Phenylpropanolamine: effects on subjective and cardiovascular variables at recommended over-the-counter dose levels.

Two controlled clinical studies evaluated the effects of phenylpropanolamine HCL (PPA) on measures of blood pressure, pulse, and subjective state (mood). One hundred fifty subjects participated in a parallel groups design that compared a 75-mg sustained release (SR) preparation with a 25-mg tid. dosing regimen and placebo. Fifty-nine of these subjects participated in an additional cross-over component that compared SR PPA 75 mg with placebo. Measures of blood pressure, pulse, and subjective drug effect were obtained nine times throughout the course of a 12-hour session. Data analysis revealed no clinically and few statistically significant effects due to drug treatment. As expected, most measures showed circadian changes on both the cardiovascular and mood variables, which were not related to drug treatment. No euphorogenic or "amphetamine-like" effects were noted. Although further work is warranted regarding the effects of chronic or higher-than-normal doses of PPA, the current studies suggest that PPA, at currently recommended dose levels, is not associated with adverse effects on either cardiovascular or subjective functioning.

RCT Entities:   Population Interventions Outcomes