Table 1.
Medical and psychiatric history in patients entering the open-label period of the randomized withdrawal study
| Patients | |
|---|---|
| N = 116 | |
| Fibromyalgia diagnosis, n (%) | |
| Yunus and Masi criteria only | 19 (16.4) |
| 1990 ACR criteria only | 1 (0.9) |
| Both criteria | 96 (82.8) |
| Psychiatric disorders or symptoms, n (%)a | |
| Insomnia | 20 (17.2) |
| Depression | 19 (16.4) |
| Anxiety | 11 (9.5) |
| Attention deficit/hyperactivity disorder | 8 (6.9) |
| Sleep disorder | 5 (4.3) |
| Lifetime suicidality, n (%) | |
| Suicidal ideation | 24 (20.7) |
| Suicidal behavior | 4 (3.4) |
| Pain disorders or symptoms, n (%)a | |
| Headache | 40 (34.5) |
| Migraine | 26 (22.4) |
| Gastroesophageal reflux disease | 17 (14.7) |
| Back pain | 14 (12.1) |
| Dysmenorrhea | 14 (12.1) |
| Irritable bowel syndrome | 8 (6.9) |
| Arthralgia | 7 (6.0) |
| Fatigue | 6 (5.2) |
| Restless leg syndrome | 5 (4.3) |
| Abdominal pain | 4 (3.4) |
| Hypermobility syndrome | 4 (3.4) |
| Abdominal pain upper | 3 (2.6) |
| Myalgiab | 3 (2.6) |
| Raynaud’s phenomenon | 3 (2.6) |
| Temporomandibular joint syndrome | 3 (2.6) |
| Other medical symptoms or conditions, n (%)c | |
| Asthma | 27 (23.3) |
| Drug hypersensitivity | 21 (18.1) |
| Seasonal allergy | 19 (16.4) |
| Tonsillectomy | 18 (15.5) |
aIncludes MedDRA preferred terms related to symptoms or disorders that have been associated with fibromyalgia. Additional terms of potential interest that were reported in 1 patient each: bipolar disorder, carpal tunnel syndrome, chronic fatigue syndrome, dysthymic disorder, juvenile arthritis, major depression, obsessive-compulsive disorder, osteoarthritis, osteochondrosis, panic attack, post-traumatic stress disorder, psychotic disorder, seasonal affective disorder, social phobia, spinal osteoarthritis, tendonitis, tic; scoliosis was reported in 5 patients
bDoes not include symptoms that would be classified under the MedDRA preferred term of “fibromyalgia”
cIncludes all other MedDRA preferred terms that were reported in ≥10 % of the open-label population
ACR = American College of Rheumatology