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1.
Cephalalgia ; 41(13): 1285-1297, 2021 11.
Article in English | MEDLINE | ID: mdl-34171973

ABSTRACT

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.


Subject(s)
Calcitonin Gene-Related Peptide Receptor Antagonists , Migraine Disorders , Adult , Antibodies, Monoclonal, Humanized , Asia , Double-Blind Method , Female , Humans , Latin America/epidemiology , Middle East , Migraine Disorders/prevention & control , Treatment Outcome
2.
Acta Medica Philippina ; : 92-99, 2017.
Article in English | WPRIM (Western Pacific) | ID: wpr-633390

ABSTRACT

BACKGROUND: Despite the availability of clinical guidelines for stroke, variation exists in the management patterns of stroke among neurologists.OBJECTIVE: To determine the current practice patterns of Filipino adult neurologists in stroke and their adherence to the current clinical guidelines of the Stroke Society of the Philippines (SSP).METHODS: Cross-sectional survey using a 3-page, 17-item questionnaire reviewed by the Stroke Council of the Philippine Neurological Association (PNA).RESULTS AND OBSERVATIONS: From November 2013 to July 2014, 136 of 277 (49%) locally practicing board certified adult neurologists of the PNA were surveyed. Some important findings from the survey include: (1) 70% of respondents underestimated the benefit of warfarin in stroke prevention in nonvalvular atrial fibrillation (NVAF); (2) for acute ischemic stroke, although the recommended systolic blood pressure (SBP) threshold is >220 mm Hg, 43% would initiate antihypertensive therapy at SBP >180 mm Hg; (3) for acute primary intracerebral hemorrhage (ICH), 42% would start antihypertensives at SBP >140 mm Hg; (4) despite the absence of guidelines recommending the use of neuroprotectant drugs for acute stroke, 75% and 56% of neurologists have prescribed it to >80% of their patients with infarcts and ICH respectively; (5) 46% of neurologists have not experienced giving thrombolytic therapy to any of their patients with acute ischemic stroke; (6) among patients with clinically stable hemorrhagic strokes, 77% of neurologists would give antithrombotics, while 28% of them would start it 30 days after the onset of stroke; (7) only 21% of respondents have ordered carotid studies as part of their work up in >80% of their patients with ischemic strokes; and (8) 64% of respondents have requested carotid revascularization procedures for patients with significant carotid stenosis, and about 38% of these patients underwent the procedure.CONCLUSION: The management patterns in stroke remain varied among Filipino neurologists, although the patterns show increasing adherence toward guideline recommendations. The following practices are noted: underestimation of the benefits of oral anticoagulation for stroke prevention among patients with NVAF; use of pharmacologic control of blood pressure below the recommended threshold for acute ischemic stroke; widespread use of neuroprotectant drugs despite lack of definite evidence for its use; low utilization of carotid studies in the work-up of patients with ischemic stroke and the low rate of revascularization procedures in confirmed cases of carotid stenosis; and a relative increase in experience with thrombolysis.


Subject(s)
Humans , Male , Female , Adult , Carotid Stenosis , Atrial Fibrillation , Antihypertensive Agents , Neuroprotective Agents , Neurologists , Stroke , Cerebral Hemorrhage , Thrombolytic Therapy , Blood Pressure Determination
3.
Front Neurol ; 7: 96, 2016.
Article in English | MEDLINE | ID: mdl-27445963

ABSTRACT

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.

4.
Article in English | WPRIM (Western Pacific) | ID: wpr-633342

ABSTRACT

BACKGROUND: This paper synthesizes two unique cases of an adult Filipino patient presenting with involuntary unilateral extremity movements which upon further workup revealed cerebral toxoplasmosis as their primary etiology, further revealing their immunocompromised states. To our best knowledge there is limited available data on cerebral toxoplasmosis in our local setting. RATIONALE AND OBJECTIVES: The Filipino population is not spared from the pervasive global upsurge of AIDS cases as well as HIV-related infections. The aim of this report is to document the clinical features and diagnostics of two patients with cerebral toxoplasmosis presenting with unilateral involuntary extremity movements to heighten the level of awareness of Filipino physicians on the need to further explore possible etiologies of common neurological signs and symptoms as well as document additional cases of HIV-related infection in our country. CASE DESCRIPTION: The first case is a 30 year old male with no comorbidities who presented with fever and sudden onset of choreoathetoid movements of the left extremities. MRI revealed a rim enhancing nodule in the left supraorbital frontal lobe and in the middle cerebral peduncle. The second case is a 40 year old male, known hypertensive, initially diagnosed to have pulmonary tuberculosis, who presented with sudden onset of focal left arm myoclonic jerks. MRI revealed a rim enhancing cortical nodule on the right precentral gyrus. Both lesions were consistent with characteristics of toxoplasmosis. Both patients also showed positive serological titers for toxoplasmosis and had low CD4 T-cell count on flow cytometry. Both patients were treated with high dose trimethoprim-sulfamethoxazole and were further worked up for HIV-related infections. CONCLUSION: Majority of Filipino patients are still not provided with the opportunity to be diagnosed and treated for HIV-related infections, with one reason being the low index of suspicion for such cases. There is still limited amount of data available locally regarding patients presenting with Cerebral Toxoplasmosis, and that common neurological signs and symptoms as presented in this report should provide the much needed enlightenment in a physician's clinical eye to entertain such etiologies.


Subject(s)
Humans , Male , Adult , Acquired Immunodeficiency Syndrome , CD4-Positive T-Lymphocytes , Cerebral Peduncle , HIV Infections , Myoclonus , Toxoplasmosis, Cerebral , Trimethoprim, Sulfamethoxazole Drug Combination , Tuberculosis, Pulmonary , Chorea
5.
Article in English | WPRIM (Western Pacific) | ID: wpr-633087

ABSTRACT

Sulodexide was evaluated in an investigator-initiated, multi-center, randomized, controlled, open-labeled study to determine its safety and tolerability profile, and effect on the neurological recovery and functional outcome of patients with acute ischemic stroke. Sixty-five (65) patients were randomized to Standard care group and 46 to Standard care plus Sulodexide Treatment group. Sulodexide was observed to be safe and well-tolerated among patients included in this study. Although not statistically significant, Modified Rankin Scale Responder Analysis consistently showed higher proportions of functionally improved patients in the Sulodexide group than in the Standard Care group on treatment days 10, 30, and 90 respectively.


Subject(s)
Humans , Male , Female , Aged , Middle Aged , Adult , Research Personnel , Stroke , Glycosaminoglycans
6.
Cochrane Database Syst Rev ; (3): CD004573, 2008 Jul 16.
Article in English | MEDLINE | ID: mdl-18646107

ABSTRACT

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.


Subject(s)
Peripheral Nervous System Diseases/drug therapy , Vitamin B Complex/therapeutic use , Humans , Randomized Controlled Trials as Topic
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