Effect of ramipril on walking times and quality of life among patients with peripheral artery disease and intermittent claudication: A randomized controlled trial

JAMA

Volumn 309, Issue 5, 2013, Pages 453-460

  Ahimastos, Anna A ^a   Walker, Philip J ^b   Askew, Christopher ^c   Leicht, Anthony ^d   Pappas, Elise ^d   Blombery, Peter ^e   Reid, Christopher M ^f   Golledge, Jonathan ^d   Kingwell, Bronwyn A ^a  

^a BAKER IDI HEART AND DIABETES INSTITUTE   (Australia)

^b UNIVERSITY OF QUEENSLAND   (Australia)

^c QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^d JAMES COOK UNIVERSITY   (Australia)

^e ALFRED HOSPITAL   (Australia)

^f MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RAMIPRIL;

AGED; ANKLE BRACHIAL INDEX; ARTICLE; BLOOD PRESSURE; CONTROLLED STUDY; CORONARY ARTERY DISEASE; COUGHING; DIZZINESS; DOPPLER ECHOGRAPHY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FUNCTIONAL ASSESSMENT; HUMAN; INTERMITTENT CLAUDICATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PARALLEL DESIGN; PATIENT ASSESSMENT; PATIENT COMPLIANCE; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; SIDE EFFECT; ST SEGMENT DEPRESSION; THORAX PAIN; TRANSLUMINAL CORONARY ANGIOPLASTY; TREADMILL EXERCISE; WALKING; WALKING IMPAIRMENT QUESTIONNAIRE; WALKING TIME;

EID: 84873276032     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.216237     Document Type: Article

References (58)

