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After 4 weeks, 59% (44/74) of the elderly omeprazole-treated patients were symptom-free compared with 33% (23/69) of the elderly [H.sub.2]RA-treated patients (p0.005); these figures rose to 79% (52/66) and 51% (29/57) on completion of the study (p0.005; Figure 2a). The corresponding figures for the young omeprazole- and [H.sub.2]RA-treated patients were 52% (101/193) and 27% (49/183) at 4 weeks (p0.001) and 68% (119/ 176) and 42% (69/164) on completion of the study (p0.001, Figure 2a). The therapeutic gain for omeprazole over [H.sub.2]RA at 4 weeks was 26% (95% CI 9% to 43%) in the elderly patient group and 25% (95% CI 15% to 35%) in the young patient group; the corresponding figures on completion were 28% (95% CI 11% to 45%) and 26% (95% CI 15% to 37%) in the elderly and young patient group, respectively.
[Chart Omitted]
Heartburn, the commonest symptom recorded at entry, was relieved more rapidly by omeprazole than by [H.sub.2]RA in both the elderly and young omeprazole-treated patients at 4 weeks and on completion of the study (Figure 2b). Furthermore, at 4 weeks more young omeprazole-treated patients were relieved of regurgitation compared with young [H.sub.2]RA-treated patients (p0.01) and on completion of the study more elderly omeprazole-treated patients were relieved of dysphagia than were elderly [H.sub.2]RA-treated patients (p0.01). In all variables a trend existed for more rapid symptom relief with omeprazole compared with [H.sub.2]RA (Table IV).
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After four weeks, the proportion of elderly omeprazole-treated patients (47%, 34/73) healed and symptom free was three times that of elderly [H.sub.2]RA-treated patients (14%, 10/69; p0.001); similar findings were found in young omeprazole- (40%, 76/191) and [H.sub.2]RA-treated patients (15%, 28/183; p0.001; Figure 3a). On completion of the study the figures were 68% (45/66) and 23% (13/57) for elderly omeprazole- and [H.sub.2]RA-treated patients (p0.001) and 57% (101/176) and 29% (48/163) for young omeprazole- and [H.sub.2]RA-treated patients (p0.001), respectively. The therapeutic gain for omeprazole over [H.sub.2]RA at 4 weeks was 33% (95% CI 18% to 45%) in the elderly patient group and 25% (95% CI 16% to 34%) in the young patient group; the corresponding figures on completion of the study were 45% (95% CI 27% to 63%) and 28% (95% CI 17% to 39%) in the elderly and young patient groups, respectively.
Treatment failures were common in the [H.sub.2]RA-treated group with the proportion of elderly and young [H.sub.2]RA-treated patients both symptomatic and unhealed being nearly three times that of the omeprazole-treated groups on completion of the study (Figure 3b). Furthermore, the distribution between the four possible outcomes of treatment (healed and symptom-free, healed but symptomatic, unhealed but symptom-free, and unhealed and symptomatic) was significant and in favour of omeprazole in both the elderly and young patient group at 4 weeks (both p0.001) and on completion of the study (both p0.001).
The elderly and young [H.sub.2]RA-treated patients consumed respectively 64% and 54% more antacids during the first 4 weeks of treatment than the elderly and young omeprazole-treated patients (Figure 4).
Serious adverse events and reasons for withdrawal from the study are shown in Table V. In general, both drugs were well tolerated and only one serious adverse event was considered drug-related (urticaria following cimetidine treatment). Full details have been described elsewhere (11)(12).
Discussion
This analysis demonstrates that omeprazole 20 mg once daily is superior to histamine [H.sub.2]-receptor antagonists in resolving both the lesions of oesophagitis and the symptoms of gastro-oesophageal reflux in elderly patients ([greater than or equal to]65 years), as in young ones (65 years).
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It is a generally held view that disease presentation in older people is different from that in younger adults. Raiha et al. reported that the typical symptoms of gastro-oesophageal disease in elderly patients were regurgitation, respiratory problems and vomiting rather than heartburn (13); in our series heartburn was the predominant symptom in both young and elderly patients but regurgitation and dysphagia were common in the elderly.
Landahl et al. showed that in elderly people there was an increase in the bioavailability of omeprazole, a reduction in mean systemic clearance and a prolongation of the mean elimination half-life compared with that found in earlier studies of healthy young volunteers. Despite these findings, the considerable overlap in the pharmacokinetic parameters between young and elderly volunteers, together with data from previous pharmacodynamic studies and the wide therapeutic range of omeprazole, indicated that dose reductions were not needed in elderly patients (14). Lind et al. showed at least 20 mg had to be given to obtain a marked inhibitory effect in all elderly duodenal ulcer patients and increasing the dose to 40 mg had only slight additional effect (15). Solvell reported no difference in the frequency or type of adverse events in elderly patients over 65 years of age compared with younger patients in omeprazole versus placebo comparative studies (16). This study showed the incidence of adverse events resulting in withdrawal from the study was low and similar in the young and elderly omeprazole-treated patients.
It is clear that omeprazole results in more complete resolution of both lesions and symptoms of reflux oesophagitis than histamine [H.sub.2]-receptor antagonists in elderly patients despite their slightly different symptomatology and endoscopic findings compared with younger patients. There was no evidence that tolerability was less among the older patients.
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