Trial Outcomes & Findings for Statin Discontinuation in Advanced Illness (NCT NCT01415934)
NCT ID: NCT01415934
Last Updated: 2018-09-21
Results Overview
To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
381 participants
Primary outcome timeframe
Within 60 days of Subject Enrollment
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
Continue Statins
Participant will continue on statins as per usual
|
Discontinue Statins
Participant will stop taking their statin drugs
discontinue statins: patients will be randomized to either continue taking statins or discontinue.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
189
|
|
Overall Study
COMPLETED
|
189
|
182
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statin Discontinuation in Advanced Illness
Baseline characteristics by cohort
| Measure |
Continue Statins
n=192 Participants
Patients in the continuation group continued to receive statins.
|
Discontinue Statins
n=189 Participants
Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
154 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Age, Continuous
|
73.5 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
74.8 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
74.1 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
182 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 participants
n=5 Participants
|
189 participants
n=7 Participants
|
381 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 60 days of Subject EnrollmentPopulation: Intent to treat
To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.
Outcome measures
| Measure |
Continue Statins
n=192 Participants
Patients in the continuation group continued to receive statins.
|
Discontinue Statins
n=189 Participants
Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.
|
|---|---|---|
|
Proportion of Deaths Within 60 Days of Enrollment.
|
0.203 proportion of deaths
Interval 0.156 to 0.257
|
0.238 proportion of deaths
Interval 0.188 to 0.295
|
Adverse Events
Continue Statins
Serious events: 4 serious events
Other events: 4 other events
Deaths: 39 deaths
Discontinue Statins
Serious events: 6 serious events
Other events: 7 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
Continue Statins
n=192 participants at risk
Participant will continue on statins as per usual
|
Discontinue Statins
n=189 participants at risk
Participant will stop taking their statin drugs
discontinue statins: patients will be randomized to either continue taking statins or discontinue.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation and severe depression
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Bowel Obstruction
|
1.0%
2/192 • Number of events 2 • 12 months
|
0.00%
0/189 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
General disorders
Dehydration
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
General disorders
Edema
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
General disorders
Shortness of Breath
|
0.00%
0/192 • 12 months
|
1.6%
3/189 • Number of events 3 • 12 months
|
|
General disorders
Fever
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Cardiac disorders
Low Blood Pressure
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
General disorders
Pain
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Rectal Bleed
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
Other adverse events
| Measure |
Continue Statins
n=192 participants at risk
Participant will continue on statins as per usual
|
Discontinue Statins
n=189 participants at risk
Participant will stop taking their statin drugs
discontinue statins: patients will be randomized to either continue taking statins or discontinue.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.52%
1/192 • Number of events 1 • 12 months
|
1.1%
2/189 • Number of events 2 • 12 months
|
|
Nervous system disorders
Encephalpathy
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
General disorders
Fall
|
0.52%
1/192 • Number of events 1 • 12 months
|
3.2%
6/189 • Number of events 6 • 12 months
|
|
General disorders
Fever
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
General disorders
Headache
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Cardiac disorders
Hypotension
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Blood and lymphatic system disorders
Sepsis
|
0.52%
1/192 • Number of events 1 • 12 months
|
0.00%
0/189 • 12 months
|
|
Ear and labyrinth disorders
Rehospitalization
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Psychological Distress
|
0.00%
0/192 • 12 months
|
0.53%
1/189 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place