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ผลัดที่2 6101769 ปภัสรา JC
ผลัดที่2 6101769 ปภัสรา JC
ปภัสรา เพชรชารี
วิทยาลัยเภสัชศาสตร์ มหาวิทยาลัยรังสิต
แหล่งฝกปฏิบัติงาน โรงพยาบาลบ้านหมี
ระหว่างวันที 1 พ.ค. - 9 มิย. 66
OUTLINES
Introduction
APPRAISE the evidence
- CASP checklist
APPLY the evidence
References
INTRODUCTION
INTRODUCTION
Statins are the recommended first-line class of lipid-lowering drugs
for the primary and secondary prevention of cardiovascular events.
Objective
We aim to directly assess, evaluate and compare
statins and fibrates in terms of efficacy in reducing
the risk of cardiovascular events and mortality.
8
Question 1.1
All the important, relevant studies were included?
Methods
9
Question 1.1
All the important, relevant studies were included?
We systematically searched for published and unpublished studies using Ovid MEDLINE and Epub
Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, EMBASE via Ovid, the Cochrane
Central Register of Controlled Trials, ClinicalTrials.gov, and the WHO International Controlled Trials
Registry Platform, from database inception until October 30, 2019.
Search strategies were developed using keywords and medical subject headings for statins, fibrates,
and the key efficacy and safety outcomes. We used recommended search terms (filters) which provide
the best balance of sensitivity and specificity for studies of treatment.
10
Question 1.1
All the important, relevant studies were included?
11
Question 1.1
All the important, relevant studies were included?
YES
Can't tell
No
12
Question 1.2
Were the criteria used to select articles for inclusion appropriate?
13
Question 1.2
Were the criteria used to select articles for inclusion appropriate?
14
Question 1.2
Were the criteria used to select articles for inclusion appropriate?
Outcomes
The primary efficacy outcome is defined as:
Cardiovascular mortality: any death due to a confirmed
or suspected cardiovascular cause.
15
Question 1.2
Were the criteria used to select articles for inclusion appropriate?
17
Question 1.2
Were the criteria used to select articles for inclusion appropriate?
YES
Can't tell
No
18
Question 1.3
Were assessment of studies reproducible?
19
Question 1.3
Were assessment of studies reproducible?
Data extraction
Two authors (GKYT and SP or SP and JEB) independently extracted
relevant study characteristics and outcomes using a standardized data
extraction form. Data were extracted from all identified relevant study
reports.
If discrepancies between published journal articles and trial registries
were identified, we extracted results from ClinicalTrials.gov, since
reporting of outcomes and severe adverse events is more complete than
in journal publications.
20
Question 1.3
Were assessment of studies reproducible?
YES
Can't tell
No
21
Risk of bias assessment
Question 1.4 Two authors (SP and JEB) independently assessed
the risk of bias within each study using the
Were the Cochrane Risk of Bias Tool.
included studies
sufficiently
valid for the
type of question
asked ?
22
Question 1.4
Were the included studies sufficiently valid for the type of question asked ?
23
Question 1.4
Were the included studies sufficiently valid for the type of question asked ?
funnel plot
24
Question 1.4
Were the included studies sufficiently valid for the type of
question asked ?
YES
Can't tell
No
25
Question 1.5
Were the results similar from the study to study ?
Assessment of Heterogeneity
1. Forest plot
- overlapping between 95% CI of each study
2. Statistical test
- Chi-squared test : P value < 0.1
- I squared > 50%
26
Question 1.5
Were the results similar from the study to study ?
Efficacy outcomes
Fig 2 . Forest plot of comparison: Statins versus fibrates, outcome: Cardiovascular mortality. Fig 4 . Forest plot of comparison: Statins versus fibrates, outcome: Major cardiovascular events.
27
Fig 5. Forest plot of comparison: Statins versus fibrates, outcome: Myocardial infarction.
Fig 3. Forest plot of comparison: Statins versus fibrates, outcome: All-cause mortality.
Question 1.5
Were the results similar from the study to study ?
95% CI
Overlab 95% CI No
Overlab
No Heterogeneity
low Heterogeneity
Fig 2 . Forest plot of comparison: Statins versus fibrates, outcome: Cardiovascular mortality. Fig 4 . Forest plot of comparison: Statins versus fibrates, outcome: Major cardiovascular events.
Fig 3. Forest plot of comparison: Statins versus fibrates, outcome: All-cause mortality.
28
Fig 5. Forest plot of comparison: Statins versus fibrates, outcome: Myocardial infarction.
Question 1.5
Were the
results
similar from Fig 6. Forest plot of comparison: Statins versus fibrates, outcome: Coronary artery disease.
the study to
study ?
moderate Heterogeneity
Fig 7. Forest plot of comparison: Statins versus fibrates, outcome: Unstable angina.
