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EVIDENCE-BASED MEDICINE

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by

Gwen Garrido

on 19 March 2014

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Transcript of EVIDENCE-BASED MEDICINE

EVIDENCE-BASED MEDICINE
Clinical Scenario
50/F came in for follow up with lab results.

Hypertension Stage 2
Diabetes Mellitus Type 2 Suspect
Obese Class I
Dilemma
In my patient who is 50 years old with type 2 diabetes and cardiovascular disease is it safe to target the normal HbA1c level of 6%?

Question
In patients 40 years and older with Type 2 diabetes and cardiovascular disease or cardiovascular risk factors will a target glycated hemoglobin of <6.0% result in more deaths due to cardiovascular causes than a target glycated hemoglobin of 7.0-7.9% in a randomized controlled trial?

Appraisal
Therefore...
A Critical Appraisal on Harm
SC Gwen G. Garrido
S
Losartan 50mg + HCTZ 12.5mg, 1 tab OD

O
Weight: 70kg
Height: 1.57m
BMI: 28.45
BP: 140/100


Glucose: 357.67
BUA: 4.06
Crea: 0.91
Chol: 226.01
HDL: 40.62
Trig: 148.6
LDL: 155.7
HbA1c: 13.6
A
Hypertension Stage 1
Diabetes Type 2 -Uncontrolled
Dyslipidemia
Obese Class I
P
Losartan 50mg + HCTZ 12.5mg, 1 tab OD at 6am
Atorvastatin 40mg ½ tab OD at bedtime
Insulin glargine pre-filled pen 10 U SQ at bedtime
Vildagliptin (Galvusmet) 50/100mg, 1 tab OD at breakfast
Patients aged ≥ 40 with diabetes and cardiovascular disease or cardiovascular risk factors

target glycated hemoglobin level is below 6.0%
vs
target glycated hemoglobin level of 7.-7.9%
death due to cardiovascular causes

randomized controlled trial

RELEVANCE

IS THE OBJECTIVE OF THE ARTICLE COMPARING OCCURRENCE OF HARM SIMILAR TO YOUR CLINICAL DILEMMA?

IS THE OBJECTIVE OF THE ARTICLE COMPARING OCCURRENCE OF HARM SIMILAR TO YOUR CLINICAL DILEMMA?

Non-fatal MI
Non-fatal stroke
Death from cardiovascular causes
Death from any cause
Randomized Controlled Trial
VALIDITY

Are the defined groups of patients similar – other than through their exposure status to the treatment under study?

Were participants and researchers blinded to the measures of interest?

Intention-to-treat analyses
Mean of 3.7 years of an intensive glycemic intervention on cardiovascular disease
Mean of 1.2 years of standard glycemic therapy

Was the follow-up period sufficiently long and complete?

Do the results satisfy some “diagnostic tests for causation”?

STUDY RESULTS

What is the magnitude of the association between the exposure and the outcome?

Relative Risk


= Rt – Rc
= 0.037 – 0.029
= 0.008

Absolute Risk Increase (ARI)

=1/ARI
= 125



NUMBER NEEDED TO HARM
(NNH)

Confidence interval 95%
p Value = 0.02

HOW PRECISE WAS THE ESTIMATE OF TREATMENT EFFECT?

Can the results be applied to my patient care?


Blood pressure and dyslipidemia were also managed in the study and there were no significant interactions noted between the glucose-lowering study and the blood-pressure study or between the glucose-lowering study and the lipid study.

Were all clinically important outcomes considered?

In one meta-analysis of glucose lowering studies, they suggested that multifactorial interventions by aggressive management of hypertension, dyslipidemia and hyperglycemia, use of aspirin, and cessation of smoking
should be the goal of therapy in Diabetes Type 2 patients with cardiovascular risk factors.
What alternative treatments are available?

The results of the ACCORD trial show that in persons who have a high risk of cardiovascular disease and suboptimally controlled, long-standing diabetes and intensive therapeutic approach targeting normal glycated hemoglobin levels is associated with higher mortality.
CONCLUSION

RESOLUTION


Gerstein HC, Miller ME, et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. The New England Journal of Medicine 2011:818-828.

Boussageon, R., et al., Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ 2011;343:d4169.

American Diabetes Association: Standards of Medical Care in Diabetes - 2013

http://ktclearinghouse.ca/cebm

REFERENCES

Population:

Intervention:
IS THE OBJECTIVE OF THE ARTICLE COMPARING OCCURRENCE OF HARM SIMILAR TO YOUR CLINICAL DILEMMA?

Outcome:
IS THE OBJECTIVE OF THE ARTICLE COMPARING OCCURRENCE OF HARM SIMILAR TO YOUR CLINICAL DILEMMA?

Methodology
APPLICABILITY
Is the study relevant?
Participants

Researchers
Is the study valid?
Relative Risk Increase
(RRI)
= (Rt– Rc ) / Rc x 100
= 0.037-.029/ 0.029 x 100
= 28%

Boussageon, R., et al., Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ 2011;343:d4169.
HbA1c goal of <7%
has been shown to reduce microvascular complications of diabetes and if implemented soon after the diagnosis of diabetes is associated with long-term reduction in macrovascular disease.
<6.5% HbA1c goal
for selected individuals, if it can be achieved without significant hypoglycemia. these might include those with short duration of diabetes, long life expectancy and no significant cardiovascular disease.
<8% Hba1c goal
for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions and long-standing diabetes.
American Diabetes Association: Standards of Medical Care in Diabetes - 2013
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