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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Diabetes; Hyperlipidemia
• Intervention / Treatment: Behavioral: N of 1 Trials

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; N of 1 trials of statin therapy	Behavioral: N of 1 Trials; N of 1 Trials of statin therapy; Other Names: usual care
Other: 2; usual care	Behavioral: N of 1 Trials; N of 1 Trials of statin therapy; Other Names: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean LDL levels	end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
the proportions of participants taking statins at the end of the trial	end of study

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Charlotte G McDonald, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: March 2, 2006
• First Submitted That Met QC Criteria: March 2, 2006
• First Posted (Estimate): March 6, 2006

Study Record Updates

• Last Update Posted (Estimate): January 8, 2008
• Last Update Submitted That Met QC Criteria: January 4, 2008
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: cardiovascular disease; diabetes mellitus; N of 1 trial; HMG CoA Reductase Inhibitors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Diabetes Mellitus; Hyperlipidemias
• Other Study ID Numbers: R-06-135; IRF-061-05