Trial Outcomes & Findings for Clinical Outcomes After Bowel Resection in Patients Receiving Alvimopan Versus Patients Not Receiving Alvimopan in the Premier Perspective Database (NCT NCT01150760)

Results Overview

All-cause

Recruitment status

COMPLETED

Target enrollment

7050 participants

Primary outcome timeframe

Participants were followed up until their hospital discharge after bowel resection

Results posted on

2015-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Alvimopan Users Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls 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 Study STARTED	3525	3525
Overall Study COMPLETED	3525	3525
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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 n=7050 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 14.1 • n=39 Participants	61.8 years STANDARD_DEVIATION 14.7 • n=41 Participants	61.9 years STANDARD_DEVIATION 14.4 • n=35 Participants
Sex: Female, Male Female	1847 Participants n=39 Participants	1872 Participants n=41 Participants	3719 Participants n=35 Participants
Sex: Female, Male Male	1678 Participants n=39 Participants	1653 Participants n=41 Participants	3331 Participants n=35 Participants
Race/Ethnicity, Customized Black or African American	331 Participants n=39 Participants	368 Participants n=41 Participants	699 Participants n=35 Participants
Race/Ethnicity, Customized White	2675 Participants n=39 Participants	2543 Participants n=41 Participants	5218 Participants n=35 Participants
Race/Ethnicity, Customized Other	519 Participants n=39 Participants	614 Participants n=41 Participants	1133 Participants n=35 Participants
Procedure type Laparoscopic colon or rectal resection	1427 Participants n=39 Participants	1427 Participants n=41 Participants	2854 Participants n=35 Participants
Procedure type Open colon or rectal resection	1171 Participants n=39 Participants	1171 Participants n=41 Participants	2342 Participants n=35 Participants
Procedure type Laparoscopic or open colon or rectal resection	424 Participants n=39 Participants	424 Participants n=41 Participants	848 Participants n=35 Participants
Procedure type Laparoscopic or open small bowel resection	181 Participants n=39 Participants	181 Participants n=41 Participants	362 Participants n=35 Participants
Procedure type Laparoscopic or open ostomy takedown, bypass,other	322 Participants n=39 Participants	322 Participants n=41 Participants	644 Participants n=35 Participants
Surgeon type General surgeon	1809 Participants n=39 Participants	1809 Participants n=41 Participants	3618 Participants n=35 Participants
Surgeon type Colorectal surgeon	1357 Participants n=39 Participants	1357 Participants n=41 Participants	2714 Participants n=35 Participants
Surgeon type Other	359 Participants n=39 Participants	359 Participants n=41 Participants	718 Participants n=35 Participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

All-cause

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients Who Died	0.4 Percent of participants	1.0 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity	29.8 Percent of participants	35.7 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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).

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Cardiovascular Morbidity	19.4 Percent of participants	24.0 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Cerebrovascular Morbidity	0.2 Percent of participants	0.5 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Pulmonary Morbidity	7.3 Percent of participants	10.5 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Infection Morbidity	9.2 Percent of participants	11.5 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Thromboembolic Morbidity	1.2 Percent of participants	2.1 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients With In-hospital Other Morbidity	0.6 Percent of participants	0.7 Percent of participants

PRIMARY outcome

Timeframe: Within 15 days of discharge from hospitalization for bowel resection

Population: 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)

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients Who Were Readmitted Within 15 Days of Discharge	7.4 Percent of partcipants	8.7 Percent of partcipants

PRIMARY outcome

Timeframe: Between 16-30 days after hospital discharge after bowel resection

Population: 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)

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge	1.9 Percent of participants	2.5 Percent of participants

PRIMARY outcome

Timeframe: Between 0-30 days after hospital discharge after bowel resection

Population: 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)

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients Who Were Readmitted Within 30 Days of Discharge	9.3 Percent of participants	11.2 Percent of participants

PRIMARY outcome

Timeframe: Hospital discharge after bowel resection

Population: 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)

Location of discharge for patients who were admitted to the hospital for their bowel resection from home

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Percentage of Patients Discharged to Various Locations Health care facility	7.9 Percent of participants	13.8 Percent of participants
Percentage of Patients Discharged to Various Locations Home	87.5 Percent of participants	80.7 Percent of participants

PRIMARY outcome

Timeframe: Participants were followed up until their hospital discharge after bowel resection

Population: 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)

Outcome measures

Outcome measures
Measure	Alvimopan Users n=3525 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=3525 Participants 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
Intensive Care Unit Length of Stay	0.3 Days Standard Deviation 1.4	0.6 Days Standard Deviation 2.4

SECONDARY outcome

Timeframe: Measured from the day after bowel resection to the day of hospital discharge

Population: 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)

Calendar day of discharge - calendar day of surgery = postoperative length of stay

Outcome measures

Outcome measures
Measure	Alvimopan Users n=2323 Participants Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)	Matched Controls n=2323 Participants 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
Postoperative Length of Hospital Stay	5.3 Days Standard Deviation 3.1	6.4 Days Standard Deviation 4.8

Adverse Events

Alvimopan Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Matched Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place