Gastric peroral endoscopic pyloromyotomy for decompensated gastroparesis: comprehensive motility analysis in relation to treatment outcomes

Abstract Background and study aims There are no reliable data to predict which patients with gastroparesis (GP) would benefit the most from gastric peroral endoscopic pyloromyotomy (G-POEM). The aim of the present study was to assess whether antro-duodenal motility patterns and pyloric distensibility can predict the outcome of G-POEM in patients with decompensated GP. Patients and methods In an open-label study, patients with GP and refractory symptoms were eligible for treatment with G-POEM if treatment attempts according to a standardized stepwise protocol had failed. Baseline assessment included Gastroparesis Cardinal Symptom Index (GCSI), C13-octanoic gastric emptying breath test and high-resolution antro-duodenal manometry. Pyloric distensibility using EndoFlip measurements was assessed at baseline and 3 months after the procedure. Explorative analyses were performed on potential predictors of response using logistic regression analyses. Results Twenty-four patients with decompensated GP underwent G-POEM. At baseline, 78.3 % and 61.9 % of patients showed antral hypomotility and neuropathic motor patterns, respectively. The technical success rate was 100 % (24/24). Mean GCSI improved significantly at 3, 6, and 12 months after G-POEM (P = 0.01). Median distensibility index (DI) improved significantly as compared with baseline (7.5 [6.9;11.7] vs. 5.3[3.1;8.1], P = 0.004). A significant correlation was found between clinical response at 6 months and pyloric DI improvement (P = 0.003). No potential predictors of clinical response after G-POEM could be identified in an explorative analysis. Conclusions G-POEM improved pyloric distensibility patterns in patients with decompensated GP. Clinical response at 6 months after G-POEM was associated with pyloric distensibility improvement. However, no potential predictors of response could be identified from either antro-duodenal motility patterns or pyloric distensibility.

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Efficacy of Venlafaxine and Predictors of Response in a Prospective Open-Label Study of Patients With Treatment-Resistant Major Depression

Journal of Clinical Psychopharmacology ◽

10.1097/00004714-200008000-00014 ◽

2000 ◽

Vol 20 (4) ◽

pp. 483-487 ◽

Cited By ~ 35

Author(s):

Philip B. Mitchell ◽

Isaac Schweitzer ◽

Graham Burrows ◽

Gordon Johnson ◽

Athula Polonowita

Keyword(s):

Major Depression ◽

Treatment Resistant ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Predictors Of Response

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Individual Variability in Reaction Time and Prediction of Clinical Response to Methylphenidate in Adult ADHD: A Prospective Open Label Study Using Conners’ Continuous Performance Test II

Journal of Attention Disorders ◽

10.1177/1087054719829822 ◽

2019 ◽

pp. 108705471982982 ◽

Cited By ~ 1

Author(s):

Mats Fredriksen ◽

Jens Egeland ◽

Jan Haavik ◽

Ole Bernt Fasmer

Keyword(s):

Reaction Time ◽

Clinical Response ◽

Adult Adhd ◽

Performance Test ◽

Continuous Performance Test ◽

Individual Variability ◽

Continuous Performance ◽

Open Label ◽

Open Label Study ◽

Label Study

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The association of change in serum cholesterol levels and clinical treatment response in patients with schizophrenia: a prospective, randomized and open-label study

10.21203/rs.2.12759/v1 ◽

2019 ◽

Author(s):

Yi-Lung Chen ◽

Chih-Chiang Chiu ◽

Kun-Po Chen ◽

Ming-Hong Tai ◽

For-Wey Lung

Keyword(s):

Total Cholesterol ◽

Clinical Response ◽

Treatment Response ◽

Atypical Antipsychotics ◽

Serum Total Cholesterol ◽

Antipsychotic Treatment ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Cholesterol Levels

