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Antireflux surgery and esomeprazole similarly efficacious (printer-friendly)
Antireflux Surgery and Esomeprazole Similarly Efficacious (pri.
Laparoscopic Antireflux Surgery and
Esomeprazole Similarly Efficacious
for Symptoms in People With
Gastro-oesophageal Reflux Disease
Who Respond Well to Proton Pump
Posted: 02/06/2012; Evid Based Med. 2012;17(1):17-18. 2012 BMJ Publishing Group
Abstract and Introduction
Commentary on: Galmiche JP, Hatlebakk J, Attwood S, et al
. Laparoscopic antireflux surgery vs esomeprazoletreatment for chronic GERD: the LOTUS randomized clinical trial. JAMA
Gastro-oesophageal reflux disease (GERD) is a chronic, relapsing condition – manifesting mostly with heartburnand acid regurgitation – that negatively affects daily quality of life. The two main treatments for GERD are medical –proton pump inhibitors (PPIs) and laparoscopic antireflux surgery (LARS). Both treatments have advantages andside effects that continue to be debated. On one hand, medical therapy may be associated with residualregurgitation and the potential long-term side effects of PPI (eg, osteoporotic fractures, drug–drug interaction). Onthe other hand, LARS may be associated with technical failures, dysphagia and bloating.
Under the acronym LOTUS, this 5-year randomised study compared efficacy and safety of LARS with 'optimised'PPI/oral esomeprazole (ESO) therapy for the long-term management of GERD. LOTUS is an open, parallel group,multicentre, randomised, control ed trial undertaken in expert and dedicated centres in 11 European countries.
LARS was performed with a standardised protocol, incorporating a total fundoplication and a crural repair. Medicaltreatment involved oral ESO 20 mg once daily, which could be increased stepwise to 40 mg once daily and then 20mg twice daily in the case of incomplete GERD control. A total of 372 patients (ESO, n=192; LARS, n=180)completed 5-year fol ow-up. Two hundred sixty-six patients were randomly assigned to receive 'optimised' ESO,20–40 mg/day, al owing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actual yunderwent the operation. Its main outcome measure was time-to-treatment failure (for LARS, defined as need foracid suppressive therapy; for ESO, inadequate symptom control after dose adjustment), expressed as estimatedremission rates and analysed using the Kaplan–Meier method.
Estimated remission rates at 5 years were 92% (95% CI 89% to 96%) in the ESO group and 85% (95% CI 81% to90%) in the LARS group (log-rank p=0.048). The difference between groups was not statistical y significant fol owingbest-case scenario model ing of the effects of study dropout. The prevalence and severity of symptoms at 5 years inthe ESO and LARS groups, respectively, were 16% and 8% for heartburn (p=0.14), 13% and 2% for acidregurgitation (p<0.001), 5% and 11% for dysphagia (p<0.001), 28% and 40% for bloating (p<0.001) and 40% and57% for flatulence (p<0.001). Mortality during the study was low (four deaths in the ESO group and one death in the
Antireflux Surgery and Esomeprazole Similarly Efficacious (pri.
LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events weresimilar in the ESO group (24.1%) and in the LARS group (28.6%). In conclusion, this multicentre clinical trialdemonstrates that, either by drug-induced acid suppression with ESO or by LARS, most patients achieve andremain in symptomatic remission at 5 years.
It is essential that this monumental, non-equivalence, non-superiority, exploratory study is dissected careful y, andits findings and conclusions are not misinterpreted or overstated. To this end, several important points need to beconsidered. First, the participating patients were responders to medical therapy (except for mild symptoms), notpartial or complete non-responders. As such, the evidence provided by LOTUS would help the decision aboutproceeding with the alternative of surgery in those patients who are doing wel on PPI but do not wish to take dailyPPI with their associated, hitherto theoretical, long-term risks. Hence, these patients and their physicians wil haveto balance the gains (ie, equal benefits of surgery) with the risks – al nuisance symptoms such as bloating,flatulence and dysphagia – that may happen in the operated patients twice as frequently and may require visits andfurther interventions. LOTUS's results wil not apply to patients with complex, poorly responsive GERD, those withlarge hiatal hernias and ongoing regurgitation despite PPI or even those patients with heartburn and regurgitation,proven by extensive functional assessment with endoscopy/biopsies, pH monitoring and motility studies to haveclear-cut GERD but with grades C or D oesophagitis at baseline. The study would not be applicable to most patientswho require ESO 40 mg taken twice daily for symptom control.
Second, this multicentre study was performed in very careful y selected patients who were operated on by expertsurgeons at large, academic centres. The results with patients operated on in the community setting or the resultsamong poorly evaluated patients may not be similar, and the success/complication rates of LARS may be inferior tothose seen in LOTUS. Numerous studies of long-term outcomes of LARS ranging from 5 to 12 years of fol ow-upsuggest that the percentage of patients experiencing new, recurrent or persistent GERD-related symptoms afterprimary surgery ranges from 2% to 30%. Between 3% and 10% of these patients with a failed primary surgeryundergo a revision, certainly less favourable than that in LOTUS.
What is the take-home message of this study and how do its results fit in with what is currently known in the field?LARS and dose-adjusted ESO are equal y effective at 5 years if patients are careful y selected PPI responders andoperated on by experts at large centres.
Evid Based Med. 2012;17(1):17-18. 2012 BMJ Publishing Group
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