Join us on November 5th, 2025, from 4-5 pm for a free crash course on acute kidney injury.
Speaker details: Dr. Mike Fralick is a Clinician Scientist who works in Toronto and Sault Ste. Marie.
Do aldosterone synthase inhibitors have a use in resistant hypertension?
Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension
The BaxHTN Trial. NEJM (August 2025)
Bottom Line: This phase 3, multinational, double-blind, randomized, placebo-controlled trial evaluated the efficacy of baxdrostat versus placebo in patients with uncontrolled or resistant hypertension over 12 weeks. A total of 796 patients were randomized to receive either baxdrostat (1 mg and 2 mg) or placebo, in addition to background therapy, after a 2-week run-in period. The primary outcome was the change in seated systolic blood pressure, with results showing a reduction of -14.5 mm Hg (1 mg) and -15.7 mm Hg (2 mg) compared to -5.8 mm Hg with placebo ((95% CI, –16.5 to –12.5), (95% CI, –17.6 to –13.7), (95% CI, –7.9 to –3.8) respectively.) Safety outcomes indicated that elevated potassium levels occurred in 2.3% (1 mg baxdrostat) and 3.0% (2 mg baxdrostat) of patients receiving baxdrostat. The study concluded that baxdrostat significantly lowers seated systolic blood pressure compared to placebo.
Do the benefits of Telitacicept in SLE outweigh the risks?
A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus
The 18C010 Trial. NEJM (October 2025)
Bottom line: This phase 3 trial evaluated the efficacy of telitacicept (160 mg) versus placebo in adults with active systemic lupus erythematosus (SLE) over 52 weeks, with random assignment in a 1:1 ratio. A total of 335 participants were enrolled. The primary outcome was the response on the modified SLE Responder Index 4 (SRI-4) at week 52, with 67.1% in the telitacicept group achieving a response compared to 32.7% in the placebo group (adjusted difference, 34.5 percentage points; 95% confidence interval [CI], 24.3 to 44.7; P<0.001). Safety outcomes revealed a higher incidence of adverse events associated with telitacicept, including upper respiratory infections and reduced serum levels of IgG and IgM. The trial concluded that telitacicept led to a higher clinical response but also increased adverse events.
How effective is the oral nonpeptide GLP-1 receptor agonist, orforglipron, in early type 2 diabetes?
Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes
The ACHIEVE-1 Trial. NEJM (June 2025)
Bottom Line: This phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of orforglipron, a nonpeptide GLP-1 receptor agonist, in 559 adults with early type 2 diabetes treated with diet and exercise alone. Participants received orforglipron at doses of 3 mg, 12 mg, or 36 mg, or placebo daily for 40 weeks. The primary outcome was the change in glycated hemoglobin levels, with results showing a reduction of -1.24, -1.47, and -1.48 percentage points for the respective doses compared to -0.41 percentage points for placebo (P<0.001). The mean glycated hemoglobin level at baseline was 8.0%, and 6.5 to 6.7% with orforglipron at 40 weeks. Safety outcomes indicated mild-to-moderate gastrointestinal events, with no severe hypoglycemia reported.
Trial Files Issue #2025-23