Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD
| Autor: | Galmiche, Jp, Hatlebakk, J, Attwood, S, Ell, C, Fiocca, R, Eklund, S, Långström, G, Lind, T, Lundell, L, LOTUS Trial Collaborators including, Cestari, Renzo |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Laparoscopic surgery medicine.medical_specialty medicine.medical_treatment Severity of Illness Index Gastroenterology Esomeprazole law.invention Erosive esophagitis Randomized controlled trial law Internal medicine medicine Humans Adverse effect Digestive System Surgical Procedures Omeprazole Proton-pump inhibitors business.industry Remission Induction Heartburn General Medicine Middle Aged Anti-Ulcer Agents medicine.disease digestive system diseases Surgery Clinical trial Treatment Outcome Gastroesophageal-reflux disease Proton-pump inhibitors Erosive esophagitis Chronic Disease Gastroesophageal Reflux GERD Female Laparoscopy medicine.symptom business Gastroesophageal-reflux disease medicine.drug |
| Zdroj: | Galmiche, J-P, Hatlebakk, J, Attwood, S, Ell, C, Fiocca, R, Eklund, S, Långström, G, Lind, T T, Lundell, L, LOTUS Trial Collaborators & Lauritsen, K 2011, ' Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial ', JAMA : the journal of the American Medical Association, vol. 305, no. 19, pp. 1969-77 . https://doi.org/10.1001/jama.2011.626 |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2011.626 |
| Popis: | Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery.To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD.The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation.Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method.Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P.001), 5% and 11% for dysphagia (P.001), 28% and 40% for bloating (P.001), and 40% and 57% for flatulence (P.001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%).This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years.clinicaltrials.gov Identifier: NCT00251927. |
| Databáze: | OpenAIRE |
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