Trial Outcomes & Findings for Fibromyalgia Health Outcome Study on Cost of Treatments (NCT NCT00725101)

Results Overview

Recruitment status

COMPLETED

Target enrollment

1700 participants

Primary outcome timeframe

Baseline through 12 months

Results posted on

2012-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Fibromyalgia (FM) Participants FM participants starting any new pharmacologic FM agent.
Overall Study STARTED	1700
Overall Study COMPLETED	1205
Overall Study NOT COMPLETED	495

Reasons for withdrawal

Reasons for withdrawal
Measure	Fibromyalgia (FM) Participants FM participants starting any new pharmacologic FM agent.
Overall Study Death	3
Overall Study Lost to Follow-up	353
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	127
Overall Study not specified/no reason given	11

Baseline Characteristics

Fibromyalgia Health Outcome Study on Cost of Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fibromyalgia (FM) Participants n=1700 Participants FM participants starting any new pharmacologic FM agent.
Age Continuous	50.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	1601 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants
Race/Ethnicity, Customized White	1391 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	209 participants n=5 Participants
Race/Ethnicity, Customized Other	100 participants n=5 Participants
Region of Enrollment United States	1539 participants n=5 Participants
Region of Enrollment Puerto Rico	161 participants n=5 Participants
Number of Unique Baseline Medications Taken for Fibromyalgia (FM; Newly-Initiated and Continuing)	181 unique baseline medications n=5 Participants
Mean Number of Concurrent Baseline Medications Taken for Fibromyalgia (FM)	2.6 concurrent baseline medications STANDARD_DEVIATION 1.2 • n=5 Participants
Brief Pain Inventory-Severity (BPI-S) Average Subscale Score	5.5 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
Brief Pain Inventory-Interference (BPI-I) Average Subscale Score	6.1 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants
Fibromyalgia Impact Questionnaire (FIQ)	54.4 units on a scale STANDARD_DEVIATION 13.7 • n=5 Participants
Sheehan Disability Scale (SDS) Total Score	18.3 units on a scale STANDARD_DEVIATION 7.6 • n=5 Participants
Opioid Use No	1288 participants n=5 Participants
Opioid Use Yes	412 participants n=5 Participants
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use No	1245 participants n=5 Participants
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use Yes	455 participants n=5 Participants
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Felt better	6 participants n=5 Participants
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Did not help	332 participants n=5 Participants
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Adverse events	81 participants n=5 Participants
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Too costly	14 participants n=5 Participants
Main Reasons for Discontinuing Medications Before Starting Fibromyalgia (FM) Treatment at Baseline Other	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who took part in all follow-up interviews.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1073 Participants FM participants starting any new pharmacologic FM agent.
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months	5.2 medications Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had non-missing covariates used in logistic regression.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1275 Participants FM participants starting any new pharmacologic FM agent.
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 Interval 1.247 to 1.558
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 Interval 0.338 to 0.845
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 Interval 1.192 to 2.325
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 Interval 1.864 to 3.802
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 Interval 1.758 to 4.06
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 Interval 0.498 to 0.893
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 Interval 0.337 to 0.594

PRIMARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had non-missing covariates used in logistic regression.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=212 Participants FM participants starting any new pharmacologic FM agent.
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 Interval 1.01 to 1.12
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 Interval 1.16 to 6.22
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 Interval 1.0 to 5.08

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=978 Participants FM participants starting any new pharmacologic FM agent.
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Felt better	49 participants
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Did not help	637 participants
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Adverse events	731 participants
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Too costly	121 participants
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Other	458 participants
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study No reason provided	116 participants

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included participants who were using opioids at Baseline.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=412 Participants FM participants starting any new pharmacologic FM agent.
Percentage of Participants Who Discontinued Opioids Discontinued opioid use by 12 months of treatment	22.0 percentage of participants
Percentage of Participants Who Discontinued Opioids Discontinued opioid use by 3 months of treatment	11.9 percentage of participants
Percentage of Participants Who Discontinued Opioids Discontinued opioid use by 6 months of treatment	15.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included participants who were using opioids at Baseline.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=325 Participants FM participants starting any new pharmacologic FM agent.
Hazard Ratios for Factors Associated With Discontinued Opioid Use Age: younger more likely to discontinue	0.97 hazard ratio
Hazard Ratios for Factors Associated With Discontinued Opioid Use BPI-I: higher baseline score=more likely	1.57 hazard ratio
Hazard Ratios for Factors Associated With Discontinued Opioid Use PHQ-15: lower baseline score=more likely	0.93 hazard ratio

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: The analysis population included participants who had non-missing BPI-I scores at Baseline and 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1202 Participants FM participants starting any new pharmacologic FM agent.
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 outcome

Timeframe: Baseline, 12 months

Population: The analysis population included participants who had non-missing BPI-S scores at Baseline and 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1172 Participants FM participants starting any new pharmacologic FM agent.
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 outcome

Timeframe: Baseline, 12 months

Population: The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1182 Participants FM participants starting any new pharmacologic FM agent.
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months	-3.81 units on a scale Standard Deviation 13.47

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1180 Participants FM participants starting any new pharmacologic FM agent.
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months	-2.28 units on a scale Standard Deviation 7.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1600 Participants FM participants starting any new pharmacologic FM agent.
Number of Outpatient Visits Due to Fibromyalgia (FM)	21.2 outpatient visits Standard Deviation 28.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1598 Participants FM participants starting any new pharmacologic FM agent.
Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)	0.9 ER visits Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had at least 1 follow-up visit.

Partial (day or night) care included day care, day nursing home, and partial hospitalization.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1600 Participants FM participants starting any new pharmacologic FM agent.
Number of Days of Partial Care for Fibromyalgia (FM) Participants Partial day care	1.2 days Standard Deviation 8.1
Number of Days of Partial Care for Fibromyalgia (FM) Participants Partial night care	0.6 days Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had at least 1 follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1600 Participants FM participants starting any new pharmacologic FM agent.
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
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 outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had at least 1 follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1599 Participants FM participants starting any new pharmacologic FM agent.
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)	36.4 days Standard Deviation 76.6

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had at least 1 follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1600 Participants FM participants starting any new pharmacologic FM agent.
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
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
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 outcome

Timeframe: Baseline through 12 months

Population: The analysis population included enrolled participants who had at least 1 follow-up visit.

Participant productivity was described as the number of days a participant missed work due to FM.

Outcome measures

Outcome measures
Measure	Fibromyalgia (FM) Participants n=1590 Participants FM participants starting any new pharmacologic FM agent.
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)	25.0 days Standard Deviation 56.1

Adverse Events

Fibromyalgia (FM) Participants

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

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60