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Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

This study has been terminated.
(insufficient recruitment/enrollment)
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00299169
First received: March 2, 2006
Last updated: January 4, 2008
Last verified: September 2006
History of Changes
  Purpose

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
Diabetes
Cardiovascular Disease
Hyperlipidemia
 Behavioral: N of 1 Trials
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Statins
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • mean LDL levels [ Time Frame: end of study ]

Secondary Outcome Measures:
  • the proportions of participants taking statins at the end of the trial [ Time Frame: end of study ]

Enrollment: 6
Study Start Date: September 2006
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1
N of 1 trials of statin therapy
 Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
Other Name: usual care
2
usual care
 Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
Other Name: usual care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established diagnosis of type 1 or 2 diabetes
  • Age 18-80 years
  • Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
  • Willingness to re-try a statin despite previous apparent intolerance
  • Provision of signed informed consent

Exclusion Criteria:

  • Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation
  • Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
  • Presence of a condition such as malignancy for which the one-year prognosis is poor
  • Inability of the patient to comply with the rigorous conditions of the trial
  • Any other condition deemed to render the study harmful to the participant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299169

Locations
Canada, Ontario
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Charlotte G McDonald, MD University of Western Ontario, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00299169     History of Changes
Other Study ID Numbers: R-06-135, IRF-061-05
Study First Received: March 2, 2006
Last Updated: January 4, 2008
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
N of 1 trial
diabetes mellitus
HMG CoA Reductase Inhibitors
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013