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Randomized Controlled Trial
. 2008 Sep;57(9):1207-13.
doi: 10.1136/gut.2008.148833. Epub 2008 May 9.

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial

L Lundell  1 , S Attwood, C Ell, R Fiocca, J-P Galmiche, J Hatlebakk, T Lind, O Junghard; LOTUS trial collaborators
Affiliations
Randomized Controlled Trial

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial

L Lundell et al. Gut. 2008 Sep.

Abstract

Background: With the introduction of laparoscopic antireflux surgery (LARS) for gastro-oesophageal reflux disease (GORD) along with the increasing efficacy of modern medical treatment, a direct comparison is warranted. The 3-year interim results of a randomised study comparing both the efficacy and safety of LARS and esomeprazole (ESO) are reported.

Methods: LOTUS is an open, parallel-group multicentre, randomised and controlled trial conducted in dedicated centres in 11 European countries. LARS was completed according to a standardised protocol, comprising a total fundoplication and a crural repair. Medical treatment comprised ESO 20 mg once daily, which could be increased stepwise to 40 mg once daily and then 20 mg twice daily in the case of incomplete GORD control. The primary outcome variable was time to treatment failure (Kaplan-Meier analysis). Treatment failure was defined on the basis of symptomatic relapse requiring treatment beyond that stated in the protocol.

Results: 554 patients were randomised, of whom 288 were allocated to LARS and 266 to ESO. The two study arms were well matched. The proportions of patients who remained in remission after 3 years were similar for the two therapies: 90% of surgical patients compared with 93% medically treated for the intention to treat population, p = 0.25 (90% vs 95% per protocol). No major unexpected postoperative complications were experienced and ESO was well tolerated. However, postfundoplication complaints remain a problem after LARS.

Conclusions: Over the first 3 years of this long-term study, both laparoscopic total fundoplication and continuous ESO treatment were similarly effective and well-tolerated therapeutic strategies for providing effective control of GORD.

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Conflict of interest statement

Competing interests: SA is on the steering committee of the Aspect trial, which is partly supported by AstraZeneca, and is a speaker for meetings sponsored by AstraZeneca, and by Janssen Cilag and Ethicon Endosurgery (subsidiaries of Johnson and Johnson). JPG is consultant for several pharmaceutical companies (AstraZeneca, Janssen-Cilag, Negma Gild, Sanofi-Aventis). His research has been supported by grants from AstraZeneca, and Negma-Gild and Janssen-Cilag. TL and OJ are employees of AstraZeneca.

Figures

Figure 1
Figure 1. Patient flow during the 3 years from enrolment.
Figure 2
Figure 2. Proportion of patients in remission (ie, not classified as treatment failure). Intention to treat analysis after laparoscopic antireflux surgery (LARS) or on medical treatment.
Figure 3
Figure 3. Bars represent the daily doses of esomeprazole used during the 3 years of the study. The numbers of patients at each time point are also given. bid, twice a day; od, once daily.
Figure 4
Figure 4. Symptoms of heartburn (A), acid regurgitation (B), dysphagia (C) and flatulence (D) in gastro-oesophageal reflux disease (GORD) patients randomised either to LARS (laparoscopic antireflux surgery) or daily esomeprazole (ESO).
See this image and copyright information in PMC

Comment in

  • The cure(s) of LOTUS.
    Triadafilopoulos G. Triadafilopoulos G. Gastroenterology. 2009 Jan;136(1):356-7. doi: 10.1053/j.gastro.2008.11.058. Epub 2008 Dec 4. Gastroenterology. 2009. PMID: 19059258 No abstract available.

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