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Background: EMPOwER, a 12-week, double-blind (DB), randomized, placebo-controlled study evaluated the efficacy and safety of erenumab in adult patients with episodic migraine (EM) from Asia, the Middle East, and Latin America. This study analyzes the Indian experience for the use of erunumab for prevention of episodic migraine. Objective: The study aimed to evaluate the efficacy and tolerability of erenumab (70 mg and 140 mg) in EM patients from India. Methods: Randomized patients received monthly subcutaneous injections of placebo and erenumab 70 mg or 140 mg for 3 months. The primary endpoint was a change from the baseline in monthly migraine days (MMDs) at month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in MMD; a change in monthly acute migraine-specific medication treatment days; a change in patient-reported outcomes; and safety assessment. Results: Of the 539 patients screened, 351 patients were randomized (erenumab, 70 mg: n = 133 and 140 mg: n = 94; placebo: n = 124). The mean (±SD) age, disease duration, and MMD were 35.1 (±8.6) years, 6.77 (±6.01) years, and 7.82 (±2.89) days, respectively. The placebo-adjusted difference in mean MMD for erenumab 70 mg was -0.88 (95% CI, -2.16, 0.39; P = 0.174) days, and that for erenumab 140 mg was -1.01 (-2.42, 0.41; P = 0.164) days versus placebo. Secondary and exploratory endpoints demonstrated consistently better results in both erenumab dosage groups versus placebo. Treatment-emergent adverse events were comparable across groups (erenumab, 70 mg: 22.7% and 140 mg: 24.5%; placebo: 25.2%). Conclusion: Both doses of erenumab showed numerical improvement for efficacy endpoints and were well-tolerated in the Indian population. No new safety signals were reported.
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BACKGROUND: Recent evidence points to a possible link between the inflammatory modulatory protein S100B protein and the pathogenesis of Alzheimer's disease (AD). OBJECTIVE: To investigate the elevated levels of serum S100B protein among AD in a South Indian cohort and its correlation with severity of cognitive impairment. METHODS: A cross-sectional study was conducted with 100 AD patients and 100 age and sex matched healthy controls. Diagnosis of AD was made by a qualified neurologist using NINCDS ADRDA criteria. Measurement of serum S100B protein was performed using solid phase sandwich ELISA method in both cases and controls. RESULTS: Significantly higher prevalence of elevated serum S100B protein 44(44%) (p<0.0001), hypertension 52(52%) (p=0.02), diabetes mellitus 58(58%) (p=0.002), thyroid dysfunction 28(28%) (p=0.009), positive CRP 46(46%) (p<0.0001) and lower mean Mini-Mental State Examination (MMSE) values 20.4±5.1 (p<0.0001) were seen in AD patients compared to controls. Elevated S100B protein levels were significantly associated with Clinical dementia rating (CDR) score 2(34%) (p=0,05) and score 3 (61.3%) (p=0.03) compared to normal levels. After multivariable logistic regression analysis positive C-Reactive Protein (odds: 3.2; 95%CI: 2.8-9.8)(p=0.001), elevated S100B protein (odds: 9.0;95%CI:2.2-35.8) and diabetes mellitus (odd:1.2;95%CI:1.0-4.9)(p<0.0001), were significantly associated with AD. CONCLUSION: In our study, we established an independent association of elevated serum S100B protein levels with AD. Elevated S100B protein levels higher in CDR score 3.