Abbott Laboratories is faced with the dilemma of an expiring drug patent and is seeking an additional indication from the Food and Drug Administration (FDA) for its cholesterol drug Niaspan. In order to receive an indication from the FDA, a drug company must present two successful studies with the intended outcome. Niaspan has the FDA indication to raise HDL-C, reduce secondary non-fatal myocardial infarction, and regression of atherosclerosis in combination with a bile acid resin. In a recent study (cite) patients taking Niaspan demonstrated regression of atherosclerosis in combination with statin, a popular cholesterol treatment agent. Abbott is now looking to replicate the study in order to receive an additional FDA indication and extended patent life for the prescription drug Niaspan. Albert Einstein said “The formulation of a problem is far more often essential than its solution, which may be merely a matter of mathematical or experimental skill. To raise new questions, new possibilities, to regard old problems from a new angle require creative imagination and marks real advance in science”. The value of this statement in terms of the research process is an understanding the importance of asking the right question before formulating a solution. If the right research question is not asked the solution may not solve the Abbott Laboratories’ dilemma. The research question for additional indication from the FDA is, “Does Extended Release Niacin (Niaspan) with statin in combination therapy slow or reduce the progression of atherosclerosis in secondary prevention patients treated with statin monotherapy?” The research study is an explanatory double blind experimental design. Random sampling will be used to assign participants into either the placebo or the treatment group. The treatment group will receive extended-release niacin (Niaspan 1000mg) added to Zocor (simvastatin 20 mg) monotherapy. The sample will consist of 167 males patients (mean age 67 years) with a known coronary heart disease and low levels of HDL-C (high density lipoprotein cholesterol < 45 mg.dL). Independent variables for the study include age, diabetes status, hypertension status, tobacco use, family history of CHD, metabolic syndrome status, history of CHD, and patient prescribed medications. The dependent variable is atherosclerosis (plaque build-up in the arteries). Subjects for the study completed a questionnaire (see Appendix A) to determine inclusion validity and categorical variables that may affect results. All subjects are required to be currently treated with a statin drug and subjects with a known intolerance to niacin or a history of liver disease were excluded. Subjects were randomized in a 1:1 fashion to receive either extended-release niacin or a matching placebo. Randomization was performed with a computer-generated sequence of random numbers. Participants were assigned a unique study identification number used by the research pharmacy to dispense proper medication. The predefined primary end point of the study was the change in mean common CIMT after one year, assessed within each study medication group via a paired t test. Secondary end points included changes in serum lipid concentrations, adverse events, hospitalization for coronary syndrome, or sudden cardiac death. The statistical analysis of the data required an unpaired t test for independent groups and a within-group paired analysis. The trial was to detect a mean difference between study groups in IMT. Between-group data for continuous variables were assessed with a t test for independent variables or ANOVA. The chi-square test was appropriate for categorical variables. Data were analyzed on an intention-to-treat principle. Values are reported as mean ± SD. A two-sided probability value of ≤0.05 was considered statistically significant.
Appendix and Tables
Variables for Categorical Response to Survey...