Canadian Diabetes Association
Clinical Practice Guidelines
Dyslipidemia
Chapter 24
G. B. John Mancini, Robert A. Hegele,
Lawrence A. Leiter
Dyslipidemia Checklist
2013
 CHECK lipid profile at diagnosis then yearly or every
3-6 months when on treatment
 USE statins as first-line therapy
 ADD second line agent only when LDL-C is not at
target despite statin therapy
 USE fibrate when TG >10.0 mmol/L
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Measure Lipids at Diagnosis
•
Repeat yearly if treatment not started
•
Repeat q3-6mos if on treatment
•
Fasting (8-hr) profile:
–
•
Total cholesterol, triglycerides, HDL-C, LDL-C
or
Non-fasting profile:
–
–
ApoB
Non-HDL-C
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Who should receive
statin therapy?
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HPS: Statin Therapy Beneficial Among
Patients with Diabetes
SIMVASTATIN PLACEBO
Rate ratio & 95% CI
(10269)
(10267) STATIN better PLACEBO better
Previous MI
999 (23.5%)
1250 (29.4%)
Other CHD (not MI)
460 (18.9%)
591 (24.2%)
No prior CHD
CVD
172 (18.7%)
212 (23.6%)
PVD
327 (24.7%)
420 (30.5%)
Diabetes
276 (13.8%)
367 (18.6%)
ALL PATIENTS
2033 (19.8%)
2585 (25.2%)
24%
reduction
(P<0.00001)
HPS = Heart Protection Study
0.4
HPS Lancet 2002;360:7-22
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0.6
0.8
1.0
1.2
1.4
CARDS: Effect of Statin for PRIMARY
Prevention in DM
•
•
•
n = 2838
Age 40-75, no history of CVD
T2DM plus one or more:
–
–
–
–
Retinopathy
Albuminuria
Hypertension
Smoking
•
Intervention: Atorvastatin 10 mg vs. Placebo
• Outcome: ACS, revascularization, stroke
Colhoun HM, et al. Lancet 2004;364:685.
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CARDS: Statins Reduced CVD in Patients with DM
Colhoun HM, et al. Lancet 2004;364:685.
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Who Should Receive Statins?
(regardless of baseline LDL-C)
•
•
•
•
•
2013
≥40 yrs old or
Macrovascular disease or
Microvascular disease or
DM >15 yrs duration and age >30 years or
Warrants therapy based on the 2012 Canadian
Cardiovascular Society lipid guidelines
Among women with childbearing potential, statins should only
be used in the presence of proper preconception counseling &
reliable contraception. Stop statins prior to conception.
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What if baseline LDL-C ≤2.0 mmol/L?
•
Within CARDS and HPS, the subgroups that started
with lower baseline LDL-C still benefited to the same
degree as the whole population
•
If the patient qualifies for statin therapy based on the
algorithm, use the statin regardless of the baseline
LDL-C and then target an LDL reduction of ≥50%
HPS Lancet 2002;360:7-22
Colhoun HM, et al. Lancet 2004;364:685.
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Statin Options
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If on therapy, target
LDL ≤2.0 mmol/L
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Statin Therapy Should be Concomitant with
Lifestyle Therapy
•
Smoking cessation
•
Energy-restricted diet (see CPG Chapter 11)
–
–
–
–
–
•
Low cholesterol
Low saturated and trans fatty acids
Low refined carbohydrates
Include viscous fibres, plant sterols, nuts, soy proteins
Alcohol in moderation
Physical activity (see CPG Chapter 10)
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Second- Line Agents: Only if LDL-C Target
not Reached with Statin
•
Bile acid sequestrants
•
Cholesterol absorption inhibitors
•
Fibrates
•
Nicotinic acid
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Drug Class
•
Principal Effects Other Considerations
Generic name (Trade
name)
Bile Acid Sequestrant
Lowers LDL-C
Gastrointestinal intolerability
TG elevation
Colesevelam: A1C lowering effect
Lowers LDL-C
Effective in combination with statin
Lowers TG
Variable LDL-C
effect
Variable HDL-C
effect
May creatinine + homocysteine (but
long term fenofibrate use has
favorable renal effects)
Do not combine gemfibrozil + statin
Lower TG + LDL-C
Raise HDL-C
Dose related deterioration in glycemia
ER Niacin more tolerable than IR
Long-acting niacin should NOT be
used
•Cholestyramine resin (Questran)
•Colestipol HCl (Colestid)
•Colesevalam (Lodalis)
Cholesterol Absorption
Inhibitor
•Ezetimibe (Ezetrol)
Fibrate
•Bezafibrate (Bezalip SR)
•Fenofibrate (Lipidil)
•Gemfibrozil (Lopid)
Nicotinic Acid
•ER Niacin (Niaspan, Niaspan
FCT)
•IR Niacin (non-prescription)
•LA (“no-flush”) Niacin – not
recommended
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ER Copyright
= extended
release;
IR = immediate
release; LA=long acting; TG=triglycerides; FCT=film coated tablet; SR=sustained release
© 2013
Canadian
Diabetes Association
If Triglycerides >10.0 mmol/L…
2013
•
Use a FIBRATE to reduce the risk of pancreatitis
•
Optimize glycemic control
•
Implement lifestyle interventions
–
–
–
Weight loss
Optimal dietary strategies
Reduce alcohol
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Recommendation 1
2013
1. A fasting (8-hour fast) lipid profile (TC, HDL-C, TG and
calculated LDL- C) or non-fasting lipid profile (apo B),
should be measured at the time of diagnosis of
diabetes.
If lipid lowering treatment is not initiated, repeat
testing is recommended yearly.
Frequent testing (every 3-6 months) should be
performed if treatment for dyslipidemia is initiated
[Grade D, Consensus]
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Recommendation 2 and 3
2. For patients with indications for lipid lowering therapy
treatment (see Vascular Protection chapter), treatment
should be initiated with a statin [Grade A, Level 1] to achieve
an LDL-C ≤2.0 mmol/L [Grade C, Level 3]
3. In patients achieving target LDL-C with statin therapy,
the routine addition of fibrates or niacin for the sole
2013
purpose of further reducing cardiovascular risk should
not be used [Grade A, Level 1].
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Recommendation 4
4. For individuals not at LDL-C target despite statin
therapy as described above, a combination of
statin therapy with second-line agents may be
used to achieve the LDL-C targets [Grade D Consensus]
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Recommendation 5
2013
5. For those who have serum TG >10.0 mmol/L, a
fibrate should be used to reduce the risk of
pancreatitis [Grade D, Consensus] while also optimizing
glycemic control and implementing lifestyle
interventions (e.g. weight loss, optimal dietary
strategies, and reduction of alcohol).
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Vascular Protection Checklist
2013

A • A1C – optimal glycemic control (usually ≤7%)

B • BP – optimal blood pressure control (<130/80)

C • Cholesterol – LDL ≤2.0 mmol/L if decided to treat

D • Drugs to protect the heart (regardless of baseline BP or LDL)
A – ACEi or ARB │ S – Statin │ A – ASA if indicated

E • Exercise / Eating healthily – regular physical
activity, achieve and maintain healthy body weight

S • Smoking cessation
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CDA Clinical Practice Guidelines
www.guidelines.diabetes.ca – for professionals
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www.diabetes.ca – for patients