Summary
251 patients from 23 primary health care centres were recruited to a clinical trial in which either felodipine or placebo was added to baseline metoprolol treatment. Three methods of symptom reporting were used in 191 patients, namely two previously documented self-administered questionnaires and an adverse event monitoring system (spontaneous reports to treating physician).
Higher frequencies of symptoms were seen with the questionnaires compared to spontaneous reporting. However, the overlap between the methods was moderate and they were found to complement one another. The questionnaires were completed twice during the study and the adverse event monitoring system was applied on five occasions. The rate of application had consequences for the ability of each method to detect transient, dose-related symptoms, e.g. headache and dizziness.
Regardless of method, the possibility of detecting dose-related symptoms was enhanced when symptoms were measured not only during active treatment but also during a run-in or other baseline period, and both phases were considered in the analyses.
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References
Aitkens RCB (1969) Measurements of feelings using visual analogue scales. Proc Roy Soc (B) Lond 62: 989–993
Avery CW, Ibelle BP, Allison B, Mandell N (1967) Systematic errors in the evaluation of side effects. Am J Psychiat 123: 875–878
Bengtsson C, Edström K, Furunes B, Sigurdsson JA, Tibblin G (1987) Prevalence of subjectively experienced symptoms in a population sample of women with special reference to women with arterial hypertension. Scand J Prim Health Care 5: 1–8
Borghi C, Pallavini G, Comi D, Grillo G, Lombardo M, Mantero O, Minetti L, Selvini A, Suppa G (1984) Comparison of three different methods of monitoring unwanted effects during antihypertensive therapy. Int J Clin Pharmacol Ther Toxicol 22: 324–328
Bradley JV (1968) Distribution-free statistical tests. 68–86 Prentice-Hall, London
Brun J, Fröberg L, Kronmann P, Olsson L-B, Skoug P, Tygesen G, Bengtsson C, Scherstén B, Tibblin G (1990) Optimal felodipine dose when combined with metoprolol in arterial hypertension: a Swedish multicenter study within primary health care. J Cardiovasc Pharmacol 15 [Suppl 4]: S60-S64
Bulpitt CJ, Dollery CT, Carne S (1974) A symptom questionnaire for hypertensive patients. J Chron Dis 27: 309–323
Bulpitt CJ, Fletcher AE (1985) Quality of life in hypertensive patients on different hypertensive treatments: rationale for methods employed in a multicenter randomized controlled trial. J Cardiovasc Pharmacol 7 [Suppl 1]: S137-S145
Ciccolunghi SN, Chaudri HA (1975) A methodological study of some factors influencing the reporting of symptoms. J Clin Pharmacol 15: 496–505
Costa FV, Ambrosioni E, Magnani B (1979) Side effects of antihypertensive drugs. Incidence and methods of collection. Int J Clin Pharmacol Biopharm 17: 405–409
Dimenäs E, Dahlöf C, Olofsson B, Wiklund I (1990) An instrument for quantifying subjective symptoms among untreated and treated hypertensives. Development and documentation of the SSA-profile. J Clin Res Pharmacoepidemiol
Dimenäs E, Wallander M-A, Svärdsudd K, Wiklund I (1990) Aspects of quality of life on treatment with felodipine. Eur J Clin Pharmacol
Dimenäs E, Wiklund IK, Dahlöf CG, Lindvall KG, Olofsson BK, De Faire UH (1989) Differences in the subjective well-being and symptoms of normotensives, borderline hypertensives and hypertensives. J Hypertension 7: 890–895
Elmfeldt D, Westerling S (1987) Aspects on the benefit-risk balance of felodipine in hypertension. Drugs 34 [Suppl 3]: 132–135
Eriksson H, Svärdsudd K, Larsson B, Welin L, Ohlsson L-O, Tibblin G, Wilhelmsen L (1988) Quality of life in early heart failure. Scand J Prim Health Care 6: 161–167
Fagard R, Lijnen P, Moerman E, Staessen J, Amery A (1987) Acute hemodynamic and humoral responses to felodipine and metoprolol in mild hypertension. Eur J Clin Phramacol 32: 71–75
Furberg C, Schucker B, Chesney M (1984) Report of the working group: Mild hypertension. In: Assessment of quality of life in clinical trials of cardiovascular therapies. Ed Wenger N Le Jacq Inc 285–295
Guyatt G, Van Zantem S, Feeny D, Patrick D (1989) Measuring quality of life in clinical trials: a taxonomy and review. Can Med Assoc J 140: 1441–1448
Huskisson EC, Wojtulewski JA (1974) Measurement of side effects of drugs. Br Med J 2: 698–699
Jahuck SJ, Brierley H, Jahuck S, Willcox PM (1982) The effect of hypotensive drugs on the quality of life. J Roy Coll Gen Pract 32: 103–105
Kirshner B, Guyatt G (1985) A methodological framework for assessing health indices. J Chron Dis 38: 27–36
Ljung B, Boström S-L, Hallbäck-Nordlander M (1980) Vascular versus myocardial selectivity in vitro of H 154/82 — a new dihydropyridine. Blood Vessels 17: 154
Lund-Johansen P, Omvik P (1990) Chronic hemodynamic effects of tiapamil and felodipine in essential hypertension at rest and during exercise. J Cardiovasc Pharmacol 15 [Suppl 4]: S42-S47
Peace KE (1987) Design, monitoring, and analysis issues relative to adverse events. Drug Information J 21: 21–28
Petrie WM, Levine J (1979) The assessment of adverse drug reactions through clinical trials. Psychopharmacol Bull 15: 62–63
Rudin R, Svärdsudd K (1987) Otitis media and well-being in a male population in Gothenburg. The study of men born in 1913. Acta Otolaryngol 104: 454–462
Sackett DI (1980) Hypertension: V. Compliance with antihypertensive therapy. Can J Public Health 71: 153–156
Saltiel E, Ellrodt AG, Monk JP, Langley MS (1988) Felodipin a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in hypertension. Drugs 36: 387–428
Skegg DCG, Doll R (1977) The case for recording events in clinical trials. Br Med J 2: 1523–1524
Tibblin G (1986) Kunskap om symtomens naturalhistoria hjälp för läkaren i kontakten med patienten. Läkartidningen 83: 1186–1190
Tibblin G, Bengtsson C, Furunes B, Lapidus L (1990) Symptoms by age and sex. Scand J Prim Health Care 8: 9–17
Vandenburg MJ, Evans SJW, Kelly BJ, Bradshaw F, Currie WJC, Cooper WD (1984) Factors affecting the reporting of symptoms by hypertensive patients. Br J Clin Pharmacol 10: 189–195
Wallander M-A, Lundborg P (1989) Application of a new method for adverse experience monitoring to premarketing studies on two new drugs: some experiences. In: Edlavitch SA (ed) Pharmacoepidemiology. Lewis Publishers, Chelsea Michigan, pp 163–169
Wallander M-A, Palmer L (1986) A monitoring system for adverse drug experiences in a pharmaceutical company: the integration of pre- and postmarketing data. Drug Information J 20: 225–235
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Wallander, M.A., Dimenäs, E., Svärdsudd, K. et al. Evaluation of three methods of symptom reporting in a clinical trial of felodipine. Eur J Clin Pharmacol 41, 187–196 (1991). https://doi.org/10.1007/BF00315428
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DOI: https://doi.org/10.1007/BF00315428