Michael Blocker
7/26/96
Case #1:
53 y.o. Black male with h/o cocaine use, s/p non Q wave MI 1 yr ago (by enzymes and chest
pain), with subsequent cardiac catheterization showing no significant disease who presents
to ER with chest pain without EKG changes and positive cocaine in the urine, and
ROS suggesting reflex symptoms. Course: admitted to telemetry and r/o'd for MI; UGI
seriesshowed reflex disease. Sx relieved with omeprazole.
Case #2: 39 y.o. Black female with h/o GERD (rx'd with ranitidine), and severe asthma who
presents to ER with severe reflex symptoms and subsequent asthma attack. Course: required
albuterol 35mg over 4 hour period and admission secondary to poor peak flows and
hypokalemia.
Assumption: Both admissions were secondary to recurrent GERD.
Clinical Question: What is the most efficacious medication regimen to prevent
recurrent reflux esophagitis?
Data: (from Vigneri, S et. al., NEJM, 1995, 333:1106-1110)
| Treatment Group | Grade 1 | Grade2 | Grade3 | vs. omeprazole | vs. omeprazole/ cisapride |
| # of patients (%) with recurrence | |||||
| ciapride (n=35) | |||||
| endoscopic signs | 3 (20) | 4 (27) | 5 (100) | p=0.2 | p=0.003 |
| symptoms | 2 (13) | 5 (40) | 5 (100) | p<0.001 | p<0.001 |
| ranitidine (n=35) | |||||
| endoscopic signs | 4 (27) | 4 (27) | 5 (100) | p=0.003 | p<0.001 |
| symptoms | 4 (27) | 5 (33) | 5 (100) | p<0.001 | p<0.001 |
| omeprazole (n=35) | |||||
| endoscopic signs | 0 | 2 (13) | 3 (60) | n/a | ns |
| symptoms | 0 | 0 | 1(20) | n/a | ns |
| ranitidine/cisapride (n=35) | |||||
| endoscopic signs | 1 (7) | 3 (20) | 4 (80) | ns | p=0.003 |
| symptoms | 2 (13) | 1 (7) | 3 (60) | ns | ns |
| meprazole/cisapride (n=35) | |||||
| endoscopic signs | 0 | 0 | 3 (60) | ns | n/a |
| symptoms | 0 | 0 | 0 | ns | n/a |
1. Univariate analysis showed relapse was assoc. with higher frequency of grade 3
esophagitis (49%, p<0.001) and EtOH intake (54%, p<0.001).
2. Independent risk factors for relapse were found to be only grade of esophagitis
(p<0.001) and maintenance therapy (p<0.001).
3. When all treatment groups were combined, risk of relapse (endoscopically) was 22.6
times higher for patients with symptoms vs without (95% CI = 7.3-69.9).
4. Side effects of treatment occurred in 28 (16%) of patients. 5 patients withdrew from
the study secondary to side effects. All side effects resolved spontaneously or after
withdrawal of medication.
5. At the end of the healing phase, all groups had similar elevation in gastric levels.
After treatment, only the cisapride group had significantly decreased gastrin levels
(p<0.001).
Conclusions:
1. Omeprazole and omeprazole/cisapride treatment is more effective than cisapride or
ranitidine alone at preventing recurrent GERD
2. Cisapride/ranitadine treatment is more effective than ranitidine alone, but not
cisapride alone, at preventing recurrent GERD (data not shown)
3. Financial constraints and patient compliance with multi-drug regimens need to be
considered in choosing treatment regimen .
4. Use of ranitidine alone was not supported by this study, as there was no direct
comparison with placebo