- Fibromyalgia etiology is complex and multifaceted.
- Syndrome affects millions of patients worldwide.
- Fibromyalgia has significant negative personal, interpersonal, professional, and socioeconomic repercussions.
- While fibromyalgia is frequently recalcitrant, pregabalin has been found to be an anchor therapy for the syndrome.
- The syndrome afflicts between 6.5 million and more than 13 million Americans.
- Pharmacoeconomic studies have revealed that pregabalin is cost-effective.
Fibromyalgia has been estimated to afflict 1% to 5% of the U.S. population, or 3.3 million to >16 million people. It has come to be recognized as one of the most prevalent rheumatic disorders in the U.S. and worldwide. This exceedingly common syndrome carries profound and significant negative personal, interpersonal, occupational, and socioeconomic effects.
Fibromyalgia has also come to be recognized as one of the most important debilitating disorders in the U.S. and worldwide. While the syndrome is often very difficult to treat, a recent review of the large volume of high-quality data on fibromyalgia reveals that pregabalin is the most clinically effective and cost-effective therapies available.
Fibromyalgia is a clinical syndrome characterized by chronic widespread somatic pain associated with fatigue, unrefreshing sleep, cognitive disorders, and other symptoms. The syndrome overwhelmingly afflicts women at approximately a 9:1 female-to-male ratio. It is the third most common rheumatologic condition after low back pain and osteoarthritis and the most common reason for work-related disability leave in the developed world, according to a report published recently in Drug, Healthcare and Patient Safety.
Effects on Patient, Workplace, and Society
Fibromyalgia has been associated with a global burden in patient’s health. The syndrome effects every aspect of health-related quality of life (HRQoL). “In short form (SF) 36 questionnaires, patients with fibromyalgia have significant deficits in all 8 components of physical and mental health compared to controls, whereas greater deficits in the scales measuring mental health (mental health, role limitations due to emotional health, social functioning, and vitality) over functional disability (physical functioning and role limitations due to physical function) are noted compared to rheumatoid arthritis patients,” the reviewers noted.
With regard to interpersonal relationships, patients with fibromyalgia report receiving less support from their partners compared patients with osteoarthritis. These patients also report higher caregiver burden when they are particularly disabled by the disease. These patients live with both chronic pain and acute exacerbations sometimes referred to as breakthrough pain. They also frequently report feeling that their complaints are doubted because no clear etiology of the pain can be detected.
From an occupational perspective, patients with fibromyalgia are reported to miss work at a higher rate and to have greater levels of on-the-job impairment compared to patients with arthritis pain or back pain. Fibromyalgia patients are 2x to 3x more likely to miss work compared to controls. On average, fibromyalgia patients miss 15% of workdays, or nearly 30 days per year. This number is higher than that reported by osteoarthritis patients (25.7 days; P<0.0001).
Patients who report particularly troublesome fibromyalgia symptoms are more likely to retire early than are their asymptomatic twin counterparts (cumulative incidence: 25.7% vs 6.8%, respectively). The rate of Social Security disability claims among fibromyalgia patients is comparable to that among patients with osteoarthritis and rheumatoid arthritis (42% vs 42.4% vs 54.6%, respectively).
At the societal level, fibromyalgia is significantly costly. “Mean annual direct costs to the payers and patients amount to US$7,973 (standard deviation [SD] US$7,341) per subject in the USA, US$2,234 (SD US$2,261) in Germany, and US$924 (SD US$862) in France; the primary drivers of costs are prescription medications, physician office visits (~10/year), and out of pocket expenses. Indirect costs due to lost productivity, absenteeism, and disability are much higher and approximates about two-third to three-fourth of total costs. For example, mean annual indirect costs were US$10,697 in the USA, US$7,898 in Germany, and US$9,819 in France. Not surprisingly, the costs increase with increasing severity of disease,” according to the authors of the review in Drug, Healthcare and Patient Safety.
Efficacy of Pregabalin
Many well-structured studies conducted in the U.S. and worldwide have supported the efficacy of pregabalin as an analgesic in fibromyalgia patients. Patients who received pregabalin in randomized trials reported statistically significant improvement in pain scores versus placebo as well as versus other active treatments. Patients participating in these trials generally reported 30% to 50% reduction in pain scores. The proportion of patients achieving >50% reduction of pain from baseline was significantly higher irrespective of dosage, as was the proportion of patients achieving >30% improvement in pain scores. Pregabalin has also been found to enhance slow-wave sleep, with patients feeling significantly more refreshed upon waking. Patients taking pregabalin were also found to miss significantly fewer days of work when compared with those who received placebo or other active treatment. Pharmacoeconomic studies have revealed that pregabalin is cost-effective.
“Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness,” according to the review Drug, Healthcare and Patient Safety. Accumulating data strongly suggest that pregabalin confers “a meaningful benefit on sleep, functioning, quality of life, and work productivity,” the authors added.
The side effects of pregabalin are considered to be mild to moderate in intensity. While common, these untoward effects frequently appear early in therapy and improve or disappear with dose adjustment. Clinicians have observed that in most patients, tolerance develops to the most common side effects—dizziness and somnolence—and these diminish over time. Pregabalin can be effectively used by primary care physicians.
“Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness,” the review authors noted.
“The relevance of pregabalin therapy in fibromyalgia treatment cannot be overstated. It was the first medicine approved by the FDA for fibromyalgia treatment in 2007. Since then, only two other medications, duloxetine and milnacipran, have been approved. The usefulness of pregabalin as an “anchor drug”, discussed earlier, is relevant not only for its benefit in pain, but also for its benefits in sleep and HRQoL,” they concluded.