Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study.

OBJECTIVE: EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. METHODS: Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. RESULTS: At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was -3.1, -4.2, and -4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. CONCLUSIONS: This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab's efficacy and safety to patients under-represented in previous trials.ClinicalTrials.gov identifier: NCT03333109.

Anticonvulsant Drug Regimen and Cost of Acute Treatment for Status Epilepticus in a Philippine Tertiary Hospital: A Retrospective Cohort Study.

Background: Status epilepticus (SE) is a neurological emergency requiring prompt evaluation and management to prevent disease refractoriness associated with significant mortality and morbidity. Thus, estimating costs attributable to the treatment of SE is important because of the severity of this disease. In the Philippines, healthcare provisions are mostly out-of-pocket expenses; hence the cost of treatment is a critical determinant for disease management. Unfortunately, the availability of data regarding the cost of illness of SE in developing countries is limited. Objectives: To determine the frequently used anticonvulsant drug regimen and direct inpatient costs of acute treatment for status epilepticus within five years in a private tertiary hospital in the Philippines. Methods: Records from patients diagnosed with SE who were admitted under or referred to the Adult Neurology Service in a private tertiary hospital from January 2015 to December 2019 were retrospectively evaluated. The SE type was classified as non-refractory (NRSE), refractory (RSE), and super refractory (SRSE). Demographic data, clinical features, SE type, etiology, antiepileptic drugs (AEDs) and anesthetic drugs used, total cost of AEDs and anesthetic drugs, total cost of 5-day hospitalization, and total cost of entire length of stay were recorded. Results: We retrieved the records of 61 patients admitted for SE. Of these patients, 23 were classified as nonrefractory, 20 as refractory, and 18 as super refractory. Diazepam was given to all SE patients as first-line treatment. Valproic acid and levetiracetam were used as second-line treatments. The most frequently given anesthetic drug was midazolam. The mean hospitalization cost per patient was ₱52,0982.3 for SE, ₱659,638.7 for RSE, and ₱134,1451 for SRSE. The mean cost of 5-day hospitalization was ₱193,572.3 for NRSE, ₱358,808.5 for RSE, and ₱652,781 for SRSE. The mean cost of medications was ₱18,546 for NRSE, ₱30,780 for RSE, and ₱128,263 for SRSE. Conclusion: The direct cost of SE varied depending on subtype and response to treatment. Costs increased with disease refractoriness. Direct inpatient treatment costs for SRSE were twice as high as that of NRSE and RSE.

Vitamin B for treating peripheral neuropathy.

BACKGROUND: Vitamin B is frequently used for treating peripheral neuropathy but its efficacy is not clear. OBJECTIVES: The objective of this review was to assess the effects of vitamin B for treating generalised peripheral neuropathy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Trials Register (searched August 2005), MEDLINE (January 1966 to September 2005), EMBASE (January 1980 to September 2005), Philippine databases (searched September 2005) and reference lists of articles. We also contacted manufacturers and researchers in the field. SELECTION CRITERIA: Randomised and quasi-randomised trials where vitamin B was compared with placebo or another treatment in generalised peripheral neuropathy. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. MAIN RESULTS: Thirteen studies involving 741 participants with alcoholic or diabetic neuropathy were included. In the comparison of vitamin B with placebo, two small trials showed no significant short-term benefit in pain intensity while one of the trials showed a small significant benefit in vibration detection from oral benfotiamine, a derivative of thiamine. In the larger of two trials comparing different doses of vitamin B complex, there was some evidence that higher doses resulted in a significant short-term reduction in pain and improvement in paraesthesiae, in a composite outcome combining pain, temperature and vibration, and in a composite outcome combining pain, numbness and paraesthesiae. There was some evidence that vitamin B is less efficacious than alpha-lipoic acid, cilostazol or cytidine triphosphate in the short-term improvement of clinical and nerve conduction study outcomes but the trials were small. There were few minor adverse effects reported. AUTHORS' CONCLUSIONS: There are only limited data in randomised trials testing the efficacy of vitamin B for treating peripheral neuropathy and the evidence is insufficient to determine whether vitamin B is beneficial or harmful. One small trial in alcoholic peripheral neuropathy reported slightly greater improvement in vibration perception threshold with oral benfotiamine for eight weeks than placebo. In another small study, a higher dose of oral vitamin B complex for four weeks was more efficacious than a lower dose in reducing symptoms and signs. Vitamin B administered by various routes for two to eight weeks was less efficacious than alpha-lipoic acid, cilostazol or cytidine triphosphate in short-term improvement of clinical and nerve conduction study outcomes. Vitamin B is generally well-tolerated.

Clinical Profile and Outcome of Postthymectomy versus Non-Thymectomy Myasthenia Gravis Patients in the Philippine General Hospital: A 6-Year Retrospective Study.

BACKGROUND: Myasthenia gravis is an autoimmune neuromuscular disorder characterized by the production of abnormal autoantibodies directed against the receptors present in the neuromuscular junction. It has been the standard practice to offer thymectomy in all generalized myasthenia gravis patients despite the lack of robust evidence. OBJECTIVES: The objectives of this study are to describe the clinical profile and differentiate the clinical outcomes of thymectomy versus non-thymectomy and thymomatous versus non-thymomatous myasthenia gravis patients in the Philippine General Hospital. METHODOLOGY: Between 2009 and 2014, a total of 69 postthymectomy and 16 non-thymectomy patient records were successfully retrieved. The demographic characteristics, surgical approach, and histopathologic results were obtained. The clinical outcome after 6 months or 1 year-follow-up was also determined and grouped according to the following: (1) complete remission, (2) pharmacological remission, (3) no clinical change, (4) worsening symptoms, and (5) mortality. RESULTS: Majority of the patients were females (68.0%) with a mean age of 39.8 years and a mean duration of myasthenic symptoms of 21 months. Using the Myasthenia Gravis Foundation of America classification, 54.1% of patients fell under Class II and 48.2% of them presented with generalized weakness. In this study, 60.8% of postthymectomy myasthenia gravis patients had either complete remission or pharmacologic remission compared with 12.5% among non-thymectomy patients (p-value <0.001). No significant difference in the clinical outcome was found between thymomatous and non-thymomatous myasthenia gravis after thymectomy (p-value = 0.29). CONCLUSION: This study showed that both thymomatous and non-thymomatous myasthenia gravis patients who underwent thymectomy had a higher incidence of complete stable remission and pharmacologic remission as compared with myasthenia gravis patients who did not undergo thymectomy.