pregabalin (pregabalin, YuHan / YHD 1119 / YHD1119)

The Efficacy and Safety of Pregabalin Combined with Venlafaxine in Fibromyalgia Patients: Protocol for a Prospective, Randomized, Open-Label, Blinded-Endpoint Trial.

Liu Minying M, He Ruilin R, Wang Likui L, Cui Jian J et al.

Fibromyalgia (FM) is a chronic condition characterized by widespread pain and a range of somatic and psychological symptoms that impose a substantial burden on patients. While pregabalin is an approved and effective monotherapy for many individuals with FM, the efficacy of this medication is often incomplete, particularly for symptoms like fatigue and anxiety. Combination therapy incorporating selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has shown promise for enhancing therapeutic outcomes. Venlafaxine, an SNRI with demonstrated efficacy as an FM treatment, has a distinct pharmacological mechanism from pregabalin. However, the synergistic potential of pregabalin and venlafaxine in combination has not been formally evaluated. This study protocol describes a trial designed to test the hypothesis that the combination of pregabalin and venlafaxine is superior to pregabalin monotherapy in providing pain relief to patients with FM. This is a multicenter, prospective, randomized, open-label, blinded-endpoint study. This study will be conducted at 7 different hospitals. We will recruit 750 adults with a diagnosis of FM and moderate-to-severe pain. Patients will be randomly assigned in a one-to-one ratio to receive either pregabalin monotherapy or combination therapy consisting of pregabalin and venlafaxine for 12 weeks. Both groups will follow a flexible, forced-titration schedule to achieve the maximum tolerated dose. While the patients and treating physicians will be aware of the treatment allocation, the outcome assessors will remain blinded. The primary outcome is the mean daily pain intensity at week 4, measured on an 11-point numeric rating scale. Secondary outcomes will be evaluated at baseline and at weeks one, 2, 4, 8, and 12 after the treatment initiation. Secondary outcomes include the worst pain intensity, the responder rates (≥ 30% and ≥ 50% pain reduction), the dose of pregabalin and/or venlafaxine, the Revised FM Impact Questionnaire, the Brief Pain Inventory severity and interference subscales, the 36-Item Short Form Survey (SF-36), the Medical Outcomes Study Sleep Scale, the Beck Depression Inventory-II, and adverse events (AEs) occuring throughout the study. Statistical analyses will be performed on the modified intention-to-treat population. An open-label design will be employed, with patient follow-up limited to 12 weeks. If the combination of pregabalin and venlafaxine proves to be more effective and better tolerated than pregabalin monotherapy, the combination therapy could establish a new standard of care for FM patients who struggle to achieve sufficient pain relief through nonpharmacological therapies.

Corrigendum to: Efficacy and safety of pregabalin and duloxetine in painful diabetic neuropathy: a systematic review and meta-analysis.

Integrating Pain Management in a Patient With Cystic Fibrosis and Fibromyalgia: A Case Report.

Kritikou Persefoni P, Koffa Nikoletta N, Loukou Ioanna I, Vadalouca Athina A

Chronic pain is increasingly recognized in individuals with cystic fibrosis (CF), especially as survival improves. However, the coexistence of CF and fibromyalgia-a centralized pain syndrome-has not been previously reported and presents a unique diagnostic challenge.. A 26-year-old woman with confirmed CF presented with chronic, widespread musculoskeletal pain unresponsive to CF-specific treatment. Evaluation revealed neuropathic features and positive findings on fibromyalgia screening tools. Management included duloxetine, pregabalin, Pilates-based rehabilitation, and reflexology-based manual therapy. With consistent care, the patient achieved significant symptom control and improved quality of life. Our case highlights the importance of individualized, multimodal pain management in CF, particularly when symptoms suggest overlapping centralized pain syndromes. Clinicians should consider fibromyalgia in CF patients presenting with persistent, widespread pain unresponsive to standard treatment.

Combination Therapy with Pregabalin and Morphine Relieves Dinutuximab-Induced Pain in a 3-Year-Old Girl: A Case Report.

Akazawa Maiko M, Shigetsura Yuki Y, Kawakatsu Kazuko K, Matsuyama Naomi N et al.

Opioids are commonly initiated prior to dinutuximab (DIN)-an anti-disialoganglioside 2 antibody used in the treatment of neuroblastoma-and continued for approximately 2 hours after administration to manage DIN-associated pain. However, pain control remains insufficient with standard opioid treatment. We treated a 3-year-old girl with high-risk neuroblastoma who received DIN after tandem transplantation. During the first treatment cycle, despite scheduled morphine therapy, she developed abdominal pain rated as 5 on the Faces Pain Scale (FPS; range 0-5, where 0 indicates no pain and 5 indicates the worst pain), indicating the need for higher doses, prolonged infusion, and additional bolus analgesia. The dosing period and DIN dosage in the second cycle were similar to those in the first cycle. To improve pain control during the second cycle, pregabalin was initiated at a dose of approximately 1 mg/kg/day 3 days prior to DIN administration. This approach significantly reduced abdominal pain, with the maximum FPS score decreasing to 2. This case highlights that adding pregabalin to standard opioid therapy can contribute to improved management of DIN-induced pain.