Template for Reports Developed
Appendix Table C124 Overview of anti-lipid trialsStudy/Region/Funding SourceInclusion/Exclusion CriteriaPatient Characteristics (expressed in means unless otherwise noted)Intervention/DurationStudy QualityHMG-CoA Reductase Inhibitor versus Placebo trials (n=12)Kendrick, 2010PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZW5kcmljazwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA 87AFCAPS/TexCAPSUnited StatesFunding Source: Industry and otherInclusion Criteria: Men aged 45-73 years or postmenopausal women aged 55-73 years who met the lipid entrance criteria at both 4 and 2 weeks before randomization with a <15% difference in LDL-C values between visits. Lipid entry criteria included total cholesterol 180-264 mg/dL, LDL-C 130-190 mg/dL, HDL-C ≤ 45 mg/dL for men or ≤ 47 mg/dL for women, and triglycerides ≤ 400 mg/dL. Exclusion Criteria: Clinical evidence atherosclerotic CVD, secondary hyperlipoproteinemia, nephrotic syndrome, uncontrolled HTN, and type 1 or 2 diabetes mellitus.N=304 (Post hoc analysis in subgroup with baseline GFR < 60 ml/min/ 1.73m2 from total of 6605 randomized).Age (yr): 62 Gender (Male %): 79Race/Ethnicity (%): White NR, Mexican American NR, African American 1BMI: 26Systolic BP (mm Hg): 142 Diastolic BP (mm Hg): 79Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): 1.4Estimated GFR (ml/min/1.73m2): 53Total cholesterol (mg/dL): 222LDL cholesterol (mg/dL): 151Diabetes (%): 2 History of HTN (%): 35 (p<0.05 between groups)History of CAD (%): 0History of CHF (%): NRHistory of MI (%): 0PTCA (%): 0CABG (%): 0 History of Stroke (%): NRPeripheral arterial disease (%):NRCurrent smoker (%): 8Lovastatin initiated at 20 mg/d, titrated up to 40 mg/d to reach goal LDL ≤110 mg/dL (n=145)Placebo (n=159)Followup period: mean 5.1 yearsStudy withdrawals (%): No information reported for CKD group; stated both that all had complete data and that 24% of original AFCAPS/TexCAPS participants did not have data to calculate yearly change in GFR.Allocation Concealment: UnclearBlinding: double, end points adjudicated by blinded committeeIntention to Treat Analysis (ITT): yesWithdrawals/ Dropouts adequately described: Study reported available followup data on all participantsAppendix Table C124 Overview of anti-lipid trials (continued)Study/Region/Funding SourceInclusion/Exclusion CriteriaPatient Characteristics (expressed in means unless otherwise noted)Intervention/DurationStudy QualityRidker, 2010PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SaWRrZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 88JUPITERUnited StatesFunding Source: Industry Inclusion Criteria: apparently healthy men over age 50 years andwomen over age 60 years with LDL-C <130 mg/dl at increased vascular risk due to high-sensitivity C-reactive protein (hsCRP) ≥2 mg/l.Exclusion Criteria: treatment within 6 weeks of screening with any lipid lowering therapies, current use ofhormone replacement therapy, evidence of hepatic dysfunction,creatinine >2.0 mg/dl, diabetes, uncontrolled hypertension, prior malignancy, uncontrolled hypothyroidism, or a recent history of alcohol, drug abuse, or other medical condition that might compromise safety.N=3,267 (Post hoc analysis in subgroup with baseline GFR < 60 ml/min/ 1.73m2 from total of 17,795 randomized).Age (yr): 70Gender (Male %): 35Race/Ethnicity (%): White 74, Hispanic 19, African American 3BMI: 29Systolic BP (mm Hg): 133 Diastolic BP (mm Hg): 80Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): 56 (51 to 58)Total cholesterol (mg/dL): 189LDL cholesterol (mg/dL): 109Diabetes (%): 0 History of HTN (%): NR (none with uncontrolled)History of CAD (%): NRHistory of CHF (%): NRHistory of MI (%): NRPTCA (%): NRCABG (%): NR History of Stroke (%): NRPeripheral arterial disease (%): NRCurrent smoker (%): 8Rosuvastatin 20 mg/d (n=1638)Placebo (n=1629)Followup period: median 1.9 years (maximum 5 years)Study withdrawals (%): No information reported for CKD group in this secondary analyses.Allocation Concealment: adequateBlinding: double, end points adjudicated by blinded committeeIntention to Treat Analysis (ITT): yesWithdrawals/ Dropouts adequately described: No information reportedNakamura, 2009PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYWthbXVyYTwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+
