Clinical impact ratings: Mental Health: [Formula: see text] GIM/FP/GP: [Formula: see text].
Clinical impact ratings: Mental Health: [Formula: see text] GIM/FP/GP: [Formula: see text].
Clinical impact ratings: GIM/FP/GP: [Formula: see text] Cardiology: [Formula: see text].
Background: Guidelines emphasize quiet settings for blood pressure (BP) measurement.
Objective: To determine the effect of noise and public environment on BP readings.
Design: Randomized crossover trial of adults in Baltimore, Maryland. (ClinicalTrials.gov: NCT05394376).
Setting: Study measures were obtained in a clinical research office and a public food market near Johns Hopkins University School of Medicine in Baltimore, Maryland.
Participants: 108 community-dwelling adults from the Baltimore, Maryland, area recruited through measurement-screening campaigns, mailings to previous study participants, and referrals from hypertension clinics.
Intervention: Participants were randomly assigned to the order in which they had triplicate BP measurements in each of 3 settings: 1) private quiet office (private quiet [reference]); 2) noisy public space (public loud); and 3) noisy public space plus earplugs (public quiet).
Measurements: Differences in mean BP readings obtained in public loud and public quiet versus private quiet, overall and stratified by baseline systolic BP (SBP), age, and recent health care utilization.
Results: Of the 108 randomly assigned participants, mean age was 56 years (SD, 17), 84% were self-reported Black, 41% were female, and 45% had an SBP of 130 mm Hg or more. The average noise level in public loud was 74 dB and in private quiet was 37 dB. Mean SBPs were: 128.9 mm Hg (SD, 22.3) in private quiet, 128.3 mm Hg (SD, 21.7) in public loud, and 129.0 mm Hg (SD, 22.2) in public quiet. Corresponding diastolic BPs (DBPs) were 74.2 mm Hg (SD, 11.4), 75.9 mm Hg (SD, 11.6), and 75.7 mm Hg (SD, 12.0), respectively. Public-loud and public-quiet BPs had minimal, non-clinically important differences from private quiet BPs: public loud: ΔSBP, -0.66 mm Hg (95% CI, -2.25 to 0.93 mm Hg) and ΔDBP, 1.65 mm Hg (CI, 0.77 to 2.54 mm Hg); public quiet: ΔSBP, 0.09 mm Hg (-1.53 to 1.72 mm Hg) and ΔDBP, 1.45 mm Hg (0.64 to 2.27 mm Hg). The patterns were generally consistent across subgroups.
Limitations: Single-center trial. Imbalance in the numbers and characteristics across the randomly assigned groups.
Conclusion: The BP readings obtained in public spaces were minimally different from BPs obtained in a private office, suggesting that public spaces are reasonable settings to screen for hypertension.
Primary funding source: Resolve to Save Lives.
Clinical impact ratings: GIM/FP/GP: [Formula: see text] Cardiology: [Formula: see text] Nephrology: [Formula: see text].
Background: The evidence informing the harms of gabapentin use are at risk of bias from comparing users with nonusers.
Objective: To describe the risk for fall-related outcomes in older adults starting treatment with gabapentin versus duloxetine.
Design: New user, active comparator study using a target trial emulation framework.
Setting: MarketScan (IBM) commercial claims between January 2014 and December 2021.
Participants: Adults aged 65 years or older with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia and without depression, anxiety, seizures, or cancer in the 365 days before cohort entry.
Intervention: New initiation of treatment with gabapentin or duloxetine (comparator).
Measurements: The primary outcome was the hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until discontinuation of treatment. Secondary outcomes were hazard of severe fall-related events defined as a fall associated with hip fracture or emergency department visit or hospitalization associated with a fall. Stabilized inverse probability of treatment weighting was used to adjust for baseline characteristics.
Results: Our analytic cohort included 57 086 older adults with a diagnosis of interest initiating treatment with gabapentin (n = 52 152) or duloxetine (n = 4934). Overall median follow-up duration was 30 days (IQR, 30 to 90 days). Weighted cumulative incidence of a fall-related visit per 1000 person-years at 30, 90, and 180 days was 103.60, 90.44, and 84.44 for gabapentin users and 203.43, 177.73, and 158.21 for duloxetine users, respectively. At 6-month follow-up, incident gabapentin users had lower hazard of falls (hazard ratio, 0.52 [95% CI, 0.43 to 0.64]), but there was no difference in the hazards of experiencing severe falls. Results were similar across sensitivity and subgroup analyses.
Limitation: Claims may contain fewer frail adults and undercount falls.
Conclusion: Compared with incident use of duloxetine, incident use of gabapentin was not associated with increased fall-related visits.
Primary funding source: None.
Background: Recent randomized controlled trials (RCTs) have investigated glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual or triple co-agonists for weight loss among adults with overweight or obesity and without diabetes.
Purpose: To assess the efficacy and safety of GLP-1 RAs and co-agonists for the treatment of obesity among adults without diabetes.
Data sources: MEDLINE, Embase, and Cochrane CENTRAL from inception to 4 October 2024.
Study selection: Placebo-controlled RCTs in otherwise healthy participants with overweight or obesity.
Data extraction: The primary outcome was change in relative or absolute body weight from baseline to maximum on-treatment follow-up. Safety outcomes included death, serious adverse events (SAEs), any adverse events (AEs), and gastrointestinal AEs.
Data synthesis: A total of 26 RCTs comprising 15 491 participants (72% female; mean body mass index, 30 to 41 kg/m2; mean age, 34 to 57 years) and 12 agents (3 commercially available agents [liraglutide, semaglutide, and tirzepatide] and 9 premarket agents for long-term weight management) were included. Treatment ranged from 16 to 104 weeks (median, 43 weeks). Compared with placebo, tirzepatide (15 mg once weekly) resulted in weight loss of up to 17.8% (95% CI, 16.3% to 19.3%) after 72 weeks of therapy; semaglutide (2.4 mg once weekly), up to 13.9% (CI, 11.0% to 16.7%) after 68 weeks; and liraglutide (3.0 mg once daily), up to 5.8% (CI, 3.6% to 8.0%) after 26 weeks. Retatrutide (12 mg once weekly) produced greater weight loss of up to 22.1% (CI, 19.3% to 24.9%) after 48 weeks; other novel single and combination GLP-1 agents were also efficacious to varying degrees. Although AEs were frequent (GLP-1 RA vs. placebo: 80% to 97% vs. 63% to 100%), the majority were gastrointestinal-related (47% to 84% vs. 13% to 63%, respectively), most commonly nausea, vomiting, diarrhea, and constipation. AEs requiring treatment discontinuation (0% to 26% vs. 0% to 9%, respectively) and SAEs (0% to 10% vs. 0% to 12%, respectively) were rare.
Limitations: No head-to-head RCTs were available. Heterogeneity prevented meta-analysis.
Conclusion: GLP-1 RAs and co-agonists are efficacious for weight loss, with reported safety concerns predominantly gastrointestinal in nature, when used among adults with overweight or obesity and without diabetes.
Primary funding source: None. (PROSPERO: CRD42024505558).