N/A
N=1,700
Fibromyalgia Health Outcome Study on Cost of Treatments
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00725101 ↗Enrolled (actual)
1,700
Serious AEs
—
Results posted
Jun 2012
Primary outcome: Primary: Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months — 5.2 medications
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Treatment for Fibromyalgia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months |
5.2 | — |
| PRIMARY Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication |
0.535; 1.665; 2.662; 2.671; 0.667; 0.447 | 0.0074 sig |
| 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 |
1.06; 2.69; 2.25 | 0.026 sig |
| SECONDARY Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study |
49; 637; 731; 121; 458; 116 | — |
| SECONDARY Percentage of Participants Who Discontinued Opioids |
11.9; 15.3; 22.0 | — |
| SECONDARY Hazard Ratios for Factors Associated With Discontinued Opioid Use |
0.97; 1.57; 0.93 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months |
-0.66 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months |
-0.33 | — |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months |
-3.81 | — |
| SECONDARY Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months |
-2.28 | — |
| SECONDARY Number of Outpatient Visits Due to Fibromyalgia (FM) |
21.2 | — |
| SECONDARY Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM) |
0.9 | — |
| SECONDARY Number of Days of Partial Care for Fibromyalgia (FM) Participants |
1.2; 0.6 | — |
| SECONDARY Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver) |
2.7; 2.7 | — |
| SECONDARY Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver) |
36.4 | — |
| SECONDARY Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) |
40.6; 86.5; 98.2 | — |
| SECONDARY Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work) |
25.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00725101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.