Debate: At what level of coronary heart disease risk should a statin be prescribed?

Current Opinion in Lipidology

Volumn 11, Issue 4, 2000, Pages 357-361

  Jackson, Peter R ^a   Ramsay, Lawrence E ^a  

^a ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PRAVASTATIN; SIMVASTATIN; STATIN;

CARDIOVASCULAR RISK; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; HEALTH CARE COST; HEALTH CARE PLANNING; HIGH RISK PATIENT; HUMAN; ISCHEMIC HEART DISEASE; META ANALYSIS; MORBIDITY; MORTALITY; PRACTICE GUIDELINE; PRESCRIPTION; PRIMARY PREVENTION; PRIORITY JOURNAL; REVIEW; SECONDARY PREVENTION; UNITED KINGDOM; WORKLOAD;

ANTILIPEMIC AGENTS; CORONARY DISEASE; COST-BENEFIT ANALYSIS; GREAT BRITAIN; HUMANS; RISK FACTORS; TIME FACTORS; VASCULAR DISEASES;

EID: 0033854471     PISSN: 09579672     EISSN: None     Source Type: Journal    
DOI: 10.1097/00041433-200008000-00003     Document Type: Review

References (52)

1. 1 Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-1389.
2. 2 Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med 1996; 335:1001-1009.
3. 3 The Long-term Intervention with Pravastatin in Ischaemic Heart Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998; 339:1349-1357.
4. 4 Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolaemia. N Engl J Med 1995; 333:1301-1307.
5. 5 Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels. JAMA 1998; 279:1615-1622.
6. 6 Crouse III JR, Byington RP, Furberg CD. HMG-CoA reductase inhibitor therapy and stroke risk reduction: an analysis of clinical trials data. Atherosclerosis 1998; 138:11-24.
7. 7 Ul Haq I, Ramsay LE, Pickin DM, et al. Lipid-lowering for prevention of coronary heart disease: what policy now? Clin Sci 1996; 91:399-413.
8. 8 Assman G, Cullen P, Jossa F, et al. Coronary heart disease: reducing the risk: the scientific background to primary and secondary prevention of coronary heart disease. A worldwide view. Arterioscler Thromb 1999; 19:1819-1824. An overview of the current major risk factors and how these contribute to the global risk of CHD.
9. 9 Durrington PN, McInnes G, Poulter N, et al. Joint British recommendations on prevention of coronary heart disease in clinical practice. Heart 1998; 80 (Suppl. 2):S1-S29.
10. 10 Wood D, De Backer G, Faergemann O, et al. Prevention of coronary heart disease in clinical practice: recommendations of the Second Joint Task Force of European and other societies on coronary prevention. J Hypertens 1998; 16:1407-1414.
11. 11 Grundy S. Primary prevention of coronary heart disease: integrating risk assessment with intervention. Circulation 1999; 100:988-998. This paper lays out a strategy of risk assessment based on the new Framingham risk scores with additional measures of subclinical vascular disease and integrates this with a strategy of primary prevention. Despite discussing risk assessment there appears to be reluctance to refrain from treating individual risk factors even in patients in whom the overall risk is low.
12. 12 Murabito JM, Anderson KM, Kannel WB, Evans JC. Risk of coronary heart disease in subjects with chest discomfort: the Framingham Heart Study. Am J Med 1990; 89:297-302.
13. 13 Sigurdsson E, Sigfusson N, Agnarsson U, et al. Long-term prognosis of different forms of coronary heart disease: the Reykjavik Study. Int J Epidemiol 1995; 24:58-68.
14. 14 Hankey GJ, Slattery JM, Warlow CP. The prognosis of hospital-referred transient ischaemic attacks. J Neurol Neurosurg Psychiatry 1991; 54:793-802.
15. 15 Dennis MS, Burn JP, Sandercock PA, et al. Long-term survival after first-ever stroke: the Oxford Community Stroke Project. Stroke 1993; 24:796-800.
16. 16 Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med 1992; 326:381-386.
17. 17 Grover SA, Paquet S, Levinton C, et al. Estimating the benefits of modifying risk factors of cardiovascular disease. Arch Intern Med 1998; 158:655-662.
18. 18 Assman G. Lipid metabolism disorders and coronary heart disease. München: MMV-Medizin-Verlag; 1993.
19. 19 Anderson KM, Odell PM, Wilson PWF, Kannel WB. Cardiovascular disease risk profiles. Am Heart J 1990; 121:293-298.
20. 20 Shaper AG, Pocock SJ, Phillips AN, et al. Identifying men at high risk of heart attacks: strategy for use in general practice. BMJ 1986; 293:474-480.
