antihyperten-sive agent that is aimed at elderly hypertensive participants with prior heart disease. Because this is a high-risk group, the company is hesitant to withhold antihypertensive therapy from these patients and instead proposes an equivalence study comparing the new agent (drug A) with the current antihyper-tensive therapy used by those participants. Hence, the partici-pants will
A drug company proposes to introduce a new antihyperten-sive agent that is aimed at elderly hypertensive participants with prior heart disease. Because this is a high-risk group, the company is hesitant to withhold antihypertensive therapy from these patients and instead proposes an equivalence study comparing the new agent (drug A) with the current antihyper-tensive therapy used by those participants. Hence, the partici-pants will be randomized to either maintenance of their current therapy or replacement of their current therapy with drug A. Suppose the endpoint is total cardiovascular disease (CVD) mortality, and it is assumed that under their current therapy 15% of participants will die of CVD over the next 5 years.
13.36 Suppose drug A will be considered equivalent to the current therapy if the 5-year CVD mortality is not worse than 20%. How many participants must be enrolled in the study to ensure at least an 80% chance of demonstrating equiva-lence if equivalence will be based on a one-sided 95% CI approach, an equal number of subjects are randomized to drug A and current therapy, and the underlying mortality rates of the two therapies are the same?
13.37 Suppose in the actual study that 200 participants are randomized to each group. Forty-four participants who receive drug A and 35 participants who receive current therapy die of CVD in the next 5 years. Can the treatments be considered equivalent? Why or why not?
13.38 How much power did the study described in Problem 13.37 have of demonstrating equivalence under the assumptions in Problem 13.36?
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