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Safety Signals in Phase II While efficacy was impressive, the trials also raised important safety concerns: Heart rate increases: Mean increases of 7.4 bpm (0.5 mg) and 9.1 bpm (1.0 mg) versus placebo Blood pressure: Modest systolic increases at higher doses Psychiatric effects: Insomnia (2135%), dry mouth (3044%), and mood changes in some patients Gastrointestinal: Nausea, diarrhea, and constipation at rates above placebo The cardiovascular signal particularly the heart rate increase would become the central obstacle in tesofensine's regulatory path
The post hoc analysis, which included the four SURMOUNT trials [1], compared tirzepatide with a placebo for up to 72 to 88 weeks in 4,677 adults (2,999 females, 1,678 males) living with obesity, highlighting potential sex differences in the response
The medication has been shown to improve other cardiovascular risk factors, such as lowering blood pressure and improving lipid profiles, thereby further mitigating potential heart-related issues
Among resmetirom-treated patients with a 120% increase in SHBG (marker of drug exposure), NR was seen in 34% and 37% and FR in 22% and 20% more resmetirom 80mg and 100mg patients than placebo
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