Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia

Abstract

Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. 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.

Tolerability, pharmacokinetics, and pharmacodynamics of mirogabalin in healthy subjects: Results from phase 1 studies

“…However, with pregabalin treatment, subjects developed tolerance to these TEAEs. 15 In the multiple-ascending-dose study, somnolence or dizziness resolved or improved within 4-5 days, suggesting that tolerance developed to these CNS TEAEs. Asymptomatic elevation of hepatic transaminase levels was reported in 1 subject receiving mirogabalin 10 mg BID in the multiple-ascending-dose study.…”

“…Therefore, it was not unexpected that, in both the single‐ and multiple‐ascending‐dose studies, dizziness and somnolence were among the most commonly reported TEAEs. However, with pregabalin treatment, subjects developed tolerance to these TEAEs . In the multiple‐ascending‐dose study, somnolence or dizziness resolved or improved within 4‐5 days, suggesting that tolerance developed to these CNS TEAEs.…”

Pregbalin induced recurrent syncopal attacks with prolong QT interval

“…ECG monitoring should be recommended for the patients undergoing pregabalin therapy, if necessary. Furthermore, pregabalin itself, which is commenced as an auxiliary medication for the treatment of epilepsy (Baldwin et al., ; Bhusal, Diomampo, & Magrey, ) can be the cause of next syncope by prolonging the QT interval. Prolonged QT interval should be excluded during epileptic attacks in the patients receiving pregabalin for epilepsy.…”

“…Prolonged QT interval should be excluded during epileptic attacks in the patients receiving pregabalin for epilepsy. Pregabalin is a gamma‐aminobutyric acid analogue it acts by blocking L‐type calcium canals resulting in decreased level of neurotransmitters such as substance p, norepinephrine, and glutamate (Baldwin et al., ; Bhusal et al., ). Most common side effects of pregabalin include dizziness, sensation of numbness and blurred vision.…”

Does pregabalin improve sleep disorders in fibromyalgia?

“…With PG, many patients manage to obtain significant benefits regarding pain control, quality of life, and especially in sleep improvement. Moreover, the side effects, even though they are somewhat common, are normally mild and well tolerated in the long term, and may also be monitored in primary care 17 . Based on the above, a discussion on the relationship between PG and sleep in cases of FM becomes valid, so that the doctor may have the best possible grounding in establishing his or her conduct for the cases considered.…”