Takaisin Tulosta

NNT-luku (potilasmäärä, joka on hoidettava, jotta yksi hyötyisi) ja lumeryhmän kardiovaskulaaritapahtumien absoluuttinen vaara tärkeimmissä lumekontrolloiduissa dyslipidemian pitkäkestoisissa lääkehoitotutkimuksissa

Käypä hoito -kuvat
Käypä hoito -työryhmä Dyslipidemiat
27.10.2020
Kuva 1.

NNT-luku (potilasmäärä, joka on hoidettava, jotta yksi hyötyisi) ja lumeryhmän kardiovaskulaaritapahtumien absoluuttinen vaara tärkeimmissä lumekontrolloiduissa dyslipidemian pitkäkestoisissa lääkehoitotutkimuksissa.

Molemmat luvut on laskettu tutkimuksen keskimääräistä kestoaikaa kohden. Useimmiten kestoaika on ollut noin 5 vuotta. Koska JUPITER-tutkimus oli kestoltaan selvästi lyhyempi (mediaani vain 1,9 vuotta), siitä on esitetty sekä 2:ta että 5:ttä vuotta kohden lasketut luvut «Ridker PM, Danielson E, Fonseca FA ym. Rosuvastati...»2. HPS1 = merkittävät sepelvaltimotautitapahtumat Heart Protection Studyssa, HPS2 = sepelvaltimo- ja aivovaltimotautitapahtumat Heart Protection Studyssa «Heart Protection Study Collaborative Group. MRC/BH...»3.

Kuviosta voidaan päätellä, että

  • hoidosta saatava absoluuttinen hyöty on sitä suurempi, mitä suurempi kardiovaskulaaritapahtumien riski on
  • tulokset sijoittuvat varsin hyvin samalle uralle, olipa dyslipidemiaa hoidettu kolestyramiinilla (LRC), fibraatilla (HHS, VA-HIT) tai statiinilla (kaikki muut tutkimukset)
  • muista selvästi poikkeavia tuloksia voi selittää pieni LDL-kolesterolipitoisuuden nettoero hoito- ja verrokkiryhmän välillä (ALLHAT) tai komplisoitu kohderyhmä (sydämen vajaatoimintapotilaat CORONA-tutkimuksessa)
  • NNT-lukua arvioitaessa on otettava huomioon hoidon kesto (JUPITER-tutkimuksen 2 ja 5 vuoden tulokset. Ks. «Kassai B, Gueyffier F, Boissel JP ym. Absolute ben...»1)
Taulukko 1. Tutkimuksista käytetyt lyhenteet
AFCAPS/TexCAPS Air Force / Texas Coronary Atherosclerosis Prevention Study «Downs JR, Clearfield M, Weis S ym. Primary prevent...»4
ALLHAT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial «ALLHAT Officers and Coordinators for the ALLHAT Co...»5
ALERT Assessment of Lescol in Renal Transplantation «Holdaas H, Fellström B, Jardine AG ym. Effect of f...»6
ASCOT Anglo-Scandinavian Cardiac Outcomes Trial «Sever PS, Dahlöf B, Poulter NR ym. Prevention of c...»7
ASPEN Atorvastatin Study for Prevention of coronary heart disease Endpoints in Non-insulin-dependent diabetes mellitus «Knopp RH, d'Emden M, Smilde JG ym. Efficacy and sa...»8
CARE Cholesterol And Recurrent Events «Sacks FM, Pfeffer MA, Moye LA ym. The effect of pr...»13
HPS Heart Protection Study «Heart Protection Study Collaborative Group. MRC/BH...»3
HHS Helsinki Heart Study «Frick MH, Syvänne M, Nieminen MS ym. Prevention of...»22
JUPITER Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin «Ridker PM, Danielson E, Fonseca FA ym. Rosuvastati...»2
LIPID Long-term Intervention with Pravastatin in Ischemic Disease «Prevention of cardiovascular events and death with...»25
LIPS Lescol Intervention Prevention Study «Serruys PW, de Feyter P, Macaya C ym. Fluvastatin ...»26
LRC-CPPT Lipid Research Clinics - Cholestyramine Primary Prevention Trial «The Lipid Research Clinics Coronary Primary Preven...»28
PROSPER Prospective Study of Pravastatin in the Elderly at Risk «Shepherd J, Blauw GJ, Murphy MB ym. Pravastatin in...»31
SPARCL Stroke Prevention by Aggressive Reduction in Cholesterol Levels «Amarenco P, Goldstein LB, Szarek M ym. Effects of ...»36
VA-HIT Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial «Bloomfield Rubins H, Davenport J, Babikian V ym. R...»38
WOSCOPS West Of Scotland Coronary Prevention Study «Shepherd J, Cobbe SM, Ford I ym. Prevention of cor...»39
4S Scandinavian Simvastatin Survival Study «Randomised trial of cholesterol lowering in 4444 p...»40

