{"title":"Letter: A Patient Centric Approach to Tapering Steroids in Steroid Responsive Moderate to Severely Active Ulcerative Colitis. Authors' Reply.","authors":"Amol N Patil,Ankit Kumar,Vishal Sharma","doi":"10.1111/apt.70552","DOIUrl":"https://doi.org/10.1111/apt.70552","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"73 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David Beaton,Mahmoud Mohamed,Linda Sharp,Keith Pohl,Matthew Rutter
BACKGROUNDThe UK has adopted faecal immunochemical testing (FIT) to triage symptomatic colonoscopy referrals.OBJECTIVEQuantify diagnostic yield and independent effects of FIT, age, sex and symptoms on polyp and cancer detection in symptomatic colonoscopy.DESIGNNationwide analysis of prospectively collected colonoscopy reports (June 2023-August 2025) from the National Endoscopy Database. Symptomatic procedures, including iron-deficiency anaemia (IDA), were identified and diagnostic yields calculated. Mixed-effects logistic regression estimated adjusted odds ratios (aORs) with age, sex, symptom group and FIT. Post-estimation margins modelled cancer yield by age, FIT and symptoms.RESULTSAnalysis of 447,109 symptomatic colonoscopies, with FIT recorded in 202,219 (45.2%). Overall cancer yield was 1.9% (95% CI, 1.8-1.9). Cancer yield was 3.8% (95% CI, 3.7-3.9) in FIT ≥ 10, including 2.5% (95% CI, 2.3-2.7) at age 40-49 and 0.6% (95% CI, 0.5-0.7) at age 16-39; yield in FIT < 10 was 0.3% (95% CI, 0.2-0.3). FIT concentration showed a strong, graded association with cancer risk, weaker association with large polyps, and minimal association with small polyps. IDA was associated with higher cancer risk versus rectal bleeding (aOR 2.2, 95% CI, 2.0-2.3; p < 0.01). With FIT < 10, cancer yield exceeded 1% only in IDA patients aged > 80 and remained < 0.5% otherwise. A model combining FIT, age, and IDA detected > 94% of cancers while reducing colonoscopy demand by > 40%.CONCLUSIONThis national analysis demonstrates the superiority of FIT-based triage over symptom-based referral, with FIT ≥ 10 identifying high-risk patients, including those aged 40-49, while FIT < 10 indicated very low risk.
{"title":"Real-World Performance of FIT Triage for Symptomatic Colonoscopy: Analysis of the UK National Endoscopy Database (NED).","authors":"David Beaton,Mahmoud Mohamed,Linda Sharp,Keith Pohl,Matthew Rutter","doi":"10.1111/apt.70537","DOIUrl":"https://doi.org/10.1111/apt.70537","url":null,"abstract":"BACKGROUNDThe UK has adopted faecal immunochemical testing (FIT) to triage symptomatic colonoscopy referrals.OBJECTIVEQuantify diagnostic yield and independent effects of FIT, age, sex and symptoms on polyp and cancer detection in symptomatic colonoscopy.DESIGNNationwide analysis of prospectively collected colonoscopy reports (June 2023-August 2025) from the National Endoscopy Database. Symptomatic procedures, including iron-deficiency anaemia (IDA), were identified and diagnostic yields calculated. Mixed-effects logistic regression estimated adjusted odds ratios (aORs) with age, sex, symptom group and FIT. Post-estimation margins modelled cancer yield by age, FIT and symptoms.RESULTSAnalysis of 447,109 symptomatic colonoscopies, with FIT recorded in 202,219 (45.2%). Overall cancer yield was 1.9% (95% CI, 1.8-1.9). Cancer yield was 3.8% (95% CI, 3.7-3.9) in FIT ≥ 10, including 2.5% (95% CI, 2.3-2.7) at age 40-49 and 0.6% (95% CI, 0.5-0.7) at age 16-39; yield in FIT < 10 was 0.3% (95% CI, 0.2-0.3). FIT concentration showed a strong, graded association with cancer risk, weaker association with large polyps, and minimal association with small polyps. IDA was associated with higher cancer risk versus rectal bleeding (aOR 2.2, 95% CI, 2.0-2.3; p < 0.01). With FIT < 10, cancer yield exceeded 1% only in IDA patients aged > 80 and remained < 0.5% otherwise. A model combining FIT, age, and IDA detected > 94% of cancers while reducing colonoscopy demand by > 40%.CONCLUSIONThis national analysis demonstrates the superiority of FIT-based triage over symptom-based referral, with FIT ≥ 10 identifying high-risk patients, including those aged 40-49, while FIT < 10 indicated very low risk.