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ADDIN EN.CITE.DATA 89MEGAJapanFunding Source: Government and industryInclusion Criteria: Men and postmenopausal women aged 40-70 years with total cholesterol 220-270 mg/dL and no history of CHD and/or stroke.Exclusion Criteria: Familial hypercholesterolemia, history of CVD, cancer, serum creatinine ≥1.5 mg/dL, significant liver disease, and secondary hyperlipidemiaN=2,978 (Secondary analysis in subgroup with baseline GFR 30 to 59 ml/min/ 1.73m2 from total of 7,196 patients randomized. Age (yr): 60 Gender (Male %): 24Race/Ethnicity (%): NRBMI: NRSystolic BP (mm Hg): 133 Diastolic BP (mm Hg): NRAlbuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): 53Total cholesterol (mg/dL): 244LDL cholesterol (mg/dL): 155Diabetes (%): 19 History of HTN (%): 46History of CAD (%): 0 History of CHF (%): NRHistory of MI (%): 0PTCA (%): 0 CABG (%): 0 History of stroke (%): 0 Peripheral arterial disease (%): NR Current smoker (%): 13Pravastatin (low dose) 10-20 mg/d + Step I diet counseling (n=1471)Diet counseling (n=1,507)Followup period 5.3 yearsStudy withdrawals (%): No information reportedAllocation Concealment: Adequate (from main paper)Blinding: open-labelIntention to Treat Analysis (ITT): yesWithdrawals/ Dropouts adequately described: No information reportedColhoun, 2009PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db2xob3VuPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48
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ADDIN EN.CITE.DATA 90CARDSUnited Kingdom and IrelandFunding Source: IndustryInclusion Criteria: Diabetes and at least 1 of the following risk factors: (1) history of HTN, (2) retinopathy (i.e., any retinopathy, maculopathy, or prior photocoagulation), (3) microalbuminuria (urinary albumin/creatinine ratio 22 to 221 mg/g) or microalbuminuria (urinary albumin/creatinine ratio >221 mg/g), or (4) current smoking.Exclusion Criteria: History of MI, angina, coronary vascular surgery, cerebrovascular accident, or severe peripheral vascular disease (defined as warranting surgery); creatinine concentration > 1.7 mg/dL or glycated hemoglobin (hemoglobin A1c) level >12%.N=970 (Secondary analysis in subgroup with baseline GFR <60 ml/min/ 1.73m2 from total of 2,838 randomized)Age (yr): 65 Gender (Male %): 48Race/Ethnicity (%): white 96 BMI: NRSystolic BP (mm Hg): NRDiastolic BP (mm Hg): NR Albuminuria (% > Micro): 21Albumin/creatinine ratio: 10Serum creatinine (mg/dL): 1.3Estimated GFR (ml/min/1.73m2): 54Total cholesterol (mg/dL): 211LDL cholesterol (mg/dL): 120Diabetes (%): 100 History of HTN (%): NR History of CAD (%): 0 History of CHF (%): NRHistory of MI (%): 0PTCA (%): 0CABG (%): 0 History of Stroke (%): 0 Peripheral arterial disease (%): NRCurrent smoker (%): NRAtorvastatin 10 mg/d (n=482)Placebo (n=488)Followup period: median 3.9 yearsStudy withdrawals (%): No information reportedAllocation Concealment: Adequate ( from main paper)Blinding: double, end points adjudicated by blinded committeeIntention to Treat Analysis (ITT): yesWithdrawals/ Dropouts adequately described: No information reportedKoren, 2009PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb3JlbjwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 92ALLIANCEUnited StatesFunding Source: IndustryInclusion