Abstract Background: In the past, it was suggested that dyslipidemia was associated with clinical improvement in patients with schizophrenia treated with antipsychotics; however, measurement at a single time point post-treatment, as done in most studies, could have contributed to the inconsistent results. The aim of this study was to investigate whether changes in serum levels of lipid and other covariates were associated with clinical response in patients with schizophrenia treated with atypical antipsychotics, using repeated measurements and considering time effects. Method: A total of 90 patients with schizophrenia were enrolled in this 12-week prospective, randomized and open label study. Positive and Negative Syndrome Scale (PANSS) score and a standard serum lipid profile were measured at baseline (day 0) and subsequently followed up at weeks 4, 8 and 12. The generalized estimating equation (GEE) model was applied to examine the relationship between serum lipids and treatment response, controlling for other potential variables. Results: The results of GEE analysis showed that the increase in serum total cholesterol levels during 12 weeks’ antipsychotic treatment was significantly associated with a reduction in PANSS total score (β = −0.37, p = 0.02) and positive symptom score (β = −0.34, p = 0.01) over time. Conclusions: These findings revealed that the change in serum total cholesterol level was positively associated with the therapeutic efficacy of atypical antipsychotics. Serum total cholesterol may be a potential predictor of clinical response in patients with schizophrenia treated with atypical antipsychotics. Trial Registration: ClinicalTrials.gov identifier: NCT03730857. The trial was retrospectively registered on 11 Feb, 2019.

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Certolizumab Pegol Induces Clinical Response and Remission in Patients With Moderate to Severe Ulcerative Colitis: An Open-Label Study

The American Journal of Gastroenterology ◽

10.14309/00000434-201710001-00763 ◽

2017 ◽

Vol 112 ◽

pp. S425

Author(s):

Scott D. Lee ◽

Kindra Clark-Snustad ◽

Susan Parrott ◽

Anand Singla ◽

Mark T. Osterman

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Certolizumab Pegol ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Severe Ulcerative Colitis

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Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-218122 ◽

2020 ◽

Vol 79 (10) ◽

pp. 1277-1285 ◽

Cited By ~ 41

Author(s):

Emanuel Della-Torre ◽

Corrado Campochiaro ◽

Giulio Cavalli ◽

Giacomo De Luca ◽

Angela Napolitano ◽

...

Keyword(s):

Clinical Improvement ◽

Inflammatory Markers ◽

Standard Treatment ◽

Comparison Group ◽

Standard Of Care ◽

Open Label ◽

Open Label Study ◽

Lung Consolidation ◽

Predictors Of Response

ObjectivesTo assess the safety and efficacy of interleukin (IL)−6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation.MethodsWe conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO2/FiO2 <300 mm Hg) with hyperinflammation (elevated inflammatory markers and serum IL-6 levels). Sarilumab 400 mg was administered intravenously in addition to standard of care and results were compared with contemporary matched patients treated with standard of care alone. Clinical improvement, mortality, safety and predictors of response were assessed at 28 days.ResultsTwenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO2/FiO2 ratio >100 mm Hg and lung consolidation <17% at CT scan predicted clinical improvement in patients treated with sarilumab. Median time to clinical improvement in patients with lung consolidation <17% was shorter after sarilumab (10 days) than after standard treatment (24 days; p=0.01). The rate of infection and pulmonary thrombosis was similar between the two groups.ConclusionsAt day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.

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Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Journal of Pharmaceutics and Therapeutics ◽

10.18314/jpt.v4i1.1050 ◽

2018 ◽

Vol 4 (1) ◽

Author(s):

Jason Heckert ◽

Ron Schey ◽

Henry Paul Parkman

Keyword(s):

Abdominal Pain ◽

Daily Diary ◽

Open Label ◽

Symptom Index ◽

Early Satiety ◽

Postprandial Fullness ◽

Fda Guidance ◽

Idiopathic Gastroparesis ◽

A Prospective Study ◽

Cardinal Symptom

Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p<0.05) during treatment when compared to the baseline week. Nausea significantly decreased on day 5 (p<0.01) of treatment. Episodes of vomiting did not significantly change. Side effects included pruritus (2 patients) and redness (1) at the patch site, headache (1), constipation (1), and poor patch adherence (5). Conclusions & Inferences: GTS significantly reduced nausea severity in patients with gastroparesis. There were also significant improvements in early satiety, postprandial fullness, and abdominal pain. Nausea improvement occurred on the fifth day of treatment. Thus, GTS has therapeutic effect on nausea, as well as other gastroparesis symptoms, in patients with gastroparesis as captured using a daily diary for gastroparesis.

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