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"397 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146056493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ana Alberola,Adolfo de Salazar,Ana Fuentes,Raquel Carracedo,Marta Illescas-López,María Del Carmen Rodríguez Baños,Carolina Freyre,Berta Becerril,Isabel Viciana,Inmaculada López-Rodríguez,Natalia Montiel,Ana María Domínguez Castaño,María Pilar Luzón-García,Encarnación Ramírez Arellano,Carmen Liébana-Martos,Francisco Franco Álvarez de Luna,María Del Carmen Lozano,Begoña Palop,Antonio Sampedro,Ana Belén Pérez,Sonia Algarate,Susana Rojo Alba,Pablo Fraile,Dolores Ocete,María Jesús Alcaraz,Juan Carlos Rodríguez,Francisco Javier Hernández-Felices,Olalla Martínez,Victoria Domínguez,Nieves Orta,Dolores Gómez,Carmen Cortell,Jorge Camacho,Susana Sabater,Luis Ángel Iglesias Sánchez,Yasmina Martín,Aldara Vallejo,Lourdes Molina,María Aroca,Beatriz Castro,Magdalena Lara,María José Pena,Ana Rodríguez-Fernández,Alejandro González Praetorius,José Joaquín Blas,Alicia Beteta,César Gómez,María José Rodríguez,Soledad Illescas,Melanie Abreu,Julio García Díez,Inocencio Beltrán,Marta Sandoval Torrientes,Ruth Sáez,Teresa Martín,Pilar Tajada Alegre,Belén Lorenzo,María Teresa García Valero,Isabel Jiménez Sansegundo,Susana García-de Cruz,Sonsoles Garcinuño,Miguel Ángel Sáiz,Santiago Muñoz,Isabel Fernández,Helena Miriam Lorenzo Juanes,María Reyes Vidal-Acuña,Luz María Moldes,Noelia Calvo,Matilde Trigo,María José Gude,Patricia Ordóñez,Sandra Cortizo,Miriam Blasco,Mayra Sigcha,Iker Falces,Juan Carlos Galán,Ana Arribi,Roberto Alonso,Asunción Iborra,María Jesús Del Amor Espín,Eva Cascales,Cayetano Pérez,Pablo Fernández,María Dolores Navarro,María Luz Nuñez,Jorge Galán Ros,Luis Javier Gil-Gallardo,Ana Miqueleiz,Gabriel Reina,Luis Elorduy,Mikele Macho,Carmen Gómez,Paloma Liendo,Yolanda Salicio,Antonio Aguilera,Federico García
BACKGROUNDHepatitis delta virus accelerates liver disease progression in chronic hepatitis B, yet remains underdiagnosed. Guidelines recommend double reflex diagnostic testing with antibody testing followed by viral load testing, but uptake remains inconsistent.AIMSTo evaluate double reflex diagnostic implementation in Spain during the retrospective phase of the Spain Double Reflex Diagnostic study.METHODSNationwide, multicenter retrospective analysis of individuals positive for hepatitis B surface antigen (2022-2024) from 80 centers. Laboratory data included hepatitis B surface antigen, hepatitis delta virus antibody and hepatitis delta virus viral load. Uptake rates, hepatitis delta virus antibody positivity, viral load confirmation and viral load-confirmed prevalence were calculated with 95% confidence intervals.RESULTSAmong 65,763 individuals positive for hepatitis B surface antigen, hepatitis delta virus antibody testing uptake increased from 55.1% (54.4-55.8) in 2022 (n = 18,986) to 72.5% (71.9-73.1) in 2023 (n = 22,463) and 85.8% (85.1-86.4) in 2024 (n = 24,314; p < 0.0001). Antibody positivity remained stable (5.6%, 4.9%, 5.3%). Viral load confirmation among antibody-positive patients improved from 72.6% in 2022 to 90.8% in 2023 and 91.0% in 2024. Viral load-confirmed prevalence among antibody-positive individuals was 40.3% in 2022, 31.6% in 2023, and 30.1% in 2024. Regional heterogeneity was marked, with several autonomous communities achieving near-universal uptake (> 95%).CONCLUSIONBetween 2022 and 2024, double reflex diagnostic implementation expanded rapidly, demonstrating national feasibility and describing hepatitis D virus seroprevalence. However, regional inequities persist. Sustained uptake will require standardised reflex protocols, harmonization of viral load assays and continuous training to reduce underdiagnosis and improve care of coinfected patients.
