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Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT)
Packer M et al. NEJM (November 2024)
Bottom Line: This international, double-blind, randomized, placebo-controlled trial evaluated the effects of tirzepatide on cardiovascular outcomes in patients with heart failure with an ejection fraction ≥ 50% and obesity with BMI of ≥ 30 kg/m2. 731 patients were randomly assigned to receive either tirzepatide (up to 15 mg subcutaneously once per week) or placebo for at least 52 weeks. The primary outcome was a composite of adjudicated death from cardiovascular causes or a worsening heart-failure event, and the secondary outcome was the change in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS). The results showed that tirzepatide led to a lower risk of the primary outcome compared to placebo (9.9% vs. 15.3%, hazard ratio, 0.62; 95% confidence interval [CI], 0.41 to 0.95; P=0.026), and also improved health status in patients (mean change in KCCQ-CSS of 19.5±1.2 in the tirzepatide group as compared with 12.7±1.3 in the placebo group; between-group difference, 6.9; 95% CI, 3.3 to 10.6; P<0.001). Adverse events (mainly gastrointestinal) leading to discontinuation of the trial drug occurred in 6.3% of the tirzepatide group and 1.4% in the placebo group.
Fracture Prevention with Infrequent Zoledronate in Women 50 to 60 Years of Age
Bolland M et al. NEJM (January 2025)
Bottom Line: This 10-year, prospective, double-blind, randomized, placebo-controlled trial involved 1054 early postmenopausal women ages 50 to 60 without osteoporosis and with bone mineral density T scores lower than 0 and higher than −2.5 at the lumbar spine, femoral neck, or hip. Participants were randomly assigned to receive zoledronate 5 mg at baseline and 5 years, placebo at both time points, or a combination of zoledronate 5 mg and placebo. Spine radiographs were obtained at baseline, 5 years, and 10 years. The primary outcome was morphometric vertebral fracture with at least 20% change in vertebral height from baseline radiograph at 10 years, which occurred in 6.3% of the zoledronate-zoledronate group, 6.6% of the zoledronate-placebo group, and 11.1% of the placebo-placebo group (relative risk, zoledronate–zoledronate vs. placebo–placebo, 0.56 [95% confidence interval {CI}, 0.34 to 0.92; P=0.04]; and zoledronate–placebo vs. placebo–placebo, 0.59 [95% CI, 0.36 to 0.97; P=0.08]). The relative risk of vertebral, fragility, any, and major osteoporotic fractures was significantly lower in the zoledronate-zoledronate group compared to the placebo-placebo group. Zoledronate was found to be effective in preventing morphometric vertebral fracture in early postmenopausal women without osteoporosis after 10 years of follow-up.
In-Hospital Diabetes Management by a Diabetes Team and Insulin Titration Algorithms Based on Continuous Glucose Monitoring or Point-of-Care Glucose Testing in Patients With Type 2 Diabetes (DIATEC): A Randomized Controlled Trial
Olsen M et al. Diabetes Care (January 2025)
Bottom line: The DIATEC trial was a two-center, randomized clinical trial that evaluated the effects of inpatient continuous glucose monitoring (CGM)-guided insulin titration in 166 non-intensive care unit patients with type 2 diabetes. The primary outcome was the difference in time in range (3.9–10.0 mmol/L) between the CGM arm and the comparator arm (point-of-care glucose testing, POCT) during hospitalization. The results showed that the CGM arm had a significantly higher median time in range compared to POCT (77.6 vs. 62.7%, P<0.001), as well as lower time above range and lower time below range. Additionally, the CGM arm had a lower incidence of prolonged hypoglycemic events, decreased glycemic variability, and reduced insulin usage. A composite of complications was also lower in the CGM arm. In conclusion, in-hospital CGM improved glycemic control and reduced complications in non-intensive care unit patients with type 2 diabetes.
Trial Files Issue #2025-05