Fibrate and cardiovascular disease: Evident from meta-analysis. Thongchai Pratipanawatr
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1 Fibrate and cardiovascular disease: Evident from meta-analysis Thongchai Pratipanawatr
2 ??? ย คห นใหม ย คห นกลาง ย คห นเก า
3 ?? Statin era? ย คห นใหม ย คห นกลาง ย คห นเก า
4 CURRENT ROLE OF FIBRATE What are the roles of fibrate in statin era. Severe hypertriglyceridemia Allergy to statin Side effect from statin Myopathy GI : N/V Hepatitis Combination with statin in combined dyslipidemia
5 DRUG AFFECTING LIPOPROTEIN METABOLISM Drug class Lipid effects Side effects Contraindications Statin Decrease LDL Myopathy, increase liver enzyme Fibrate Bile acid sequestr ants Decrease TG and increase HDL Decrease LDL Dyspepsia, gall stones, myopathy Gastrointestinal distress, constipation, decrease absorption of other drugs Active or chronic liver disease Severe renal and hepatic disease Dysbetalipoproteinemia, Hypertriglyceridemia (TG>400 mg/dl) Ecetimide Decrease LDL increase liver enzyme Hypertriglyceridemia (TG>400 mg/dl) Nicotinic acid Decrease LDL Flushing, hyperglycemia, hyperuricemia, hepatotoxicity Chronic liver disease, severe gout
6 เราท าไมต องร กษาโรคไขม นส ง? 1.ให ผ ป วยอาย ย นยาว 2. ให ผ ป วยไม เจ บไม ป วย 3. ให ผ ป วยให ผ ป วยม ความส ข
7 THREE CATEGORIES OF RISK THAT MODIFY LDL CHOLESTEROL GOALS Risk Category LDL Goal CHD and CHD risk equivalents < 100 (Optional <70) Multiple (2+) risk factors < risk factor <160
8 CHD and CHD risk equivalents CHD DM Peripheral artery disease Abdominal aortic aneurysm Symptomatic carotid artery disease
9 ATHEROSCLEROTIC RISK FACTORS Age : male>45 female>55 yrs Smoking Hypertension Low HDL (<40 mg/l) Family history of premature CHD(male>55, female>45 yrs)
10 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
11 LIPID METABOLISM
12 CHOLESTEROL TRANSPORT SYSTEM Bile HMG coa reductase VLDL CE TG TG TG TGTG B TG IDL CE TG CE TG TG B Lipoprotein lipase LDL CE TG CE B TG Peripheral cell Chylomicron remnant CE TG TG Lipoprotein lipase Chylomicron CE TG TG TG TGTG TG Small bowel
13 REVERSE CHOLESTEROL TRANSPORT SYSTEM VLDL/LDL CE Bile CE C CE SR-B1 A-I CE Mature HDL A-I CETP LCAT A-I C Nascent HDL A-I ABC-A1 C CE Peripheral cell CE-depleted HDL Kidney
14 Activation of PPAR alpha alters expression of specific genes PPARα RXR retinoic AGGTCA X AGGTCA PPRE (DR-1)
15 Activation of PPAR alpha alters expression of specific genes Fibrate PPARα RXR retinoic Gene expression -Increase LPL, A I -Decrease C III AGGTCA X AGGTCA PPRE (DR-1)
16 CHOLESTEROL TRANSPORT SYSTEM Decrease apo C III Bile HMG coa reductase VLDL CE TG TG TG TGTG B TG IDL CE TG CE TG TG B Lipoprotein lipase LDL CE TG CE B TG Peripheral cell Chylomicron remnant CE TG TG Lipoprotein lipase Chylomicron CE TG TG TG TGTG TG Small bowel
17 REVERSE CHOLESTEROL TRANSPORT SYSTEM VLDL/LDL CE Bile CE C CE SR-B1 A-I CE Mature HDL A-I CETP LCAT A-I C Nascent HDL A-I ABC-A1 C CE Peripheral cell CE-depleted HDL Kidney
18 META-ANALYSIS:THE EFFECT OF FIBRATE ON CARDIOVASCULAR DISEASE
19 Search methodology
20 PUBMED SEARCH #1. cardiovascular disease [ Mesh ] 63,052 papers #2. fibrate 74 papers #3. fibric acid 44 papers #4. gemfibrozil 316 papers #5. bezafibrate 185 papers #6. fenofibrate 1,256 papers #7. #1 OR #2 177 papers #8. #1 OR #3 115 papers #9. #1 OR #4 379 papers #10. #1 OR #5 230 papers #11. #1 OR #6 274 papers
21 INCLUDE STUDY 1. Randomized control trials 2. Intervention : fenofibrate, bezafibrate, gemfibrozil 3. Outcome : death, cardiovascular disease (CVD) death, myocardial infarction, stroke, side effects 4. Duration of study more than 6 month
22 META ANALYSIS OF FIBRATE STUDIES Study year Treatment Control Helsigki BECAIT SENDCAP VA HIT BIP DAIS Leader FIELD Total