Efficacy outcomes
moderate Heterogeneity
study ? Fig 9. Forest plot of comparison: Statins versus fibrates, outcome: Study withdrawal due to adverse effects.
Safety outcomes
Fig 10. Forest plot of comparison: Statins versus fibrates, outcome: Serious adverse effects.
30
Question 1.5
Were the
Fig 11. Forest plot of comparison:
Statins versus fibrates, outcome:
Myalgia.
results
similar from
the study to
study ? Fig 12. Forest plot of comparison:
Statins versus fibrates, outcome:
Elevated alanine aminotransferase.
moderate Heterogeneity
Safety outcomes
Fig 13. Forest plot of comparison:
Statins versus fibrates, outcome:
Elevated serum creatinine.
31
Question 1.5
Were the results similar from the study to study ?
YES
Can't tell
No
32
2. What are the results?
Question 2.1
What are the overall results of the review?
Efficacy outcomes
Fig 2 . Forest plot of comparison: Statins versus fibrates, outcome: Cardiovascular mortality. Fig 4 . Forest plot of comparison: Statins versus fibrates, outcome: Major cardiovascular events.
34
Fig 5. Forest plot of comparison: Statins versus fibrates, outcome: Myocardial infarction.
Fig 3. Forest plot of comparison: Statins versus fibrates, outcome: All-cause mortality.
Question 2.1
What are the
overall
results of the Fig 6. Forest plot of comparison: Statins versus fibrates, outcome: Coronary artery disease.
review?
Fig 7. Forest plot of comparison: Statins versus fibrates, outcome: Unstable angina.
Efficacy outcomes
35
Fig 8. Forest plot of comparison: Statins versus fibrates, outcome: Stroke.
Question 2.1 Surrogate efficacy outcomes
1. There were greater reductions in percent change from baseline for
What are the TC (MD -11.49%, 95% CI -12.20 to -10.77, I2 = 96%; 15 studies,
n = 6002; S1 Fig),
overall LDL-C (MD -19.63%, 95% CI -20.70 to -18.55, I2 = 96%; 15 studies,
results of the n = 5795; S2 Fig)
non-HDL-C (MD -20.94%, -22.46 to -19.41, I2 = 93%; four studies,
review?
n = 2008; S3 Fig)
and apoB (MD -16.83%, 95% CI -18.10 to -15.56, I2 = 86%; nine
studies, n = 3003; S4 Fig)
among statin therapy than fibrate therapy.
Surrogate
Fibrates reduced triglyceride levels by 15.34% (95% CI 13.52 to
outcomes 17.15, I2 = 71%; 15 studies, n = 5922; S5 Fig) and increased HDL-C
concentrations (MD 8.15%, 95% CI 9.23 to 7.07, I2 = 69%; 15 stud-
ies, n = 5850; S6 Fig) more than statins.
36
Question 2.1
What are the
overall
results of the
review?
Fig 9. Forest plot of comparison: Statins versus fibrates, outcome: Study withdrawal due to adverse effects.
Safety outcomes
Fig 10. Forest plot of comparison: Statins versus fibrates, outcome: Serious adverse effects.
37
Question 2.1
Fig 11. Forest plot of comparison:
overall
results of the
review?
Fig 12. Forest plot of comparison: Statins
versus fibrates, outcome: Elevated alanine
aminotransferase.
Safety outcomes
Fig 13. Forest plot of comparison:
Statins versus fibrates, outcome:
Elevated serum creatinine.
38
Question 2.1
What are the overall results of the review?
Publication Bias
39
Question 2.1
What are the overall results of the review?
40
Question 2.1
What are the overall results of the review?
41
Question 2.1
What are the overall results of the review?
42
Question 2.1
What are the overall results of the review?
YES
Can't tell
No
43
Question 2.2
How precise are the results?
Efficacy outcomes
Fig 4 . Forest plot of comparison: Statins versus fibrates, outcome: Major cardiovascular events.
Fig 2 . Forest plot of comparison: Statins versus fibrates, outcome: Cardiovascular mortality.
44
Fig 5. Forest plot of comparison: Statins versus fibrates, outcome: Myocardial infarction.
Fig 3. Forest plot of comparison: Statins versus fibrates, outcome: All-cause mortality.
Question 2.2
How precise
are the
results? Fig 6. Forest plot of comparison: Statins versus fibrates, outcome: Coronary artery disease.
Fig 7. Forest plot of comparison: Statins versus fibrates, outcome: Unstable angina.
Efficacy outcomes
45
Fig 8. Forest plot of comparison: Statins versus fibrates, outcome: Stroke.
Question 2.2
How precise
are the
results?
Fig 9. Forest plot of comparison: Statins versus fibrates, outcome: Study withdrawal due to adverse effects.
Safety outcomes
Fig 10. Forest plot of comparison: Statins versus fibrates, outcome: Serious adverse effects.
