Table 37Adverse events in RCTs comparing medical to surgical treatments

Author year [UI]
Trail Name
Follow-up duration
TreatmentDeathOther reported adverse eventsP value between groups
Lundell 200816 [18469091]
LOTUS

3 years
Esomeprazole 20 mg/d1/266 (0.4%) aAny serious adverse events: 42/266 (14.3%)
  • Myocardial infarction: 1/266 (0.4%)
  • Injury, poisoning, procedural: 2/266 (0.8%)
  • GI disorders: 5/266 (1.9%)
  • Musculoskeletal/connective tissue: 8/266 (3.0%)
  • Infections and infestations: 6/266 (2.3%)
  • General disorders: 4/266 (1.5%)
  • Cardiac disorders: 3/266 (1.1%)
  • Neoplasms, benign/malignant: 6/266 (2.3%)
  • Reproductive system including breast: 4/266 (1.5%)
  • Respiratory, thoracic, mediastinal: 1/266 (0.4%)
  • Vascular disorders: 3/266 (1.1%)
  • Hepatobiliary disorders: 0/266 (0%)
ndb
Laparoscopic antireflux surgery0/288Any serious adverse events: 55/248 (21%)
  • Myocardial infarction: 1/248 (0.4%)
  • Injury, poisoning, procedural: 15/248 (6.0%)
  • GI disorders: 12/248 (4.8%)
  • Musculoskeletal/connective tissue: 2/248 (0.8%)
  • Infections and infestations: 3/248 (1.2%)
  • General disorders: 5/248 (2.0%)
  • Cardiac disorders: 4/248 (1.6%)
  • Neoplasms, benign/malignant: 2/248 (0.8%)
  • Reproductive system including breast: 1/248 (0.4%)
  • Respiratory, thoracic, mediastinal: 5/248 (2.0%)
  • Vascular disorders: 3/248 (1.2%)
  • Hepatobiliary disorders: 3/248 (1.2%)
Lundell 2006157 [16480403]; Lundell 200715 [17256807]; Lundell 2009c17 [19490952]
SOPRAN

12 years
Omeprazole 20-40 mg/d0% 7 year

8/154d (5.2%) 12 year
7 year follow up
  • Gastritis: 17/96 (17.7%)
  • Atrophic gastritis: 5/96 (5.2%)
  • Argyrophil cell hyperplasia: 14/96 (14.6%)
12 year follow up
  • Esophageal cancer: 0/78 (0%)
  • Non-fatal heart attacks: 9/78 (11.5%)
nde
Open antireflux surgery: Nissen (primarily)1/144 (0.7%)f 7 year

2/144g (1.4%) 12 year
7 year follow up
  • Gastritis: 16/72 (22.2%)
  • Atrophic gastritis: 3/72 (4.2%)
  • Argyrophil cell hyperplasia: 4/72 (5.6%)
12 year follow up
  • Esophageal cancer: 1/59h (1.7%)
  • Non-fatal myocardial infarction: 2/59 (3.4%)

n/a=not applicable; GI=gastrointestinal

a

One patient died from pneumonia

b

Estimated by chi-square testing: Significantly more patients withdrew from the study due to adverse events in esomeprazole than in surgery group (P=0.03). Marginal significant for any serious adverse events (P=0.06) between esomeprazole and surgery groups.

c

The FDA concluded that there are baseline differences between surgical and medical treatment groups (e.g., age, history of previous myocardial infarction).

d

Patients died of heart-related causes. These data were from FDA database, and claimed that FDA concluded that baseline differences and other confounding factors (eg, withdrawal from the surgical group and/or receiving both therapies) could have biased the safety data.

e

Estimated by chi-square testing: Significantly more patients withdrew from the study due to adverse events in omeprazole than in surgery group (P=0.04). Not significant for gastritis and atrophic gastritis, and marginally significant for argyrophil cell hyperplasia (P=0.06) between omeprazole and surgery groups.

f

One patient, who had an uneventful post-operative course, died 3 months after the operation due to myocardial infarction.

g

Patients died of heart-related causes. These data were from FDA database, and claimed that FDA concluded that baseline differences and other confounding factors (eg, withdrawal from the surgical group and/or receiving both therapies) could have biased the safety data.

h

Barrett's diagnosed at baseline endoscopy

From: Results

Cover of Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update
Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update [Internet].
Comparative Effectiveness Reviews, No. 29.
Ip S, Chung M, Moorthy D, et al.

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