23 META ANALYSIS OF FIBRATE STUDIES Study year Treatment Control Helsigki 1987 Gemfibrozil Primary BECAIT 1997 Bezafibrate Secondary SENDCAP 1998 Bezafibrate Primary VA HIT 1999 Gemfibrozil Secondary BIP 2000 Bezafibrate Secondary DAIS 2001 Fenofibrate Mix Leader 2002 Bezafibrate Primary FIELD 2005 Fenofibrate Mix Total
24 HETEROGENEITY Statistic : chi2 Subgroup analysis Primary vs secondary Drugs
25 RESULTS
26 Myocardial infarction
27 FATAL AND NON-FATAL MYOCARDIAL INFARCTION Study Treatment Control Genfibrozil Helsigki 51/ /2030 VA HIT 219/ /1267 Fenofibrate DAIS 9/207 11/211 FIELD 158/ /4900 Bezalifrate BECAIT 3/42 11/39 SENDCAP 6/81 17/83 BIP 168/ /1542 Leader 90/ /785 Total Favours treatment Favours control 0.72 ( ) 0.76 ( ) 0.79 ( ) 0.76 ( ) ratipanawatr T MD, unpublished
28 FATAL AND NON-FATAL MYOCARDIAL INFARCTION Study Treatment Control Primary Helsigki 51/ /2030 SENDCAP 6/81 17/83 Leader 90/ /785 Secondary BECAIT 3/42 11/39 BIP 168/ /1542 VA HIT 219/ /1267 Mix DAIS 9/207 11/211 FIELD 158/ /4900 Total Favours treatment Favours control 0.69 ( ) 0.79 ( ) 0.76 ( ) 0.76 ( ) ratipanawatr T MD, unpublished
29 CORONARY REVASCULIZATION Study Treatment Control Genfibrozil VA HIT 284/ /1267 Fenofibrate DAIS 19/207 31/211 FIELD 290/ /4900 Bezalifrate BIP 72/ /1542 Favours treatment Favours control 0.86 ( ) 0.77 ( ) 1.05 ( ) Total ( ) ratipanawatr T MD, unpublished
30 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
31 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
32 Conclusions Treatment with fibrate significantly reduced myocardial infarction (by 24%) and coronary artery revascularization (by 16%).
33 Stroke
34 STROKE Study Treatment Control Genfibrozil Helsigki 6/2051 4/2030 VA HIT 64/ /1267 Fenofibrate Shiming et al 13/115 24/110 FIELD 158/ /4900 Bezalifrate BIP 72/ /1542 Leader 60/783 49/785 Favours treatment Favours control 0.75 ( ) 0.85 ( ) 1.05 ( ) Total ( ) ratipanawatr T MD, unpublished
35 Study Treatment Control Primary Helsigki 6/2051 4/2030 Leader 60/783 49/785 Shiming et al 13/115 24/110 Secondary BIP 72/ /1542 VA HIT 64/ /1267 Mix STROKE FIELD 158/ /4900 Favours treatment Favours control 1.02 ( ) 0.81 ( ) 0.90 ( ) Total ( ) ratipanawatr T MD, unpublished
36 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
37 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
38 Conclusions Treatment with fibrate reduced incidence of stroke by 11%.
39 Compared with statin: MI, revascularization and Stroke Cholesterol Treatment Trialists (CTT) Collaborators. Lancet 2005; 366:
40
41 Death
42 TOTAL DEATH Study Treatment Control Genfibrozil Helsigki 45/ /2030 VA HIT 198/ /1267 Fenofibrate DAIS 6/207 9/211 FIELD 356/ /4900 Bezalifrate BIP 161/ /1542 Leader 204/ /785 Favours treatment Favours control 0.92 ( ) 1.10 ( ) 1.06 ( ) Total ( ) ratipanawatr T MD, unpublished
43 Study Treatment Control Primary Helsigki 45/ /2030 Leader 204/ /785 Secondary BIP 161/ /1542 VA HIT 219/ /1267 Mix TOTAL DEATH DAIS 6/207 9/211 FIELD 356/ /4900 Favours treatment Favours control 1.07 ( ) 0.96 ( ) 1.10 ( ) Total ( ) ratipanawatr T MD, unpublished
44 CVD DEATH Study Treatment Control Genfibrozil Helsigki 14/ /2030 VA HIT 93/ /1267 Fenofibrate FIELD 140/ /4900 Bezalifrate BIP 95/ /1542 Leader 64/783 65/785 Favours treatment Favours control 0.77 ( ) 1.11 ( ) 1.04 ( ) Total ( ) ratipanawatr T MD, unpublished
45 Study Treatment Control Primary Helsigki 14/ /2030 Leader 64/783 65/785 Secondary BIP 95/ /1542 VA HIT 93/ /1267 Mix CVD DEATH FIELD 140/ /4900 Favours treatment Favours control 0.92 ( ) 0.91 ( ) 1.11 ( ) Total ( ) ratipanawatr T MD, unpublished
46 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
47 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
48 Conclusions Fibrate did not reduce rate of death and cardiovascular death. However, gemfibrozil may reduce risk of cardiovascular death
