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With the exception of orlistat, the currently approved antiobesity drugshave not been studied well among patients with overweight/obesity andhypertension. There are no published RCTs of the short- and long-term effects ofphentermine on blood pressure, the #1 prescribed antiobesity drug, accountingfor 3 of 4 prescriptions for all drugs in this class, with > 8 millionAmericans exposed to the drug yearly. This is a major therapeutic gap and anunmet need. With the exception of naltrexone/bupropion, the currently approvedantiobesity drugs have not been tested for short- and long-term changes inambulatory blood pressure, which provides a better assessment of hypertensionthan office blood pressure alone andis superior to office-based measurements in predicting cardiovascular events andtarget organ injury . Furthermore, ABPM gathers a wealth ofinformation including 24-hr, daytime, and nighttime averages of systolic bloodpressure, diastolic blood pressure, mean arterial pressure, the degree ofnocturnal dipping, and morning surges, and the proportions of recordings withvalues higher than the established cut-off values .Therefore, an ABPM substudy should be incorporated into the portfolio of phase 2and phase 3 trials included in every new drug application of an antiobesity drugseeking FDA approval.

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