Business Research Methods 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 Table 1 Variables for Categorical Response to Survey Variable| Categories| Level of Measurement| Order of Power| Age| Any| Ratio| 1| Type 2 Diabetes| Yes/No| Nominal| 4| Hypertension| Yes/No| Nominal| 4| Tobacco Use| Yes/No| Nominal| 4|
Family History of CHD| Yes/No| Nominal| 4| Metabolic Syndrome| Yes/No| Nominal| 4| History of MI| Yes/No| Nominal| 4| History of Coronary Revascularization| Yes/No| Nominal| 4| History of CABG| Yes/No| Nominal| 4| History of Angina with Ischemia| Yes/No| Nominal| 4| Take ? -Blocker| Yes/No| Nominal| 4| Take Aspirin| Yes/No| Nominal| 4| Take ACE inhibitor| Yes/No| Nominal| 4| Take Vitamin E| Yes/No| Nominal| 4| Take Vitamin C| Yes/No| Nominal| 4| Table 2 Baseline Characteristics of 167 Patients Randomly Assigned to Either Placebo or Extended-Release Niacin Placebo Niacin| Male gender, n 74 78|
Age, mean6867| Type 2 diabetes mellitus, n2224| Hypertension, n6164| Tobacco use, n512| Family History of CHD, n3933| Metabolic Syndrome, n4243| History of CHD| MI4241| Coronary Revascularization3542| CABG2840| Angina with ischemia2726| Medications, n| ?-Blocker6369| Aspirin 6875| ACE inhibitor4254| Vitamin E1422| Vitamin C810| Appendix A Questionnaire for Sample Question| Response| What is your age? | | Do you have type-2 diabetes? | Yes/No| Do you experience hypertension? | Yes/No| Do you use tobacco? | Yes/No| Do you have a family history of CHD? | Yes/No| Do you experience metabolic syndrome? | Yes/No|
Do you have a history of MI? | Yes/No| Do you have a history of coronary revascularization? | Yes/No| Do you have a history of CABG? | Yes/No| Do you have a history of angina with ischemia? | Yes/No| Do you take any ? -Blockers? | Yes/No| Do you take aspirin? | Yes/No| Do you take an ACE inhibitor? | Yes/No| Do you take Vitamin E? | Yes/No| Do you take Vitamin C? | Yes/No| Appendix B Definitions Age: A term to define how old an individual is. Type 2Diabetes: A term used to identify a chronic (lifelong) disease marked by high levels of sugar in the blood. Hypertension: A term used to define blood pressure.
High blood pressure (hypertension) is when an individual’s blood pressure is 140/90 mmHg or above most of the timeTobacco Use: The term used to define active consumption of tobacco products. Family History of CHD: The term that define an individual whom has an immediate family member with coronary heart disease. Metabolic Syndrome: The term for a group of risk factors that occur together and increase the risk for coronary heart disease, stroke, and type 2 diabetes (e. g. central obesity, insulin resistance). History of MI: The term to describe an individual whom has had a previous myocardial infarction (heart attack).
History of Coronary Revascularization: A term used to describe an individual who has received a surgical procedure to replace vessels around existing blockage to restore necessary blood flow to the heart. History of CABG: The term used to describe an individual who has received a coronary artery bypass graft. History of Angina with Ischemia: The term used to define an individual who has poor circulation in the heart. ?-Blocker: A term used to define a class of pharmaceuticals with the indications of lowering hypertension levels and reducing rates of fatal cardiovascular incidents.
Aspirin: A term used to define a class of pharmaceuticals with the indications of reducing pain, reducing inflammation, lowering fever, thinning blood, lowering hypertension levels and reducing rates of fatal cardiovascular incidents. ACE inhibitor: A term used to define a class of pharmaceuticals with the indications of lowering hypertension levels and reducing rates of fatal cardiovascular incidents. Vitamin E: A natural supplement which is contraindicated with the use of Niaspan (Niacin). Vitamin C: A natural supplement which is contraindicated with the use of Niaspan (Niacin).