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Sponsored by: |
Lawson Health Research Institute |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00299169 |
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.
Condition | Intervention | Phase |
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Diabetes Cardiovascular Disease Hyperlipidemia |
Behavioral: N of 1 Trials |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes |
Enrollment: | 6 |
Study Start Date: | September 2006 |
Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Experimental
N of 1 trials of statin therapy
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Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
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2
usual care
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Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
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Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.
Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous. Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.
At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
St. Joseph's Health Care London | |
London, Ontario, Canada, N6A 4V2 |
Principal Investigator: | Charlotte G McDonald, MD | University of Western Ontario, Canada |
Study ID Numbers: | R-06-135, IRF-061-05 |
Study First Received: | March 2, 2006 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00299169 History of Changes |
Health Authority: | Canada: Health Canada |
N of 1 trial diabetes mellitus HMG CoA Reductase Inhibitors cardiovascular disease |
Antimetabolites Hyperlipidemias Metabolic Diseases Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |