Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo
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1 (2001) 15, Nature Publishing Group All rights reserved /01 $ ORIGINAL ARTICLE Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo EC Rake 1, E Breeze 2 and AE Fletcher 2 1 Institute for Cancer Research, London School of Hygiene and Tropical Medicine (LSHTM), London, UK; 2 Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine (LSHTM), London, UK The objective of this study was to compare the quality of life and incidence of dry cough with the angiotensin II antagonist eprosartan, the ACE-inhibitor enalapril, and placebo, in hypertensive patients with a history of ACEinhibitor cough. The study was a multicentre, randomised, double-blind, parallel group controlled trial. A total of 136 patients judged to have ACE-inhibitor cough during single-blind enalapril treatment which was lost during a subsequent placebo washout phase, were randomised to receive either eprosartan 300 mg twice daily, or enalapril 20 mg once daily, or placebo for 6 weeks. Self-completion questionnaires assessing quality of life and cough were examined at baseline and end of study. At study end point 23% of patients in the enalapril group and 5% in the eprosartan and placebo groups reported cough (which included definite, probable and possible coughs) (P 0.02). After adjusting for multiple comparisons, the eprosartan group was not significantly different from either placebo or enalapril. There were no significant differences in the Psychological General Wellbeing Index (PGWB). In conclusion the incidence of self-reported cough on eprosartan was similar to that on placebo, and lower than on enalapril but this difference was not significant when adjustments were made for multiple comparisons. There were no differences in quality of life. (2001) 15, Keywords: quality of life; dry cough; clinical trial; ACE-II inhibitor; ACE-I inhibitor; PGWB Introduction Persistent non-productive dry cough is the most common side effect of antihypertensive treatment with angiotensin-converting enzyme (ACE) inhibitors 1 and has been reported as the leading cause for discontinuation of this class of agents. 2 Cough associated with ACE inhibitors such as enalapril is thought to result from a non-specific pharmacological action related to inhibition of kininases. 3 Clinical research has shown that antihypertensive therapy with angiotensin II (A- II) receptor antagonists, which have a different mechanism of action than ACE inhibitors, is associated with a much lower incidence of persistent non-productive cough. In two studies of ACE coughers comparing the angiotensin-ii receptor antagonist losartan with the ACE inhibitor lisinopril, the incidence of cough was found to be significantly lower in the losartan group, Correspondence: Ms Elizabeth Breeze, Epidemiology Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. elizabeth.breeze Ishtm.ac.uk Received 20 December 2000; revised 3 June 2001; accepted 3 July 2001 compared to lisinopril. 3 6 Little is known about the more general aspects of quality of life (QOL) on ACE- II inhibitors. The present study was designed to compare the QOL and incidence of dry, non-productive cough in ACE-inhibitor sensitive patients treated with eprosartan, an A-II receptor antagonist, with that in patients treated with enalapril, or with placebo. Methods The present study was a randomised, double-blind, parallel group, controlled trial, involving 18 centres in the United States. The protocol was approved by the London School of Hygiene and Tropical Medicine (LSHTM) Ethics Committee and by each centre s local Ethics Review Committee. Written informed consent was obtained from all patients. Male and female patients, of at least 18 years of age, with mild to moderate hypertension and a history of ACE inhibitor induced cough were recruited for the trial. Patients had to be able to read and write in the local language of the centre. Figure 1 shows the study design. At screening, patients discontinued any previous antihypertensive treatment
2 QOL and cough on eprosartan, enalapril and placebo 864 Figure 1 Study design. before entering a 4- to 5-week, single-blind, placebo run-in period. Patients without a dry cough and with an average sitting diastolic blood pressure (DBP) of mm Hg at the last 2-weekly visits of the run-in period entered the 3- to 4-week, singleblind period of treatment with enalapril 20 mg daily (10 mg for the initial 3 days). Patients developing a persistent non-productive dry cough judged by the investigator to be related to the treatment entered a 2- to 4-week placebo washout period and those with no cough at the end of the washout period were randomly assigned (1:1:1) to double-blind treatment with eprosartan 300 mg twice daily (200 mg for the initial 3 days), enalapril 20 mg once daily (10 mg for the initial 3 days), or placebo for 6 weeks. Active and placebo forms of eprosartan and enalapril (double-dummy) were used during each period as appropriate to maintain blinding and to conceal period transitions. Throughout the study patients attended the clinic weekly or biweekly for blood pressure measurement and other vital signs. Patients experiencing any adverse side effects were also invited to return to the clinic between visits. Each patient completed both a QOL questionnaire, and a pulmonary questionnaire. Questionnaires were completed by the patient in privacy before they saw the clinician. The primary outcome from the QOL questionnaire was the Psychological General Wellbeing Index (PGWB). 7 This is a validated scale 8,9 of 22 items used to measure subjective wellbeing or distress with subscales for anxiety, depressed mood, positive wellbeing, self-control, general health and vitality. Higher scores reflect more positive wellbeing. The QOL questionnaire also contained six questions forming a sleep disturbance scale, 10,11 two questions measuring life satisfaction and one question on satisfaction with spouse. 12 Scores for each subscale were included in the analysis provided at least 80% of the items for that scale were answered. Where less than 20% of items were missing, the score was increased pro-rata as if patients had assigned their average score to the missing items. The primary pulmonary outcome was selfreported dry unproductive cough. The pulmonary questionnaire contained nine questions on pulmonary symptoms experienced during the previous 2 weeks and, for those who reported experiencing a persistent cough, a further nine questions. Three categories of cough were used for the primary analyses and are described in Table 1. Patients were asked to complete the QOL and pulmonary questionnaires at the beginning of the placebo run-in period, during the placebo washout phase just prior to randomisation, and at the last visit of the double-blind treatment. Those who withdrew before the end of the 6-week double-blind period were asked to complete the questionnaires at the visit at which they withdrew or, failing that, at a follow-up visit within 7 to 14 days. LSHTM were responsible for quality control checks, data entry, data processing and statistical analysis. The investigator completed a pulmonary questionnaire during every clinical assessment. This was similar to the patient-completed questionnaire but investigators also stated the probable cause of any cough reported by the patient and whether or not the patient was being withdrawn from the trial due to cough. The questionnaires were translated from English into Spanish for one centre in the study. It was hypothesised that 68% of those on enalapril Table 1 Category Persistent Dry/wet Duration of cough a Definite cough Yes Dry At least 14 days or caused to withdraw Probable cough Yes Dry Not known Possible cough Yes Not known As definite cough or No/not Dry As definite cough known a Duration defined as difference between end date and start date or, if cough still present at time of visit, as difference between visit date and start date.
3 and 33% of those on placebo would re-develop a dry unproductive cough during the double-blind treatment period, the percentage on eprosartan developing a cough being closer to that on placebo than to that on enalapril. With the expected marked difference in incidence of cough during the doubleblind treatment a substantial treatment effect size on the PGWB scales was anticipated, but it was recognised that the study (powered to detect a large percentage cough difference) would be less effective at detecting small differences in PGWB. With 45 patients per group the study would have 80% power at the 5% level to detect an effect size between treatments of 0.6, where effect size is defined as the difference between treatments in mean changes in scores from baseline to end point, divided by the pooled baseline standard deviation of the scores. 13 Analysis strategy The statistical analysis was performed without knowledge of the treatment codes. Using the intention-to-treat approach, QOL and pulmonary outcomes were compared at the end of study. This was the time at which the individual left the study, whether as a withdrawal or on completion. If no questionnaire was completed at the time the patient stopped medication then the latest questionnaire available was used, whether completed at follow-up or at a visit prior to the end of medication. For some patients the last QOL and pulmonary questionnaires were completed on different dates. Baseline was defined as the questionnaire completed at the last visit of the placebo washout period, determined by the patient having qualified for randomisation. Analyses were undertaken for those who had both a baseline and end point questionnaire. Changes in scores were analysed by Kruskal Wallis ANOVA. Chi-square tests were used to see if there were any between-group differences in the incidence of cough. Fisher s exact test was used to make pairwise comparisons, the comparisons of interest being eprosartan against placebo (to test the hypothesis of no difference) and eprosartan against enalapril (to see whether there was evidence of a difference). Significance of the two comparisons of interest were determined using the modified Bonferroni procedure due to Hochberg. 14 Under the Hochberg procedure if both P-values are less than 0.05 then both are statistically significant; if one is greater than 0.05 the other has to be less than to be considered statistically significant. Descriptive analyses were undertaken for the subsidiary QOL outcomes of sleep disturbance, satisfaction with life and satisfaction with spouse. Results A total of 231 patients were screened for the study. Of these, 136 patients were randomised: 45 patients each to enalapril and placebo, and 46 to the eprosar- QOL and cough on eprosartan, enalapril and placebo tan group. Four patients had insufficient information to analyse QOL; one because there was no end point questionnaire and a further three because the baseline questionnaires were completed while the patient was still in the washout phase. Thus QOL analyses covered 42 patients from the placebo group, 44 from the enalapril group and 46 from the eprosartan group. There were fewer self-completed pulmonary than QOL questionnaires for baseline and end point (41 for the placebo group and 39 each for the enalapril and eprosartan groups). Investigator-completed pulmonary questionnaires were completed for 45 patients in the placebo group, 44 in the enalapril group and 46 in the eprosartan group. At randomisation, there was no difference between the treatment groups for blood pressure or any of the demographic characteristics (Table 2). Fifteen percent of patients on eprosartan, 22% on enalapril and 24% on placebo withdrew from randomised treatment. The main reasons for withdrawal were adverse experiences and lack of efficacy. Withdrawals due to lack of efficacy occurred with similar frequency across the three treatment groups. Withdrawals resulting from adverse experiences occurred in 8.9% of the enalapril group, 4.4% of the placebo group and 2.2% of the eprosartan group. Of these, coughing was reported as the reason for withdrawal for two patients in the enalapril group and one patient in the eprosartan group. All but one patient completed withdrawal questionnaires. Quality of life The three treatment groups scored similarly for the PGWB scales at baseline. The P-values for the Kruskal Wallis ANOVA test of between-treatment changes indicate there were no significant effects between treatment groups (Table 3). Cough One definite cough and one probable cough were selfreported at baseline from the placebo group and epro- Table 2 Characteristics of those who had a baseline and end point QOL questionnaire Characteristic Placebo Enalapril Eprosartan (n = 42) (n = 44) (n = 46) Average age (years) Sex Male 20 (48%) 22 (50%) 27 (59%) Female 22 (52%) 22 (50%) 19 (41%) Mean DBP at baseline (mm Hg) Smoking history? Yes 5 (12%) 3 (7%) 4 (9%) No 37 (88%) 41 (93%) 42 (91%) Smokers cough? Yes 1 (2%) 0 (0%) 0 (0%) No 41 (98%) 44 (100%) 46 (100%) 865
4 QOL and cough on eprosartan, enalapril and placebo 866 Table 3 PGWB subscale scores at baseline and mean change between baseline and end point Scale (no. of items) Baseline Scores: Median (quartiles) Mean change Kruskal Wallis Placebo Enalapril Eprosartan Placebo Enalapril Eprosartan P-value Anxiety (5) n = 41 n = 39 n = 42 n = 41 n = 39 n = (22, 27) 25 (21, 28) 24 (22, 26) Depression (3) n = 41 n = 41 n = 45 n = 41 n = 41 n = (14, 18) 18 (15, 18) 17 (15, 18) Positive wellbeing (4) n = 38 n = 40 n = 43 n = 38 n = 40 n = (15, 21) 19.5 (15, 20) 18 (16, 21) Self-control (3) n = 41 n = 41 n = 46 n = 41 n = 41 n = (14, 18) 17 (16, 18) 17 (15, 18) General Health (3) n = 41 n = 40 n = 46 n = 41 n = 40 n = (12, 16) 15 (13.5, 16) 14 (12, 16) Vitality (4) n = 42 n = 43 n = 43 n = 42 n = 43 n = (15, 20) 19 (16, 21) 18 (14, 20) PGWB total (22) n = 42 n = 43 n = 46 n = 42 n = 43 n = (92, 116) 111 (100, 116) 104 (95, 119) sartan group respectively; neither of these baseline coughs were reported to the investigator. At the study end point, the numbers of self-reported definite dry coughs were five in the enalapril group, two in the placebo group and one in the eprosartan group; too few from which to draw any conclusions of statistical significance (Table 4). When all types of cough were included (definite plus probable plus possible), there were nine (23%) self-reported dry coughs in the enalapril group as compared with two (5%) coughs for patients on placebo or eprosartan (P 0.02 on a chisquared test). The incidence of cough was almost identical for eprosartan and placebo so eprosartan appeared to be no worse than placebo; the P-value for the difference between eprosartan and enalapril using Fisher s exact test was Under Hochberg s formula this is not statistically significant. Overall, investigators reported coughs for more people (n 19) than patients did (n 13). The number of investigator-reported definite dry coughs were three in the enalapril group as compared with one in each of the other two groups. When all types of cough were included (definite plus probable plus possible), there were 11 coughs in the enalapril group, five in the eprosartan group and three in the placebo group (P 0.039, ). Neither pairwise comparison involving eprosartan was statistically significant (P 0.48 for eprosartan against placebo and P 0.09 for eprosartan against enalapril). Table 4 Prevalence of self-assessed cough at study end point Cough Placebo Enalapril Eprosartan Chi-square categorisation (n = 41) (n = 39) (n = 39) P-value Definite dry cough Probable dry cough Possible dry cough All coughs P = 0.02 Secondary outcome measures There was a very slight improvement in measures of central tendency between baseline and end point across all three groups for life satisfaction. The mean scores for spouse satisfaction and sleep disturbance were similar for both baseline and study end point (not shown), and provide no indication of any treatment effect. Blood pressure control Patients responded to treatment if, at study end point, the mean sitting DBP was 90 mm Hg or less, or between 90 and 100 mm Hg, having decreased from baseline by at least 10 mm Hg. By study end point 54% of patients in the eprosartan group responded to treatment compared with 41% in the enalapril group and 25% the placebo group. Eprosartan had a statistically significant greater response rate than placebo (P 0.004) but not than enalapril. Discussion There were no significant differences between enalapril, eprosartan or placebo in their effects on PGWB in the present trial. The original study hypotheses of large differences in QOL between treatments were based on the assumption that there would be a high proportion of coughers in the enalapril group (68%) as compared to the eprosartan or placebo groups (33%). The numbers and percentages of coughers at end point were markedly less than anticipated. The percentage of coughs at study end point was 23% for the enalapril group (which included both probable and possible coughs) as against 5% for eprosartan and placebo. In trials of similar design to the present study much higher percentages of people were reported with coughs. In one trial the percentages were 72% on lisi-
5 nopril and 29% on losartan; 3 5 in the other trial the percentages were 87.5% and 36.7%. 15 There was also a marked difference in another trial which compared the effects of losartan, lisinopril and metolazone on patients with a history of ACE inhibitor-related cough (18% on losartan against 97% on lisinopril), although the threshold for cough detection was lowered for the double-blind phase of the study. 