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- Rubino, Domenica, et al.
(författare)
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Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity The STEP 4 Randomized Clinical Trial
- 2021
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Ingår i: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 325:14, s. 1414-1425
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people with overweight or obesity is unknown. OBJECTIVE To compare continued once-weekly treatment with subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention) in adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or 7 , -27 with >1 weight-related comorbidity) and without diabetes. INTERVENTIONS A total of 902 participants received once-weekly subcutaneous semaglutide during run-in. After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups. MAIN OUTCOMES AND MEASURES The primary end point was percent change in body weight from week 20 to week 68; confirmatory secondary end points were changes in waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36]). RESULTS Among 803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741(92.3%) completed treatment. With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 [95% CI, -16.0 to -13.5] percentage points; P < .001). Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3,3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001). Gastrointestinal events were reported in 49.1% of participants who continued subcutaneous semaglutide vs 26.1% with placebo; similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%). CONCLUSIONS AND RELEVANCE Among adults with overweight or obesity who completed a 20-week run-in period with subcutaneous semaglutide, 2.4 mg once weekly, maintaining treatment with semaglutide compared with switching to placebo resulted in continued weight loss over the following 48 weeks.
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| 2. |
- Toft, Jens, et al.
(författare)
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The optimal reference population for cardiac normality in myocardial SPET in the detection of coronary artery stenoses: patients with normal coronary angiography or subjects with low likelihood of coronary artery disease?
- 2001
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Ingår i: European Journal Of Nuclear Medicine. - : Springer Science and Business Media LLC. - 1432-105X .- 0340-6997 .- 1619-7089. ; 28:7, s. 831-835
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Tidskriftsartikel (refereegranskat)abstract
- Both subjects with a low likelihood for coronary artery disease (CAD) and patients with normal findings on coronary angiography have been used as reference populations in non-invasive stress testing, including myocardial perfusion scintigraphy. Both of these criteria of normality--low likelihood of CAD and normal coronary angiography--have been criticised, and consensus on this issue is lacking. The aim of this study was to compare two different reference populations by testing the performance of artificial neural networks designed to interpret myocardial scintigrams. The networks were trained on myocardial perfusion scintigrams from 87 patients with angiographically documented CAD and on studies from one of two different reference groups: 48 patients with no signs of CAD based on angiography or 128 healthy volunteers with a likelihood for CAD <5%. The performance of the two different networks was then tested using scintigrams from a separate test group of 68 patients. Coronary angiography was used as the gold standard in this group. The network trained on patients with no signs of CAD based on angiography showed an area under the receiver operating characteristic (ROC) curve of 93%. The ROC area for the network trained on healthy volunteers was 72%, and this difference was statistically significant (P=0.03). The results of this study using artificial neural networks suggest that normal angiography should be preferred as the reference standard in myocardial scintigraphy when a patient is examined for CAD prior to possible angiography. Whether the same is true for other indications, e.g. in prognostic evaluation, is unknown.
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