With a pooled prevalence of 3.4%, the burden of disease among the elderly due to severe AS is substantial. Under the current indications, approximately 290,000 elderly patients with severe AS are TAVR candidates. Nearly 27,000 patients become eligible for TAVR annually.
The aim of this review was to provide strong clinical evidence of the efficacy of deep brain stimulation (DBS) of the globus pallidus internus (GPi) in isolated inherited or idiopathic dystonia. Eligible studies were identified after a systematic literature review of the effects of bilateral GPi‐DBS in isolated dystonia. Absolute and percentage changes from baseline in the Burke–Fahn–Marsden Dystonia Rating Scale (BFMDRS) motor and disability scores were pooled, and associations between treatment effect and patient characteristics were explored using meta‐regression. In total, 24 studies were included in the meta‐analysis, comprising 523 patients. The mean absolute and percentage improvements in BFMDRS motor score at the last follow‐up (mean 32.5 months; 24 studies) were 26.6 points [95% confidence interval (CI), 22.4–30.8] and 65.2% (95% CI, 59.6–70.7), respectively. The corresponding changes in disability score at the last follow‐up (mean 32.9 months; 14 studies) were 6.4 points (95% CI, 5.0–7.8) and 58.6% (95% CI, 50.3–66.9). Multivariate meta‐regression of absolute scores indicated that higher BFMDRS motor and disability scores before surgery, together with younger age at time of surgery, were the main factors associated with significantly better DBS outcomes at the latest follow‐up. Reporting of safety data was frequently inconsistent and could not be included in the meta‐analysis. In conclusion, patients with isolated inherited or idiopathic dystonia significantly improved after GPi‐DBS. Better outcomes were associated with greater dystonia severity at baseline. These findings should be taken into consideration for improving patient selection for DBS.
Aims: A systematic review of the literature, in combination with a meta-analysis of randomized controlled trials comparing treatments with placebo, was conducted to provide an update on the clinical efficacy and safety of incretin-based medications in adult patients with type 2 diabetes. Methods: A literature search (2000–2009) identified 38 placebo-controlled trials (phase II or later – parallel design) comparing exenatide (n = 8), liraglutide (n = 7), vildagliptin (n = 11) and sitagliptin (n = 12) with placebo. Outcomes were change from baseline in HbA1c and in weight, and the number of patient-reported hypoglycemic episodes. HbA1c and weight outcomes were analyzed as weighted mean differences (WMD), and the number of hypoglycemic episodes as relative risks (RR). Results: Patients receiving liraglutide showed greater reduction in HbA1c in comparison to placebo (WMD = –1.03, 95% confidence interval, CI = –1.16 to –0.90, p < 0.001) than those on sitagliptin (WMD = –0.79, 95% CI = –0.93 to –0.65, p < 0.001), exenatide (WMD = –0.75, 95% CI = –0.83 to –0.67, p < 0.001) or vildagliptin (WMD = –0.67, 95% CI = –0.83 to –0.52, p < 0.001). Weight was statistically significantly negatively associated with exenatide (WMD = –1.10, 95% CI = –1.32 to –0.87, p < 0.001) and positively associated with sitagliptin (WMD = 0.60, 95% CI = 0.33–0.87, p < 0.001) and vildagliptin (WMD = 0.56, 95% CI = 0.27–0.84, p < 0.001). The number of patient-reported hypoglycemic episodes was statistically significantly associated with the use of sitagliptin (RR = 2.56, 95% CI = 1.23–5.33, p = 0.01) and exenatide (RR = 2.40, 95% CI = 1.30–4.11, p = 0.002). Conclusion: Incretin-based therapies are effective in glycemic control and also offer other advantages such as weight loss (exenatide and liraglutide). This may have an important impact on patient adherence to medication.
SummaryBackground Biologic therapy has become established as an important treatment option in patients with severe psoriasis, but is significantly more expensive in terms of drug costs than traditional treatment options. Relatively little is known about the total healthcare cost of treating severe psoriasis in daily clinical practice and what the budgetary impacts of such high-cost drugs are when compared with standard systemic therapy. Objectives To describe the impact of biologic therapy introduction on the use of medical resources, costs and where available, outcomes in patients with moderate to severe psoriasis. Methods Data were extracted from case notes of a sequential patient cohort with psoriasis attending a tertiary referral severe psoriasis service and initiated on biologics (adalimumab, efalizumab, etanercept or infliximab) for treatment of their psoriasis. Data on hospital resource use (inpatient, outpatient, day ward, accident and emergency visits and phototherapy sessions) and drug usage (systemic nonbiologic and biologic psoriasis therapies and supportive drugs) were collected for 12 months prior to, and at least 6 months following initiation of biologic therapy. Outcome was measured using the Psoriasis Area and Severity Index (PASI). Differences in resource use and associated costs and outcomes, between 12 months before and after initiation of biologic therapy, were tested using Wilcoxon paired sign tests for continuous data and the McNemar test for categorical data. Confidence intervals (CI) around treatment costs were constructed using a 5000-sample bootstrap analysis. Results The primary analysis population comprised 76 patients completing 12 months of biologic therapy: 71% males; mean age at time of study 47AE3 years (range 23-74); mean duration of psoriasis 24AE7 years (range 5AE3-45AE5). Significant reductions (P < 0AE05) in the year following initiation of biologic therapy were observed for all hospital resource use categories, with mean annual costs reduced by £1682 (95% CI )3182 to )182AE2; P = 0AE05). Mean annual drug costs increased by £9456 (95% CI 8732-10 182; P < 0AE001). Mean PASI fell by 8AE9 points from 18AE7 to 9AE8 (95% CI )10AE8 to )7AE1; P < 0AE001). Conclusions Total healthcare costs associated with treatment of severe psoriasis with biologic therapy are significantly greater than with traditional systemic therapy. However, some of these are offset by substantial reductions in the number and length of hospital admissions and use of photo-and systemic therapy, and result in significantly improved patient outcome (as inferred by improvement in PASI).
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