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Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database

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ClinicalTrials.gov Identifier: NCT01150760
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : September 8, 2010
Last Update Posted : August 7, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Retrospective
Condition Ileus
Intervention Drug: Alvimopan
Enrollment 7050
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Period Title: Overall Study
Started 3525 3525
Completed 3525 3525
Not Completed 0 0
Arm/Group Title Alvimopan Users Matched Controls Total
Hide Arm/Group Description Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan Total of all reporting groups
Overall Number of Baseline Participants 3525 3525 7050
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3525 participants 3525 participants 7050 participants
61.9  (14.1) 61.8  (14.7) 61.9  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3525 participants 3525 participants 7050 participants
Female
1847
  52.4%
1872
  53.1%
3719
  52.8%
Male
1678
  47.6%
1653
  46.9%
3331
  47.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3525 participants 3525 participants 7050 participants
Black or African American 331 368 699
White 2675 2543 5218
Other 519 614 1133
Procedure type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3525 participants 3525 participants 7050 participants
Laparoscopic colon or rectal resection 1427 1427 2854
Open colon or rectal resection 1171 1171 2342
Laparoscopic or open colon or rectal resection 424 424 848
Laparoscopic or open small bowel resection 181 181 362
Laparoscopic or open ostomy takedown, bypass,other 322 322 644
[1]
Measure Description: Category of bowel resection that patients underwent during their hospitalization
Surgeon type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3525 participants 3525 participants 7050 participants
General surgeon 1809 1809 3618
Colorectal surgeon 1357 1357 2714
Other 359 359 718
[1]
Measure Description: The type of surgeon that performed the patient's bowel resection during their hospitalization
1.Primary Outcome
Title Percentage of Patients Who Died
Hide Description All-cause
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
0.4 1.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity
Hide Description GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
29.8 35.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Patients With In-hospital Cardiovascular Morbidity
Hide Description Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
19.4 24.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.6
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Patients With In-hospital Cerebrovascular Morbidity
Hide Description Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
0.2 0.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1022
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percentage of Patients With In-hospital Pulmonary Morbidity
Hide Description Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
7.3 10.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.2
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percentage of Patients With In-hospital Infection Morbidity
Hide Description Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
9.2 11.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Estimation Comments [Not Specified]
7.Primary Outcome
Title Percentage of Patients With In-hospital Thromboembolic Morbidity
Hide Description Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
1.2 2.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Estimation Comments [Not Specified]
8.Primary Outcome
Title Percentage of Patients With In-hospital Other Morbidity
Hide Description Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
0.6 0.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7637
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Estimation Comments [Not Specified]
9.Primary Outcome
Title Percentage of Patients Who Were Readmitted Within 15 Days of Discharge
Hide Description [Not Specified]
Time Frame Within 15 days of discharge from hospitalization for bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of partcipants
7.4 8.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0402
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Estimation Comments [Not Specified]
10.Primary Outcome
Title Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge
Hide Description [Not Specified]
Time Frame Between 16-30 days after hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
1.9 2.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0755
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Estimation Comments [Not Specified]
11.Primary Outcome
Title Percentage of Patients Who Were Readmitted Within 30 Days of Discharge
Hide Description [Not Specified]
Time Frame Between 0-30 days after hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
9.3 11.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0532
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Estimation Comments [Not Specified]
12.Primary Outcome
Title Percentage of Patients Discharged to Various Locations
Hide Description Location of discharge for patients who were admitted to the hospital for their bowel resection from home
Time Frame Hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Measure Type: Number
Unit of Measure: Percent of participants
Health care facility 7.9 13.8
Home 87.5 80.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Primary Outcome
Title Intensive Care Unit Length of Stay
Hide Description [Not Specified]
Time Frame Participants were followed up until their hospital discharge after bowel resection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 3525 3525
Mean (Standard Deviation)
Unit of Measure: Days
0.3  (1.4) 0.6  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Postoperative Length of Hospital Stay
Hide Description Calendar day of discharge - calendar day of surgery = postoperative length of stay
Time Frame Measured from the day after bowel resection to the day of hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description:
Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
Overall Number of Participants Analyzed 2323 2323
Mean (Standard Deviation)
Unit of Measure: Days
5.3  (3.1) 6.4  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alvimopan Users, Matched Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected in this retrospective observational study.
 
Arm/Group Title Alvimopan Users Matched Controls
Hide Arm/Group Description Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses) Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
All-Cause Mortality
Alvimopan Users Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alvimopan Users Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alvimopan Users Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01150760     History of Changes
Other Study ID Numbers: Premier clinical outcomes
First Submitted: June 23, 2010
First Posted: June 25, 2010
Results First Submitted: August 17, 2010
Results First Posted: September 8, 2010
Last Update Posted: August 7, 2015