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The research in the following abstract was reported to be industry-initiated (Paper/Poster Disclosures)

Program Number: P866      Day / Time: Monday, Oct 22, 10:30 AM – 4:00 PM

Risk of Developing Colorectal Cancer and Benign Neoplasm in Patients with Chronic Constipation

Category: Colon       
Reema Mody2, Annie Guerin1, Beverly Fok5, Zhou Zhou3, Eric Wu4, Katherine Brewer2, Wen Zhou 2, Karen L. Lasch2, Nicholas J. Talley3
1. Analysis Group, Inc., Montreal, QC, Canada. 2. Takeda Pharmaceuticals International, Inc., Deerfield, IL, United States. 3. University of Newcastle, Callaghan, NSW, Australia. 4. Analysis Group, Inc., Boston, MA, United States. 5. Analysis Group, Inc., New Yort, NY, United States.


Purpose: To estimate the relative risk of developing colorectal cancer (CRC) and benign neoplasm for patients with chronic constipation (CC) vs. CC-free patients.
Methods: Patients =18 years with CC (=2 diagnoses of constipation (ICD-9-CM: 564.0x) between 60 to 365 days apart) were identified from a large retrospective U.S. claims database (Jan1999-Sep2011). Patients with diagnoses of irritable bowel syndrome or diarrhea were excluded. The index date was patient's first eligible diagnosis of constipation. Patients were eligible for the study if they remained enrolled in their health plan for at least 12 months after their index date. The study period for each patient was defined as the time from the patient's index date until the end of his or her available data or diagnosis with CRC or benign neoplasm. Each CC patient was matched 1:3 to CC-free patients by year of birth, sex, and region of residence. CC-free patients were defined as patients who had never been diagnosed for constipation and never had a prescription filled for a laxative during the entire observation period. CRC and benign neoplasm were defined as =1 diagnosis for CRC or colorectal benign neoplasm. Prevalence of CRC and benign neoplasm was measured for the one-year period following the index date. In patients free of CRC and benign neoplasm at index date, Poisson regression models were used to determine the relative incidence of developing CRC or benign neoplasm for patients with CC vs. CC-free patients. A sensitivity analysis controlled for the number of colonoscopies, in addition to age, gender, index year, comorbidities and family history of malignancies.
Results: On average, CC (N=28,854) and CC-free (N=86,562) patients were 61.9 years old and 33.3% male. The average observation period was 3.99 years (SD=2.45). The one-year prevalence of CRC was 2.7 vs. 1.7% and that of benign neoplasm was 24.8 vs. 11.9% for CC and CC-free patients, respectively. Incidence (per 1,000 patient-years) and incidence rate ratios (IRR) are shown in the result table.
Conclusion: In a large, retrospective, U.S. claims database, patients with CC had significantly greater risk of developing CRC and benign neoplasms over time compared to CC-free patients.

Industry support provided by: Takeda Pharmaceuticals International, Inc.

Disclosures: Annie Guérin: employee of Analysis Group, Inc, which has received consulting fees from Takeda Pharmaceuticals International, Inc.; Reema Mody: employee of Takeda Pharmaceuticals International, Inc.; Beverly Fok: employee of Analysis Group, Inc, which has received consulting fees from Takeda Pharmaceuticals International, Inc.; Zhou Zhou: employee of Analysis Group, Inc, which has received consulting fees from Takeda Pharmaceuticals International, Inc.; Eric Wu: employee of Analysis Group, Inc, which has received consulting fees from Takeda Pharmaceuticals International, Inc.; Wen Zhou: employee of Takeda Pharmaceuticals International, Inc.; Karen Lasch: employee of Takeda Pharmaceuticals International, Inc.; Nicholas J. Talley: Research support from Takeda Pharmaceuticals International, Inc.; Katherine Brewer: employee of Takeda Pharmaceuticals International, Inc.

 Incidence
(per 1,000 patient-years)
IRR
[95% CI]
 CC Patients CC-free Patients Unadjusted Adjusted1 Adjusted1,2
Colorectal Cancer 5.2 2.9 1.78 [1.60 - 1.99] 1.59 [1.43 - 1.78] 1.20 [1.07 - 1.35]
Benign Neoplasm 71.9 26.6 2.70 [2.61 - 2.79] 2.60 [2.51 - 2.70] 2.06 [1.98 - 2.15]
1- Adjusted for age, gender, index year, comorbidities, family history of malignancies
2- Adjusted for number of colonoscopies

Citation: . RISK OF DEVELOPING COLORECTAL CANCER AND BENIGN NEOPLASM IN PATIENTS WITH CHRONIC CONSTIPATION. Program No. P866. ACG 2012 Annual Scientific Meeting Abstracts. Las Vegas, NV: American College of Gastroenterology.

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