#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Cardiovascular and Renal Outcomes of Renin–Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses


In a systematic review with network meta-analyses, Ferrán Catalá-López and colleagues synthesize published and unpublished data from randomized controlled trials of renin-angiotensin system inhibitors.


Vyšlo v časopise: Cardiovascular and Renal Outcomes of Renin–Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses. PLoS Med 13(3): e32767. doi:10.1371/journal.pmed.1001971
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001971

Souhrn

In a systematic review with network meta-analyses, Ferrán Catalá-López and colleagues synthesize published and unpublished data from randomized controlled trials of renin-angiotensin system inhibitors.


Zdroje

1. Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries for 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800. doi: 10.1016/S0140-6736(15)60692-4 26063472

2. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015; 385:117–171. doi: 10.1016/S0140-6736(14)61682-2 25530442

3. GBD 2013 DALYs and HALE Collaborators, Murray CJ, Barber RM, Foreman KJ, Abbasoglu Ozgoren A, Abd-Allah F, et al. Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990–2013: quantifying the epidemiological transition. Lancet. 2015;386:2145–2191. doi: 10.1016/S0140-6736(15)61340-X 26321261

4. Clarke PM, Glasziou P, Patel A, Chalmers J, Woodward M, Harrap SB, et al. Event rates, hospital utilization, and costs associated with major complications of diabetes: a multicountry comparative analysis. PLoS Med. 2010;7:e1000236. doi: 10.1371/journal.pmed.1000236 20186272

5. Sanders GD, Coeytaux R, Dolor RJ, Hasselblad V, Patel UD, Powers B, et al. Angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor antagonists (ARBs), and direct renin inhibitors for treating essential hypertension: an update. 2011 Jun [cited 25 Jul 2015]. Rockville (Maryland): Agency for Healthcare Research and Quality. Available: http://www.ncbi.nlm.nih.gov/books/NBK61789/.

6. American Diabetes Association. Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(Suppl 1):S1–S94.

7. James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311:507–520. doi: 10.1001/jama.2013.284427 24352797

8. Rydén L, Grant PJ, Anker SD, Berne C, Cosentino F, Danchin N, et al. ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the task force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013;34:3035–3087. doi: 10.1093/eurheartj/eht108 23996285

9. Dasgupta K, Quinn RR, Zarnke KB, Rabi DM, Ravani P, Daskalopoulou SS, et al. The 2014 Canadian Hypertension Education Program recommendations for blood pressure measurement, diagnosis, assessment of risk, prevention, and treatment of hypertension. Can J Cardiol. 2014;30:485–501. doi: 10.1016/j.cjca.2014.02.002 24786438

10. UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ. 1998;317:713–720. 9732338

11. Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21:597–603. 9571349

12. Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RW. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med. 1998;338:645–652. 9486993

13. Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet. 2000;355:253–259. 10675071

14. Lindholm LH, Hansson L, Ekbom T, Dahlöf B, Lanke J, Linjer E, et al. Comparison of antihypertensive treatments in preventing cardiovascular events in elderly diabetic patients: results from the Swedish Trial in Old Patients with Hypertension-2. STOP Hypertension-2 Study Group. J Hypertens. 2000;18:1671–1675.

15. Niskanen L, Hedner T, Hansson L, Lanke J, Niklason A, CAPPP Study Group. Reduced cardiovascular morbidity and mortality in hypertensive diabetic patients on first-line therapy with an ACE inhibitor compared with a diuretic/beta-blocker-based treatment regimen: a subanalysis of the Captopril Prevention Project. Diabetes Care. 2001;24:2091–2096. 11723089

16. Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851–860. 11565517

17. Parving HH, Lehnert H, Bröchner-Mortensen J, Gomis R, Andersen S, Arner P, et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001;345:870–878. 11565519

18. Brenner BM, Cooper ME, de Zeeuw D, Keane WF, Mitch WE, Parving HH, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345:861–869. 11565518

19. Lindholm LH, Ibsen H, Dahlöf B, Devereux RB, Beevers G, de Faire U, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint Reduction in Hypertension Study (LIFE): a randomised trial against atenolol. Lancet. 2002;359:1004–1010. 11937179

20. Whelton PK, Barzilay J, Cushman WC, Davis BR, Iamathi E, Kostis JB, et al. Clinical outcomes in antihypertensive treatment of type 2 diabetes, impaired fasting glucose concentration, and normoglycemia: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005;165:1401–1409. 15983290

21. Patel A, ADVANCE Collaborative Group, MacMahon S, Chalmers J, Neal B, Woodward M, et al. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007;370:829–840. 17765963

22. Parving HH, Brenner BM, McMurray JJ, de Zeeuw D, Haffner SM, Solomon SD, et al. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012;367:2204–2213. doi: 10.1056/NEJMoa1208799 23121378