Kirjallisuutta

  1. Kassai B, Gueyffier F, Boissel JP ym. Absolute benefit, number needed to treat and gain in life expectancy: which efficacy indices for measuring the treatment benefit? J Clin Epidemiol 2003;56:977-82 PubMed
  2. Ridker PM, Danielson E, Fonseca FA ym. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195-207 PubMed
  3. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22 PubMed
  4. Downs JR, Clearfield M, Weis S ym. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279:1615-22 PubMed
  5. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA 2002;288:2998-3007 PubMed
  6. Holdaas H, Fellström B, Jardine AG ym. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet 2003;361:2024-31 PubMed
  7. Sever PS, Dahlöf B, Poulter NR ym. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003;361:1149-58 PubMed
  8. Knopp RH, d'Emden M, Smilde JG ym. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN). Diabetes Care 2006;29:1478-85 PubMed
  9. de Lemos JA, Blazing MA, Wiviott SD ym. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004;292:1307-16 PubMed
  10. Ericsson CG, Hamsten A, Nilsson J ym. Angiographic assessment of effects of bezafibrate on progression of coronary artery disease in young male postinfarction patients. Lancet 1996;347:849-53 PubMed
  11. Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study. Circulation 2000;102:21-7 PubMed
  12. Colhoun HM, Betteridge DJ, Durrington PN ym. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685-96 PubMed
  13. Sacks FM, Pfeffer MA, Moye LA ym. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med 1996;335:1001-9 PubMed
  14. Kjekshus J, Apetrei E, Barrios V ym. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248-61 PubMed
  15. Clofibrate and niacin in coronary heart disease. JAMA 1975;231:360-81 PubMed
  16. Ansquer JC, Foucher C, Rattier S ym. Fenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: results from the Diabetes Atherosclerosis Intervention Study (DAIS). Am J Kidney Dis 2005;45:485-93 PubMed
  17. Fung TT, Chiuve SE, McCullough ML ym. Adherence to a DASH-style diet and risk of coronary heart disease and stroke in women. Arch Intern Med 2008;168:713-20 PubMed
  18. Kastelein JJ, Akdim F, Stroes ES ym. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008;358:1431-43 PubMed
  19. De Bacquer D, De Backer G, Ostör E ym. Predictive value of classical risk factors and their control in coronary patients: a follow-up of the EUROASPIRE I cohort. Eur J Cardiovasc Prev Rehabil 2003;10:289-95 PubMed
  20. Gissi-HF Investigators, Tavazzi L, Maggioni AP ym. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:1231-9 PubMed
  21. Athyros VG, Papageorgiou AA, Mercouris BR ym. Treatment with atorvastatin to the National Cholesterol Educational Program goal versus 'usual' care in secondary coronary heart disease prevention. The GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) study. Curr Med Res Opin 2002;18:220-8 PubMed
  22. Frick MH, Syvänne M, Nieminen MS ym. Prevention of the angiographic progression of coronary and vein-graft atherosclerosis by gemfibrozil after coronary bypass surgery in men with low levels of HDL cholesterol. Lopid Coronary Angiography Trial (LOCAT) Study Group. Circulation 1997;96:2137-43 PubMed
  23. Pedersen TR, Faergeman O, Kastelein JJ ym. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005;294:2437-45 PubMed
  24. Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103). (Online http://www.clinicaltrials.gov/ct/show/NCT00202878) 26.10.08
  25. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med 1998;339:1349-57 PubMed
  26. Serruys PW, de Feyter P, Macaya C ym. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention: a randomized controlled trial. JAMA 2002;287:3215-22 PubMed
  27. Frick MH, Syvänne M, Nieminen MS ym. Prevention of the angiographic progression of coronary and vein-graft atherosclerosis by gemfibrozil after coronary bypass surgery in men with low levels of HDL cholesterol. Lopid Coronary Angiography Trial (LOCAT) Study Group. Circulation 1997;96:2137-43 PubMed
  28. The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA 1984;251:351-64 PubMed
  29. Crouse JR 3rd, Raichlen JS, Riley WA ym. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007;297:1344-53 PubMed
  30. Schwartz GG, Olsson AG, Ezekowitz MD ym. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001;285:1711-8 PubMed
  31. Shepherd J, Blauw GJ, Murphy MB ym. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002;360:1623-30 PubMed
  32. Cannon CP, McCabe CH, Belder R ym. Design of the Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT)-TIMI 22 trial. Am J Cardiol 2002;89:860-1 PubMed
  33. Conroy RM, Pyörälä K, Fitzgerald AP ym. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J 2003;24:987-1003 PubMed
  34. Rossebø AB, Pedersen TR, Allen C ym. Design and baseline characteristics of the simvastatin and ezetimibe in aortic stenosis (SEAS) study. Am J Cardiol 2007;99:970-3 PubMed
  35. Baigent C, Landry M. Study of Heart and Renal Protection (SHARP). Kidney Int Suppl 2003;:S207-10 PubMed
  36. Amarenco P, Goldstein LB, Szarek M ym. Effects of intense low-density lipoprotein cholesterol reduction in patients with stroke or transient ischemic attack: the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Stroke 2007;38:3198-204 PubMed
  37. LaRosa JC, Grundy SM, Waters DD ym. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425-35 PubMed
  38. Bloomfield Rubins H, Davenport J, Babikian V ym. Reduction in stroke with gemfibrozil in men with coronary heart disease and low HDL cholesterol: The Veterans Affairs HDL Intervention Trial (VA-HIT). Circulation 2001;103:2828-33 PubMed
  39. Shepherd J, Cobbe SM, Ford I ym. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995;333:1301-7 PubMed
  40. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) Lancet 1994;344:1383-9 PubMed