Long-term outcome of microscopic esophagitis in chronic GERD patients treated with esomeprazole or laparoscopic antireflux surgery in the LOTUS trial.
OBJECTIVE
Gastroesophageal reflux disease (GERD)-associated changes in esophageal histology have been reported mainly after short-term medical antireflux therapy, and few individual lesions have been examined. We report detailed histological findings from the LOTUS study, at baseline and at 1 and 3 years after laparoscopic antireflux surgery (LARS) or esomeprazole treatment in patients with chronic GERD.


METHODS
LOTUS is a long-term, open, parallel-group, multicenter, randomized, controlled trial conducted in 11 European countries that compared LARS (n=248) with esomeprazole 20-40 mg daily (n=266). Biopsies from the distal esophagus 2 cm above the Z-line and at the Z-line were taken at baseline, and 1 and 3 years. The following lesions were assessed: basal cell hyperplasia (BCH), papillary elongation (PE), intercellular space dilatations (ISDs), intraepithelial eosinophils (EOSs), neutrophils, and necrosis/erosion. A severity score (SS, range 0-2) was calculated by taking the average score of all assessable lesions.


RESULTS
All lesions were more severe on Z-line biopsies than at 2 cm, and almost all improved significantly from baseline to 1 and 3 years. The average SS (from 2 cm to Z-line) changed from 0.95 to 0.57 (1 year) and to 0.49 (3 years) on esomeprazole, and from 0.91 to 0.56 (1 year) and to 0.52 (3 years) after LARS (P<0.001 for both treatments at 1 and 3 years, with no significant difference between treatments). The proportions of patients with severe histological changes decreased from approximately 50% at baseline to 11% at 3 years.


CONCLUSIONS
Both continuous esomeprazole treatment and laparoscopic fundoplication are associated with significant and similar overall improvement in microscopic esophagitis after 1 year that is maintained at 3 years.
Fiocca
Roberto
R
Department of Anatomic Pathology, University of Genova, Genova, Italy. fiocca@unige.it
Mastracci
Luca
L
Engström
Cecilia
C
Attwood
Stephen
S
Ell
Christian
C
Galmiche
Jean-Paul
JP
Hatlebakk
Jan
J
Junghard
Ola
O
Lind
Tore
T
Lundell
Lars
L
D000328:Adult; D017677:Age Distribution; D001707:Biopsy, Needle; D002908:Chronic Disease; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects*; D050782:Esophageal pH Monitoring; D004942:Esophagitis, Peptic / Q000453:epidemiology / Q000209:etiology* / Q000473:pathology*; D004945:Esophagoscopy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects* / Q000379:methods; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D007150:Immunohistochemistry; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D017678:Sex Distribution; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
D064098:Esomeprazole