Trial Outcomes & Findings for Simvastatin Therapy for Moderate and Severe COPD (NCT NCT01061671)
NCT ID: NCT01061671
Last Updated: 2018-01-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
885 participants
Primary outcome timeframe
up to 37 months
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Simvastatin
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Overall Study
STARTED
|
433
|
452
|
|
Overall Study
COMPLETED
|
386
|
397
|
|
Overall Study
NOT COMPLETED
|
47
|
55
|
Reasons for withdrawal
| Measure |
Simvastatin
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
20
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Death
|
28
|
30
|
Baseline Characteristics
Simvastatin Therapy for Moderate and Severe COPD
Baseline characteristics by cohort
| Measure |
Simvastatin
n=433 Participants
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=452 Participants
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
Total
n=885 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
498 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
429 Participants
n=5 Participants
|
445 Participants
n=7 Participants
|
874 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
99 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
328 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
674 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
362 participants
n=5 Participants
|
376 participants
n=7 Participants
|
738 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
71 participants
n=5 Participants
|
76 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Smoking History (Pack Years)
|
50.0 Pack Years
STANDARD_DEVIATION 26.1 • n=5 Participants
|
51.2 Pack Years
STANDARD_DEVIATION 28.7 • n=7 Participants
|
50.6 Pack Years
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
Post-bronchodilator FEV1 (forced expiratory volume at one second)
|
1.19 liters (L)
STANDARD_DEVIATION 0.58 • n=5 Participants
|
1.19 liters (L)
STANDARD_DEVIATION 0.56 • n=7 Participants
|
1.19 liters (L)
STANDARD_DEVIATION 0.57 • n=5 Participants
|
|
FEV1/FVC (forced expiratory volume at one second/forced vital capacity)
|
0.44 Ratio
STANDARD_DEVIATION 0.13 • n=5 Participants
|
0.44 Ratio
STANDARD_DEVIATION 0.13 • n=7 Participants
|
0.44 Ratio
STANDARD_DEVIATION 0.13 • n=5 Participants
|
|
FEV1 (% Predicted)
|
41.5 percent predicted
STANDARD_DEVIATION 17.8 • n=5 Participants
|
41.6 percent predicted
STANDARD_DEVIATION 17.6 • n=7 Participants
|
41.6 percent predicted
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Acute COPD Exacerbation requiring Hospitalization or ED visit within previous 12 mo
Yes
|
216 participants
n=5 Participants
|
238 participants
n=7 Participants
|
454 participants
n=5 Participants
|
|
Acute COPD Exacerbation requiring Hospitalization or ED visit within previous 12 mo
No
|
217 participants
n=5 Participants
|
214 participants
n=7 Participants
|
431 participants
n=5 Participants
|
|
Systemic glucocorticoid or antibiotic use within previous 12 mo
Yes
|
367 participants
n=5 Participants
|
382 participants
n=7 Participants
|
749 participants
n=5 Participants
|
|
Systemic glucocorticoid or antibiotic use within previous 12 mo
No
|
66 participants
n=5 Participants
|
70 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Use of supplemental oxygen within previous 12 mo
Yes
|
198 participants
n=5 Participants
|
222 participants
n=7 Participants
|
420 participants
n=5 Participants
|
|
Use of supplemental oxygen within previous 12 mo
No
|
235 participants
n=5 Participants
|
230 participants
n=7 Participants
|
465 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 37 monthsPopulation: Analysis excludes participants without any follow-up data.
Outcome measures
| Measure |
Simvastatin
n=430 Participants
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=447 Participants
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Rates of COPD Exacerbations
|
1.36 exacerbations/person-year
Standard Deviation 1.61
|
1.39 exacerbations/person-year
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: up to 37 monthsPopulation: Analysis excludes participants without any follow-up data.
Outcome measures
| Measure |
Simvastatin
n=430 Participants
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=447 Participants
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Time to First COPD Exacerbation
|
223 Days to the first exacerbation
Interval 195.0 to 275.0
|
231 Days to the first exacerbation
Interval 193.0 to 303.0
|
SECONDARY outcome
Timeframe: Baseline, last measure at up to 37 monthsPopulation: Analysis excludes participants without any follow-up data.
Outcome measures
| Measure |
Simvastatin
n=356 Participants
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=356 Participants
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Change in FEV1 (% Pred) From Baseline to Last Measure
|
-0.86 percent predicted
Interval -11.04 to 8.67
|
-1.81 percent predicted
Interval -10.62 to 7.1
|
SECONDARY outcome
Timeframe: up to 37 monthsPopulation: Analysis excludes participants without any follow-up data.