{"title":"Nationwide Implementation of Double Reflex Testing for Hepatitis Delta in Spain: Results From the Retrospective Phase of the Spain-DDR Study.","authors":"Ana Alberola,Adolfo de Salazar,Ana Fuentes,Raquel Carracedo,Marta Illescas-López,María Del Carmen Rodríguez Baños,Carolina Freyre,Berta Becerril,Isabel Viciana,Inmaculada López-Rodríguez,Natalia Montiel,Ana María Domínguez Castaño,María Pilar Luzón-García,Encarnación Ramírez Arellano,Carmen Liébana-Martos,Francisco Franco Álvarez de Luna,María Del Carmen Lozano,Begoña Palop,Antonio Sampedro,Ana Belén Pérez,Sonia Algarate,Susana Rojo Alba,Pablo Fraile,Dolores Ocete,María Jesús Alcaraz,Juan Carlos Rodríguez,Francisco Javier Hernández-Felices,Olalla Martínez,Victoria Domínguez,Nieves Orta,Dolores Gómez,Carmen Cortell,Jorge Camacho,Susana Sabater,Luis Ángel Iglesias Sánchez,Yasmina Martín,Aldara Vallejo,Lourdes Molina,María Aroca,Beatriz Castro,Magdalena Lara,María José Pena,Ana Rodríguez-Fernández,Alejandro González Praetorius,José Joaquín Blas,Alicia Beteta,César Gómez,María José Rodríguez,Soledad Illescas,Melanie Abreu,Julio García Díez,Inocencio Beltrán,Marta Sandoval Torrientes,Ruth Sáez,Teresa Martín,Pilar Tajada Alegre,Belén Lorenzo,María Teresa García Valero,Isabel Jiménez Sansegundo,Susana García-de Cruz,Sonsoles Garcinuño,Miguel Ángel Sáiz,Santiago Muñoz,Isabel Fernández,Helena Miriam Lorenzo Juanes,María Reyes Vidal-Acuña,Luz María Moldes,Noelia Calvo,Matilde Trigo,María José Gude,Patricia Ordóñez,Sandra Cortizo,Miriam Blasco,Mayra Sigcha,Iker Falces,Juan Carlos Galán,Ana Arribi,Roberto Alonso,Asunción Iborra,María Jesús Del Amor Espín,Eva Cascales,Cayetano Pérez,Pablo Fernández,María Dolores Navarro,María Luz Nuñez,Jorge Galán Ros,Luis Javier Gil-Gallardo,Ana Miqueleiz,Gabriel Reina,Luis Elorduy,Mikele Macho,Carmen Gómez,Paloma Liendo,Yolanda Salicio,Antonio Aguilera,Federico García","doi":"10.1111/apt.70543","DOIUrl":"https://doi.org/10.1111/apt.70543","url":null,"abstract":"BACKGROUNDHepatitis delta virus accelerates liver disease progression in chronic hepatitis B, yet remains underdiagnosed. Guidelines recommend double reflex diagnostic testing with antibody testing followed by viral load testing, but uptake remains inconsistent.AIMSTo evaluate double reflex diagnostic implementation in Spain during the retrospective phase of the Spain Double Reflex Diagnostic study.METHODSNationwide, multicenter retrospective analysis of individuals positive for hepatitis B surface antigen (2022-2024) from 80 centers. Laboratory data included hepatitis B surface antigen, hepatitis delta virus antibody and hepatitis delta virus viral load. Uptake rates, hepatitis delta virus antibody positivity, viral load confirmation and viral load-confirmed prevalence were calculated with 95% confidence intervals.RESULTSAmong 65,763 individuals positive for hepatitis B surface antigen, hepatitis delta virus antibody testing uptake increased from 55.1% (54.4-55.8) in 2022 (n = 18,986) to 72.5% (71.9-73.1) in 2023 (n = 22,463) and 85.8% (85.1-86.4) in 2024 (n = 24,314; p < 0.0001). Antibody positivity remained stable (5.6%, 4.9%, 5.3%). Viral load confirmation among antibody-positive patients improved from 72.6% in 2022 to 90.8% in 2023 and 91.0% in 2024. Viral load-confirmed prevalence among antibody-positive individuals was 40.3% in 2022, 31.6% in 2023, and 30.1% in 2024. Regional heterogeneity was marked, with several autonomous communities achieving near-universal uptake (> 95%).CONCLUSIONBetween 2022 and 2024, double reflex diagnostic implementation expanded rapidly, demonstrating national feasibility and describing hepatitis D virus seroprevalence. However, regional inequities persist. Sustained uptake will require standardised reflex protocols, harmonization of viral load assays and continuous training to reduce underdiagnosis and improve care of coinfected patients.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"18 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146056848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter: A Patient Centric Approach to Tapering Steroids in Steroid Responsive Moderate to Severely Active Ulcerative Colitis.","authors":"Ganesh Bhat,Athish Shetty","doi":"10.1111/apt.70546","DOIUrl":"https://doi.org/10.1111/apt.70546","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"72 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUND AND AIMSHomozygosity for the SERPINA1 Pi*Z deficiency allele is the culprit of alpha-1 antitrypsin deficiency-related liver disease, while harbouring a single Z-allele (e.g., the common Pi*MZ genotype) is the strongest genetic risk factor for advanced chronic