Criteria: Male or female older than 18 years of age with known CHD, defined as prior acute MI, CABG, or unstable angina >3 months before screening, or PTCA >6 months before screening. LDL-C 110-200 mg/dL for patients on antilipid drugs or 130-250 mg/dL for patients receiving no antilipid drugs.Exclusion Criteria: Patients with chronic stable angina or awaiting revascularization procedures. Breastfeeding or pregnancy; women of childbearing age planning to become pregnant during the study or who did not practice a method of birth control acceptable to the investigator; any significant abnormalities investigator believed may compromise the patient’s safety or successful completion of the study; any disease process likely to limit life to less than the duration of the study; all cancers (excluding basal cell and squamous cell skin cancers); New York Heart Association class III or IV congestive heart failure; known hypersensitivities to hydroxymethylglutaryl coenzyme A reductase inhibitors.N= 579 (Secondary analysis in subgroup with baseline GFR <60 ml/min/ 1.73m2) from total of 2,442 randomized). Age (yr): 65 Gender (Male %): 77Race/Ethnicity (%): white 88; African American 9BMI: 29Systolic BP (mm Hg): 137 Diastolic BP (mm Hg): 78Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): 1.5Estimated GFR (ml/min/1.73m2): 51Total cholesterol (mg/dL): 228LDL cholesterol (mg/dL): 147Diabetes (%): 28 History of HTN (%): NR History of CAD (%): 100 History of CHF (%): 10History of MI (%): 62PTCA (%): 33 CABG (%): 53 History of Stroke (%): 10 Peripheral arterial disease (%): NR Current smoker (%): 15Atorvastatin, started at 10 mg/day, then titrated up to achieve LDL goal of <80 mg/dL up to maximum of 80 mg/day (n=286)Usual care (n=293)Followup period: median 4.5 yearsStudy withdrawals (%): 19% (n=465/2,442) withdrawals from main study, but data not reported for CKD subgroup.Allocation Concealment: Adequate Blinding: open-labelIntention to Treat Analysis (ITT): yesWithdrawals/Dropouts adequately described: No information reported.Rahman, 2008PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWhtYW48L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 93ALLHAT-LLT United States, Puerto Rico, U.S. Virgin Islands, and CanadaFunding: Government and IndustryInclusion Criteria: age ≥55 years and stage 1 or 2 hypertension with at least 1 additional CHD risk factor); fasting LDL-C level of 120-189 mg/dL for those with no known CHD, or 100-129 mg/dL for those with known CHD, and fasting triglyceride levels lower than 350 mg/dL. Exclusion Criteria: currently using prescribed lipid-lowering agents or large doses (500 mg/day) of nonprescription niacin; were known to be intolerant of statins or to have significant liver dysfunction (serum alanine aminotransferase >100 IU/L); had other contraindications for statin therapy; or had a known secondary cause of hyperlipidemia.N=1,557 (Secondary analysis in subgroup with baseline GFR < 60 ml/min/1.73m2) from total of 10,060 randomized). Age (yr): 71 Gender (Male %): 46Race/Ethnicity (%): white 51 , black 29, Hispanic 15BMI: 29Systolic BP (mm Hg): 146 Diastolic BP (mm Hg): 82Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): 50Total cholesterol (mg/dL): 225LDL cholesterol (mg/dL): 146Diabetes, type 2 (%): 31 History of HTN (%): 100History of CAD (%): 18History of CHF (%): NRHistory of MI or Stroke (reported pooled % only): 22.0History of coronary revascularization: 9Peripheral arterial disease (%): NR Current smoker (%): 19Pravastatin 40 mg/d (n=779)Usual care (n=778)Followup period: mean 4.8 yearsStudy withdrawals (%): No information reportedAllocation Concealment: UnclearBlinding: open-labelIntention to Treat Analysis (ITT): yesWithdrawals/Dropouts adequately described: No information reportedChonchol, 2007PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaG9uY2hvbDwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+
