Effect of lovastatin on early carotid atherosclerosis and cardiovascular events

Circulation

Volumn 90, Issue 4 I, 1994, Pages 1679-1687

  Furberg, Curt D ^a,b   Adams Jr , Harold P ^c   Applegate, William B ^d   Byington, Robert P ^a   Espeland, Mark A ^a   Hartwell, Tyler ^e   Hunninghake, Donald B ^f   Lefkowitz, David S ^b   Probstfield, Jeffrey ^g   Riley, Ward A ^h   Young, Byron ⁱ  

^a Department of Public Health Sciences ^*  (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF IOWA   (United States)

^d UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^e RTI INTERNATIONAL   (United States)

^f UNIVERSITY OF MINNESOTA   (United States)

^g FRED HUTCHINSON CANCER RESEARCH CENTER   (United States)

^h AUTREC Inc ^*  (United States)

ⁱ UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

Author keywords

atherosclerosis; cardiovascular diseases; clinical trial; lovastatin

Indexed keywords

ACETYLSALICYLIC ACID; ALANINE AMINOTRANSFERASE; ANTILIPEMIC AGENT; DIURETIC AGENT; ESTROGEN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PLACEBO; WARFARIN;

ADULT; AGED; ARTERY INTIMA PROLIFERATION; ARTICLE; ATHEROSCLEROSIS; B SCAN; CAROTID ARTERY OBSTRUCTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HEART INFARCTION; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MUSCLE CRAMP; MUSCLE WEAKNESS; MYALGIA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN TOXICITY; STROKE;

EID: 0028020982     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.90.4.1679     Document Type: Article

References (40)

1. Bradford RH, Shear CL, Chremos AN, Dujovne C, Downton M, Franklin FA, Gould AL, Hesney M, Higgins J, Hurley DP, Langendorfer A, Nash DT, Pool JL, Schnaper H. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results, I: efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med. 1991;151:43-49.
2. The Pravastatin Multinational Study Group for Cardiac Risk Patients. Effects of pravastatin in patients with serum total cholesterol levels from 5.2 to 7.8 mmol/liter (200 to 300 mg/dL) plus two additional atherosclerotic risk factors. Am J Cardiol. 1993;72: 1031-1037.
3. Mellies MJ. Ongoing and planned clinical trials for atherosclerosis prevention and regression. Curr Opin Invest Drugs. 1993;2:529-539.
4. Blankenhorn DH, Azen SP, Kramsch DM, Mack WJ, Cashin-Hemphill L, Hodis HN, DeBoer LWV, Mahrer PR, Masteller MJ, Vailas LI, Alaupovic P, Hirsch LJ, and the MARS Research Group. Coronary angiographie changes with lovastatin therapy: the Monitored Atherosclerosis Regression Study (MARS). Ann Intern Med. 1993;119:969-976.
5. Waters D, Higginson L, Gladstone P, Kimball B, LeMay M, Boccuzzi SJ, Lespérance J, and the CCAIT Study Group. Effects of monotherapy with an HMG CoA reductase inhibitor upon the progression of coronary atherosclerosis as assessed by serial quantitative arteriography: the Canadian Coronary Atherosclerosis Intervention Trial (CCAIT). Circulation. 1994;89:959-968.
6. Furberg CD, Byington RP, Crouse JR, Espeland MA. Pravastatin, lipids and major coronary events. Am J Cardiol. 1994;73:1133-1134.
7. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Arch Intern Med. 1988;148:36-69.
8. The ACAPS Group. Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). Control Clin Trials. 1992; 13:293-314.
9. Furberg CD, Byington RP, Craven TE. Lessons learned from clinical trials with ultrasound endpoints. J Intern Med. In press.
10. Riley WA, Barnes RW, Applegate WB, Dempsey R, Hartwell T, Davis VG, Bond MG, Furberg CD. Reproducibility of noninvasive ultrasonic measurement of carotid atherosclerosis. Stroke. 1992;23: 1062-1068.
11. Fried LP, Borhani NO, Enright P, Furberg CD, Gardin JM, Kronmal RA, Kuller LH, Manolio TA, Mittelmark MB, Newman A, O'Leary DH, Psaty B, Rautaharju P, Tracy RP, Weiler PG, for the Cardiovascular Health Study Research Group (CHS). The Cardiovascular Health Study: design and rationale. Ann Epidemiol. 1991;1:263-276.
12. Rautaharju RM, MacInnis PJ, Warren JW, Wolf HK, Rykers PM, Calhoun HP. Methodology of ECG interpretation in the Dalhousie program: NOVACODE ECG classification procedure for clinical trials and population health surveys. Methods Inf Med. 1990;29:362-374.
13. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265:3255-3264.
14. Brittain E, Wittes J. Factorial designs in clinical trials: the effects of non-compliance and subadditivity. Stat Med. 1989;8:161-171.
15. Snedecor GW, Cochran WG. Statistical Methods. Ames, Iowa: The Iowa State University Press; 1980:283-287.
16. Carroll RJ, Ruppert D. Transformation and weighting in regression. New York, NY: Chapman & Hall; 1988.
17. Espeland MA, Byington RP, Hire D, Davis VG, Hartwell T, Probstfield J. Analysis strategies for serial multivariate ultrasonographic data that are incomplete. Stat Med. 1992;11:1041-1056.
18. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38:963-974.
19. SAS Technical Report P-229, SAS/STAT Software: Changes and Enhancements, Release 6.07. Cary, NC: SAS Institute Inc; 1992.
20. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
21. Havel RJ, Hunninghake DB, Illingworth DR, Lees RS, Stein EA, Tobert JA, Bacon SR, Bolognese JA, Frost PH, Lamkin GE, Lees AM, Leon AS, Gardner K, Johnson G, Mellies MJ, Rhymer PA, Tun P. Lovastatin (mevinolin) in the treatment of heterozygous familial hypercholesterolemia: a multicenter study. Ann Intern Med. 1987;107:609-615.
22. Shear CL, Franklin FA, Stinnett S, Hurley DP, Bradford RH, Chremos AN, Nash DT, Langerdorfer A. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: effect of patient characteristics on lovastatin-induced changes in plasma concentrations of lipids and lipoproteins. Circulation. 1992;85:1293-1303.
23. The Lovastatin Study Group II. Therapeutic response to lovastatin (mevinolin) in nonfamilial hypercholesterolemia: a multicenter study. JAMA. 1986;256:2829-2834.
24. Heiss G, Sharrett AR, Barnes R, Chambless LE, Szklo M, Alzola C, and the ARIC Investigators. Carotid atherosclerosis measured by B-mode ultrasound in populations: associations with cardiovascular risk factors in the ARIC study. Am J Epidemiol. 1991;134: 250-256.
25. O'Leary DH, Polak JF, Kronmal RA, Kittner SJ, Bond MG, Wolfson SK, Bommer W, Price TR, Gardin JM, Savage PJ, on behalf of the CHS Collaborative Research Group. Distribution and correlates of sonographically detected carotid artery disease in the Cardiovascular Health Study. Stroke. 1992;23:1752-1760.
26. Blankenhorn DH, Selzer RH, Crawford DW, Barth JD, Liu C-r, Liu C-h, Mack WJ, Alaupovic P. Beneficial effects of colestipolniacin therapy on the common carotid artery: two- and four-year reduction of intima-media thickness measured by ultrasound. Circulation. 1993;88:20-28.
27. Furberg CD, Borhani NO, Byington RP, Gibbons ME, Sowers JR. Calcium antagonists and atherosclerosis: the Multicenter Isradipine/Diuretic Atherosclerosis Study. Am J Hypertens. 1993;6: 24S-29S.
28. Salonen R, Salonen JT. Progression of carotid atherosclerosis and its determinants: a population-based ultrasonography study. Atherosclerosis. 1990;81:33-40.
29. Salonen R. Risk factors for ultrasonographically assessed common carotid atherosclerosis: a cross-sectional and longitudinal population-based study in eastern Finnish men. University of Kuopio (Finland) Community Health Originals Reports. 1991:64-65.
30. Craven TE, Ryu JE, Espeland MA, Kahl FR, McKinney WM, Toole JF, McMahan MR, Thompson CJ, Heiss G, Crouse JR. Evaluations of the association between carotid artery atherosclerosis and coronary artery stenosis: a case-comparison study. Circulation. 1990;82:1230-1242.
31. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results, I: reduction in the incidence of coronary heart disease. JAMA. 1984;251:351-364.
32. Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P, Manninen V, Mäenpää H, Mälkönen M, Mänttäri M, Norola S, Pasternack A, Pikkarainen J, Romo M, Sjöblom T, Nikkilä EA. Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia: safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med. 1987;317:1237-1245.
33. Howard G, Sharrett AR, Heiss G, Evans GW, Chambless LE, Riley WA, Burke GL, for the ARIC Investigators. Carotid artery intimal-medial thickness distribution in general populations as evaluated by B-mode ultrasound. Stroke. 1993;24:1297-1304.
34. Brown G, Albers JJ, Fisher LD, Schaefer SM, Lin J-T, Kaplan C, Zhao X-Q, Bisson BD, Fitzpatrick VF, Dodge HT. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B. N Engl J Med. 1990;323:1289-1298.
35. Waters D, Craven TE, Lespérance J. Prognostic significance of progression of coronary atherosclerosis. Circulation. 1993;87: 1067-1075.
36. Buchwald H, Matts JP, Fitch LL, Campos CT, Sanmarco ME, Amplatz K, Castaneda-Zuniga WR, Hunter DW, Pearce MB, Bissett JK, Edmiston WA, Sawin HS, Weber FJ, Varco RL, Campbell GS, Yellin AE, Smink RD, Long JM, Hansen BJ, Chalmers TC, Meier P, Stamler J, for the Program on the Surgical Control of the Hyperlipidemias (POSCH) Group. Changes in sequential coronary arteriograms and subsequent coronary events. JAMA. 1992;268:1429-1433.
37. Brown BG, Zhao X-Q, Sacco DE, Albers JJ. Lipid lowering and plaque regression: new insights into prevention of plaque disruption and clinical events in coronary disease. Circulation. 1993; 87:1781-1791.
38. Holme I. An analysis of randomized trials evaluating the effect of cholesterol reduction on total mortality and coronary heart disease incidence. Circulation. 1990;82:1916-1924.
39. Smith GD, Song F, Sheldon TA. Cholesterol lowering and mortality: the importance of considering initial level of risk. BMJ. 1993;306:1367-1373.
40. LaRosa JC, Cleeman JI. Cholesterol lowering as a treatment for established coronary heart disease. Circulation. 1992;85:1229-1235.