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OBJECTIVE: To determine whether semaglutide slows progression of glycemia in people with cardiovascular disease and overweight or obesity but without diabetes. RESEARCH DESIGN AND METHODS: In a multicenter, double-blind trial, participants aged ≥45 years, with BMI ≥27 kg/m2, and with preexisting cardiovascular disease but without diabetes (HbA1c <6.5%) were randomized to receive subcutaneous semaglutide (2.4 mg weekly) or placebo. Major glycemic outcomes were HbA1c and proportions achieving biochemical normoglycemia (HbA1c <5.7%) and progressing to biochemical diabetes (HbA1c ≥6.5%). RESULTS: Of 17,604 participants, 8,803 were assigned to semaglutide and 8,801 to placebo. Mean ± SD intervention exposure was 152 ± 56 weeks and follow-up 176 ± 40 weeks. In both treatment arms mean nadir HbA1c for participants was at 20 weeks. Thereafter, HbA1c increased similarly in both arms, with a mean difference of −0.32 percentage points (95% CI −0.33 to −0.30; −3.49 mmol/mol [−3.66 to −3.32]) and with the difference favoring semaglutide throughout the study (P < 0.0001). Body weight plateaued at 65 weeks and was 8.9% lower with semaglutide. At week 156, a greater proportion treated with semaglutide were normoglycemic (69.5% vs. 35.8%; P < 0.0001) and a smaller proportion had biochemical diabetes by week 156 (1.5% vs. 6.9%; P < 0.0001). The number needed to treat was 18.5 to prevent a case of diabetes. Both regression and progression were dependent on glycemia at baseline, with the magnitude of weight reduction important in mediating 24.5% of progression and 27.1% of regression. CONCLUSIONS: In people with preexisting cardiovascular disease and overweight or obesity but without diabetes, long-term semaglutide increases regression to biochemical normoglycemia and reduces progression to biochemical diabetes but does not slow glycemic progression over time. 6357437865112 dc240491video1 Video 1. This image is from a video available online at https://bcove.video/3WedKuq. American Diabetes Association 84th Scientific Sessions: SELECT Trial—New Looks at Glycemia, Inflammation, and Heart Failure. [ABSTRACT FROM AUTHOR]

Objective: This paper describes the baseline characteristics of the Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) study, one of the largest cardiovascular (CV) outcome studies in the field of obesity, which evaluates the effect of semaglutide versus placebo on major CV events. Methods: SELECT enrolled individuals with overweight or obesity without diabetes, with prior myocardial infarction, stroke, and/or peripheral artery disease. This study reports participants' baseline characteristics in the full study population and subgroups defined by baseline glycated hemoglobin (HbA1c; <5.7%, ≥5.7 to <6.0%, ≥6.0 to <6.5%), baseline waist to height ratio tertile, and qualifying prior CV event or condition. Results: The study enrolled 17,605 participants (72.5% male) with an average (SD) age of 61.6 (8.9) years and BMI of 33.34 (5.04) kg/m2. The most common prior CV event was myocardial infarction (76.3% of participants), followed by stroke (23.3%) and peripheral artery disease (8.6%). Furthermore, 24.3% had a heart failure diagnosis. Two‐thirds of participants (66%) had HbA1c in the prediabetes range (5.7%‐6.4%). Across groups of increasing HbA1c, prevalence of all CV risk factors increased. Conclusions: The enrolled population in SELECT includes participants across a broad range of relevant risk categories. This will allow the study to garner information about the CV benefits of semaglutide across these relevant clinical subgroups. [ABSTRACT FROM AUTHOR]

Rapid MRI scans may be less cost-effective than a traditional X-ray for detecting the cause of low back pain, according to a study of 380 patients. Although both doctors and patients preferred the MRI scan over an X-ray, it was more expensive and did not lead to better outcomes. In fact, patients who had the MRI scan had more back operations than those who had an X-ray.

Insulin-like growth factors (IGF) are essential for normal growth and maintenance of lean muscle mass; however, high insulin-like growth factor-I (IGF-I) and low IGF binding protein-3 (IGFBP-3) levels are also associated with several cancers. To test the hypothesis that long-term soy isoflavone supplementation decreases circulating IGF-I concentrations, we conducted a controlled, parallel-arm, double-blind intervention study with 150 participants (85% men), 50-80 y old. Participants were randomly assigned to consume a soy beverage powder daily for 12 mo. The active treatment group (+ISO) received soy protein containing 83 mg isoflavones, whereas the comparison group (-ISO) received soy protein containing 3 mg isoflavones. Serum IGF-I and IGFBP-3 were measured by ELISA. Mean change in serum IGF-I concentrations was similar in the two groups (+1.4 nmol/L in +ISO, +1.2 nmol/L in -ISO; P = 0.74, 95% confidence interval -1.1, +1.5 nmol/L for the 0.21 nmol/L difference between groups), indicating no effect of the isoflavone intervention. Similarly, the changes in IGFBP-3 and the IGF-I/ IGFBP-3 ratio were similar in both groups, again showing no effect of +ISO treatment. A 12 mo, 83 mg/d soy isoflavone intervention did not modulate serum IGF in an older, mostly male population. KEY WORDS: * isoflavones * insulin-like growth factor (IGF) * randomized controlled trial

Patients with end-stage kidney disease who are on dialysis or receive a kidney transplant have an increased risk of hip fracture, according to a study of 101,039 patients. Those who got a kidney transplant had a slightly higher risk than those on dialysis, but after two years, the risk was the same in both groups. Prolonged dialysis appears to increase the risk of hip fracture in patients who eventually get a kidney transplant.

EaSt 2.0 is an ideal software for group sequential analysis, a statistical method used in the evaluation of clinical trials aimed at determining the effectiveness of proposed disease treatment strategies. Among other features, EaSt 2.0 comes with an easy-to-use tutorial documentation. It also boasts of a well-designed user interface. The package is organized into three main programs, each of which contains a Design Module and an Analysis Module. EaSt 2.0 is available from Cytel Software Corp., Cambridge, MA., 1. INTRODUCTION Proper evaluation of a proposed treatment for a particular disease should involve a carefully executed clinical trial comparing the new treatment to either a placebo or some existing [...]

PEST3, which stands for Planning and Evaluation of Sequential Trials 3, is an ideal software for group sequential analysis, a statistical method used in the evaluation of clinical trials aimed at determining the effectiveness of proposed disease treatment strategies. Among other features, PEST3 comes with a logically organized, although poorly formatted, documentation. The user interface is quite adequate, but suffers from poor design. PEST3 is available from the MPS Research Unit of the University of Reading, UK., 1. INTRODUCTION Proper evaluation of a proposed treatment for a particular disease should involve a carefully executed clinical trial comparing the new treatment to either a placebo or some existing [...]