21. 21 Tunstall-Pedoe H. The Dundee coronary risk-disk for management of change in risk factors. BMJ 1991; 303:744-747.
22. 22 Concato J, Feinstein AR, Holford TR. The risk of determining risk with multivariable models. Ann Intern Med 1993; 118:201-210.
23. 23 Grover SA, Coupal L, Hu X-P. Identifying adults at increased risk of coronary disease. How well do the current cholesterol guidelines work? JAMA 1995; 274:801-806.
24. 24 Pickin DM, McCabe CJ, Ramsay LE, et al. Cost effectiveness of HMG-CoA reductase inhibitor (statin) treatment related to the risk of coronary heart disease and cost of drug treatment. Heart 1999; 82:325-332. A cost-effectiveness study investigating the effect of drug costs and the risk threshold for treatment. Based on the results of the 4S and WOSCOPS studies the analysis covered cost effectiveness for cohorts at CHD risk of 1.5, 2, 3 and 4.5% per annum. Sensitivity analyses showed the extent of the reduction in costs with falling drug prices.
25. 25 Caro J, Klittich W, McGuire A, et al. International economic analysis of primary prevention of cardiovascular disease with pravastatin in WOSCOPS. Eur Heart J 1999; 20:263-268. An attempt to generalize an earlier cost-effectiveness model based on the results of the WOSCOPS study using United Kingdom cost data. The model incorporates country-specific information about local drug costs, costs of MI and local life expectancy. The model performed well in validation against independent UK and Canadian assessments of cost effectiveness, showing a UK cost effectiveness of US$13000 per life-year gained.
26. 26 McGee D. The Framingham Study: an epidemiologic investigation of cardiovascular disease, section 27. Bethesda, MD: US Government Printing Office; 1973.
27. 27 Currie CJ, Morgan CL, Peters JR. Patterns and costs of hospital care for coronary heart disease related and not related to diabetes. Heart 1997; 78:544-549.
28. 28 Haq IU, Ramsay LE, Yeo WW, et al. Is the Framingham risk function valid for northern European populations? A comparison of methods for estimating absolute coronary risk in high risk men. Heart 1999; 81:40-46. An external validation of the Framingham equation for predicting the risk of coronary events using a comparison with the prediction from an equation derived from a more recent European population (PROCAM) in a consecutive series from a hospital hypertension clinic. The results suggest that on average the Framingham equation performs well but that at low risk it might overestimate and at high risk underestimate an individual patient's risk.
29. 29 Ramachandran S, French JM, Vanderpump MPJ, et al. Using the Framingham model to predict heart disease in the United Kingdom: retrospective study. BMJ 2000; 320:676-677. This paper uses a UK cohort, initially investigated as part of a thyroid disease study, to validate the Framingham equation. Data on demographics and risk factors were collected in the 1970s and morbidity and mortality data from death certificates and hospital and primary care notes. In patients at very low risk the Framingham equation appeared to underestimate total CHD risk.
30. 30 West of Scotland Coronary Prevention Study Group. Baseline risk factors and their association with outcome in the West of Scotland coronary prevention study. Am J Cardiol 1997; 79:756-762.
31. 31 Laurier D, Phong Chau N, Cazelles B, Segond P, and the PCV-METRA Group. Estimation of CHD risk in a French working population using a modified Framingham model. J Clin Epidemiol 1994; 47:1353-1364.
32. 32 Gordon T, Garcia-Palmieri MR, Kagan A, et al. Differences in coronary heart disease in Framingham Honolulu and Puerto Rico. J Chron Dis 1974; 27:329-344.
33. 33 Huse DM, Russell MW, Miller JD, et al. Cost-effectiveness of statins. Am J Cardiol 1998; 82:1357-1363.
34. 34 Farmer JA, Gotto Jr AM. Choosing the right lipid-regulating agent. A guide to selection. Drugs 1996; 52:649-661.
35. 35 Tobert JA. Efficacy and long-term adverse effect pattern of lovastatin. Am J Cardiol 1988; 62:28J-34J.
36. 36 Pogson GW, Kindred LH, Carper BG. Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy. Am J Cardiol 1999; 83:1146.
