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FDA-approved branded medications (such as Ozempic, Wegovy, Zepbound, and Mounjaro) are the actual products manufactured by their respective companies and have undergone FDA review for safety and effectiveness for their approved indications
Sometimes, rare side effects that were not seen in trials can show up after the drug is on the market
This is probably related to the drugs incretin effect.20 The demonstrated potential of SEMA to reduce adipose accumulation at the lingual level may represent an additional mechanismbeyond weight lossfor improving the control of sleep apnoea.22 The SCALE programme also demonstrated the ability of LIRA 3 mg to improve cardiovascular risk factors (CVRFs), including blood pressure, lipid profile and inflammation markers.13 The effects on glycaemic control and CVRFs associated with SEMA 2.4 mg in the STEP programme are qualitatively similar, but quantitatively superior to those observed with LIRA 3 mg, possibly related to the different weight loss.16 The SELECT study, conducted with SEMA 2.4 mg, consistently showed a reduction of major adverse cardiac events (MACE) of triple composite endpoint (non-fatal myocardial infarction, non-fatal stroke, cardiovascular mortality) of 20% relative to placebo in a population with established cardiovascular disease and BMI greater than 27 kg/m2 without diabetes after 39.8 months of follow-up.23 Although a direct role of SEMA cannot be ruled out, the influence of adipose reduction and the improvement of adipocyte dysfunction probably contribute to the evolving profile of cardiovascular risk factors
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