9. (23.18) Subjects with pre-existing cardiovascular symptoms who were receiving

Question

9. (23.18) Subjects with pre-existing cardiovascular symptoms who were receiving sibutramine, an appetite suppressant, were found to be at increased risk of cardiovascular events while taking the drug. The study included 9804 overweight or obese subjects with pre-existing cardiovascular disease and/or type 2 diabetes. The subjects were randomly assigned to sibutramine (4906 subjects) or a placebo (4898 subjects) in a doubleblind fashion. The primary outcome measured was the occurrence of any of the following events: nonfatal myocardial infarction or stroke, resuscitation after cardiac arrest, or cardiovascular death. The primary outcome was observed in 561 subjects in the sibutramine group and 490 subjects in the placebo group. eBook Step 1: Find the proportion of subjects experiencing the primary outcome for both the sibutramine and placebo groups. (Round your answers to 4 decimal places.) For the sibutramine group, Answer 1- For the placebo group, -Answer2 Answer 1. Answer 2 Step 2: Can we safely use the large-sample confidence interval for comparing the proportions of sibutramine and placebo subjects who experienced the primary outcome? Yes ONo

Explanation / Answer

Solution

Step1 :

Proportion for the submarine group, p1 : 561/4906 = 0.1143

Proportion for placebo group, p2 : 490/4898 = 0.1000

Step 2 :

Yes we can use the large sample confidence interval

Step 3:

95% Confidence interval for difference in proportions : (p1-p2)+-z0.025((p1)(1-p1)/n1 + (p2)(1-p2)/n2)0.5

= (0.1143 - 0.1000)+-1.96((0.1143)(0.8857)/4906 + (0.1)(0.9)/4898)0.5

=(0.0021, 0.0265

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