Fibromyalgia
Conditions
Brief summary
The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants diagnosed by their physician with fibromyalgia (FM) and who are starting any new pharmacologic agent for FM. The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize management of FM. This study will address current gaps in a rapidly growing body of literature on FM.
Interventions
DRUGTreatment for Fibromyalgia
FM participants starting any new pharmacologic FM agent.
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet criteria for fibromyalgia (FM) in the opinion of the investigator * Must be prescribed a 'new' treatment for FM * Male and female participants at least 18 years of age * Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation * Currently under the care of the participating physician * Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI) * Available for 12 months to participate in the study
Exclusion criteria
* Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted * Are Lilly employees * Are Terminally ill * Currently participating in other research studies or if beginning a research study while participating in this study * Unable to respond via telephone for CATI * Incompetent for interview as deemed by the participating physician * Unwilling to provide written ICD or other required forms to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Baseline through 12 months | Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications. |
| Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months | Baseline through 12 months | — |
| Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use | Baseline through 12 months | Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity \[not at all severe, severe for several days, severe for more than half the days, severe nearly every day\]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months | Baseline, 12 months | Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. |
| Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months | Baseline, 12 months | BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months | Baseline, 12 months | FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter \[mm\] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact. |
| Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months | Baseline, 12 months | The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life. |
| Number of Outpatient Visits Due to Fibromyalgia (FM) | Baseline through 12 months | — |
| Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Baseline through 12 months | Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication. |
| Number of Days of Partial Care for Fibromyalgia (FM) Participants | Baseline through 12 months | Partial (day or night) care included day care, day nursing home, and partial hospitalization. |
| Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver) | Baseline through 12 months | Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM. |
| Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver) | Baseline through 12 months | Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM. |
| Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) | Baseline through 12 months | Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM. |
| Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work) | Baseline through 12 months | Participant productivity was described as the number of days a participant missed work due to FM. |
| Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM) | Baseline through 12 months | — |
| Percentage of Participants Who Discontinued Opioids | Baseline through 12 months | — |
| Hazard Ratios for Factors Associated With Discontinued Opioid Use | Baseline through 12 months | Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fibromyalgia (FM) Participants FM participants starting any new pharmacologic FM agent. | 1,700 |
| Total | 1,700 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 353 |
| Overall Study | not specified/no reason given | 11 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 127 |
Baseline characteristics
| Characteristic | Fibromyalgia (FM) Participants |
|---|---|
| Age Continuous | 50.4 years STANDARD_DEVIATION 11.9 |
| Brief Pain Inventory-Interference (BPI-I) Average Subscale Score | 6.1 units on a scale STANDARD_DEVIATION 2.2 |
| Brief Pain Inventory-Severity (BPI-S) Average Subscale Score | 5.5 units on a scale STANDARD_DEVIATION 1.8 |
| Fibromyalgia Impact Questionnaire (FIQ) | 54.4 units on a scale STANDARD_DEVIATION 13.7 |
| Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Adverse events | 81 participants |
| Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Did not help | 332 participants |
| Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Felt better | 6 participants |
| Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Other | 59 participants |
| Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Too costly | 14 participants |
| Mean Number of Concurrent Baseline Medications Taken for Fibromyalgia (FM) | 2.6 concurrent baseline medications STANDARD_DEVIATION 1.2 |
| Nonsteroidal Anti-Inflammatory Drug (NSAID) Use No | 1245 participants |
| Nonsteroidal Anti-Inflammatory Drug (NSAID) Use Yes | 455 participants |
| Number of Unique Baseline Medications Taken for Fibromyalgia (FM; Newly-Initiated and Continuing) | 181 unique baseline medications |
| Opioid Use No | 1288 participants |
| Opioid Use Yes | 412 participants |
| Race/Ethnicity, Customized Hispanic | 209 participants |
| Race/Ethnicity, Customized Other | 100 participants |
| Race/Ethnicity, Customized White | 1391 participants |
| Region of Enrollment Puerto Rico | 161 participants |
| Region of Enrollment United States | 1539 participants |
| Sex: Female, Male Female | 1601 Participants |
| Sex: Female, Male Male | 99 Participants |
| Sheehan Disability Scale (SDS) Total Score | 18.3 units on a scale STANDARD_DEVIATION 7.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who took part in all follow-up interviews.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months | 5.2 medications | Standard Deviation 2.1 |
Primary
Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication
Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had non-missing covariates used in logistic regression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Age over 65 | 0.535 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Female physician | 1.665 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Rheumatology versus Primary Care Physician (PCP) | 2.662 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Other specialty versus PCP | 2.671 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Use of opioids | 0.667 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Use of NSAIDs | 0.447 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication | Number of baseline medications taken | 1.394 odds ratio |
p-value: <0.0001Regression, Logistic
p-value: 0.0028Regression, Logistic
p-value: 0.0074Regression, Logistic
p-value: <0.0001Regression, Logistic
p-value: 0.0064Regression, Logistic
p-value: <0.0001Regression, Logistic
p-value: <0.0001Regression, Logistic
Primary
Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity \[not at all severe, severe for several days, severe for more than half the days, severe nearly every day\]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had non-missing covariates used in logistic regression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use | GAD-7 | 1.06 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use | Pregabalin use | 2.69 odds ratio |
| Fibromyalgia (FM) Participants | Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use | NSAID use | 2.25 odds ratio |
p-value: 0.026Regression, Logistic
p-value: 0.021Regression, Logistic
p-value: 0.05Regression, Logistic
Secondary
Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Time frame: Baseline, 12 months
Population: The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months | -0.66 units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.
