Hypercholesterolemia
Conditions
Keywords
atorvastatin, Hypercholesterolemia
Brief summary
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
Interventions
DRUGAtorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NA
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age (19 in Alabama). * Provide written informed consent. * Never participated in a study about cholesterol medicines.
Exclusion criteria
* Females subjects who are pregnant or breastfeeding. * Subjects with active liver disease. * Subjects taking cyclosporine. * Subjects with a known allergy to atorvastatin calcium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level | Day 1 up to Week 26 | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed. |
| Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results | Day 1 up to Week 26 | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (\>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication | Day 1 up to Week 26 | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy. |
| Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms | Day 1 up to Week 26 | Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The Stop use and ask a doctor symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe. |
Countries
United States
Participant flow
Pre-assignment details
Participants were screened by phone, then referred to their participating retail pharmacy site for a scheduled face-to-face interview, after which they were given an empty atorvastatin(Lipitor) over-the-counter(OTC) package to review the information on the outside of the entire package,after which decision was made to purchase the medicine by them.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks. | 1,234 |
| Total | 1,234 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 48 |
| Overall Study | Death | 2 |
| Overall Study | Did not meet eligibility criteria | 1 |
| Overall Study | Investigator Discretion | 1 |
| Overall Study | Lost to Follow-up | 88 |
| Overall Study | No Longer Meets Eligibility Criteria | 1 |
| Overall Study | Other | 9 |
| Overall Study | Physician Decision | 55 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 87 |
Baseline characteristics
| Characteristic | Atorvastatin |
|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 593 Participants |
| Sex: Female, Male Male | 641 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 589 / 1,234 |
| serious Total, serious adverse events | 53 / 1,234 |
Outcome results
Primary
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.
Time frame: Day 1 up to Week 26
Population: The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level | 49.7 Percentage of participants |
Primary
Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (\>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.
Time frame: Day 1 up to Week 26
Population: The analysis was performed on continuing users who checked their LDL-C during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results | 52.6 Percentage of participants |
Secondary
Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.
Time frame: Day 1 up to Week 26
Population: The analysis was performed on the participants from the user set who reported the use of any Ask a doctor or pharmacist before use medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication | 29.2 Percentage of participants |
Secondary
Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The Stop use and ask a doctor symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe.
Time frame: Day 1 up to Week 26
Population: The analysis was performed on the participants from the user set who experienced any of the labeled Stop use and ask a doctor symptoms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms | 10.2 Percentage of participants |