23. Cheng J, Zhang W, Zhang X, Han F, Li X, He X, et al. Effect of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on all-cause mortality, cardiovascular deaths, and cardiovascular events in patients with diabetes mellitus: a meta-analysis. JAMA Intern Med. 2014;174:773–785. doi: 10.1001/jamainternmed.2014.348 24687000

24. Wu HY, Huang JW, Lin HJ, Liao WC, Peng YS, Jung KY, et al. Comparative effectiveness of renin-angiotensin system blockers and other antihypertensive drugs in patients with diabetes: systematic review and Bayesian network meta-analysis. BMJ. 2013;347:f6008. doi: 10.1136/bmj.f6008 24157497

25. Vejakama P, Thakkinstian A, Lertrattananon D, Ingsathit A, Ngarmukos C, Attia J. Reno-protective effects of renin-angiotensin system blockade in type 2 diabetic patients: a systematic review and network meta-analysis. Diabetologia. 2012;55:566–578. doi: 10.1007/s00125-011-2398-8 22189484

26. Nakao YM, Teramukai S, Tanaka S, Yasuno S, Fujimoto A, Kasahara M, et al. Effects of renin-angiotensin system blockades on cardiovascular outcomes in patients with diabetes mellitus: a systematic review and meta-analysis. Diabetes Res Clin Pract. 2012;96:68–75. doi: 10.1016/j.diabres.2011.11.025 22197527

27. Casas JP, Chua W, Loukogeorgakis S, Vallance P, Smeeth L, Hingorani AD, et al. Effect of inhibitors of the renin-angiotensin system and other antihypertensive drugs on renal outcomes: systematic review and meta-analysis. Lancet. 2005;366:2026–2033. 16338452

28. Strippoli GF, Craig M, Deeks JJ, Schena FP, Craig JC. Effects of angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists on mortality and renal outcomes in diabetic nephropathy: systematic review. BMJ. 2004;329:828. 15459003

29. Xue H, Lu Z, Tang WL, Pang LW, Wang GM, Wong GW, et al. First-line drugs inhibiting the renin angiotensin system versus other first-line antihypertensive drug classes for hypertension. Cochrane Database Syst Rev. 2015;1:CD008170. doi: 10.1002/14651858.CD008170.pub2 25577154

30. Makani H, Bangalore S, Desouza KA, Shah A, Messerli FH. Efficacy and safety of dual blockade of the renin-angiotensin system: meta-analysis of randomized trials. BMJ. 2013;346:f360. doi: 10.1136/bmj.f360 23358488

31. Savarese G, Costanzo P, Cleland JG, Vassallo E, Ruggiero D, Rosano G, et al. A meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heart failure. J Am Coll Cardiol. 2013;61:131–142. doi: 10.1016/j.jacc.2012.10.011 23219304

32. van Vark LC, Bertrand M, Akkerhuis KM, Brugts JJ, Fox K, Mourad JJ, et al. Angiotensin-converting enzyme inhibitors reduce mortality in hypertension: a meta-analysis of randomized clinical trials of renin-angiotensin-aldosterone system inhibitors involving 158,998 patients. Eur Heart J. 2012;33:2088–2097. doi: 10.1093/eurheartj/ehs075 22511654

33. Sciarretta S, Palano F, Tocci G, Baldini R, Volpe M. Antihypertensive treatment and development of heart failure in hypertension: a Bayesian network meta-analysis of studies in patients with hypertension and high cardiovascular risk. Arch Intern Med. 2011;171:384–394. doi: 10.1001/archinternmed.2010.427 21059964

34. Bangalore S, Kumar S, Wetterslev J, Messerli FH. Angiotensin receptor blockers and risk of myocardial infarction: meta-analyses and trial sequential analyses of 147 020 patients from randomised trials. BMJ. 2011;342:d2234. doi: 10.1136/bmj.d2234 21521728

35. Kuenzli A, Bucher HC, Anand I, Arutiunov G, Kum LC, McKelvie R, et al. Meta-analysis of combined therapy with angiotensin receptor antagonists versus ACE inhibitors alone in patients with heart failure. PLoS ONE. 2010;5:e9946. doi: 10.1371/journal.pone.0009946 20376345

36. Baker WL, Coleman CI, Kluger J, Reinhart KM, Talati R, Quercia R, et al. Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers for ischemic heart disease. Ann Intern Med. 2009;151:861–871. doi: 10.7326/0003-4819-151-12-200912150-00162 20008762

37. Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, et al. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003;289:2534–2544. 12759325

38. Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004;363:2022–2031. 15207952

39. Pfeffer MA, McMurray JJ, Velazquez EJ, Rouleau JL, Køber L, Maggioni AP, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med. 2003;349:1893–1906. 14610160

40. ONTARGET Investigators, Yusuf S, Teo KK, Pogue J, Dyal L, Copland I, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358:1547–1559. doi: 10.1056/NEJMoa0801317 18378520