liver disease (ACLD) and its progression. However, the impact of the Pi*MZ genotype on hepatocellular carcinoma (HCC) development in patients who have already progressed to ACLD has yet to be established. Thus, we investigated the impact of the Pi*MZ genotype on the development of HCC among longitudinally followed ACLD patients.METHODSPatients undergoing hepatic venous pressure gradient (HVPG) measurement and genotyping at the Vienna Hepatic Haemodynamic Lab were included, excluding those with HCC. Competing risk analyses with HCC as the outcome of interest and death/liver transplantation as competing events were performed.RESULTSWe included 815 patients (mean age: 54 ± 11 years; viral hepatitis: 53%, alcohol-related liver disease: 37% and metabolic dysfunction-associated steatotic liver disease: 10%). Overall, 30 patients (4%) harboured the Pi*MZ genotype. During a median follow-up of 47.3 months, 68 patients developed an HCC (8/30 with Pi*MZ). The Pi*MZ genotype was associated with increased risks of HCC development in univariable as well as in multivariable analyses, accounting for other important factors (i.e., age, sex, removal of the primary aetiological factor, aspartate-aminotransferase, albumin and HVPG) identified in our study (adjusted subdistribution hazard ratio [aSHR]: 3.31 [95% confidence interval (CI): 1.26-8.65]; p = 0.015). The impact of the Pi*MZ genotype was confirmed adjusting for the aMAP score (aSHR: 2.94 [95% CI: 1.45-5.97]; p = 0.003).CONCLUSIONThe SERPINA1 Pi*MZ genotype is associated with an increased risk of HCC development in patients with ACLD, independently of other HCC risk factors.
{"title":"The Alpha-1 Pi*MZ Genotype Is an Independent Risk Factor for Hepatocellular Carcinoma Development in Patients With ACLD.","authors":"Lorenz Balcar,Georg Semmler,Bernhard Scheiner,Rafael Paternostro,Benedikt Simbrunner,Tina Jasmin Haunold,Mathias Jachs,Lukas Hartl,Benedikt Silvester Hofer,Nina Dominik,Michael Schwarz,Georg Kramer,Christian Sebesta,Paul Thöne,Matthias Pinter,Michael Trauner,Thomas Reiberger,Albert Friedrich Stättermayer,Mattias Mandorfer","doi":"10.1111/apt.70530","DOIUrl":"https://doi.org/10.1111/apt.70530","url":null,"abstract":"BACKGROUND AND AIMSHomozygosity for the SERPINA1 Pi*Z deficiency allele is the culprit of alpha-1 antitrypsin deficiency-related liver disease, while harbouring a single Z-allele (e.g., the common Pi*MZ genotype) is the strongest genetic risk factor for advanced chronic liver disease (ACLD) and its progression. However, the impact of the Pi*MZ genotype on hepatocellular carcinoma (HCC) development in patients who have already progressed to ACLD has yet to be established. Thus, we investigated the impact of the Pi*MZ genotype on the development of HCC among longitudinally followed ACLD patients.METHODSPatients undergoing hepatic venous pressure gradient (HVPG) measurement and genotyping at the Vienna Hepatic Haemodynamic Lab were included, excluding those with HCC. Competing risk analyses with HCC as the outcome of interest and death/liver transplantation as competing events were performed.RESULTSWe included 815 patients (mean age: 54 ± 11 years; viral hepatitis: 53%, alcohol-related liver disease: 37% and metabolic dysfunction-associated steatotic liver disease: 10%). Overall, 30 patients (4%) harboured the Pi*MZ genotype. During a median follow-up of 47.3 months, 68 patients developed an HCC (8/30 with Pi*MZ). The Pi*MZ genotype was associated with increased risks of HCC development in univariable as well as in multivariable analyses, accounting for other important factors (i.e., age, sex, removal of the primary aetiological factor, aspartate-aminotransferase, albumin and HVPG) identified in our study (adjusted subdistribution hazard ratio [aSHR]: 3.31 [95% confidence interval (CI): 1.26-8.65]; p = 0.015). The impact of the Pi*MZ genotype was confirmed adjusting for the aMAP score (aSHR: 2.94 [95% CI: 1.45-5.97]; p = 0.003).CONCLUSIONThe SERPINA1 Pi*MZ genotype is associated with an increased risk of HCC development in patients with ACLD, independently of other HCC risk factors.