Outcome measures
| Measure |
Simvastatin
n=430 Participants
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=447 Participants
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)
|
0.31 events per patient year
Interval 0.24 to 0.38
|
0.31 events per patient year
Interval 0.23 to 0.38
|
Adverse Events
Simvastatin
Serious events: 178 serious events
Other events: 316 other events
Deaths: 0 deaths
Placebo
Serious events: 190 serious events
Other events: 329 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simvastatin
n=433 participants at risk
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=452 participants at risk
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Viral Infection
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Infections and infestations
Other Infection
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Cancer
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 2 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory Cancer
|
2.1%
9/433 • Number of events 12 • Up to 37 months
|
2.2%
10/452 • Number of events 14 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Neoplasm
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.88%
4/452 • Number of events 4 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genitourinary Neoplasm
|
0.92%
4/433 • Number of events 5 • Up to 37 months
|
1.1%
5/452 • Number of events 7 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphatic Neoplasm
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Neoplasm
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Metabolism and nutrition disorders
Metabolic disorders
|
1.2%
5/433 • Number of events 6 • Up to 37 months
|
1.1%
5/452 • Number of events 5 • Up to 37 months
|
|
Blood and lymphatic system disorders
Cavernous Hemangioma
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 2 • Up to 37 months
|
|
Psychiatric disorders
Mental Disorder
|
0.69%
3/433 • Number of events 4 • Up to 37 months
|
1.1%
5/452 • Number of events 6 • Up to 37 months
|
|
Nervous system disorders
Central Nervous System disorders
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Nervous system disorders
Pain
|
0.00%
0/433 • Up to 37 months
|
0.44%
2/452 • Number of events 2 • Up to 37 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Eye disorders
Orbital cellulitis
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Cardiac disorders
Rheumatic Heart Disease
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Cardiac disorders
Ischemic Heart Disease
|
0.92%
4/433 • Number of events 4 • Up to 37 months
|
1.3%
6/452 • Number of events 6 • Up to 37 months
|
|
Cardiac disorders
Pulmonary Circulation disorders
|
0.92%
4/433 • Number of events 5 • Up to 37 months
|
1.3%
6/452 • Number of events 6 • Up to 37 months
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Cardiac disorders
Cardiac Dysrhythmias
|
1.6%
7/433 • Number of events 7 • Up to 37 months
|
0.88%
4/452 • Number of events 5 • Up to 37 months
|
|
Cardiac disorders
Heart Failure
|
0.92%
4/433 • Number of events 6 • Up to 37 months
|
1.1%
5/452 • Number of events 7 • Up to 37 months
|
|
Vascular disorders
Cerebrovascular
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
1.3%
6/452 • Number of events 6 • Up to 37 months
|
|
Vascular disorders
Artery disorder
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.44%
2/452 • Number of events 3 • Up to 37 months
|
|
Vascular disorders
Vein disorder
|
0.92%
4/433 • Number of events 4 • Up to 37 months
|
0.66%
3/452 • Number of events 4 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infection
|
0.23%
1/433 • Number of events 3 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.9%
34/433 • Number of events 40 • Up to 37 months
|
6.0%
27/452 • Number of events 32 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.2%
5/433 • Number of events 5 • Up to 37 months
|
1.3%
6/452 • Number of events 9 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 2 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.69%
3/433 • Number of events 3 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoconioses
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
22.2%
96/433 • Number of events 155 • Up to 37 months
|
21.5%
97/452 • Number of events 187 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD other
|
2.1%
9/433 • Number of events 9 • Up to 37 months
|
2.2%
10/452 • Number of events 15 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory
|
2.8%
12/433 • Number of events 14 • Up to 37 months
|
2.9%
13/452 • Number of events 20 • Up to 37 months
|
|
Gastrointestinal disorders
Esophagus and stomach disorders
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
1.1%
5/452 • Number of events 5 • Up to 37 months
|
|
Gastrointestinal disorders
Appendicitis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.44%
2/452 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Enteritis
|
0.69%
3/433 • Number of events 3 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Gastrointestinal disorders
Other Intestinal disorders
|
1.6%
7/433 • Number of events 9 • Up to 37 months
|
1.1%
5/452 • Number of events 5 • Up to 37 months
|
|
Gastrointestinal disorders
Other Digestive Disorders
|
2.5%
11/433 • Number of events 14 • Up to 37 months
|
1.5%
7/452 • Number of events 8 • Up to 37 months
|
|