41. Mann JF, Schmieder RE, McQueen M, Dyal L, Schumacher H, Pogue J, et al. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet. 2008;372:547–553. doi: 10.1016/S0140-6736(08)61236-2 18707986

42. Palmer SC, Mavridis D, Navarese E, Craig JC, Tonelli M, Salanti G, et al. Comparative efficacy and safety of blood pressure-lowering agents in adults with diabetes and kidney disease: a network meta-analysis. Lancet. 2015;385:2047–2056. doi: 10.1016/S0140-6736(14)62459-4 26009228

43. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097. doi: 10.1371/journal.pmed.1000097 19621072

44. Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med. 2015;162:777–784. doi: 10.7326/M14-2385 26030634

45. Sampson M, Shojania KG, McGowan J, Daniel R, Rader T, Iansavichene AE, et al. Surveillance search techniques identified the need to update systematic reviews. J Clin Epidemiol. 2008;61:755–762. doi: 10.1016/j.jclinepi.2007.10.003 18586179

46. Hutton B, Tetzlaff J, Yazdi F, Thielman J, Kanji S, Fergusson D, et al. Comparative effectiveness of monotherapies and combination therapies for patients with hypertension: protocol for a systematic review with network meta-analyses. Syst Rev. 2013;2:44. doi: 10.1186/2046-4053-2-44 23809864

47. Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, et al. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008;359:1225–1237. doi: 10.1056/NEJMoa0804593 18753639

48. Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (TRANSCEND) Investigators, Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, et al. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008;372:1174–1183. doi: 10.1016/S0140-6736(08)61242-8 18757085

49. Mann JF, Schmieder RE, Dyal L, McQueen MJ, Schumacher H, Pogue J, et al. Effect of telmisartan on renal outcomes: a randomized trial. Ann Intern Med. 2009;151:1–10,W1-W2. 19451556

50. Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, et al. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907–917. doi: 10.1056/NEJMoa1007994 21388309

51. Daly CA, Fox KM, Remme WJ, Bertrand ME, Ferrari R, Simoons ML, et al. The effect of perindopril on cardiovascular morbidity and mortality in patients with diabetes in the EUROPA study: results from the PERSUADE substudy. Eur Heart J. 2005;26:1369–1378. 15860521

52. Chaturvedi N, Porta M, Klein R, Orchard T, Fuller J, Parving HH, et al. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials. Lancet. 2008;372:1394–1402. doi: 10.1016/S0140-6736(08)61412-9 18823656

53. Bilous R, Chaturvedi N, Sjølie AK, Fuller J, Klein R, Orchard T, et al. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. Ann Intern Med. 2009;151:11–20,W3-W4. 19451554

54. Sjølie AK, Klein R, Porta M, Orchard T, Fuller J, Parving HH, et al. Effect of candesartan on progression and regression of retinopathy in type 2 diabetes (DIRECT-Protect 2): a randomized placebo-controlled trial. Lancet. 2008;372:1385–1393. doi: 10.1016/S0140-6736(08)61411-7 18823658

55. Cohn JN, Tognoni G, Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001;345:1667–1675. 11759645

56. Gheorghiade M, Böhm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, et al. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013;309:1125–1135. doi: 10.1001/jama.2013.1954 23478743

57. Nakao K, Hirata M, Oba K, Yasuno S, Ueshima K, Fujimoto A, et al. Role of diabetes and obesity in outcomes of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. Hypertens Res. 2010;33:600–606. doi: 10.1038/hr.2010.38 20379187

58. Ogihara T, Saruta T, Rakugi H, Saito I, Shimamoto K, Matsuoka H, et al. Combinations of olmesartan and a calcium channel blocker or a diuretic in elderly hypertensive patients: a randomized, controlled trial. J Hypertens. 2014;32:2054–2063. doi: 10.1097/HJH.0000000000000281 24999799

59. Matsui K, Kim-Mitsuyama S, Ogawa H, Jinnouchi T, Jinnouchi H, Arakawa K, et al. Sex differences in response to angiotensin II receptor blocker-based therapy in elderly, high-risk, hypertensive Japanese patients: a subanalysis of the OSCAR study. Hypertens Res. 2014;37:526–532. doi: 10.1038/hr.2014.23 24599010

60. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. doi: 10.1136/bmj.d5928 22008217

61. Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64:401–406. doi: 10.1016/j.jclinepi.2010.07.015 21208779

62. Puhan MA, Schünemann HJ, Murad MH, Li T, Brignardello-Petersen R, Singh JA, et al. A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis. BMJ. 2014;349:g5630. doi: 10.1136/bmj.g5630 25252733

63. Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, et al. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014;161:347–355. doi: 10.7326/M14-0178 25047428

