Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects

Abstract

Purpose Fibromyalgia (FM) may go underdiagnosed and untreated in China in part due to a lack of awareness and understanding of the condition, and limited available treatments. Patients and Methods This randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300–450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China. Patients reported pain score of ≥40 mm on 100-mm scale (from 0 “no pain” to 100 “worst possible pain”). The primary efficacy endpoint was change from baseline to Week 14 in mean pain score (MPS). Secondary endpoints included measures of sleep and sleep interference. Safety and tolerability were monitored throughout. Results Median pregabalin dose was 335 mg/day. A significant reduction from baseline to Week 14 in weekly MPS was seen for patients treated with pregabalin (n=170) versus placebo (n=164) (least-squares mean difference [95% confidence interval]: –0.73 [–1.10 to –0.36]; P =0.0001). Significantly greater proportions of patients experienced ≥30% and ≥50% reductions in MPS at Week 14 with pregabalin versus placebo. Pregabalin-treated subjects demonstrated improvements in measures of sleep and sleep interference. Pregabalin was generally well tolerated. The most common adverse events were dizziness and somnolence; no serious adverse events (SAEs) occurred in pregabalin-treated subjects. Nine placebo-treated subjects experienced SAEs. Conclusion Pregabalin (300–450 mg/day) is a safe and effective treatment for reducing pain and improving sleep in native Chinese subjects with FM. ClinicalTrials.gov Identifier NCT01387607.

Local Administration of ElectroMagnetic Field as Add-On Therapy in the Treatment of Chronic Facial Pain: A Pilot Study

“…Inclusion and exclusion criteria are reported in Table 1 . Patients to be included in the final sample needed to be (a) be at least 18 years old, (b) provide the signed informed consent, (c) suffering from FS diagnosed following the certificated criteria of the American College of Rheumatology [ 8 ] or chronic ONP, (d) have undergone proper diagnosis, (e) be under appropriate pharmacological treatment but without complete responsiveness; appropriate treatment needed to satisfy the latest evidence in terms of effectiveness for both FS and ONP [ 19 , 20 , 21 , 22 , 23 ]. Incomplete responsiveness to drugs meant no more than a partial recovery after 6 months of follow-up.…”

“…Therapeutic approaches should be directed toward an integrated treatment plan based on medications, patient education, physical activity, and cognitive-behavioral therapy [ 16 , 17 , 18 ]. Antidepressants, anticonvulsants, opioids, and topical products are mostly prescribed [ 19 , 20 , 21 , 22 , 23 ]. More invasive treatments, such as nerve blocks or surgeries, are recommended only in patients with pain refractory to conservative therapies, although their effectiveness is only partial [ 24 ].…”

Verificação Da Temperatura Na Distribuição De Preparações Do Desjejum Em Uma Unidade De Alimentação E Nutrição Hoteleira De Maceió/Al

“…De modo geral, trata-se de uma terapia bem tolerada, mas efeitos de tontura e sonolência foram relatados. Corroborando com o achado, Zhang et al (2021), confirmaram a eficácia e segurança do tratamento com a pregabalina em doses de 300 a 450 mg/dia.…”

Recent advances in the pharmacological treatment of chronic pain: a systematic review

“…Gabapentinoids were also evaluated: pregabalin was shown to be effective in ameliorating pain in patients with fibromyalgia 59,61,71 and osteoarthritis 46,67 ; and gabapentin was shown to reduce chronic pelvic 72,73 and low back pain 46 for up to 16 weeks, but not failed back surgery syndrome 74 . Treatment with gabapentinoids was mostly associated with adverse effects such as dizziness and somnolence/drowsiness.…”