Selected Publications / Poster Presentations
For more details, click on any of the clinical trial or publication categories below:
ACTION
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Lubsen J, Poole-Wilson PA, Pocock SJ, van Dalen FJ, Baumann J, Kirwan B-A,
Parker AB – Design and current status of ACTION: A Coronary disease Trial
Investigating Outcome with Nifedipine GITS: Eur Heart J 1998: 19 (suppl 1): 120 - 132.
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JE Otterstad, J Lubsen, A Parker, Kirwan B-A, Ted Plappert, Martin G St John Sutton:
Left Ventricular Remodelling in Post –myocardial Infarction patients with Left Ventricular
Ejection Fraction 40-50% vs 25-39%: Influence of nisoldipine treatment?: Scand Cardiovasc J 1999 33; 234-241.
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J Shemesh, N Koren-Morag, S Apter, J Rozenman, B-A Kirwan, Y Itzchak, M Motro: Accelerated Progression of Coronary Calcification: Four-year follow-up in Patients with Stable Coronary Artery Disease: Radiology 2004;233:201-209.
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Philip A Poole-Wilson, Jacobus Lubsen, Bridget-Anne Kirwan et al on behalf of the ACTION investigators: Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial: Lancet 2004; 364:849-57.
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B-A Kirwan, J Lubsen, PA Poole-Wilson, on behalf of the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators: Treatment of angina pectoris: associations with symptom severity: International Journal of cardiology 98 (2005) 299-306.
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Lubsen J, Wagener G, Kirwan B-A, de Brouwer S, Poole-Wilson PA on behalf of the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators. Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with symptomatic stable angina and hypertension: the ACTION trial. Journal of Hypertension 23: 641-648 (2005)
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Tim C Clayton, Jacobus Lubsen, Stuart J Pocock, Zoltán Vokó, Bridget-Anne Kirwan, Keith A A Fox, Philip A Poole-Wilson, on behalf of the ACTION investigators: Risk score for predicting death, myocardial infarction, and stroke in patients with stable angina, based on a large randomised trial cohort of patients: BMJ 2005; 331: 869.
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Poole-Wilson PA, Kirwan B-A, Vokó Z, de Brouwer S, van Dalen F, Lubsen F. Safety of nifedipine GITS in stable angina: the ACTION trial. Cardiovascular Drugs and Therapy 20: 45-54 (2006).
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Kirwan B-A, Lubsen J, de Brouwer S, Danchin N, Dunselman P, Sutton G, Battler A, Bayes de Luna A, Glasser S, Koudstaal P, van Dalen F, Poole-Wilson PA. Diagnostic Criteria and adjudication process both determine published event rates: The ACTION trial experience. Contemp Clin Trials: in press (2007).
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Otterstad JE, Kirwan B-A, Lubsen J, de Brouwer S, Fox KA, Corell P, Poole-Wilson PA on behalf of the action investigators. Incidence and outcome of atrial fibrillation in stable symptomatic Coronary disease: Scandinavian Cardiovascular Journal 40: 152-159 (2006)
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Motro M, Kirwan B-A, de Brouwer S, Poole-Wilson PA, Shemesh J on behalf of the ACTION CC side-arm study. Tracking Coronary Calcification and Atherosclerotic Lesions in Patients with Stable Angina Pectoris Undergoing Nifedipine Therapy: Cardiology 107:165–171 (2007)
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Dart AM, Otterstad JE, Kirwan B-A, Parker JD, de Brouwer S, Poole-Wilson PA, Lubsen J on behalf of the ACTION investigators. Predictive value of local and core laboratory echocardiographic assessment of cardiac function in patients with chronic stable angina: the ACTION study. European Echocardio: in press (2007)
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Sutton GC, Otterstad JE, Kirwan B-A, Vokó Z, de Brouwer S, Lubsen J, Poole-Wilson PA on behalf of the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators. The development of heart failure in patients with stable angina pectoris. Eur J Heart Fail 9:234-242 (2007)
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Poole-Wilson PA, Kirwan B-A, Vokó Z, de Brouwer S, Dunselman P, van Dalen F, Lubsen J on behalf of the ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) investigators. Resource utilization implications of treatment was assessed when clinical trial data are reported appropriately: Journal of Clinical Epidemiology 60: 727-733 (2007).
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Lubsen J, Voko Z, Poole-Wilson PA, Kirwan B-A, de Brouwer S on behalf of the ACTION (A Coronary diseaseTrial Investigating Outcome with Nifedipine GITS) investigators. Blood pressure reduction in stable angina by nifedipine was related to stroke and heart failure reduction but not to coronary interventions: Journal of Clinical Epidemiology 60: 720-726 (2007).
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Ruilope LM, Kirwan B-A, de Brouwer S, Danchin N, Fox KA, Wagener G, Segura J, Poole-Wilson PA, Lubsen J on behalf of the ACTION investigators. Uric acid and other renal function parameters in patients with stable angina pectoris participating in the ACTION trial: impact of nifedipine GITS (gastro-intestinal therapeutic system) and relation to outcome. Journal of Hypertension 2007, 25:1711–1718.
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Poole-Wilson PA, Voko Z, Kirwan B-A, de Brouwer S, Dunselman P, Lubsen J for the ACTION investigators. Clinical course of isolated stable angina due to coronary heart disease: European Heart Journal. In press (2007)
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Lubsen J, Kirwan B-A. Combined end-points: Can we use them? (Statist. Med. 2002; 21: 2959-2970).
CARPORT
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Serruys, P. W., et al. Prevention of restenosis after percutaneous transluminal coronary angioplasty with thromboxane A2-receptor blockade. A randomized, double-blind, placebo-controlled trial. Coronary Artery Restenosis Prevention on Repeated Thromboxane-Antagonism Study (CARPORT). Circulation 84.4 (1991): 1568-80.
DEFIANT
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Lewis, B. S., et al. Left ventricular systolic and diastolic function, and exercise capacity six to eight weeks after acute myocardial infarction. The DEFIANT Study Group. Doppler Flow and Echocardiography in Functional Cardiac Insufficiency: Assessment of Nisoldipine Therapy. Am.J.Cardiol. 72.2 (1993): 149-53
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Improved diastolic function with the calcium antagonist nisoldipine (coat-core) in patients post myocardial infarction: results of the DEFIANT study. Doppler Flow and Echocardiography in Functional cardiac Insufficiency: Assessment of Nisoldipine Therapy. Eur.Heart J. 13.11 (1992): 1496-505
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The DEFIANT-II Research Group. Doppler flow and echocardiography in functional cardiac insufficiency: assessment of nisoldipine therapy. Results of the DEFIANT-II Study. Eur.Heart J. 18.1 (1997): 31-40.
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Otterstad, J. E., et al. "Left ventricular remodelling in post-myocardial infarction patients with left ventricular ejection fraction 40-50% vs 25-39%. Influence of nisoldipine treatment? An echocardiographic substudy from the DEFIANT II study."
Scand.Cardiovasc.J. 33.4 (1999): 234-41
MAAS
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Dumont, J. M. Effect of cholesterol reduction by simvastatin on progression of coronary atherosclerosis: Design, baseline characteristics, and progress of the Multicenter Anti-Atheroma Study (MAAS). Control Clin.Trials 14.3 (1993): 209-28.
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MAAS investigators. Effect of simvastatin on coronary atheroma: the Multicentre Anti-Atheroma Study (MAAS). Lancet 344.8923 (1994): 633-38
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Faxon, D. P. Effect of high dose angiotensin-converting enzyme inhibition on restenosis: final results of the MARCATOR Study, a multicenter, double-blind, placebo-controlled trial of cilazapril. The Multicenter American Research Trial With Cilazapril After Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR) Study Group. J.Am.Coll.Cardiol. 25.2 (1995): 362-69.
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Multicenter European Research Trial with Cilazapril after Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group. Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty? Results of the MERCATOR study: a multicenter, randomized, double-blind placebo-controlled trial. Circulation 86.1 (1992): 100-10.
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Lubsen, J., et al. Effect of pimobendan on exercise capacity in patients with heart failure: main results from the Pimobendan in Congestive Heart Failure (PICO) trial.
Heart 76.3 (1996): 223-31
Other Publications
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Fox, K., et al. "The effects of nisoldipine on the total ischaemic burden: the results of the ROCKET study." Eur.Heart J. 12.12 (1991): 1283-87
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De Feyter P, Serruys P, Davies M, Richardson P, Lubsen J, Oliver M. Quantitative coronary angiography to measure progression and regression of coronary atherosclerosis.
Circulation 1991;84:412-423.
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Lubsen J, Pocock S. Factorial trials in cardiology: pros and cons. Eur Heart J 1994; 15:585-588.
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Lubsen J. Exercise testing as outcome in congestive heart failure trials: design considerations when interpreting results. Drugs 1994;47:25-30.
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MacNeill AB, Lubsen J. Multi-centre trials: design and conduct. In: Ardissino D, Savonitto S, Opie LH., eds. Drug Evaluation in Angina Pectoris, 1994.
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Dumont J-M, Mpyisi S, Lubsen J. The clinical development of anti-atherosclerotic therapy: a trialist’s view. In Koenig W ed. Proceedings international symposium on current aspects in atherosclerosis: from a qualitative to a quantitative approach
(Ulm, May 14-15, 1993), Blackwell, 1994
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Hoes AW, Grobbee DE, Lubsen J, Man in’t Veld AJ, van der Does E, Hofman A. Diuretics, beta-blockers and the risk for sudden cardiac death in hypertensive patients.
Ann Intern Med 1995; 123:481-487
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Hoes AW, Grobbee DE, Lubsen J. Does drug treatment improve survival? Reconciling the trials in mild-to-moderate hypertension. J Hypertens 1995;13:805-811
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Lubsen J, Chadha DR, Yotof YT, Swedberg K. Meta-analysis of five exercise capacity trials in chronic congestive heart failure: effect of ramipril on mortality and morbidity. Am J Cardiol 1996;77:1191-1196
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St John Sutton M, Otterstadt JE, Plappert T, Parker A, Sekarski D, Keane MG, Poole-Wilson P, Lubsen K. Quantitation of left ventricular volumes and ejection fraction in post-infarction patients from biplane and single plane two-dimensional echocardiograms. A prospective study of 371 patients. Eur Heart J 1998;19:808-816
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Lubsen J. The calcium channel antagonist debate: recent developments. Eur Heart J 1998;19 (Suppl I):I3-I7.
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Feenstra J, Lubsen J, Grobbee DE, Stricker BCh. Heart failure treatments: issues of safety versus issues of quality of life. Drug Safety 1999;20:1-7
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Lubsen J, Hoes AW, Grobbee DE. Implications of trial results: the potentially misleading concepts of ‘number-needed-to-treat’ and ‘average duration of life gained’.
Lancet (accepted for publication)
Selected Posters prepared by SOCAR RESEARCH and presented at scientific meetings
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Ramsey LE, Kirwan B-A. A comparison of cough in hypertensive patients receiving Telmisartan, Enalapril or hydrochlorothiazide. Poster presented by BAK at the European Society of Hypertension meeting in 1996.
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St. John Sutton M, Poole-Wilson PA, Sekarski D, Kirwan B-A. Variability of echocardiographic ejection fraction at investigators sites versus core laboratory in the ACTION study – impact on patient selection. Poster presented by BAK at the European Society of Cardiology meeting, Stockholm 1997.
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Motro M, Shemesh J, Kirwan B-A: Prevalence of coronary calcification in relation to age, gender and risk factor profile within the ACTION population. Poster presented by BAK at the European Society of Cardiology meeting, Barcelona, 1999.
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Kirwan B-A, J Lubsen: Uniform diagnostic classification of Clinical Events in large clinical trials: A practical approach to collecting data. Poster presented by BAK at the Society for Clinical Trials meeting, April 2000, Toronto.
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Jonkers PR, Kirwan BA, Lubsen J: Streamlining the processing of large volumes of paper case report forms. Poster presented by BAK at the Society for Clinical Trials meeting, April 2000, Toronto.
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Lubsen J, Wagener G, Kirwan BA, de Brouwer S, Poole-Wilson PA: Effect of long-acting nifedipine on blood pressure control and clinical outcome in patients with stable angina: the ACTION study. Poster presented by BAK at the American Society of Hypertension meeting in San Francisco, May 2005.
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Jan Erik Otterstad, Bridget-Anne Kirwan, Jacobus Lubsen, Sophie de Brouwer, Keith A.A. Fox; Pernille Corell, Philip A. Poole-Wilson on behalf of the ACTION investigators:
Incidence and outcome of Atrial Fibrillation in Stable Symptomatic Coronary Disease:
Poster presented by BAK at the European Society of Cardiology meeting, Barcelona, 2006.
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J. Lubsen, Z. Voko, PA. Poole-Wilson, B-A. Kirwan, S. De Brouwer on behalf of the ACTION investigators. Fall of systolic blood pressure corrected for regression-to-the-mean in the ACTION trial was related to reduction of stroke and heart failure but not to coronary interventions. Poster presented by BAK at the European Society of Cardiology meeting, Barcelona 2006.
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P.A. Poole-Wilson, J-E. Otterstad, B-A. Kirwan, Z. Vokó, S. de Brouwer, J. Lubsen, G. Sutton: Clinical events preceding the development of heart failure in patients with stable angina pectoris. Poster presented by BAK at the European Society of Cardiology meeting, Barcelona 2006.
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