49 Compared with statin: Death and CVD death Cholesterol Treatment Trialists (CTT) Collaborators. Lancet 2005; 366:
50
51 Microvascular complications (FIELD tertiary endpoints)
52 Microvascular disease Retinopathy 10 Cumulative risk (%) HR = % CI = p = Placebo Fenofibrate Years from randomization Placebo Fenofibrate 4,900 4,895 4,775 4,792 4,664 4,701 4,573 4,618 4,472 4,502 2,518 2, Number of patients still followed-up at the given year FIELD Study Investigators. Lancet 2005 ; 366 (9500) :
53 Microvascular disease Retinopathy Need for laser treatment for retinopathy Percentage of patie % -30% 3.6% P= This effect cannot be explained by changes in HbA 1c or concomitant medications, or by the minor reduction in blood pressure in the fenofibrate group 0 Placebo Fenofibrate FIELD Study Investigators. Lancet 2005 ; 366 (9500) :
54 Progression of microalbuminuria (baseline to study close) Regression No change Progression Placebo (n=4900) 400 (8.2%) 3654 (74.6%) 539 (11.0%) Fenofibrate (n=4895) 462 (9.4%) 3583 (73.2%) 466 (9.5%) Mann-Whitney test:p=0.002 Albuminuria status categories: Normal: <3.5 mg/mmol; microalbuminuria:3.5-<35 mg/mmol; macroalbuminuria: > 35 mg/mol This effect cannot be explained by changes in HbA 1c or concomitant medications, or by the minor reduction in blood pressure in the fenofibrate group FIELD Study Investigators. Lancet 2005 ; 366 (9500) :
55 PATHOGENESIS OF PROLIFERATIVE DIABETIC RETINOPATHY Endothelium proliferation (Neovascularization) Microvascular obstruction Vascular Endothelium Growth Factor Retinal cell ischemia
56 POSSIBLE EFFECT OF FIBRATE ON DIABETIC RETINOPATHY Endothelium proliferation (Neovascularization) Decrease lipotoxicity Microvascular obstruction Decrease VEGF via inhibition of activate protein1 (Grau R Biocehm J (2006) 395;81) Vascular Endothelium Growth Factor Retinal cell ischemia Decrease lipid utility (14% less O2 consumption)
57 Safety results
58 CANCER Study Treatment Control Genfibrozil Helsigki 11/ /2030 VA HIT 126/ /1267 Fenofibrate DAIS 5/207 7/211 FIELD 393/ /4900 Bezalifrate BIP 161/ /1542 Favours treatment Favours control 0.91 ( ) 1.05 ( ) 0.93 ( ) Total ( ) ratipanawatr T MD, unpublished
59 Compared with statin: Cancer Cholesterol Treatment Trialists (CTT) Collaborators. Lancet 2005; 366:
60
61 ELEVATED CK Study Treatment Control Favours treatment Favours control FIELD 11/4895 7/4900 BIP 4/1548 1/1542 Total ( ) ratipanawatr T MD, unpublished
62 Laboratory variable measurements occurring in < 2 % of patients Adverse event Placebo (n = 4,900) Fenofibrate (n = 4,895) ALT 3 5 ULN 26 (< 1%) 11 (< 1%) > 5 ULN 12 (< 1%) 11 (< 1%) CPK 5 10 ULN 7 (< 1%) 11 (< 1%) > 10 ULN 3 (< 1%) 4 (< 1%) Elevated creatinine (> 200 μmol/l) 48 (1%) 73 (2%) Abbreviations: ALT = alanine aminotransferase; CPK = creatine phosphokinase; ULN = upper limit of normal. FIELD Study Investigators. Lancet 2005 ; 366 (9500) :
63 Clinically important events occurring in < 2% of patients Adverse event Placebo (n = 4,900) Fenofibrate (n = 4,895) Deep-vein thrombosis 48 (1%) 67 (1%) Pulmonary embolism 32 (0.7%) 53 (1%) Pancreatitis 23 (0.5%) 40 (0.8%) Myositis 1 (< 1%) 2 (< 1%) Rhabdomyolysis 1 (< 1%) 3 (< 1%) Renal disease requiring dialysis 21 (< 1%) 16 (< 1%) FIELD Study Investigators. Lancet 2005 ; 366 (9500) :
64 GI SIDE EFFECT Study Treatment Control Genfibrozil Helsigki 225/ /2030 VA HIT 505/ /1267 Fenofibrate DAIS 1/207 4/211 FIELD 975/ /4900 Favours treatment Favours control 1.64 ( ) 1.06 ( ) Total ( ) ratipanawatr T MD, unpublished
65 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
66 OBJECTIVES Efficacy of fibrate on Myocardial infarction Coronary artery revascularization Stroke Death Safety of fibrate
67 Conclusions Fibrate did not increase incidence of cancer. However, it may increase incidence of myopathy
68 THANK YOU
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