Question 1

Question

A pharmaceutical company reports a new antihypertensive drug reduces cardiovascular events with an NNT of 50 over 5 years based on a trial of 10,000 patients. An independent analysis reveals the benefit was driven entirely by a subgroup with resistant hypertension (20% of participants, NNT=15), while the remaining 80% showed no benefit over standard therapy (NNT approaching infinity). Evaluate the ethical and regulatory implications of reporting the overall NNT.

Accepted Answer

The overall NNT is misleading; approval should be restricted to resistant hypertension population where benefit is demonstrated

Answer

Conduct a new trial in the general hypertensive population to validate efficacy before broader approval

Answer

The subgroup analysis represents data dredging; only the overall NNT should be used for clinical decisions

Answer

The overall NNT of 50 is statistically valid and appropriate for regulatory approval and marketing

Answer

Report both overall and subgroup NNTs; allow clinicians to determine appropriate use based on patient characteristics

Number needed to treat/harm — MCQs

Number needed to treat/harm — MCQs

On this page

Practice by Chapter

Want unlimited practice?