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ADDIN EN.CITE.DATA 95ScandanaviaInclusion criteria: Men and women aged 35-70 yrs, with history of CHD (MI and/or angina), total cholesterol 212-309 mg/dL, triglycerides <221 mg/dLExclusion criteria: Secondary hypercholesterolemia, unstable angina, planned CABG or PTCA, recent MI (recent not defined), CHF requiring treatment, hypersensitivity to HMG-CoA reductase inhibitors.N=505 (Subgroup analysis of patients with eGFR <60 mL/min/1.73m2 performed within a post hoc analysis of patients with eGFR <75 mL/min/1.73m2 from the 4,420 with baseline creatinine measurements) from total of 4,444 participants randomized in 4S Trial.Baseline characteristics not reported for n=505 participants with eGFR <60 mL/min/1.73m2 in Chonchol paper, but are reported for n=409 participants (n=199 simvastatin, n=210 placebo) with eGFR <60 mL/min/1.73m2 in Huskey paper.Age (yr): 62.2Gender (% male): 54BMI (kg/m2): 25.9Systolic BP (mm Hg): 143.1Diastolic BP (mm Hg): 83.7Serum creatinine (mg/dL): 1.21Estimated GFR (mL/min/1.73m2): 54.7Total cholesterol (mg/dL): 265LDL cholesterol (mg/dL): 191.5Diabetes (%): 2.7History of HTN (%): 37.4History of CAD (%): 100History of CHF (%): NRHistory of MI (%): 77.8PTCA or CABG (%): 7.1History of Stroke (%): NRPeripheral arterial disease (%):NRCurrent smoker (%): 16Simvastatin (n=245), initiated at 20 mg/day, titrated up to 40 mg/day as needed to get total cholesterol to <200 mg/dLPlacebo (n=260)Followup duration: median 5.4 yearsStudy withdrawals (%): No data reported for eGFR<60 groupAllocation concealment: UnclearBlinding: Double blind. Outcome assessors blinded to treatment assignmentIntention to treat analysis (ITT): NoWithdrawals/dropouts adequately described: No data reportedKjekshus, 2007PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LamVrc2h1czwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+
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ADDIN EN.CITE.DATA 96CORONAMultinational, including 19 European countries, Russia, and South AfricaFunding Source: IndustryInclusion Criteria: ≥60 years of age,chronic NYHA class II, III, or IV heart failure of ischemic cause (as reported by investigators) and an ejection fraction of no more than 40% (no more than 35% in patients in NYHA class II); investigator did not think patient needed treatment with a cholesterol-lowering drug. Exclusion Criteria: Previous statin-induced myopathy/hypersensitivity reaction; decompensated heart failure or need for inotropic therapy; MI within past 6 months; unstable angina or stroke within past 3 months; PCTA, CABG, or the implantation of a cardioverter-defibrillator or biventricular pacemaker within past 3 months or planned implantation of such a device; previous or planned heart transplantation; clinically significant, uncorrected primary valvular heart disease or malfunctioning prosthetic valve; hypertrophic cardiomyopathy; acute endomyocarditis or myocarditis, pericardial disease, or systemic disease (e.g. amyloidosis); acute or chronic liver disease; levels of alanine aminotransferase or thyrotropin >2 times the ULN range; a serum creatinine level >2.5 mg/dL; chronic muscle disease or unexplained creatine kinase level >2.5 times the ULN range; previous treatment with cyclosporine; any other condition that would substantially reduce life expectancy or limit compliance with the protocol; or the receipt of <80% of dispensed placebo tablets during the run-in period.N=1,635 patients with CKD (Subgroup analysis within patients with baseline GFR < 51 ml/min/1.73m2 from among total of 5,011 randomized in CORONA study). Baseline characteristics not reported for CKD subjects only except for those identifiable