Real-life experiences with galcanezumab and predictors for treatment response in Turkey

Abstract Background The complexity of clinical practice extends far beyond the controlled settings of trials, and there is a need for real-world studies aimed at identifying which patients will respond to anti-CGRP monoclonal antibodies in different countries. This study aimed to investigate the efficacy and safety of galcanezumab in treating migraine in a real-life setting in Turkey, as well as identify predictors of treatment response. Methods A total of 476 patients who diagnosed with migraine according to ICHD-3 criteria and treated with galcanezumab by headache specialists were voluntarily participated in this cross-sectional study. Galcanezumab is indicated for the prevention of migraine in adults who have at least 4 monthly migraine days in Turkey. All patients filled out a survey on Google Form that comprised 54 questions, addressing various aspects such as demographics, migraine characteristics, previous use of acute symptomatic medication, failures with preventive drug classes, comorbidities, most bothersome symptoms, as well as the interictal burden of migraine. Results Among the participants, 89.3% reported that galcanezumab treatment was beneficial for them. A decrease in the frequency (80.0%), severity (85.7%), and acute medication usage for migraine attacks (71.4%) was reported with galcanezumab treatment. An adverse effect related to galcanezumab was reported in 16.3% of cases, but no serious adverse reactions were observed. Remarkably, 14.3% of participants reported no longer experiencing any headaches, and 18.9% did not require any acute treatment while receiving galcanezumab treatment. A logistic regression model showed that male gender, lack of ictal nausea, and previous failure of more than 2 prophylactic agents may predict the non-responders. Conclusions The first large series from Turkey showed that galcanezumab treatment is safe and effective in most of the patients diagnosed with migraine by headache experts in the real-life setting. Patients reported a significant decrease in both ictal and interictal burden of migraine and expressed satisfaction with this treatment

Gastrostomy in hospitalized patients with acute stroke: "NoroTek" Turkey point prevalence study subgroup analysis

Objective: Nutritional status assessment, dysphagia evaluation and enteral feeding decision are important determinants of prognosis in acute neurovascular diseases. Materials and Methods: NöroTek is a point prevalence study conducted with the participation of 87 hospitals spread across all health sub regions of Turkey conducted on 10-May-2018 (World Stroke Awareness Day). A total of 972 hospitalized neurovascular patients [female: 53%, age: 69±14; acute ischemic stroke in 845; intracerebral hematoma (ICH) in 119 and post-resuscitation encephalopathy (PRE) in 8] with complete data were included in this sub-study. Results: Gastrostomy was inserted in 10.7% of the patients with ischemic stroke, 10.1% of the patients with ICH and in 50% of the patients with PRE. Independent predictors of percutaneous endoscopic gastrostomy (PEG) administration were The National Institutes of Health Stroke Scale score at admission [exp (β): 1.09 95% confidence interval (CI): 1.05-1.14, per point] in ischemic stroke; and mechanical ventilation in ischemic [exp (β): 6.18 (95% CI: 3.16-12.09)] and hemorrhagic strokes [exp (β): 26.48 (95% CI: 1.36-515.8)]. PEG was found to be a significant negative indicator of favorable (modified Rankin’s scale score 0-2) functional outcome [exp (β): 0.032 (95% CI: 0.004-0.251)] but not of in-hospital mortality [exp (β): 1.731 (95% CI: 0.785-3.829)]. Nutritional and swallowing assessments were performed in approximately two-thirds of patients. Of the nutritional assessments 69% and 76% of dysphagia assessments were completed within the first 2 days. Tube feeding was performed in 39% of the patients. In 83.5% of them, tube was inserted in the first 2 days; 28% of the patients with feeding tube had PEG later. Conclusion: The NöroTek study provided the first reliable and large-scale data on key quality metrics of nutrition practice in acute stroke in Turkey. In terms of being economical and accurate it makes sense to use the point prevalence method.Amaç: Akut nörovasküler hastalıklarda nütrisyonel durum ve disfaji değerlendirmesi ve enteral beslenme kararı önemli prognoz belirleyicilerindendir. Gereç ve Yöntem: NöroTek, 10 Mayıs 2018’de (Dünya İnme Farkındalık Günü) Türkiye’nin tüm sağlık alt bölgelerine yayılmış 87 hastanenin katılımıyla gerçekleştirilen bir nokta prevalans çalışmasıdır. Hastanede yatan ve bu alt çalışma için toplanan verisi tam olan toplam 972 nörovasküler hasta (kadın: %53, yaş: 69±14 yıl; 845’i akut iskemik inme; 119’u intraserebral hematom ve 8’i post-resüsitasyon ensefalopatisi) analiz edildi. Bulgular: Gastrostomi iskemik inmeli hastaların %10,7, intraserebral kanamalıların %10,1 ve post-resusitasyon ensefalopatisi olanların %50’sine uygulanmıştır. Perkütan endoskopik gastrostomi (PEG) gereksiniminin bağımsız belirleyicileri, iskemik inme grubunda kabul NIHSS [exp (β): 1,09, %95 güven aralığı (GA): 1,05-1,14, puan başına] ile hem iskemik hem de hemorajik inmelerde mekanik ventilasyon uygulanmış olmasıdır [iskemik için: exp (β): 6,18, %95 GA: 3,16- 12,09] ve hemorajik inme için: [exp (β): 26,48, 95% GA: 1,36-515,8]. İnme olgularında PEG uygulaması hastane içi mortalite için bağımsız belirleyici değildi [exp (β): 1,731, 95% GA: 0,785-3,829]. Ancak, PEG uygulanmış olması taburculuk esnasında iyi prognoza (modifiye Rankin skoru 0-2) sahip olabilme için anlamlı bir negatif etmen olarak bulundu [exp (β): 0,032, %95 GA: 0,004-0,251]. Hastanede yatan nörovasküler hastaların yaklaşık üçte ikisinde malnütrisyon ve yutma bozukluğu açısından değerlendirme yapılmıştı. Nutrisyonel status değerlendirmesinin %69’u ve disfaji değerlendirmesinin %76’sı ilk 48 saat içinde gerçekleştirilmişti. Tüple enteral nütrisyon uygulama oranı %39’du. Beslenme tüplerinin %83,5’i ilk 2 gün içinde yerleştirilirken beslenme tüpü olan hastaların %28’ine daha sonra PEG açılmıştı. Sonuç: NöroTek çalışması ile Türkiye’de hastanede yatan akut inme hastalarında nutrisyonel uygulamaların temel kalite ölçütlerine ilişkin ilk güvenilir ve büyük ölçekli veri sağlanmıştır. Ekonomik olması ve doğruluğu açısından nokta yaygınlık yönteminin bu tip verilerin temini için daha fazla kullanılması mantıklıdır