37. 37 Van Puijenbroek EP, Du Buf-Vereijken PW, Spooren PF, van Doormaal JJ. Possible increased risk of rhabdomyolysis during concomitant use of simvastatin and gemfibrozil. J Intern Med 1996; 240:403-404.
38. 38 Meier C, Stey C, Brack T, et al. Rhabdomyolyse bei mit Simvastatin und Ciclosporin behandelten Patienten: Rolle der Aktivitat des Cytochrom-P450-Enzymsystems der Leber. Schweiz Med Wochenschr 1995; 125:1342-1346.
39. 39 Davey Smith G, Pekkanen J. Should there be a moratorium on the use of cholesterol lowering drugs? BMJ 1992; 304:431-434.
40. 40 Haq IU, Wallis EJ, Yeo WW, et al. Coronary events with lipid lowering therapy: the AFCAPS/TexCAPS trial. JAMA 1999; 281:414.
41. 41 Ross SD, Allen IE, Connelly JE, et al. Clinical outcomes in statin treatment trials: a meta-analysis. Arch Intern Med 1999; 159:1793-1802. A meta-analysis of all the primary and secondary outcome studies of statin treatment, which also included data from regression studies. The results showed that treatment with statins produced a relative reduction of all vascular endpoints of 20-30%. There was also a significant reduction in overall mortality.
42. 42 Bucher HC, Griffith LE, Guyatt GH. Effect of HMGcoA reductase inhibitors on stroke. A meta-analysis of randomized, controlled trials. Ann Intern Med 1998; 128:89-95.
43. 43 Kong SX, Crawford SY, Gandhi SK, et al. Efficacy of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitors in the treatment of patients with hypercholesterolemia: a meta-analysis of clinical trials. Clin Therapeut 1997; 19:778-797.
44. 44 Jackson PR, Wallis EJ, Haq IU, Ramsay LE. HMG CoA reductase inhibitors (statins) for primary prevention: at what coronary risk is safety assured? Br J Clin Pharmacol 2000; 49:514P. This study used a new technique of meta-regression analysis to investigate the relationship between benefit in overall mortality and underlying CHD risk. Benefit increased with increasing risk but at very low risk there appeared to be no benefit or even harm.
45. 45 Andrade SE, Walker AM, Gottlieb LK, et al. Discontinuation of antihyperlipidemic drugs - do rates reported in clinical trials reflect rates in primary care settings? N Engl J Med 1995; 332:1125-1131.
46. 46 Nicholson K, Ramsay LE, Haq IU, et al. Factors affecting the acceptance of drug therapy to prevent myocardial infarction. Br J Clin Pharmacol 1999; 47:580P. This presents an attempt to gauge the potential uptake of treatment to prevent CHD. A random sample of primary care patients were surveyed to determine the level of benefit they would expect from tablet treatment to prevent CHD. Benefit was expressed as number needed to treat. Investigators also studied other factors such as smoking habit, age, and established disease, which might impinge on the willingness to prevent further disease.
47. 47 Gotto AM. Lipid-lowering therapy for the primary prevention of coronary heart disease. J Am Coll Cardiol 1999; 33:2078-2082. A review of the data from the primary prevention lipid-lowering trials reflecting how the results from the AFCAPS/TexCAPS study have expanded the numbers potentially eligible for treatment. The author also makes the point that even before this latest study the proportion of Americans receiving appropriate lipid lowering was disappointingly low.
48. 48 Robson J, Boomla K, Hart B, Feder G. Estimating cardiovascular risk for primary prevention: outstanding questions for primary care. BMJ 2000; 320:702-704. This paper puts the implications of CHD risk estimation into a primary care perspective, considers some practical methods of implementing risk assessment, and also comments on the level of risk to be targeted.
49. 49 Langham S, Thorogood M, Normand C, et al. Costs and cost effectiveness of health checks conducted by nurses in primary care: the Oxcheck study. BMJ 1996; 312:1265-1268.
50. 50 Eisenberg J. Guidelines do not consider workload implications in primary care. BMJ 2000; 320:576.
51. 51 Haynes RB, Sackett DL, Taylor DW, et al. Increased absenteeism from work after detection and labelling of hypertensive patients. N Engl J Med 1978; 299:741-744.
52. 52 Kottke TE, Tuomilehto J, Nissinen A, et al. Hypertension treatment without labelling effects: the North Karelia Project. J Hum Hypertens 1987; 1:185-194.