6 The reason for the unexpectedly low number of coughs at end point in the present study are unknown. One possible explanation is that patients treated as eligible for the double-blind treatment may have been less severely affected during the challenge period than those in the losartan trials. The data collected at the end of the enalapril challenge period provides some support for this suggestion. At this point the investigator judged all (subsequently) randomised patients to have an ACE- 1 induced cough. However, reference to self-completion data at this point reveals that only one-half to two-thirds of all randomised patients reported a definite cough and therefore non- ACE coughers may have been included in the trial. Perhaps the challenge-dechallenge study design may modify patients responses to subsequent ACE- 1 exposure. This suggestion is supported by the findings of Reisin and Schneeweiss 16 who reported the disappearance of ACE-1 induced cough after continued treatment in approximately one-half of their patients. In another report by the same authors, 64% of patients with ACE-1 associated cough reported cough disappearance, attenuation or intermittence while still on ACE inhibitors. 17 Furthermore, the high percentage of coughs in one of the losaratan trials 3 5 was achieved with a higher proportion of women in the trial (65%), who tend to develop or report cough (or both) more often than men Primary and secondary QOL outcomes were not statistically significantly different across the three treatment groups. The study had the power to detect effect sizes of 0.6 or more. In this study, between-treatment effect sizes were insignificant. For the total PGWB index the between treatment effect size for eprosartan vs placebo was 0.03 ( 0.29, 0.26) and for eprosartan versus enalapril was 0.08 ( 0.32, 0.17). The QOL analysis showed little difference among the three regimens. Acknowledgements The project was funded by Smithkline Beecham Pharmaceutical Inc (since merged into GlaxoSmithkline). References 1 Fletcher AE, Palmer AJ, Bulpitt CJ. Cough with angiotensin converting enzyme inhibitors: how much of a problem? J Hypertens 1994; 12 (Suppl 2): S43 S47. 2 Yeo WW, Ramsay LE. Persistent dry cough with enala- QOL and cough on eprosartan, enalapril and placebo pril: incidence depends on method used. J Hum Hypertens 1990; 4: Lacourcière Y et al, and the Losartan Cough Study Group. Effects of modulators of the renin-angiotensinaldosterone system on cough. J Hypertens 1994; 12: Ramsay LE, Yeo WW, on behalf of the Losartan Cough Study Group. ACE inhibitors, angiotensin II antagonists and cough. J Hum Hypertens 1995; 9 (Suppl 5): S51 S54. 5 Ramsay LE, Yeo WW, on behalf of the Losartan Cough Study Group. Double-blind comparison of losartan, lisinopril and hydrochlorothiazide in hypertensive patients with a previous angiotensin converting enzyme inhibitor-associated cough. J Hypertens 1995; 13 (Suppl 1): S73 S76. 6 Chan P et al. Double-blind comparison of losartan, lisinopril, and metolazone in elderly hypertensive patients with previous angiotensin-converting enzyme inhibitor-induced cough. J Clin Pharmacol 1997; 37: Dupuy HJ. The Psychological General Wellbeing Index. In: Wenger NK, Mattson ME, Furberg CD, Eliason J (eds). Assessment of Quality of Life in Clinical Trials of Cardiovascular Therapies. Le Jacq: New York, 1984, pp Wiklund I, Halling K, Lngström G. The Psychological General Wellbeing Index (PGWB), a reliable tool for use in cross-cultural multicentre clinical trials (abstract). Qual Life Res 1995; 4: Badia X, Gutiérrez F, Wiklund I, Alonso J. Validity and reliability of the Spanish version of the Psychological General Wellbeing Index. Qual Life Res 1996; 5: Bulpitt CJ, Fletcher AE. Measurements of quality of life in hypertension: a practical approach. Br J Clin Pharmacol 1990; 30: Crown S, Crisp AH. A short diagnostic self-rating scale for psychoneurotic patients. Br J Psychiatr 1966; 112: Developed in the Rand Corporation, Santa Monica, California. 13 Kazis LE, Anderson JJ, Meenan RS. Effect sizes for interpreting changes in health statistics. Med Care 1989; 27: Hochberg Y. A sharper Bonferroni procedure for multiple tests. Biometrika 1988; 75: Paster RZ et al. Use of Iosartan in the treatment of hypertensive patients with a history of cough induced by antiotensin-converting enzyme inhibitors. Clin Ther 1998; 20: Reisin L, Schneeweiss A. Complete spontaneous remission of cough induced by ACE-inhibitors during chronic therapy in hypertensive patients. J Hum Hypertens 1992; 6: Reisin L, Schneeweiss A. Spontaneous disappearance of cough induced by angiotensin-converting enzyme inhibitors (captopril or enalapril). Am J Cardiol 1992; 70: Israili ZH, Hall WD. Cough and angioneurotic oedema associated with angiotensin converting enzyme inhibitor therapy. Ann Intern Med 1992; 117: Yeo WW, Foster G, Ramsay L. Prevalence of persistent cough during long term enalapril treatment: controlled study versus nifedipine. QJMed1991; 293: Os I et al. Female sex as an important determination of lisinopril-induced cough (letter). Lancet 1992; 339:
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