Pharmacokinetics of propranolol after single and multiple dosing with sustained release propranolol or propranolol CR (Innopran XL), a new chronotherapeutic formulation

Heart Disease

Volumn 5, Issue 3, 2003, Pages 176-181

  Sica, Domenic ^a   Frishman, William H ^b   Manowitz, Neil ^c  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b WESTCHESTER MEDICAL CENTER   (United States)

^c Reliant Pharmaceuticals Inc   (United States)

Author keywords

Chronotherapy; Controlled release; Hypertension; Pharmacokinetics; Propranolol

Indexed keywords

PROPRANOLOL;

ADULT; ARTICLE; BRADYCARDIA; CHRONOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG SAFETY; ELECTROCARDIOGRAM; FATIGUE; HEART PROTECTION; HUMAN; INJECTION SITE; MALE; MULTIPLE DRUG DOSE; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE; SUSTAINED RELEASE PREPARATION; VERTIGO; VOLUNTEER;

1-PROPANOL; ADULT; ANALYSIS OF VARIANCE; ANTIHYPERTENSIVE AGENTS; BIOLOGICAL AVAILABILITY; BLOOD PRESSURE; CHRONOTHERAPY; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DIZZINESS; DOSE-RESPONSE RELATIONSHIP, DRUG; HEART RATE; HUMANS; HYPERTENSION; MALE; PROPANOLS; PROPRANOLOL;

EID: 0038613840     PISSN: 1521737X     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.HDX.0000074436.09658.3b     Document Type: Article

References (37)

1. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): National Cholesterol Education Program; 2001.
2. Cohen MC, Rohtla KM, Lavery CE, et al. Meta-analysis of the morning excess of acute myocardial infarction and sudden cardiac death. Am J Cardiol. 1997;79:1512-1516.
3. Second International Study of Infarct Survival Collaborative Group. Morning peak in the incidence of myocardial infarction: experience in the ISIS-2 trial. Eur Heart J 1992;13:594-598.
4. Willich SN, Levy D, Rocco MB, et al. Circadian variation in the incidence of sudden cardiac death in the Framingham Heart Study population. Am J Cardiol. 1987;60:801-806.
5. Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265:3255-3264.
6. Stamler J, Stamler R, Neaton JD. Blood pressure, systolic and diastolic, and cardiovascular risks. US population data. Arch Intern Med. 1993;153:598-615.
7. Van den Hoogen PC, Feskens EJ, Nagelkerke NJ, et al. The relation between blood pressure and mortality due to coronary heart disease among men in different parts of the world. Seven Countries Study Research Group. N Engl J Med. 2000;342:1-8.
8. Baumgart P. Circadian rhythm of blood pressure: internal and external time triggers. Chronobiol Int. 1991;8:444-450.
9. Lemmer B. The clinical relevance of chronopharmacology in therapeutics. Pharmacol Res. 1996;33:107-115.
10. Anwar YA, White WB. Chronotherapeutics for cardiovascular disease. Drugs. 1998;55:631-643.
11. Willich SN, Jimenez AH, Tofler GH, et al. Pathophysiology and triggers of acute myocardial infarction: clinical implications. Clin Invest. 1992;70(Supp 1):S73-78.
12. Cohen MC, Muller JE. Onset of acute myocardial infarction - circadian variation and triggers. Cardiovasc Res. 1992;26:831-838.
13. Feng DL, Tofler GH. Diurnal physiologic processes and circadian variation of acute myocardial infarction. J Cardiovasc Risk. 1995;2:494-498.
14. Furlan R, Guzzetti S, Crivellaro W, et al. Continuous 24-hour assessment of the neural regulation of systemic arterial pressure and RR variabilities in ambulant subjects. Circulation. 1990;81:537-547.
15. Van de Borne P, Nguyen H, Biston P, et al. Effects of wake and sleep stages on the 24-h autonomic control of blood pressure and heart rate in recumbent men. Am J Physiol. 1994;266(2 Pt 2):H548-554.
16. Muller JE, Stone PH, Turi ZG, et al. Circadian variation in the frequency of onset of acute myocardial infarction. N Engl J Med. 1985;313:1315-1322.
17. Ridker PM, Manson JE, Buring JE, et al. Circadian variation of acute myocardial infarction and the effect of low-dose aspirin in a randomized trial of physicians. Circulation. 1990;82:897-902.
18. Sayer JW, Wilkinson P, Ranjadayalan K, et al. Attenuation or absence of circadian and seasonal rhythms of acute myocardial infarction. Heart. 1997;77:325-329.
19. Willich SN, Linderer T, Wegscheider K, et al. Increased morning incidence of myocardial infarction in the ISAM Study: absence with prior beta-adrenergic blockade. Circulation. 1989;80:853-858.
20. Elliott WJ. Circadian variation in the timing of stroke onset: a metaanalysis. Stroke. 1998;29:992-996.
21. Andreotti F, Davies GJ, Hackett DR, et al. Major circadian fluctuations in fibrinolytic factors and possible relevance to time of onset of myocardial infarction, sudden cardiac death and stroke. Am J Cardiol. 1988;62:635-637.
22. Johnstone MT, Mittleman M, Tofler G, Muller JE. The pathophysiology of the onset of morning cardiovascular events. Am J Hypertens. 1996;9(4 Pt 3):22S-28S.
23. Frishman WH, Lazar EJ. Reduction in mortality, sudden death, and nonfatal reinfarction with beta-adrenergic blockers in survivors of acute myocardial infarction: a new hypothesis regarding the cardioprotective action of beta-adrenergic blockade. Am J Cardiol. 1990;66:66G-70G.
24. The Sixth Report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. JAMA. 1997;154:2413-2446.
25. Frishman WH. Alpha and beta-adrenergic blocking drugs. In: Frishman WH, Sonnenblick EH, Sica DA, eds. Cardiovascular Pharmacotherapeutics. 2nd ed. New York: McGraw-Hill; 2003:67-97.
26. Parker JO, Porter A, Parker JD. Propranolol in angina pectoris. Comparison of long-acting and standard-formulation propranolol. Circulation. 1982;65:1351-1355.
27. Frishman WH, Furberg CD, Friedewald WT. β-Adrenergic blockade in survivors of acute myocardial infarction. N Engl J Med. 1984;310:830-37.
28. The Norwegian Multicenter Study Group. Timolol-induced reduction in mortality and reinfarction in patients surviving acute myocardial infarction. N Engl J Med. 1981;304:801-807.
29. [No authors listed]. A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982;247:1707-1714.
30. Wikstrand J, Berglund G, Tuomilehto J. β-blockade in the primary prevention of coronary heart disease in hypertensive patients. Review of present evidence. Circulation. 1991;84(Supp VI):VI93-100.
31. Wikstrand J, Warnold I, Olsson G, et al. Primary prevention with metoprolol in patients with hypertension. Mortality results from the MAPHY study. JAMA. 1988;259:1976-1982.
32. Peters RW, Muller JE, Goldstein S, et al. Propranolol and the morning increase in the frequency of sudden cardiac death (BHAT Study). Am J Cardiol. 1989;63:1518-1520.
33. Palatini P, Racioppa A, Raule G, et al. Effect of timing of administration on the plasma ACE inhibitory activity and the antihypertensive effect of quinapril. Clin Pharmacol Ther. 1992;52:378-383.
34. Kario K, Matsuo T, Kobayashi H, et al. Nocturnal fall of blood pressure and silent cerebrovascular damage in elderly hypertensive patients. Advanced silent cerebrovascular damage in extreme dippers. Hypertension. 1996;27:130-135.
35. Hayreh SS, Zimmerman MB, Podhajsky P, et al. Nocturnal arterial hypotension and its role in optic nerve head and ocular ischemic disorders. Am J Ophthalmol. 1994;117:603-624.
36. Black HR, Elliott WJ, Neaton JD, et al. Rationale and design for the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial. Control Clin Trials. 1998;19:370-390.
37. Black HR, Elliot WJ, Grandits G, et al for Convince Research Group. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular Endpoints (CONVINCE) trial. JAMA. 2003;289:2073-2087.