29, 2024. DOI: https://doi.org/10.1016/j.amjcard.2024.02.039. Access the study here: [Link]


Genetic analysis reveals Lipoprotein(a) is significantly more atherogenic than LDL on a per-particle basis

20 Mar, 2024 | 19:24h | UTC

Study Design and Population: This study utilized genome-wide association studies (GWAS) within the UK Biobank population to examine the atherogenicity of lipoprotein(a) (Lp(a)) compared to low-density lipoprotein (LDL), focusing on their apolipoprotein B (apoB) content. The researchers identified two clusters of single nucleotide polymorphisms (SNPs) associated with mass concentrations of Lp(a) and LDL, comprising 107 and 143 variants, respectively. The sample included subjects from the UK Biobank, allowing for a broad and genetically diverse analysis.

Main Findings: The study’s Mendelian randomization approach found that a 50 nmol/L increase in Lp(a)-apoB was associated with a 1.28 times higher odds ratio (OR) for coronary heart disease (CHD) compared to a 1.04 times increase for the same increment in LDL-apoB. Furthermore, a comparison using polygenic scores demonstrated that the hazard ratio (HR) for CHD per 50 nmol/L increase in apoB was significantly higher for the Lp(a) cluster (1.47) than for the LDL cluster (1.04), suggesting that Lp(a) is approximately 6.6 times more atherogenic than LDL on a per-particle basis.

Implications for Practice: These findings highlight the substantial atherogenic potential of Lp(a) compared to LDL, indicating that Lp(a) should be a key focus for drug intervention strategies in populations at risk for CHD. The marked difference in atherogenicity underscores the importance of targeted treatments and monitoring for individuals with elevated Lp(a) levels.

Reference: Björnson, E., Adiels, M., Taskinen, M.-R., Burgess, S., Chapman, M. J., Packard, C. J., & Borén, J. (2024). Lipoprotein(a) Is Markedly More Atherogenic Than LDL: An Apolipoprotein B-Based Genetic Analysis. Journal of the American College of Cardiology, 83(3), 385-395. DOI: https://doi.org/10.1016/j.jacc.2023.10.039. Access the study here: Link


RCT: Quadruple quarter-dose hypertension medication versus monotherapy for ambulatory blood pressure control

20 Mar, 2024 | 18:00h | UTC

Study Design and Population: This randomized clinical trial investigated the efficacy of a combination of four ultra-low-dose blood pressure medications (quadpill) compared to standard monotherapy in adults with hypertension. A total of 591 participants, either untreated or currently on monotherapy for hypertension, were enrolled and randomly assigned to receive either the quadpill (irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) or a monotherapy control (irbesartan 150 mg).

Main Findings: At 12 weeks, the quadpill group demonstrated significantly lower mean 24-hour ambulatory systolic and diastolic blood pressure (SBP and DBP) by 7.7 mmHg and 5.3 mmHg, respectively, compared to the monotherapy group, with similar reductions observed during daytime and night-time. Additionally, the rate of blood pressure control (24-hour average BP < 130/80 mmHg) was significantly higher in the quadpill group (77% vs. 50%). The study highlighted the quadpill’s effectiveness in reducing blood pressure variability and enhancing control rates across a 24-hour period.

Implications for Practice: The findings from this study support the superior efficacy of an ultra-low-dose quadruple medication strategy over monotherapy in managing ambulatory blood pressure among hypertensive patients. These results suggest that a quadpill approach could offer a more effective means for clinicians to achieve and maintain blood pressure control in hypertensive patients, potentially improving cardiovascular outcomes.

Reference: Janis M Nolde et al. (2024). Ambulatory blood pressure after 12 weeks of quadruple combination of quarter doses of blood pressure medication vs. standard medication. J Hypertens, 2024 Feb 29. DOI: 10.1097/HJH.0000000000003683. Access the study here: [Link]


Meta-Analysis: Efficacy of exercise modalities in major depressive disorder treatment

20 Mar, 2024 | 17:54h | UTC

Study Design and Population: This article presents a systematic review and network meta-analysis of randomized controlled trials to assess the optimal dose and modality of exercise for treating major depressive disorder, comparing its effects to psychotherapy, antidepressants, and control conditions such as usual care or placebo. The review included 218 unique studies encompassing 495 arms with a total of 14,170 participants who met the clinical cutoffs for major depression.