Time frame: Baseline, 12 months
Population: The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months | -0.33 units on a scale | Standard Deviation 1.72 |
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter \[mm\] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.
Time frame: Baseline, 12 months
Population: The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months | -3.81 units on a scale | Standard Deviation 13.47 |
Secondary
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.
Time frame: Baseline, 12 months
Population: The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months | -2.28 units on a scale | Standard Deviation 7.26 |
Secondary
Hazard Ratios for Factors Associated With Discontinued Opioid Use
Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.
Time frame: Baseline through 12 months
Population: The analysis population included participants who were using opioids at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Hazard Ratios for Factors Associated With Discontinued Opioid Use | Age: younger more likely to discontinue | 0.97 hazard ratio |
| Fibromyalgia (FM) Participants | Hazard Ratios for Factors Associated With Discontinued Opioid Use | BPI-I: higher baseline score=more likely | 1.57 hazard ratio |
| Fibromyalgia (FM) Participants | Hazard Ratios for Factors Associated With Discontinued Opioid Use | PHQ-15: lower baseline score=more likely | 0.93 hazard ratio |
Secondary
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Participant productivity was described as the number of days a participant missed work due to FM.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work) | 25.0 days | Standard Deviation 56.1 |
Secondary
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) | Days participant stayed in bed due to FM | 40.6 days | Standard Deviation 58.2 |
| Fibromyalgia (FM) Participants | Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) | Days participant reduced activity by at least half | 86.5 days | Standard Deviation 76.3 |
| Fibromyalgia (FM) Participants | Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) | Days participant received disability income | 98.2 days | Standard Deviation 148.3 |
Secondary
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver) | Days family missed paid work | 2.7 days | Standard Deviation 12.2 |
| Fibromyalgia (FM) Participants | Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver) | Days family used paid caregiver | 2.7 days | Standard Deviation 17.6 |
Secondary
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver) | 36.4 days | Standard Deviation 76.6 |
Secondary
Number of Days of Partial Care for Fibromyalgia (FM) Participants
Partial (day or night) care included day care, day nursing home, and partial hospitalization.
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Days of Partial Care for Fibromyalgia (FM) Participants | Partial night care | 0.6 days | Standard Deviation 3.9 |
| Fibromyalgia (FM) Participants | Number of Days of Partial Care for Fibromyalgia (FM) Participants | Partial day care | 1.2 days | Standard Deviation 8.1 |
Secondary
Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM) | 0.9 ER visits | Standard Deviation 2.5 |
Secondary
Number of Outpatient Visits Due to Fibromyalgia (FM)
Time frame: Baseline through 12 months
Population: The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Number of Outpatient Visits Due to Fibromyalgia (FM) | 21.2 outpatient visits | Standard Deviation 28.6 |
Secondary
Percentage of Participants Who Discontinued Opioids
Time frame: Baseline through 12 months
Population: The analysis population included participants who were using opioids at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Percentage of Participants Who Discontinued Opioids | Discontinued opioid use by 3 months of treatment | 11.9 percentage of participants |
| Fibromyalgia (FM) Participants | Percentage of Participants Who Discontinued Opioids | Discontinued opioid use by 6 months of treatment | 15.3 percentage of participants |
| Fibromyalgia (FM) Participants | Percentage of Participants Who Discontinued Opioids | Discontinued opioid use by 12 months of treatment | 22.0 percentage of participants |
Secondary
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.
Time frame: Baseline through 12 months
Population: The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Felt better | 49 participants |
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Did not help | 637 participants |
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Adverse events | 731 participants |
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Too costly | 121 participants |
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | Other | 458 participants |
| Fibromyalgia (FM) Participants | Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study | No reason provided | 116 participants |