A surveillance research is being done to evaluate the efficacy and safety of tolvaptan, a medication that is presently being used in clinical settings to treat heart failure with volume overload. The trial included 8,300 participants with various medical comorbidities who were given tolvaptan once daily in the morning for two weeks. Tolvaptan displayed aquaretic effectiveness in patients with diuretic-resistant volume overload, however hypernatremia occurred in a limited percentage of individuals. To prevent hypernatremia, researchers suggested a lower dose of tolvaptan in people with normonatremia and hypokalemia. Which of the following statements best defines this sort of research?

Question

Quizplus · Accepted Answer

Eductional Objective: Phase IV trials are postmarketing surveillance studies that evaluate the long-term efficacy and adverse effects of newly licensed therapies on the market. The results of phase IV studies may result in treatment limits or removal from the market.

A Surveillance Research Is Being Done to Evaluate the Efficacy