A prospective comparison of four study designs used in assessing safety and effectiveness of drug therapy in hypertension management

American Journal of Hypertension

Volumn 10, Issue 11, 1997, Pages 1191-1200

  Levine, Mitchell A H ^a   Hamet, Pavel ^b   Novosel, Snezana ^b   Jolain, Bruno ^b  

^a CENTRE FOR EVALUATION OF MEDICINES   (Canada)

^b NONE

Author keywords

Angiotensin converting enzyme inhibitors; Postmarketing surveillance; Primary care; Randomized clinical trial; Study design

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; FOSINOPRIL;

ADULT; ADVERSE DRUG REACTION; ANTIHYPERTENSIVE THERAPY; ARTICLE; CANADA; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE DETERMINATION; CANADA; DATA COLLECTION; DOUBLE-BLIND METHOD; ENALAPRIL; FEMALE; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PERSONNEL SELECTION; PHYSICIANS; PROSPECTIVE STUDIES; RESEARCH DESIGN;

EID: 0031278639     PISSN: 08957061     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-7061(97)00227-6     Document Type: Article

References (15)

1. 1. Kramer MS, Shapiro S: Scientific challenges in the application of randomized trials. JAMA 1984;252:2739-2745.
2. 2. Faich GA: Adverse-drug-reaction monitoring. N Engl J Med 1986;314:1589-1592.
3. 3. Drummond MF: Methodological principles for economic evaluation of pharmaceuticals. Br J Med Econ 1993;6B:1-18.
4. 4. Ottenbacher K: Impact of random assignment on study outcome: an empirical examination. Controlled Clin Trials 1992;13:50-62.
5. 5. Colditz GA, Miller JN, Mosteller F: How study design affects outcomes in comparison of therapy. I: Medical. Stat Med 1989;8:441-454.
6. 6. Gehan EA: Progress of therapy in acute leukemia 1948-1981: randomized versus non-randomized clinical trials. Controlled Clin Trials 1982;3:199-207.
7. 7. Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-412.
8. 8. Sackett DL, Haynes RB, Guyatt GH, Tugwell P: Clinical Epidemiology: A Basic Science for Clinical Medicine, 2nd ed. Little, Brown, and Co., Boston, 1991.
9. 9. Goldstein RJ, on behalf of the other fosinopril investigators: A multicentre, randomized, double-blind, parallel comparison of fosinopril sodium and enalapril maleate for the treatment of mild-to-moderate essential hypertension. Drug Invest 1991;3(suppl 6):38-44.
10. 10. Huckell VF, Belanger LG, Kazimirski M, et al: Lisinopril in the treatment of hypertension: a Canadian post-marketing surveillance study. Clin Ther 1993;15:407-422.
11. 11. Poggi L, Renucci JF, Denolle T: Treatment of essential hypertension in general practice: an open-label study of 47,351 French hypertensive patients treated for one year with perindoprial. Can J Cardiol 1994;10(suppl D):21D-24D.
12. 12. Pope JE, Anderson JJ, Felson DT: A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med 1993;153:477-484.
13. 13. ASCPT Pharmacoepidemiology Section: Position paper on the use of purported post-marketing drug surveillance studies for promotional purposes. Clin Pharmacol Ther 1990;48:598.
14. 14. Kronmal RA, Rutan GH, Manolio TA, Borhani NO: Properties of the random zero sphygmomanometer. Hypertension 1993;21:632-637.
15. 15. Levine MAH: Regulatory guidelines for pharmaceutical drug economic analysis: Canadian view, in Lieberman R, Mukherjee A (eds): Principles of Drug Development in Transplantation and Autoimmunity. R.G. Landes Co., Austin, TX, 1994.