Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients
Necessity for Lipid Lowering Therapy in Type 2 Diabetes Patients
Purpose:

 To assess prior need for lipid lowering therapy in patients with type 2 diabetes.

 Background/Hypothesis:

 At present, lipid lowering therapy, usually with a HMG-CoA reductase inhibitor or "statin",
 is recommended therapy for selected patients with type 2 diabetes mellitus (DM). The use of
 statins for primary prevention of CVD is not clear. Some primary prevention studies have
 found a statistically significant benefit but others have not (CARDS and ASPEN).

 Although low-density lipoprotein (LDL) has traditionally been a key marker of cardiovascular
 disease risk (CVD) risk and thus a guide to statin treatment, in recent years apolipoprotein
 B (apoB) has emerged as an independent risk factor for CVD.

 In a recent study, Tildesley H. et al. showed that in 500 patients with type 2 DM not on
 lipid lowering therapy there was discordance between LDL and apoB values. Specifically, it
 was found that among patients who fail to achieve the LDL-C target, 13% of men, 24% of women
 less than 50 and 13% of women greater than 50 meet the apoB target. In other words, while the
 LDL level would indicate treatment, the apoB level would not.

 Objectives:

 The investigators propose to measure lipid parameters during lipid lowering therapy and
 compare this with lipid parameters at one and two months after discontinuation of therapy in
 selected patients with type 2 DM at low risk for CVD. Lipid parameters to be measured
 include: high-density lipoprotein (HDL) - cholesterol, LDL-cholesterol, triglycerides, total
 cholesterol, total cholesterol: HDL-cholesterol ratio and apoB. As well, A1C will be
 measured.
Inclusion Criteria:

 -  LDL < 2.5 mmol/L and total cholesterol: HDL-cholesterol ratio < 4.0

 -  Blood pressure ≤ 130/80 mmHg

 -  No personal or family history of CVD

 -  No history of proteinuria or renal failure

 -  Taking atorvastatin (lipitor) with a dosage ≤ 10 mg, equivalent dosages for other
 statins follow this requirement (Simvastatin ≤ 20 mg, pravastatin ≤ 40 mg,
 rosuvastatin ≤ 5 mg, fluvastatin ≤ 40 mg and lovastatin ≤ 40 mg)

 -  Calculated by the UKPDS Risk Engine to be low risk (risk is less than 15%) for
 Coronary Heart Disease (CHD), fatal CHD, stroke and fatal stroke (the UKPDS Risk
 Engine provides risk estimates in individuals with type 2 diabetes not known to have
 heart disease (1), calculating the patient's risk involves considering risk factors
 such as age, sex, incidence of smoking and lipid levels)

 Exclusion Criteria:

 -  Patients who do not meet the above criteria or are not willing to participate will not
 be included in the study