from entry criteria.Age (yr): NR Gender (Male %): NRRace/Ethnicity (%): NRBMI: NRSystolic BP (mm Hg): NR Diastolic BP (mm Hg): NRAlbuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): NRTotal cholesterol (mg/dL): NRLDL cholesterol (mg/dL): NRDiabetes (%): NR History of HTN (%): NRHistory of CAD (%): 100History of CHF (%): 100History of MI (%): NRPTCA (%): NRCABG (%): NR History of Stroke (%): NRPeripheral arterial disease (%):NRCurrent smoker (%): NRRosuvastatin 10 mg/day (n=1,418)Placebo (n=1,432)Followup period: Median 2.7 yearsStudy withdrawals (%): No data reported for CKD subgroupAllocation concealment: Adequate (centralized interactive Web-based response system)Blinding: double, end points adjudicated by blinded committeeIntention-to-treat analysis: yesWithdrawals/dropouts adequately described: No data reported for CKD subgroupLemos, 2005PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZW1vczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 97LIPSMultinationalFunding Source: IndustryInclusion Criteria: Successful completion of a first percutaneous coronary intervention (successful defined as residual stenosis <50%, no post-procedural in-hospital myocardial necrosis, repeat vascularization or death); Eligible participants had to meet at least one of the following: (1) total cholesterol level of 135 to 270 mg/dl with a fasting triglyceride level <400 mg/dl, or (2) total cholesterol level <212 mg/dl for patients whose lipids levels were measured 24 hours to 4 weeks after an episode of MI, or (3) total cholesterol level <232 mg/dl for patients who had diabetes. Exclusion Criteria: baseline serum creatinine value >1.8 mg/dlN=310 (post hoc subgroup analysis limited to patients with creatinine clearance in the lowest quintile or <55.9 ml/min from among 1,558 subjects with complete data for creatinine clearance calculation from among 1,677 randomized participants in the LIPS study) Age (yr): 69 Gender (Male %): 67Race/Ethnicity (%): NR BMI: 25.0 (calculated from given weight and height)Systolic BP (mm Hg): 132Diastolic BP (mm Hg): 75Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): 1.33 Creatinine clearance (ml/min): 47Estimated GFR (ml/min/1.73m2): NRTotal cholesterol (mg/dL): 200LDL cholesterol (mg/dL): 131Diabetes (%): 12 History of HTN (%): 51History of CAD (%): 100 History of CHF (%): NRHistory of MI (%): 47PTCA (%): 100CABG (%): NR History of Stroke (%): 5Peripheral arterial disease (%): 11Current smoker (%): 17Fluvastatin 40 mg twice daily (n=150)Placebo (n=160)Followup period: 3 to 4 yearsStudy withdrawals (%): No data reported, but 100% included in endpoint analysisAllocation Concealment: Unclear in this report Blinding: double and outcomes assessors Intention to Treat Analysis (ITT): YesWithdrawals/ Dropouts adequately described: No data reported, but 100% included in endpoint analysisAsselbergs, 2004PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc3NlbGJlcmdzPC9BdXRob3I+PFllYXI+MjAwNDwvWWVh
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ADDIN EN.CITE.DATA 98 WOSCOPS/ CARE/LIPIDMultinationalFunding Source: Not stated in current reportEntry Criteria: WOSCOPS studied high-risk patients who had not previously experienced an MI. Excluded baseline creatinine >1.7 mg/dL CARE and LIPID were trials of subjects with previous acute coronary syndromes and average cholesterol levels. Excluded baseline creatinine levels of >2.5 mg/dL and >4.5 mg/dL, respectively.Current report restricted to subjects with GFR 30-59.99 ml/min/1.73m2 using Cockroft-Gault formula. No further information on entry criteria provided. N=4,491 (post hoc subject-level pooling of results in patients with GFR 30-59.99 mL/min per 1.73m2 body surface area from 19,700 subjects in three previously completed RCTs comparing pravastatin 40 mg/day to