Main Findings: The findings revealed moderate reductions in depression symptoms for several exercise modalities when compared to active controls. Notably, walking or jogging, yoga, and strength training demonstrated the most significant effects. The effectiveness of exercise was found to be proportional to the intensity of the activity prescribed. Among these, yoga and strength training were identified as the most acceptable modalities for participants. However, the overall confidence in these results is low due to the high risk of bias in the included studies, with only one study meeting the criteria for a low risk of bias.

Implications for Practice: The study concludes that exercise, particularly walking or jogging, yoga, and strength training at sufficient intensities, can be an effective treatment for major depressive disorder. These modalities could be recommended alongside traditional treatments such as psychotherapy and antidepressants. Future research should focus on blinding participants and staff to mitigate expectancy effects and improve the reliability of findings. The inclusivity of exercise as a core treatment for depression could significantly impact treatment strategies and patient outcomes.

Reference: Noetel, M., et al. (2024). Effect of exercise for depression: systematic review and network meta-analysis of randomised controlled trials. BMJ, 384, e075847. DOI: https://doi.org/10.1136/bmj-2023-075847. Access the study here: [Link]


Phase 2 RCT: Low-dose aspirin significantly reduces hepatic fat in MASLD patients without cirrhosis

20 Mar, 2024 | 17:48h | UTC

Study Design and Population: This phase 2, randomized, double-blind, placebo-controlled clinical trial was carried out over six months at a single hospital in Boston, Massachusetts. The study included 80 participants aged 18 to 70 years diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD) but without cirrhosis. Participants were randomly assigned to receive either 81 mg of daily aspirin (n=40) or placebo (n=40).

Main Findings: The trial revealed that aspirin significantly reduced the mean absolute change in hepatic fat content by -10.2% compared with placebo, as measured by proton magnetic resonance spectroscopy (MRS), with a statistically significant difference (P=0.009). Furthermore, aspirin treatment notably decreased relative hepatic fat content, increased the proportion of patients achieving a 30% or greater reduction in hepatic fat, and reduced both absolute and relative hepatic fat content as assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Adverse events were mostly minor, with upper respiratory infections and arthralgias being the most common.

Implications for Practice: These findings suggest that low-dose aspirin may be an effective intervention for reducing liver fat in adults with MASLD without cirrhosis, potentially offering a simple, accessible treatment option. However, the results are preliminary and call for further confirmation in larger, more diverse populations. The study underscores the importance of considering low-dose aspirin as part of management strategies for MASLD, pending further research.

Reference

Simon TG et al. (2024). Randomized Clinical Trial: Low-Dose Aspirin Significantly Reduces Hepatic Fat in MASLD Patients Without Cirrhosis. JAMA, 331(11), 920-929. DOI: 10.1001/jama.2024.1215. Access the study here: [Link]


RCT: No difference in ICU length of stay or 90-day mortality between tight and liberal glucose control

2 Oct, 2023 | 11:25h | UTC

Study Design and Population: This randomized controlled trial assessed the effects of tight versus liberal glucose control on the length of ICU stay in critically ill patients. A total of 9,230 patients were included, with 4,622 in the liberal-control group (insulin initiation when blood glucose levels exceeded 215 mg/dL) and 4,608 in the tight-control group (blood glucose targeted between 80 and 110 mg/dL). In both groups, parenteral nutrition was withheld during the first week of ICU admission. The primary endpoint was the duration of ICU stay, and 90-day mortality served as a key safety outcome.

Main Findings: No significant differences were observed in the primary endpoint, the length of ICU stay, between the two groups (hazard ratio 1.00; 95% CI, 0.96 to 1.04; P=0.94). The 90-day mortality rates were also similar (10.1% in the liberal-control group vs. 10.5% in the tight-control group, P=0.51). Incidences of severe hypoglycemia were low and statistically similar in both groups (1.0% in the tight-control group vs. 0.7% in the liberal-control group). Secondary outcomes, including new infections and the duration of respiratory and hemodynamic support, showed no significant differences. However, lower incidences of severe acute kidney injury and cholestatic liver dysfunction were observed in the tight-control group.

Implications & Limitations: The study supports existing evidence that tight glucose control doesn’t provide substantial benefits in reducing ICU stay duration or mortality. This suggests that a more liberal approach to glucose control may be preferable in most ICU settings, especially to minimize hypoglycemia risk. Key limitations of the study include its narrow focus on the absence of early parenteral nutrition, which could limit generalizability, and the inability to blind caregivers to treatment assignments. Future research should investigate the impact of tight glucose control in various patient subgroups and under different nutritional conditions.

