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Khabre desk
Recent reporting, analysis and explainers from the Clinical Research desk.
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In a 192-person randomised trial, high-volume injections with or without corticosteroid did not improve Achilles pain or disability over a sham injection at 12 months. The corticosteroid injection showed a small short-term benefit, followed by worse outcomes than the injection without steroid at 26 weeks.
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In a 810-person phase 3 trial in China, all three safiglipron doses were non-inferior to dapagliflozin for HbA1c reduction at 32 weeks. The 90 mg dose also met a prespecified superiority criterion in a separate analysis, while gastrointestinal events and treatment discontinuations were more frequent with safiglipron.
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In the 52-week REMODEL trial, semaglutide was associated with changes in kidney vascular measures and tissue signals in people with type 2 diabetes and chronic kidney disease. The three coprimary MRI outcomes did not differ significantly from placebo.
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In a 284-person phase 3 trial in China, once-daily oral safiglipron lowered HbA1c more than placebo over 32 weeks in adults with early type 2 diabetes. Gastrointestinal adverse events were common and increased with dose.
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An analysis of double-blind trials found small average QTc increases with escitalopram and amitriptyline, with effects varying by individual risk factors. A separate analysis found no evidence of increased early sudden-death rates compared with placebo.
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A BMJ editorial argues that drug regulatory decisions should show more clearly when licensing committees disagree about benefits, risks and evidentiary uncertainty. It highlights the European Medicines Agency’s formal process for recording dissent.
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A BMJ qualitative study of 30 adults actively pursuing assisted suicide in Switzerland identified six interacting motivations, from autonomy and relationships to multidimensional suffering and fear of losing capacity.
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A multicentre phase 1 trial in China tested the AAV gene therapy BBM-H901 in 11 adolescents with severe or moderately severe hemophilia B. At 52 weeks, mean factor IX activity was 41.8 IU/dl and the mean annualized bleeding rate had fallen from 13.9 to 0.5.