Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension

Vocal Fold Bridge: A Complication of a Sulcus Cyst Surgery

Vocal fold bridges are rare pathologies and mostly coincidentally discovered in direct laryngoscopy. Although the pathophysiology of formation is not well established, it is attributed as a primary pathology that accompanies sulcus and related vocal fold disorders. This paper presents a vocal fold bridge formation in a professional singer after surgical removal of a sulcus cyst formed as a sequela with typical histologic findings resembling the primary bridges. This case report addresses a very rare unpublished complication of a phonomicrosurgical procedure and implicates the evidence of trauma in the etiology

Comparison of Cost-Effectiveness, Safety, and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Dyslipidemic Diabetic Patients With or Without Metabolic Syndrome

Aim: The aim of the current study was to determine the efficacy of the 4 most commonly prescribed statins (rosuvastatin, atorvastatin, pravastatin, and simvastatin) for managing dyslipidemia among diabetic patients with and without metabolic syndrome (MetS). Material and Methods: This was a cohort observational population-based study conducted at Hamad Medical Hospital and Primary Health Care Centre. The participants were 1542 consecutive diabetes patients who were diagnosed with dyslipidemia and were prescribed any of the indicated statins. Sociodemographic and clinical characteristics were taken from medical records, and lipid profile at baseline and 2 years after the initiation of statin therapy were retrieved from electronic medical records database (EMR-viewer). Reduction in different lipid profile after 2 years of therapy was compared among different types of statins between patients with and without MetS. Results: Out of total 1542 subjects, 562(36.4%) were diagnosed with MetS using the criteria of International Diabetes Federation. Among those with MetS, 125 were prescribed with atorvastatin, 162 pravastatin, 177 rosuvastatin, and 98 simvastatin. Among those without MetS, 365 used atorvastatin, 172 pravastatin, 345 rosuvastatin, and 98 simvastatin therapies. Among patients with MetS, rosuvastatin therapy resulted in significantly higher low-density lipoprotein cholesterol and total cholesterol reduction (23%, P = .006; and 20.3%, P = .015, respectively) as compared with other statins. Similarly, significantly higher percentage of patients receiving rosuvastatin therapy were successful in achieving the target of total cholesterol <4 mmol/L and triglycerides <1.7 mmol/L after 2 years (38.4%, P = .012; and 67.2%, P = .010, respectively) as compared with other therapies. In contrast, among patients without MetS, rosuvastatin therapy resulted in highest percentage drop in total cholesterol (20.1%; P = .016) than other statin therapies. Conclusion: The present study confirmed that rosuvastatin therapy in commonly prescribed doses is the most effective statin for low-density lipoprotein cholesterol goal achievement and for improving the lipid profile in hypercholesterolemic diabetic patients with and without MetS

Occult papillary thyroid carcinoma: prevalence at autopsy in Turkish people

The epidemiological features of occult papillary thyroid carcinoma (OPTC) at autopsy have not previously been reported in Turkish people. This study provides data on the prevalence of OPTC in people from the Marmara region in Turkey. The study includes thyroid glands from 93 male and 15 female cadavers between 18 and 80 years of age. The thyroid glands were removed, fixed and sectioned at 2-mm intervals. The sections were stained with hematoxylin and eosin, and were examined by a single pathologist. A total of 108 thyroid glands were examined. Macroscopic lesions were found in 36 (33.3%) glands (95% confidence interval = 24-42). OPTC was found in four (3.7%) cases (95% confidence interval = 1.0-7.5). It was concluded that in the Turkish people from the Marmara region, the prevalence of OPTC found at autopsy was relatively low. No age or sex predilection was detected. European Journal of Cancer Prevention 20:308-312 (C) 2011 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins