SL77.0499-10  (ALFUZOSIN)





1.     Malik M.  Problems of heart rate correction in assessment of drug-induced QT interval prolongation.  J Cardiovasc Electrophysiol 2001; 12:411-20.


2.     Hnatkova K, Malik M.  "Optimum" formulae for heart rate correction of the QT interval.  PACE 1999; 22:1683-7.


3.     Badilini F, Maison-Blanche P, Childers R, Coumel P.  QT interval analysis on ambulatory ECG recordings: a selective beat averaging approach.  Med Biol Eng Comput 1998; 36:1-10.


4.     Extramiana F, Maison-Blanche P, Badilini F, Pinoteau J, Deseo T, Coumel P. Circadian modulation of QT rate dependence in healthy volunteers: gender and age differences.  J Electrocardiol 1999; 32:33-43.


5.     Preliminary concept paper:  The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.  Revised version 6 February 2003.


6.     USFDA: summary basis of approval to NDA 21-085, sup 10 for moxifloxacin - Approved 27 April 2001. (Not provided).


7.     Rhodes PR, Krogh RH, Bruskewitz RC.  Impact of drug therapy on benign prostatic hyperplasia-specific quality of life.  Urology 1999; 53:1090-8.


8.     Jardin A, Bensadoun H, Delauche-Cavallier MC, et al. Alfuzosin for treatment of benign prostatic hypertrophy. Lancet 1991; 337:1457-61.


9.     Teillac P, Delauche-Cavallier MC, Attali P, et al. Urinary flow rates in patients with benign prostatic hypertrophy following treatment with alfuzosin, Br J Urol 1992; 70:58-64.


10.  Jardin A, Bensadoun H, Delauche-Cavallier MC, et al. Long-term treatment of benign prostatic hyperplasia with alfuzosin: a 12-18 month assessment. Br J Urol 1993; 72:615-20.


11.  Jardin A, Bensadoun H, Delauche-Cavallier MC, et al. Long-term treatment of benign prostatic hyperplasia with alfuzosin: a 24-30 month survey. Br J Urol 1993; 74:579-84.


12.  Buzelin JM, Roth S, Geffriaud-Ricouard C, Delauche-Cavallier MC, et al.  Efficacy and safety of sustained release alfuzosin 5 mg in patients with benign prostatic hyperplasia. Eur Urol 1997; 31:190-8.


13.  Debruyne FMJ, Jardin A, Colloi D, et al. Sustained-release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. Eur Urol 1998; 34:169-75.


14.  McNeill SA, Daruwala PD, Mitchell IDC, et al. Sustained-release alfuzosin and trial without catheter after acute urinary retention: a prospective, placebo‑controlled trial. BJU Int 1999; 84:622-7.


15.  Physicians's Desk Reference 2003, Hytrin Monographs.


16.  Physicians's Desk Reference 2003, Cardura.


17.  Physicians's Desk Reference 2003, Flomax.


18.  Funck-Brentano C, Jaillon P. Rate-corrected QT interval: Techniques and limitations. Am J Cardiol 1993;72:17B-22B.


19.  Haverkamp W, Breithardt G, Camm AJ, Janse MJ, Rosen MR, Antzelevitch C, et al.  The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: Clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology.  Eur Heart J 2000; 21:1216-31.


20.  Malik M, Camm AJ.  Evaluation of drug-induced QT interval prolongation. Implications for drug approval and labelling.  Drug Safety 2001; 24(5):323-51.


21.  Malik M.  The imprecision heart rate correction may lead to artificial observations of drug induced QT interval changes.  PACE 2002; 25(2):209-16.


22.  Aytemir K, Maarouf N, Gallagher MM, Yap YG, Waktare JEP, Malik M.

a.      Comparison of formulae for heart rate correction of QT interval in exercise electrocardiograms.  PACE  1999; 22:1397-1401.


23.  Bonate PL, Russell T. Assessment of QTc prolongation for non-cardiac-related drugs from a drug development perspective.  J Clin Pharmacol 1999; 39:349-58.


24.  NDA 20-919: Zeldox (ziprasidone mesylate IM, Pfizer.) Briefing information. Pfizer. 15 Feb 2001 (Not provided).


25.  Ketek (telithromycine) Briefing Information, Aventis. 26 April 2001 (Not provided).


26.  Malik M, Farbom P, Batchvarov V, Hnatkova K, Camm AJ.  Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval.  Heart 2002; 87:220-8.


27.  Moss AJ, Zareba W, Benhorin J, Couderc JP, Kennedy H, Locati‑Heilbron E, Maison‑Blanche P. ISHNE guidelines for electrocardiographic evaluation of drug‑related QT prolongation and other alterations in ventricular repolarization: task force summary.  A report of the Task Force of the International Society for Holter and Noninvasive Electrocardiology (ISHNE), Committee on Ventricular Repolarization. ANE 2001; 6(4):333-41.


28.  Goodman DB.

a.      Continuous 12-lead ECG recording.  Analysis of digital ECG data.  What can you do with the digitized ECG waveform that you cannot do with a paper ECG record?

b.     Public presentation at FDA ECG data standards meeting (November 2001)




30.  Molnar J, Weiss J, Zhang F, Rosenthal JE.  Evaluation of five QT correction formulas using a software-assisted method of continuous QT measurement from 24-hour Holter recordings.  Am J Cardiol 1996; 78:920-6.


31.  Lepeschkin E, Surawicz B.  The measurement of the Q-T interval of the electrocardiogram.  Circulation 1952; 6:378-88.


32.  Hoffman BB. Catecholamines, sympathomimetic drugs, and adrenergic receptor antagonists. In: Hardman JG, Limbird LE Gilman AG, editors. Goodman & Gilman's  The pharmacological basis of therapeutics, 10th ed.  New York: McGraw‑Hill; 2001.  p.215-68.


33.  Stinson JC, Pears JS, Williams AJ, Campbell RWF.  Use of 24 h ambulatory ECG recordings in the assessment of new chemical entities in healthy volunteers.  Br J Clin Pharmacol 1995; 39:651-6.


34.  Lukacs B, Blondin P, MacCarthy C, Du Boys B, Grippon P, Lassale C.  Safety profile of 3 months' therapy with alfuzosin in 13,389 patients suffering from benign prostatic hypertrophy.  Eur Urol 1996; 29: 29-35.


35.  Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54:188-202.