Article: Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU – New England Journal of Medicine

 


Pragmatic Cluster-Randomised Trial: Efficacy of a Fixed-Dose Polypill in Reducing Cardiovascular Disease Risk in Rural Iran

25 Mar, 2024 | 11:40h | UTC

Study Design and Population: The PolyPars Study was structured as a two-arm pragmatic cluster-randomised trial within the larger PARS cohort study. It targeted residents aged over 50 in a district in southern Iran, dividing 91 villages into two groups: one receiving a once-daily polypill (containing two antihypertensives, a statin, and aspirin) alongside non-pharmacological interventions, and the other receiving only the non-pharmacological interventions. The trial included 4,415 participants aged 50-75 years, with the primary endpoint being the first occurrence of major cardiovascular events.

Main Findings: Over a median follow-up of 4.6 years, adherence to the polypill was high at 86%. The intervention arm showed a significant reduction in the incidence of the primary outcome, with only 4.0% (88 participants) experiencing major cardiovascular events compared to 8.0% (176 participants) in the control arm. This translates to a hazard ratio of 0.50, indicating a 50% reduction in risk, and an absolute risk reduction of 4.0%.

Implications for Practice: The study demonstrates the significant potential of fixed-dose combination therapy with the polypill to halve the risk of major cardiovascular diseases in a population-level intervention. This finding supports the polypill as a safe and effective strategy for both primary and secondary prevention of cardiovascular diseases, particularly in settings where access to individual medications and consistent medical supervision might be limited.

Reference: Fatemeh Malekzadeh et al. (2024). Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars). Heart, heartjnl-2023-323614. DOI: 10.1136/heartjnl-2023-323614.

__________________________________________________________________________________________

Navigate Complex Conditions with IntelliDoctor

IntelliDoctor is your ally in understanding and managing a wide range of diseases. Our AI-assisted tool provides up-to-date, evidence-based information, helping you to make informed decisions about patient care.

  • Comprehensive Disease Insights: Deep dive into condition-specific knowledge.
  • Evidence-Based: Access the most current research and guidelines.
  • Free Access: Available in all languages, free for a limited time.

Master disease management with IntelliDoctor. Explore now at IntelliDoctor.ai.


Crossover RCT | Using one-size cuff results in major inaccuracy in BP readings across varying arm sizes

11 Aug, 2023 | 15:41h | UTC

Effects of Cuff Size on the Accuracy of Blood Pressure Readings: The Cuff(SZ) Randomized Crossover Trial – JAMA Internal Medicine (free for a limited period)

Commentaries:

When it comes to blood pressure cuffs, size matters – MedicalResearch.com

One-size-fits-all blood pressure cuffs ‘strikingly inaccurate,’ study says – CNN

Related:

Brief Review | Why is cuff size so important and other factors that affect accurate blood pressure measurement

[News release – not published yet] Study finds blood pressure cuff size matters, affects blood pressure readings

 

Commentary on Twitter

 


Perspective | Clinicians debate the usefulness of NAFLD name change

11 Aug, 2023 | 15:39h | UTC

Clinicians debate the usefulness of NAFLD name change – MDedge

Original article: From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

 


Presented at ASRS Meeting | Studies link GLP-1 agonists to progression of diabetic retinopathy

11 Aug, 2023 | 15:38h | UTC

Studies link GLP-1 agonists to progression of diabetic retinopathy – MDedge

 


[News Release] RCT | Semaglutide 2.4 mg reduces cardiovascular risk by 20% in adults with CVD & obesity

9 Aug, 2023 | 15:40h | UTC

Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial – Novo Nordisk

Commentaries:

SELECT: Semaglutide Cuts CV Events in Adults With Overweight or Obesity – TCTMD

Expert reaction to Novo Nordisk press release announcing the headline results from their SELECT cardiovascular outcomes semaglutide trial – Science Media Centre

Related: Role of Glucagon‐Like Peptide‐1 Receptor Agonists in Achieving Weight Loss and Improving Cardiovascular Outcomes in People With Overweight and Obesity – Journal of the American Heart Association

 


Cohort Study | Vegetarian diet linked to elevated hip fracture risk; BMI plays a partial role

9 Aug, 2023 | 15:16h | UTC

Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: a prospective cohort study of 413,914 UK Biobank participants – BMC Medicine

 


Multinational Study | No correlation between Covid-19 and onset of type 1 diabetes in children

8 Aug, 2023 | 13:32h | UTC

SARS-CoV-2 — No Increased Islet Autoimmunity or Type 1 Diabetes in Teens – New England Journal of Medicine

 


Cohort Study | Habitual calcium supplementation linked to higher CVD incidence and mortality in diabetics