1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5-S67.
2. Vodnala D, Rajagopalan S, Brook RD. Medical management of the patient with intermittent claudication. Cardiol Clin. 2011;29(3):363-379.
3. McDermott MM, Greenland P, Liu K, et al. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001;286(13):1599-1606.
4. McDermott MM, Liu K, Greenland P, et al. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004;292(4):453-461.
5. Castaño G, Más R, Gámez R, Fernández L, Illnait J. Effects of policosanol and ticlopidine in patients with intermittent claudication: a double-blinded pilot comparative study. Angiology. 2004;55(4):361-371.
6. Dawson DL, Cutler BS, Hiatt WR, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000;109(7):523-530.
7. Lièvre M, Morand S, Besse B, Fiessinger JN, Boissel JP; Beraprost et Claudication Intermittente (BERCI) Research Group. Oral beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double-blind, randomized, multicenter controlled trial. Circulation. 2000;102(4):426-431.
8. Mannarino E, Pasqualini L, Innocente S, Scricciolo V, Rignanese A, Ciuffetti G. Physical training and antiplatelet treatment in stage II peripheral arterial occlusive disease: alone or combined? Angiology. 1991;42(7):513-521.
9. Pande RL, Hiatt WR, Zhang P, Hittel N, Creager MA. A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication. Vasc Med. 2010;15(3):181-188.
10. Spengel F, Clément D, Boccalon H, Liard F, Brown T, Lehert P. Findings of the Naftidrofuryl in Quality of Life (NIQOL) European study program. Int Angiol. 2002;21(1):20-27.
11. Stevens JW, Simpson E, Harnan S, et al. Systematic review of the efficacy of cilostazol, naftidrofuyrl oxalate and pentoxifillin for the treatment of intermittent claudication. Br J Surg. 2012;99(12):1630-1638.
12. Ahimastos AA, Lawler A, Reid CM, Blombery PA, Kingwell BA. Brief communication: ramipril markedly improves walking ability in patients with peripheral arterial disease: a randomized trial. Ann Intern Med. 2006;144(9):660-664.
13. Overlack A, Adamczak M, Bachmann W, et al; Perindopril Therapeutic Safety Collaborative Research Group. ACE inhibition with perindopril in essential hypertensive patients with concomitant diseases. Am J Med. 1994;97(2):126-134.
14. Roberts DH, Tsao Y, Linge K, McLoughlin GA, Breckenridge A. Double-blind comparison of captopril with nifedipine in hypertension complicated by intermittent claudication. Angiology. 1992;43(9):748-756.
15. Schindler C, Mueller A, Bramlage P, Boecking W, Kirch W, Schweizer J. Comparison of selective AT1-receptor blockade versus ACE inhibition for restenosis prophylaxis in patients with peripheral occlusive arterial disease after stent angioplasty: a randomized, controlled, proof-of-concept study. Angiology. 2007;58(6):710-716.
16. Shahin Y, Mazari F, Chetter I. Do angiotensin-converting enzyme inhibitors improve walking distance in patients with symptomatic lower limb arterial disease? a systematic review and meta-analysis of randomised controlled trials. Int J Surg. 2011;9(3):209-213.
17. Spence JD, Arnold JM, Munoz C, Viswanatha A, Huff M, Derose G. Angiotensin-converting enzyme inhibition with cilazapril does not improve blood flow, walking time, or plasma lipids in patients with intermittent claudication. J Vasc Med Biol. 1993;4(1):23-28.
18. Van de Ven LL, Van Leeuwen JT, Smit AJ. The influence of chronic treatment with betablockade and angiotensin-convertingenzymeinhibitiononthe peripheral blood flow in hypertensive patients with and without concomitant intermittent claudication: a comparative cross-over trial. Vasa. 1994;23(4):357-362.
19. Sumner DS, Strandness DEJ Jr. The relationship between calf blood flow and ankle blood pressure in patients with intermittent claudication. Surgery. 1969;65(5):763-771.
20. Degischer S, Labs KH, Aschwanden M, Tschoepl M, Jaeger KA. Reproducibility of constant-load treadmill testingwith various treadmill protocols and predictability of treadmill test results in patients with intermittent claudication. J Vasc Surg. 2002;36(1):83-88.
21. Momsen AH, Jensen MB, Norager CB, Madsen MR, Vestersgaard-Andersen T, Lindholt JS. Drug therapy for improving walking distance in intermittent claudication: a systematic review and metaanalysis of robust randomised controlled studies. Eur J Vasc Endovasc Surg. 2009;38(4):463-474.
22. Labs KH, Nehler MR, Roessner M, Jaeger KA, Hiatt WR. Reliability of treadmill testing in peripheral arterial disease: a comparison of a constant load with a graded-load treadmill protocol. Vasc Med. 1999;4(4):239-246.
23. Sacks D, Robinson ML, Marinelli DL, Perlmutter GS. Peripheral arterial Doppler ultrasonography: diagnostic criteria. J Ultrasound Med. 1992;11(3):95-103.
24. Regensteiner JG, Steiner JF, Hiatt WR. Exercise training improves functional status in patients with peripheral arterial disease. J Vasc Surg. 1996;23(1):104-115.
25. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: The Health Institute; 1993.
26. Altman DG, Schulz KF, Moher D, et al; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663-694.
27. Harel O, Zhou XH. Multiple imputation: review of theory, implementation and software. Stat Med. 2007;26(16):3057-3077.
28. Spratt M, Carpenter J, Sterne JA, et al. Strategies for multiple imputation in longitudinal studies. Am J Epidemiol. 2010;172(4):478-487.
29. Murphy TP, Cutlip DE, Regensteiner JG, et al; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study. Circulation. 2012;125(1):130-139.
30. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G; The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000;342(3):145-153.
31. Creager MA, Pande RL, Hiatt WR. A randomized trial of iloprost in patients with intermittent claudication. Vasc Med. 2008;13(1):5-13.
32. Mohler ER III, Hiatt WR, Creager MA. Cholesterol reduction with atorvastatin improves walking distance in patients with peripheral arterial disease. Circulation. 2003;108(12):1481-1486.
33. McDermott MM, Ades PA, Dyer A, Guralnik JM, Kibbe M, Criqui MH. Corridor-based functional performance measures correlate better with physical activity during daily life than treadmill measures in persons with peripheral arterial disease. J Vasc Surg. 2008;48(5):1231-1237.
34. Beebe HG, Dawson DL, Cutler BS, et al. A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial. Arch Intern Med. 1999;159(17):2041-2050.
35. Creager MA, Olin JW, Belch JJ, et al. Effect of hypoxia-inducible factor-1alpha gene therapy on walking performance in patients with intermittent claudication. Circulation. 2011;124(16):1765-1773.
36. Elam MB, Heckman J, Crouse JR, et al. Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication. Arterioscler Thromb Vasc Biol. 1998;18(12):1942-1947.
37. Grossman PM, Mendelsohn F, Henry TD, et al. Results from a phase II multicenter, double-blind placebo-controlled study of Del-1 (VLTS-589) for intermittent claudication in subjects with peripheral arterial disease. Am Heart J. 2007;153(5):874-880.
38. Money SR, Herd JA, Isaacsohn JL, et al. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. J Vasc Surg. 1998;27(2):267-275.
39. Sonecha TN, Nicolaides AN, Kyprianou P, et al. The effect of enalapril on leg muscle blood flow in patients with claudication. Int Angiol. 1990;9(1):22-24.
40. Henriksen EJ, Prasannarong M. The role of the renin-angiotensin system in the development of insulin resistance in skeletal muscle [published online May 4, 2012]. Mol Cell Endocrinol. doi:10.1016/j.mce.2012.04.011.
41. Isami S, Kishikawa H, Araki E, et al. Bradykinin enhances GLUT4 translocation through the increase of insulin receptor tyrosine kinase in primary adipocytes: evidence that bradykinin stimulates the insulin signalling pathway. Diabetologia. 1996;39(4):412-420.
42. Kishi K, Muromoto N, Nakaya Y, et al. Bradykinin directly triggers GLUT4 translocation via an insulin-independent pathway. Diabetes. 1998;47(4):550-558.
43. Schaufelberger M, Andersson G, Eriksson BO, Grimby G, Held P, Swedberg K. Skeletal muscle changes in patients with chronic heart failure before and after treatment with enalapril. Eur Heart J. 1996;17(11):1678-1685.
44. Vescovo G, Dalla Libera L, Serafini F, et al. Improved exercise tolerance after losartan and enalapril in heart failure: correlation with changes in skeletal muscle myosin heavy chain composition. Circulation. 1998;98(17):1742-1749.
45. Ebrahimian TG, Tamarat R, Clergue M, Duriez M, Levy BI, Silvestre JS. Dual effect of angiotensinconverting enzyme inhibition on angiogenesis in type 1 diabetic mice. Arterioscler Thromb Vasc Biol. 2005;25(1):65-70.
46. Fabre JE, Rivard A, Magner M, Silver M, Isner JM. Tissue inhibition of angiotensin-converting enzyme activity stimulates angiogenesis in vivo. Circulation. 1999;99(23):3043-3049.
47. Rakusan K, Cicutti N, Maurin A, Guez D, Schiavi P. The effect of treatment with low-dose ACE inhibitor and/or diuretic on coronary microvasculature in stroke-prone spontaneously hypertensive rats. Microvasc Res. 2000;59(2):243-254.
48. Takeshita S, Tomiyama H, Yokoyama N, et al. Angiotensin-converting enzyme inhibition improves defective angiogenesis in the ischemic limb of spontaneously hypertensive rats. Cardiovasc Res. 2001;52(2):314-320.
49. Toblli JE, DeRosa G, Rivas C, et al. Cardiovascular protective role of a low-dose antihypertensive combination in obese Zucker rats. J Hypertens. 2003;21(3):611-620.
50. Zimmermann R, Kastens J, Linz W, Wiemer G, Schölkens BA, Schaper J. Effect of long-term ACE inhibition on myocardial tissue in hypertensive strokeprone rats. J Mol Cell Cardiol. 1999;31(8):1447-1456.
51. Reneland R, Haenni A, Andersson PE, Andrén B, Lithell H. Skeletal muscle angiotensin-converting enzyme and its relationship to blood pressure in primary hypertension and healthy elderly men. Blood Press. 1999;8(1):16-22.
52. Scheidegger KJ, Nelissen-Vrancken MH, Leenders PJ, Daemen MJ, Smits JF, Wood JM. Structural adaptation to ischemia in skeletal muscle: effects of blockers of the renin-angiotensin system. J Hypertens. 1997;15(12, pt 1):1455-1462.
53. Sumukadas D, Witham MD, Struthers AD, McMurdo ME. Effect of perindopril on physical function in elderly people with functional impairment: a randomized controlled trial. CMAJ. 2007;177(8):867-874.
54. Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J; PEP-CHF Investigators. The Perindopril in Elderly People With Chronic Heart Failure (PEP-CHF) study. Eur Heart J. 2006;27(19):2338-2345.
55. Onder G, Penninx BW, Balkrishnan R, et al. Relation between use of angiotensin-converting enzyme inhibitors and muscle strength and physical function in older women: an observational study. Lancet. 2002;359(9310):926-930.
56. Di Bari M, van de Poll-Franse LV, Onder G, et al; Health, Aging and Body Composition Study. Antihypertensive medications and differences in muscle mass in older persons: the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2004;52(6):961-966.
57. Cesari M, Pedone C, Incalzi RA, Pahor M. ACE inhibition and physical function: results from the Trial of Angiotensin-Converting Enzyme Inhibition and Novel Cardiovascular Risk Factors (TRAIN) study. J Am Med Dir Assoc. 2010;11(1):26-32.
58. Gray SL, LaCroix AZ, Aragaki AK, et al; Women's Health Initiative Observational Study. Angiotensin-converting enzyme inhibitor use and incident frailty in women aged 65 and older: prospective findings from the Women's Health Initiative Observational Study. J Am Geriatr Soc. 2009;57(2):297-303.