64. Cochran WG. The combination of estimates from different experiments. Biometrics. 1954;10:101–129.

65. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560. 12958120

66. Ioannidis JP. Integration of evidence from multiple meta-analyses: a primer on umbrella reviews, treatment networks and multiple treatments meta-analyses. CMAJ. 2009;181:488–493. doi: 10.1503/cmaj.081086 19654195

67. Catalá-López F, Tobías A, Cameron C, Moher D, Hutton B. Network meta-analysis for comparing treatment effects of multiple interventions: an introduction. Rheumatol Int. 2014;34:1489–1496. doi: 10.1007/s00296-014-2994-2 24691560

68. Cipriani A, Higgins JP, Geddes JR, Salanti G. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159:130–137. doi: 10.7326/0003-4819-159-2-201307160-00008 23856683

69. Catalá-López F, Hutton B, Moher D. The transitive property across randomized controlled trials: if B is better than A, and C is better than B, will C be better than A? Rev Esp Cardiol. 2014;67:597–602. doi: 10.1016/j.rec.2013.11.016 25037537

70. Dias S, Sutton AJ, Ades AE, Welton NJ. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013;33:607–617. doi: 10.1177/0272989X12458724 23104435

71. Gelman A, Rubin DB. Inference from iterative simulation using multiple sequences. Stat Sci. 1992;7:457–472.

72. Dias S, Welton NJ, Sutton AJ, Caldwell DM, Lu G, Ades AE. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making. 2013;33:641–656. doi: 10.1177/0272989X12455847 23804508

73. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011;64:163–171. doi: 10.1016/j.jclinepi.2010.03.016 20688472

74. Dias S, Sutton AJ, Welton NJ, Ades AE. Evidence synthesis for decision making 3: heterogeneity—subgroups, meta-regression, bias, and bias-adjustment. Med Decis Making. 2013;33:618–640. doi: 10.1177/0272989X13485157 23804507

75. Fried LF, Emanuele N, Zhang JH, Brophy M, Conner TA, Duckworth W, et al. Combined angiotensin inhibition for the treatment of diabetic nephropathy. N Engl J Med. 2013;369:1892–1903. doi: 10.1056/NEJMoa1303154 24206457

76. Verma S, Strauss M. Angiotensin receptor blockers and myocardial infarction. BMJ. 2004;329:1248–1249. 15564232

77. Strauss MH, Hall AS. Angiotensin receptor blockers may increase risk of myocardial infarction: unraveling the ARB-MI paradox. Circulation. 2006;114:838–854. 16923768

78. Hall AS, Strauss MH. More about the “ARB MI paradox”. Heart. 2007;93:1011–1014. 17699164

79. Hobbs FD. Angiotensin receptor blockers and cardiovascular outcomes. BMJ. 2011;342:d2193. doi: 10.1136/bmj.d2193 21527455

80. Imai E, Chan JC, Ito S, Yamasaki T, Kobayashi F, Haneda M, et al. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study. Diabetologia. 2011;54:2978–2986. doi: 10.1007/s00125-011-2325-z 21993710

81. US Food and Drug Safety Administration. FDA drug safety communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required. 2014 Jun 6 [cited 12 Jun 2015]. Available: http://www.fda.gov/Drugs/DrugSafety/ucm402323.htm.

82. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC). Minutes of the Meeting—29–31 October 2012. 2012 Nov 29 [cited 12 Jun 2015]. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2012/12/WC500135712.pdf.

83. European Medicines Agency. European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines. 2012 Feb 17 [cited 2 Jun 2015]. Available: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC0b01ac058004d5c1.

84. Krum H, Massie B, Abraham WT, Dickstein K, Kober L, McMurray JJ, et al. Direct renin inhibition in addition to or as an alternative to angiotensin converting enzyme inhibition in patients with chronic systolic heart failure: rationale and design of the Aliskiren Trial to Minimize OutcomeS in Patients with HEart failuRE (ATMOSPHERE) study. Eur J Heart Fail. 2011;13:107–114. doi: 10.1093/eurjhf/hfq212 21169387

85. Cleland JG, Clark AL, Costanzo P, Francis DP. Diabetes, aliskiren, and heart failure: let’s bring ASTRONAUT down to earth. Eur Heart J. 2013;34:3097–3099. doi: 10.1093/eurheartj/eht366 23999453

86. Montori VM, Permanyer-Miralda G, Ferreira-González I, Busse JW, Pacheco-Huergo V, Bryant D, et al. Validity of composite end points in clinical trials. BMJ. 2005;330:594–596. 15761002

87. Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334:786. 17403713

Štítky
Interné lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2016 Číslo 3
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Získaná hemofilie - Povědomí o nemoci a její diagnostika
nový kurz

Eozinofilní granulomatóza s polyangiitidou
Autori: doc. MUDr. Martina Doubková, Ph.D.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#