8 Aug, 2023 | 13:24h | UTC

Associations of Habitual Calcium Supplementation With Risk of Cardiovascular Disease and Mortality in Individuals With and Without Diabetes – Diabetes Care (link to abstract – $ for full-text)

Related: The Evidence and Controversy Between Dietary Calcium Intake and Calcium Supplementation and the Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis of Cohort Studies and Randomized Controlled Trials – Journal of the American College of Nutrition

 

Commentary on Twitter

 


Do-it-yourself automated insulin delivery: a health-care practitioner user’s guide

7 Aug, 2023 | 14:44h | UTC

Do-It-Yourself Automated Insulin Delivery: A Health-care Practitioner User’s Guide – Canadian Journal of Diabetes

 


Review | Diabetes of the exocrine pancreas: implications for pharmacological management

7 Aug, 2023 | 14:25h | UTC

Diabetes of the Exocrine Pancreas: Implications for Pharmacological Management – Drugs

 


Review | Primary aldosteronism: a pragmatic approach to diagnosis and management

4 Aug, 2023 | 12:06h | UTC

Primary Aldosteronism: A Pragmatic Approach to Diagnosis and Management – Mayo Clinic Proceedings

 


Brief Review | How do I diagnose and treat my patient’s amiodarone-induced thyrotoxicosis?

4 Aug, 2023 | 11:52h | UTC

How do I diagnose and treat my patient’s amiodarone-induced thyrotoxicosis? – Cleveland Clinic Journal of Medicine

 


Review | Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options

1 Aug, 2023 | 14:19h | UTC

Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options – Cardiovascular Research

Related:

From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

Nonalcoholic fatty liver disease from a primary care perspective – Diabetes, Obesity and Metabolism

AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease – Hepatology

Management of NAFLD in primary care settings – Liver International

Updated S2k Clinical Practice Guideline on Non-alcoholic Fatty Liver Disease (NAFLD) issued by the German Society of Gastroenterology, Digestive and Metabolic Diseases (DGVS) – Zeitschrift für Gastroenterologie

AGA Clinical Practice Update | Diagnosis and management of nonalcoholic fatty liver disease in lean individuals.

Quality standards for the management of non-alcoholic fatty liver disease (NAFLD): consensus recommendations from the British Association for the Study of the Liver and British Society of Gastroenterology NAFLD Special Interest Group – The Lancet Gastroenterology & Hepatology (free registration required)

Nonalcoholic Fatty Liver Disease and Cardiovascular Risk: A Scientific Statement From the American Heart Association – Arteriosclerosis, Thrombosis, and Vascular Biology

Advancing the global public health agenda for NAFLD: a consensus statement – Nature Reviews Gastroenterology & Hepatology

Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease – Gastroenterology

Non-alcoholic fatty liver disease: A patient guideline – JHEP Reports

 


Review | Vegetarian and vegan diets: benefits and drawbacks

1 Aug, 2023 | 14:11h | UTC

Vegetarian and vegan diets: benefits and drawbacks – European Heart Journal (free for a limited period)

 

Commentary on Twitter

 


Observational Study | More data suggesting Rosuvastatin 10mg/Ezetimibe 10mg combo may be an alternative to Rosuvastatin 20mg

31 Jul, 2023 | 14:38h | UTC

Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention – Journal of the American College of Cardiology (link to abstract – $ for full-text)

Commentaries:

Statins post PCI: Moderate intensity plus ezetimibe may be preferable – Cardiology News

Combination Lipid-Lowering Therapy After PCI – American College of Cardiology

Related: Open-label RCT | Moderate-intensity statin plus ezetimibe is noninferior to high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease.

 

Commentary on Twitter

 


WHO updates guidelines on fats and carbohydrates

28 Jul, 2023 | 14:25h | UTC

News Release: WHO updates guidelines on fats and carbohydrates – World Health Organization

Guidelines:

Saturated fatty acid and trans-fatty acid intake for adults and children: WHO guideline – World Health Organization

Total fat intake for the prevention of unhealthy weight gain in adults and children: WHO guideline – World Health Organization

Carbohydrate intake for adults and children: WHO guideline – World Health Organization

 

Commentary on Twitter (thread – click for more)

 


Study | New deep learning model effectively detects type 2 diabetes from chest X-rays

28 Jul, 2023 | 14:15h | UTC

Opportunistic detection of type 2 diabetes using deep learning from frontal chest radiographs – Nature Communications

 

Commentary on Twitter

 


Stay Updated in Your Specialty

Telegram Channels
Free

WhatsApp alerts 10-day free trial

No spam, just news.