Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome
constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. prospective,...
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Published in | Revista española de enfermedades digestivas Vol. 110; no. 7; pp. 451 - 457 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English Spanish |
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Spain
Sociedad Espanola de Patologia Digestivas
01.07.2018
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Abstract | constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management.
to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients.
prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella®, Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-μg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register.
thirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0).
long-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting. |
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AbstractList | Background: constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. Objective: to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. Methods: prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella[R], Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-pg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register. Results: thirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0). Conclusions: long-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting. Key words: Irritable bowel syndrome. Constipation. Linaclotide. Abdominal pain. Bloating. constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella®, Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-μg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register. thirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0). long-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting. BACKGROUNDconstipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management.OBJECTIVEto evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients.METHODSprospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella®, Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-μg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register.RESULTSthirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0).CONCLUSIONSlong-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting. |
Audience | Academic |
Author | Geijo Martínez, Fernando Velasco Guardado, Antonio Piñeiro Pérez, Concepción Prieto Bermejo, Ana Beatriz Sánchez Garrido, Ana Rodríguez Pérez, Antonio Álvarez Delgado, Alberto Marcos Prieto, Héctor |
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Title | Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome |
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