The drug advertisement suggests the addition of Zettiga (extended-release niacin) to low-dose simvastatin for the treatment of high-risk patients with type 2 hyperlipidemia or mixed dyslipidemia.
A 56-year-old man with exertional chest pain comes to the office because his exercise stress echocardiogram showed evidence of mild ischemia in the posterior wall. He was recently diagnosed with type 2 diabetes mellitus and hypertension. He is a current smoker but is willing to quit. His father died of a heart attack at age 51. Physical examination is unremarkable.
Laboratory results are as follows:
Based on the information in the drug advertisement, which of the following changes in HDL and LDL cholesterol would be expected if this patient was started on combined Zettiga and simvastatin compared to simvastatin alone?

Question

The drug advertisement suggests the addition of Zettiga (extended-release niacin) to low-dose simvastatin for the treatment of high-risk patients with type 2 hyperlipidemia or mixed dyslipidemia. 
A 56-year-old man with exertional chest pain comes to the office because his exercise stress echocardiogram showed evidence of mild ischemia in the posterior wall.  He was recently diagnosed with type 2 diabetes mellitus and hypertension.  He is a current smoker but is willing to quit.  His father died of a heart attack at age 51.  Physical examination is unremarkable.
Laboratory results are as follows:
 Based on the information in the drug advertisement, which of the following changes in HDL and LDL cholesterol would be expected if this patient was started on combined Zettiga and simvastatin compared to simvastatin alone?

Quizplus · Accepted Answer

Explanation: The drug advertisement compares combined Zettiga 1200 mg and simvastatin 20 mg to simvastatin 20 mg alone in patients with type 2 hyperlipidemia or mixed dyslipidemia. According to the drug ad, the primary efficacy endpoint was the percentage change from baseline in non-HDL cholesterol (non-HDL cholesterol = total cholesterol - HDL cholesterol) after 36 weeks of treatment. Secondary endpoints included the percentage change from baseline in LDL cholesterol, HDL cholesterol, triglycerides (TG), and apolipoprotein B (apo B) levels. Based on the advertisement, a p value <.05 was considered statistically significant, as denoted by the footnote α below the graph. The changes for HDL-C, non-HDL cholesterol, TG, and apo B were all statistically significant (they all have an α next to them); however, the change in LDL was not statistically significant (no α is shown next to the -11%). In sum, compared to simvastatin 20 mg alone, combined therapy with Zettiga 1200 mg and simvastatin 20 mg was associated with a significant increase in HDL (by ~23%); however, this therapy was not associated with a statistically significant change in LDL. A study's statistical significance level (alpha or α) is typically defined by investigators during the study design stage (α = 0.05 in this study). It is a predetermined cutoff value for rejecting the null hypothesis. If the p value of the study turns out to be less than the preset statistical significance level, the null hypothesis is rejected and the difference detected is considered statistically significant. If a result is statistically significant, there are 2 possible explanations to keep in mind: The 2 study populations are actually different: the null hypothesis is correctly rejected. Type I error: This occurs when researchers reject the null hypothesis when the null hypothesis is actually true. That is, a study finds a statistically significant difference between 2 groups when it does not truly exist. The α value is the maximum probability of making a type I error that a researcher is willing to accept. Educational objective: A study's statistical significance level (alpha or α) is typically defined by investigators during the study design stage (α = 0.05 in this study). It is a predetermined cutoff value for rejecting the null hypothesis. If the p value of the study is less than the preset statistical significance level, the null hypothesis is rejected and the difference detected is considered statistically significant. References: Understanding statistical significance. (http://www.ncbi.nlm.nih.gov/pubmed/20445438) Clinical versus statistical significance: interpreting P values and confidence intervals related to measures of association to guide decision making. (http://www.ncbi.nlm.nih.gov/pubmed/21507834)

The Drug Advertisement Suggests the Addition of Zettiga (Extended-Release Niacin)