46
Question 2.2
Fig 11. Forest plot of comparison:
How precise
Statins versus fibrates, outcome:
Myalgia.
are the
results?
Safety outcomes
Fig 13. Forest plot of comparison:
Statins versus fibrates, outcome:
Elevated serum creatinine.
47
Question 2.2
How precise are the results?
YES
Can't tell
No
48
3. How can I apply the results to
my patient care?
25
Question 3.1
Can the results be applied to the local population ?
Baseline characteristic
50
Question 3.1
Can the results be applied to the local population ?
Baseline characteristic
51
Question 3.1
Can the results be applied to the local population ?
Inclusion criteria
❏ Participants aged ≥18 years
Age 51 y/o
52
Question 3.1
Can the results be applied to the local population ?
YES
Can't tell
No
53
Question 3.2
Were all important outcomes considered?
54
Question 3.2
Were all important outcomes considered?
55
Question 3.2
Were all important outcomes considered?
YES
Can't tell
No
56
Question 3.3
Are the benefits worth the harms and costs?
this study adds further direct evidence to support the role of statins as a
potentially safer treatment with respect to tolerability, a reduction in serious
adverse effects, and a reduced risk of elevated serum creatinine levels.
Cost
58
Question 3.3
Are the benefits worth the harms and costs?
Benefits Harms
Cost
"Value" 59
Question 3.3
Are the benefits worth the harms and costs?
YES
Can't tell
No
60
4. APPLY THE
EVIDENCE
จากการศึกษานี จะประยุกต์ใช้งานวิจัยนี
กับผูป
้ วยหรือไม่ ? เพราะเหตุใด ?
ประยุกต์ใช้ได้
ผูป
้ วย (โรคไขมันในเลือดสูงในรพ.บ้านหมี)
มีคณุ สมบัติทีตรงกับ PICO ของงานวิจัยนี และเข้ากับ Inclusion criteria
ของงานวิจัยนี เช่นกัน เช่น
1. Dyslipidemia
2. Adults (≥18 years old)
3. All participants assigned to statin or fibrate monotherapy.
4. Lipid profile abnormality
Patients - High TC, LDL, TG
62
จากการศึกษานี จะประยุกต์ใช้งานวิจัยนี
กับผูป
้ วยของเราหรือไม่ ? เพราะเหตุใด ?
Efficacy & Prevention Cost/สิทธิการ others
รักษา
risk
factors
มีการศึกษาพบว่ายาซิมวาสแตติน, อะทอร์วาสแตตินและโรซูวาสแตตินในขนาดสูงลดไตรกลีเซอไรด์ในเลือดได้
40-50% ยาในกลุ่มนีใช้เมือมีไตรกลีเซอไรด์ในเลือดสูงไม่ถึง 500 มิลลิกรัม/เดซิลิตร ร่วมกับมีแอลดีแอล-
โคเลสเตอรอลสูง ไม่เหมาะทีจะใช้หากมีไตรกลีเซอไรด์ในเลือดสูงตังแต่ 500 มิลลิกรัม/เดซิลิตร ขึนไป และไม่ใช้
ในกรณีทีภาวะทีมีไตรกลีเซอไรด์ในเลือดสูงโดยลําพัง ประสิทธิภาพในการลดไตรกลีเซอไรด์ (รวมถึงลดวีแอลดี
แอล-โคเลสเตอรอล) จะสัมพันธ์กับฤทธิลดแอลดีแอล-โคเลสเตอรอล กล่าวคือยาทีลดแอลดีแอล-โคเลสเตอรอล
ในเลือดได้ดีทีสุดจะลดไตรกลีเซอไรด์และวีแอลดีแอล-โคเลสเตอรอลในเลือดได้มากทีสุดด้วย นอกจากนียังขึน
กับระดับไตรกลีเซอไรด์เมือเริมต้น หากมีระดับสูงยาจะให้ผลดี
ก่อนเริมการรักษาภาวะไตรกลีเซอไรด์ในเลือดสูงด้วยยา ควรเริมด้วยวิธก
ี ารไม่ใช้ยา (ดังกล่าวข้างต้น) หากได้ผล
ไม่เพียงพอจึงใช้ยาร่วมด้วย (ควบคู่ไปกับการรักษาโดยไม่ใช้ยา)
ผูท
้ ีมีความเสียงสูงต่อการเกิดโรคจากหลอดเลือดแดงแข็ง ควรลดปจจัยเสียงต่าง ๆ ด้วย ให้ความร่วมมือในการ
รักษาโรคอืนทีเปนอยู่ และผูท ้ ีเปนโรคเบาหวานควรคุมระดับนาตาลให้ได้ เพือการได้รบั ประโยชน์สงู สุดจากยา
ลดไตรกลีเซอไรด์ในเลือด