Renal and urinary disorders
Nephrotic disorders
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Renal and urinary disorders
Other Urinary Disorder
|
1.2%
5/433 • Number of events 5 • Up to 37 months
|
1.1%
5/452 • Number of events 5 • Up to 37 months
|
|
Renal and urinary disorders
Disorders of the Male Genitourinary System
|
0.00%
0/433 • Up to 37 months
|
0.44%
2/452 • Number of events 3 • Up to 37 months
|
|
Renal and urinary disorders
Disorders of the Female Genitourinary System
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.66%
3/452 • Number of events 4 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
1.1%
5/452 • Number of events 6 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Dorsopathy
|
0.92%
4/433 • Number of events 4 • Up to 37 months
|
0.66%
3/452 • Number of events 3 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatism
|
0.69%
3/433 • Number of events 3 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Osteopathy
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Nissen Fundoplication
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
General disorders
Syncope
|
1.2%
5/433 • Number of events 5 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
General disorders
Dizziness
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
General disorders
Severe Headaches
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
General disorders
Ill defined abdominal pain
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.66%
3/452 • Number of events 4 • Up to 37 months
|
|
General disorders
Sudden death of unknown cause
|
0.92%
4/433 • Number of events 4 • Up to 37 months
|
0.88%
4/452 • Number of events 4 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Fractures
|
1.6%
7/433 • Number of events 7 • Up to 37 months
|
0.88%
4/452 • Number of events 4 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Sprain
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Intracranial injury
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Internal Injury
|
0.23%
1/433 • Number of events 2 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Trauma from motorcycle accident
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
General disorders
Complications of surgical and medical care
|
0.92%
4/433 • Number of events 4 • Up to 37 months
|
0.44%
2/452 • Number of events 2 • Up to 37 months
|
|
General disorders
Respiratory Arrest
|
0.46%
2/433 • Number of events 2 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
General disorders
Abnormal Gait
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative Disc Disease
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
General disorders
Epistaxis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.00%
0/452 • Up to 37 months
|
|
General disorders
Sepsis
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.88%
4/452 • Number of events 4 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Ill Defined Respiratory events
|
2.3%
10/433 • Number of events 11 • Up to 37 months
|
2.9%
13/452 • Number of events 15 • Up to 37 months
|
|
Gastrointestinal disorders
Ill defined digestive symptoms
|
0.23%
1/433 • Number of events 1 • Up to 37 months
|
0.44%
2/452 • Number of events 2 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/433 • Up to 37 months
|
0.44%
2/452 • Number of events 2 • Up to 37 months
|
|
General disorders
Fatigue
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/433 • Up to 37 months
|
0.22%
1/452 • Number of events 1 • Up to 37 months
|
Other adverse events
| Measure |
Simvastatin
n=433 participants at risk
40 mgms of simvastatin daily
Simvastatin: 40 mgms of simvastatin daily
|
Placebo
n=452 participants at risk
Matched placebo pill daily
Placebo: Matched placebo pill daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infection
|
25.2%
109/433 • Number of events 159 • Up to 37 months
|
23.7%
107/452 • Number of events 166 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.1%
22/433 • Number of events 25 • Up to 37 months
|
3.8%
17/452 • Number of events 19 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
53.6%
232/433 • Number of events 642 • Up to 37 months
|
54.0%
244/452 • Number of events 649 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Other COPD Related Symptoms
|
9.5%
41/433 • Number of events 79 • Up to 37 months
|
9.5%
43/452 • Number of events 80 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathies
|
5.8%
25/433 • Number of events 38 • Up to 37 months
|
7.1%
32/452 • Number of events 43 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Dorsopathies
|
6.2%
27/433 • Number of events 35 • Up to 37 months
|
6.0%
27/452 • Number of events 32 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatism
|
15.5%
67/433 • Number of events 89 • Up to 37 months
|
11.9%
54/452 • Number of events 73 • Up to 37 months
|
|
Renal and urinary disorders
Urinary Infection
|
6.0%
26/433 • Number of events 56 • Up to 37 months
|
5.1%
23/452 • Number of events 30 • Up to 37 months
|
|
General disorders
Headache
|
3.7%
16/433 • Number of events 20 • Up to 37 months
|
5.1%
23/452 • Number of events 27 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
65/433 • Number of events 94 • Up to 37 months
|
13.1%
59/452 • Number of events 90 • Up to 37 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place