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A pharmacist has received information regarding a new drug to treat hypertension. The information is based on a 2 month, placebo controlled, randomized study of 1000 adults that showed a significant average decrease in systolic pressure from 160 mm Hg to 141 mm Hg and diastolic pressure from 98 mm Hg to 86 mm Hg. The most common adverse reactions were stomach upset and dizziness. Which of the following is the most significant limitation of this study?

  1. The study size was too small to assess benefits adequately.

  2. The patients did not achieve guideline targets for hypertension.

  3. Lowered blood pressure is a surrogate outcome.

  4. Long term safety and efficacy were not assessed.

The correct answer is: Long term safety and efficacy were not assessed.

The most significant limitation of this study is that long-term safety and efficacy were not assessed. While the study showed a significant decrease in systolic and diastolic pressure, it only lasted for a period of 2 months and did not evaluate the potential long-term effects of the drug. This means that the results may not be applicable to a longer treatment duration and could potentially miss any adverse reactions that may occur over time. While stomach upset and dizziness were reported as common adverse reactions, there could be other more serious side effects that were not captured in the short duration of the study. Therefore, it is important for further research to be conducted to fully assess the safety and efficacy of this new drug for the treatment of hypertension.