placebo, i.e. CARE, WOSCOPS and LIPID studies)Age (yr): 65.7 Gender (Male %): 81.7Race/Ethnicity (%): NRBMI: 25.5Systolic BP (mm Hg): 135.5 Diastolic BP (mm Hg): 79.5Albuminuria (mg/24h): NRSerum creatinine (mg/dL): 1.4Estimated GFR (ml/min/1.73m2, per MDRD): 55.0Total cholesterol (mg/dL): 221.3 LDL cholesterol (mg/dL): 151.5Diabetes (%): 9.9 History of HTN (%): 44.8 History of CAD (%): 73.7 History of CHF (%): NRHistory of MI (%): 67.6PTCA (%): NRCABG (%): NR History of Stroke (%): 5.3 Peripheral arterial disease (%): NR Current smoker (%): 10.3Pravastatin 40 mg/d (n=2217)Placebo (n=2,274)Followup period: approximately 5 years Study withdrawals (%): No data reportedAllocation Concealment: Not described in current report Blinding: double and outcomes assessors Intention to Treat Analysis (ITT): unclearWithdrawals/Dropouts adequately described: Not described in current reportTonelli, 2003PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ub25lbGxpPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48
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ADDIN EN.CITE.DATA 99CAREMulticenterFunding Source:IndustryInclusion Criteria: Men and post-menopausal women, 21-75 years, had acute MI 3-20 months before randomization, total plasma cholesterol <240 mg/dL; LDL 115-174 mg/dL; triglyceride <350 mg/dL; fasting glucose <220 mg/dL, LVEF ≥25%; no symptomatic CHF. All lipid measures collected after 4 weeks treatment with National Cholesterol Education Program Step 1 diet.Exclusion Criteria: ≥2+ proteinuria on dipstick or serum creatinine >1.5 times upper limit of normalN= 1,711 (post hoc subgroup analysis limited to patients with creatinine clearance ≤75 mL/min from among 4,159 randomized participants in the CARE study)Age (yr): 64.3 Gender (Male %): 78.4Race/Ethnicity (%): White 91.9, Other 8.1BMI: NRSystolic BP (mm Hg): 131.0Diastolic BP (mm Hg): 77.3Proteinuria (dipstick positive, %): 31Serum creatinine (mg/dL): 1.26Creatinine clearance (ml/min): 61Total cholesterol (mg/dL): 209.0LDL cholesterol (mg/dL): 138.6HDL cholesterol (mg/dL): 40.6Diabetes (%): 13.9 History of HTN (%): 47.2History of CAD (%): 100History of CHF (%): 9.6History of MI (%): 100PTCA (%): NRCABG (%): NRHistory of Stroke (%): NRPeripheral arterial disease (%): NRCurrent smoker (%): 12.3Pravastatin , 40 mg/d (n=844); Placebo (n=867)Followup Period: 4.9 yearsStudy withdrawals (%): No participants were lost to followup and 100% were included in analysesAllocation Concealment: YesBlinding: doubleIntention to Treat Analysis (ITT): YesWithdrawals/Dropouts adequately described: YesHigh versus Low Dose HMG-CoA Reductase Inhibitor trials (n=2) SEARCH, 2010PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bcm1pdGFnZTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA 100UKFunding Source: Industry and otherInclusion Criteria: Adults aged 18–80 years with a history of previousMI were eligible provided they Fulfilled the following criteria: either current statin use or clearindication for this treatment (and no clear indication for folic acid); total cholesterol of at least 3?5 mmol/L ifalready on a statin or 4?5 mmol/L if not; and no clear contraindications to the study treatments.Exclusion Criteria: Predominant medical problems that couldreduce compliance with long-term study treatment. N=1,686 patients with CKD (Subgroup analysis within patients with baseline GFR < 60 ml/min/1.73m2 from among total of 12,064 randomized.Baseline characteristics not reported for CKD subjects only except for those identifiable from entry criteria.Age (yr): NR Gender (Male %): NRRace/Ethnicity (%): NRBMI: NRSystolic BP (mm Hg): NR Diastolic BP (mm Hg): NRAlbuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): NRTotal cholesterol (mg/dL): NRLDL cholesterol (mg/dL): NRDiabetes (%): NR History of HTN (%): NRHistory of CAD (%): 100History of CHF (%): NRHistory of MI (%): 100PTCA (%): NRCABG (%): NR History of Stroke (%): NRPeripheral arterial disease (%):NRCurrent smoker (%): NRSimvastatin 80 mg/d (n=820)Simvastatin 20 mg/d (n=866)Followup Period: mean 6.7 yearsStudy withdrawals (%): No data reported for CKD subgroupAllocation concealment: Yes (centralized telephone randomisation system)Blinding: double, end points adjudicated by blinded committeeIntention-to-treat analysis: yes (overall)Withdrawals/dropouts adequately described: No data reported for CKD subgroupShepard, 2008PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVwaGVyZDwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+
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ADDIN EN.CITE.DATA 103MultinationalFunding Source: IndustryInclusion Criteria: Men and women aged 35 to 75 years with clinically evident CHD (defined as previous myocardial infarction, previous or current angina with objective evidence of atherosclerotic CHD, or a history of coronary revascularization). LDL 130-250 mg/dL and triglycerides <600 mg/dL off anti-lipid drugs, with LDL <130 mg/dL after 8 week open label run-in on atorvastatin 10 mg/d.Exclusion criteria: hypersensitivity to statins; active liver disease or hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >1.5 times the ULN; women who are pregnant or breastfeeding; nephrotic syndrome; uncontrolled DM; uncontrolled hypothyroidism; uncontrolled HTN (defined by the investigator) at the screening visit; a MI, coronary revascularization procedure or severe/unstable angina within 1 month of screening; any planned surgical procedure for the treatment of atherosclerosis; an ejection fraction <30%; hemodynamically important valvular disease; gastrointestinal disease limiting drug absorption or partial ileal bypass; any nonskin malignancy, malignant melanoma or other survival-limiting disease; unexplained creatine phosphokinase levels >6 times the ULN; concurrent therapy with long-term immunosuppressants; concurrent therapy with lipid-regulating drugs not specified as study treatment in the protocol; history of alcohol abuse; and participation in another clinical trial concurrently or within 30 days before screening.N=3,107 (Post hoc analysis of subjects with eGFR <60 ml/min/1.73 m2 from among 10,003 randomized in TNT trial; 3,078 had CKD stage 3 (GFR 30-59) and 29 had CKD stage 4 (GFR 15-29) Age (yr): 65.5 Gender (Male %): 67.7Race/Ethnicity (%): white 95.2; black 1.6, other 3.2BMI: 28.5Systolic BP (mm Hg): 133.0 Diastolic BP (mm Hg): 77.5Albuminuria (mg/24 h): NRSerum creatinine (mg/dL): NREstimated GFR (ml/min/1.73m2): 52.9Total cholesterol (mg/dL): 175.9LDL cholesterol (mg/dL): 96.4Diabetes (%): 17.6 History of HTN (%): 62.7History of CAD (%): 100 History of CHF (%): 12.2History of MI (%): 57.5PTCA (%): 50.4 CABG (%): 53.7 History of Stroke (%): 7.3 Peripheral arterial disease (%): 16.3Current smoker (%): 9.0Atorvastatin 10 mg/d (n=1505)Atorvastatin 80 mg/d (n=1602)Followup period: median 5 yearsStudy withdrawals (%): 0.4Allocation Concealment: unclearBlinding: double-blind, end points adjudicated by blinded committeeIntention to Treat Analysis (ITT): YesWithdrawals/Dropouts adequately described: YesHMG-CoA Reductase Inhibitor versus Bile Acid Sequestrant trials (n=1)Tonolo, 2006PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ub25vbG88L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 98VA-HITMulti-centerUnited StatesFunding source: Government and IndustryInclusion criteria: Male veterans with coronary artery disease (previous MI, angina corroborated by objective evidence of ischemia, coronary revascularization, or angiographic evidence of stenosis >50% in 1+ major coronary arteries, age <74 yr, HDL ≤40 mg/dL, LDL ≤140 mg/dL, triglyceride ≤300 mg/dLExclusion criteria: Serum creatinine > 2.0 mg/dLN=470 (Subgroup analysis of patients with eGFR <60 mL/min/1.73m2 performed within a post hoc analysis of 1046 patients with creatinine clearance <75 mL/min/1.73m2 from the 2,505 with baseline creatinine measurements) from total of 2,531 participants randomized in VA-HIT Trial.Baseline characteristics not reported for n=470 participants with eGFR <60 mL/min/1.73m2 in Tonelli 2004 Kidney International paper, but are reported for n=399 participants (n=199 gemfibrozil, n=200 placebo) with eGFR <60 mL/min/1.73m2 in Tonelli 2004 Am J Kidney Disease paper:Age (yr): 67.4Gender (% male): 100Race (%): White 91.0BMI (kg/m2): NRSystolic BP (mm Hg): 134.0Diastolic BP (mm Hg): 77.2Serum creatinine (mg/dL): NRCreatinine clearance (mL/min/1.73m2): 59.7 Estimated GFR (mL/min/1.73m2): 52.2Total cholesterol (mg/dL): 176LDL cholesterol (mg/dL): 111Diabetes (%): 30.3History of HTN (%): 67.2History of CAD (%): 100History of CHF (%): 10.0History of MI (%): NRPTCA or CABG (%): NRHistory of Stroke (%): NRPeripheral arterial disease (%):NRCurrent smoker (%): 14.0 Gemfibrozil 600 mg bid (n=242)Placebo (n=228)Followup period: 5.3 yr Study withdrawals (%): No participants were lost to followupAllocation Concealment: UnclearBlinding: doubleIntention to Treat Analysis (ITT): YesWithdrawals/Dropouts adequately described: Yes, because no subjects were lost to followupSamuelsson, 1997PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW11ZWxzc29uPC9BdXRob3I+PFllYXI+MTk5NzwvWWVh
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ADDIN EN.CITE.DATA 84Single CenterSwedenFunding SourceGovernment and FoundationsInclusion Criteria: Nondiabetic primary renal disease and moderately advanced renal insufficiency (GFR 10-70 ml/min/1.73m2)Exclusion Criteria: NRN=57Age (yr): 51.3Gender (Male %): 75Race/Ethnicity (%): NRWeight (kg): 81.4BMI: 26.2Systolic BP (mm Hg): 136.5Diastolic BP (mm Hg): 84.0CKD stage: NRSerum creatinine (mg/dL): 2.4Creatinine clearance (mL/min): NRAlbuminuria: 0.95g/24 hrAlbumin/creatinine ratio (mg/g): NRGFR (ml/min/1.73m2): 35.5HbA1c (%):NRTotal cholesterol (mg/dL): 243.6LDL cholesterol (mg/dL): 170.2Diabetes (%): 0 (by inclusion criteria) History of HTN (%): NRDyslipidemia (%): unclearHistory of CAD (%): NRHistory of CHF (%): NRPeripheral arterial disease (%): NRHistory of MI (%): NRHistory of Stroke (%): NRCurrent smoker (%): NR History of AKI (%): NRGemfibrizol initiated at 300mg/day, and could be titrated up to 450 mg twice daily (n=28)Triglyceride lowering Diet(n=29)Followup Period: 1.0 yrStudy withdrawals (%): 10.5Allocation Concealment: UnclearBlinding: Open labelIntention to Treat Analysis (ITT): NoWithdrawals/Dropouts adequately described: YesACEI = angiotensin converting enzyme inhibitor; ACR = albumin/creatinine ratio; AER = albumin excretion rate; AKI = acute kidney injury; ARB = angiotensin II receptor blocker; BB = bete blocker; BMI = body mass index; BP = blood pressure; CAD = coronary artery disease; CCB = calcium channel blocker; CHD = coronary heart disease; CHF = congestive heart failure; CKD = chronic kidney disease; CV = cardiovascular; CVA = cerebrovascular accident; DBP = diastolic blood pressure; DM = diabetes mellitus; GFR = glomerular filtration rate; HbA1c = hemoglobin A1c; HTN = hypertension; LDL = low density lipoprotein; LVEF = left ventricular ejection fraction; MI = myocardial infarction; NR = not reported; NSAIDS = non-steroidal anti-inflammatory drug; NYHA = New York Heart Association; PTCA = percutaneous transluminal coronary angioplasty; PVD = peripheral vascular disease; RCT = randomized controlled trial; SBP = systolic blood pressure; UACR = urinary albumin/creatinine ratio; UAE = urinary albumin excretion; ULN = upper limit of the normal ................
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