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"56 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146034055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUNDIn the United States, metoclopramide is the only medication approved for gastroparesis. There is a need to reappraise the main considerations involved in the approval of pharmacological treatments of gastroparesis.OBJECTIVES AND METHODSWe conducted a literature review to address issues that might impact the approval of medications for gastroparesis. We appraised the epidemiology, clinical presentations, variations in diagnostic tests, and their thresholds for identification of gastroparesis. Based on the review, we proposed trial designs for proof of efficacy and safety of novel medications for gastroparesis.RESULTSBased on epidemiological studies, the age-adjusted prevalence in US population is 152,005 for all categories (definite, probable and possible) of gastroparesis. The major symptoms of gastroparesis are nausea, vomiting, early satiety and postprandial fullness and may lead to hospitalisation or emergency department visits. It is essential to appraise gastric emptying with a solid meal over at least 3 h using scintigraphy or a stable isotope breath test. Diagnostic thresholds have been established for these diagnostic tests and at present, reproducibility, normative data, and coefficient of variation are well established for the 320-kcal real egg solid meal. Based on published guidelines on clinical efficacy of medications used in gastroparesis, we propose targeting the gastroparesis symptom subscales, such as nausea and vomiting, with pharmacological agents specifically directed at their causative mechanisms rather than targeting the underlying dysmotility.CONCLUSIONThe evidence documented here justifies consideration of gastroparesis as an orphan disease, as well as an innovative approach to supplement the regulatory bodies' recommendations and guidance to industry. We propose treatment trials of 4-weeks duration and considering the use of specific symptoms of gastroparesis as clinical endpoints based on a pharmaceutical agent's mechanism of action, rather than using a total gastroparesis symptom score. Such an approach would include evidence of safety and efficacy of new medications targeting gastroparesis subscales, and approval for marketing would be based on the symptoms specifically ameliorated in robust trials.
{"title":"Review Article: Drug Approval for Gastroparesis-Suggestions for Improving the Process for Positive Results.","authors":"Michael Camilleri,Henry P Parkman","doi":"10.1111/apt.70544","DOIUrl":"https://doi.org/10.1111/apt.70544","url":null,"abstract":"BACKGROUNDIn the United States, metoclopramide is the only medication approved for gastroparesis. There is a need to reappraise the main considerations involved in the approval of pharmacological treatments of gastroparesis.OBJECTIVES AND METHODSWe conducted a literature review to address issues that might impact the approval of medications for gastroparesis. We appraised the epidemiology, clinical presentations, variations in diagnostic tests, and their thresholds for identification of gastroparesis. Based on the review, we proposed trial designs for proof of efficacy and safety of novel medications for gastroparesis.RESULTSBased on epidemiological studies, the age-adjusted prevalence in US population is 152,005 for all categories (definite, probable and possible) of gastroparesis. The major symptoms of gastroparesis are nausea, vomiting, early satiety and postprandial fullness and may lead to hospitalisation or emergency department visits. It is essential to appraise gastric emptying with a solid meal over at least 3 h using scintigraphy or a stable isotope breath test. Diagnostic thresholds have been established for these diagnostic tests and at present, reproducibility, normative data, and coefficient of variation are well established for the 320-kcal real egg solid meal. Based on published guidelines on clinical efficacy of medications used in gastroparesis, we propose targeting the gastroparesis symptom subscales, such as nausea and vomiting, with pharmacological agents specifically directed at their causative mechanisms rather than targeting the underlying dysmotility.CONCLUSIONThe evidence documented here justifies consideration of gastroparesis as an orphan disease, as well as an innovative approach to supplement the regulatory bodies' recommendations and guidance to industry. We propose treatment trials of 4-weeks duration and considering the use of specific symptoms of gastroparesis as clinical endpoints based on a pharmaceutical agent's mechanism of action, rather than using a total gastroparesis symptom score. Such an approach would include evidence of safety and efficacy of new medications targeting gastroparesis subscales, and approval for marketing would be based on the symptoms specifically ameliorated in robust trials.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"122 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146014931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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