Helicobacter pylori infection affects ~35% of Americans and may lead to serious sequelae if left untreated, including gastric cancer. Obesity is a significant risk factor for antibiotic treatment failure; however, little work has been done to understand the influence of high body mass index (BMI) on the success rates of H pylori eradication regimens in treatment-naïve and refractory adult patients.
This analysis evaluated the association of subject obesity on overall H pylori eradication rates for RHB-105 (rifabutin, amoxicillin, and omeprazole magnesium; Talicia®) and its comparators using data from two Phase 3 clinical trials.
A post hoc analysis of the eradication rates of RHB-105 vs comparators in a total of 269 subjects who tested positive for H pylori was conducted. Comparators in the two studies included placebo (placebo comparator) and amoxicillin and omeprazole (active comparator). Subjects were treated for 14 days and returned for follow-up test-of-cure at 28-59 days post-therapy using urea breath testing.
Subjects receiving RHB-105 with 30 ≤ BMI < 40 or BMI ≥ 40 had pooled modified intent to treat (mITT) eradication rates of 88.1% (95% CI: 81.1-92.8) and 90.9% (95% CI: 72.2-97.5) [P = .707], respectively, compared to active comparator rates of 62.9% (95% CI: 52.5-72.2) and 31.8% (95% CI: 16.4-52.7) [P = .008].
Obese patients treated with RHB-105 were associated with efficacy rates comparable to the overall study population. This supports further evaluation of the efficacy of RHB-105 in obese populations, where H pylori is prevalent. ClinTrials.gov # NCT01980095 & NCT031985070.
Achalasia is a rare condition characterised by an absent oesophageal peristalsis and a non-relaxing lower oesophageal sphincter. The incidence of paediatric achalasia is poorly studied and inconsistently reported. We aimed to provide an up to date incidence of paediatric achalasia in the UK.
All United Kingdom hospitals with paediatric gastroenterology and/or paediatric surgery were contacted to provide data on achalasia diagnosis and myotomies performed (2008-2020). Hospital Episode Statistics includes diagnostic and procedural data for all hospitals in England that were searched for achalasia and myotomy in children (1998-2020). Proxy data (epilepsy diagnosis) were used to compare diagnosis.
The incidence of paediatric achalasia in the UK was 0.38 (England 0.43, Wales 0.09, Scotland 0.15 and Northern Ireland 0.17) per 100 000 population per year. The number of myotomies performed remained stable with an average of (±SD) 11.6 (±5) from 2000 to 2020, however, there was a gradual increase in achalasia admissions 58.4 (±19) in the same time period. Using epilepsy as proxy condition, hospitals appear to diagnose achalasia predominantly from their geographic catchment population raising concerns about underdiagnosing achalasia in children.
The incidence of paediatric achalasia in the UK is significantly higher than previously reported. Although this is still lower than the incidence in adults, the gap is narrowing. There is evidence to suggest an ongoing underdiagnosis of achalasia in childhood contributing to the wide variation in care across the UK.
Diarrhoea is a common and debilitating symptom of Carcinoid syndrome. Effective control of symptoms is achieved with somatostatin analogues (SSAs) and additional loperamide and/or codeine phosphate. Symptom control is lost with time and disease progression. There is, therefore, a strong need for additional and more effective therapies. Telotristat-ethyl is a peripheral tryptophan-hydroxylase inhibitor approved for treatment of diarrhoea. Here, we present our experience of Telotristat for treating carcinoid diarrhoea in a large cohort of patients outside of clinical trials. The primary outcome was reduction in stool frequency of >30%, as defined in most studies.
Patients were identified from a prospective database and information collected retrospectively from the hospital's electronic patient records. We included 31 patients (25 males, 6 females; Median age 69 years) on Telotristat and 10 patients on fortnightly high-dose SSA (6 males, 4 females; Median age 67 years).
The mean (range) duration of treatment in telotristat and 2 weekly SSA groups was 258 (15-479) and 689 (219-1446) days respectively. Primary endpoint was achieved in 82% (23/28) patients on Telotristat with median percentage reduction in stool frequency of 60% (IQR 50-69), compared to 28% (2/7) (22 (−30 to 55) %) in the control group. Odds ratio for reduction in stool frequency >30% was −11, (95% CI 1.71-77.1).
This real world experience supports the effectiveness and safety of Telotristat to treat carcinoid diarrhoea not adequately controlled by standard treatment with SSA.
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