The current systematic literature review found a few high quality switch studies assessing monotherapies in patients with MDD with inadequate response to SSRI/SNRIs. ITCs indicated that switching to vortioxetine leads to numerically higher remission rates compared with other antidepressants. Vortioxetine is a well tolerated treatment, showing statistically lower withdrawal rates due to AEs compared with other antidepressants. Vortioxetine is a relevant therapeutic alternative in patients experiencing inadequate response to prior SSRI or SNRI therapy.
This systematic literature review and network metaanalysis showed that 5-fluorouracil interventions were associated with the best efficacy and a satisfactory acceptability profile compared with other field-directed therapies used in the treatment of actinic keratoses. These findings may contribute to inform treatment choices. A systematic literature review was conducted to identify and qualitatively assess randomized controlled trials in immunocompetent patients ≥ 18 years with headregion lesions of actinic keratoses who were treated with field-directed, lesion-directed and other therapies. Network meta-analysis was used to quantitatively eval uate field-directed therapies (5-fluorouracil formulations, diclofenac sodium, imiquimod, ingenol mebutate, 5-aminolevulinic acid or methyl aminolevulinate plus photodynamic therapy) using complete clearance or partial clearance of actinic keratoses lesions, and adverse event-related withdrawals as a proxy of acceptability. Of 2,863 references identified, 75 trials reported in 151 publications were included. In summary, comparative network meta-analysis evaluation show ed that 5-fluorouracil formulations were the most efficacious interventions examined. 5-fluorouracil 4%, which was recently approved, showed a comparable efficacy profile to 5-fluorouracil 5%, and had satisfactory acceptability outcomes.
Background : Many trials in actinic keratoses (AK) use complete clearance rate (100% reduction in number of lesions) as the primary endpoint. We explore limitations (predominantly baseline factors) associated with this outcome. Objective : This analysis assessed the effect of baseline lesion count on complete clearance rate using randomized controlled trials (RCTs) that evaluated 5-fluorouracil (5-FU) formulations, alone or with 10% salicylic acid solution, in patients with AK. Methodology : Correlation between baseline lesion count and complete clearance rate at week 8 was assessed using Pearson’s coefficient. Results : Five RCTs assessing 5-FU (4%, 5%, or 0.5% in 10% salicylic acid solution) in 1,080 patients with AK were included. Mean lesion count at baseline ranged from 8.1 to 21.2 lesions per patient. Complete clearance rate was negatively associated with number of lesions at baseline. Correlation between mean number of lesions at baseline and complete clearance rate was strong (r 2 = 0.94) and statistically significant (p < 0.001). Conclusion : This analysis showed that, in a homogenous set of trials, complete clearance rates achieved with 5-FU interventions are inversely related to number of lesions at baseline. These findings highlight the limits of restricting treatment evaluation to complete clearance rate and the relevance of alternative measures.
Objectives: Estimating resource use [RU] in real life is an important part of health economic evaluations. RU data should reflect how patients are actually treated. In MDD, RU data are mostly obtained from expert opinion. Variability in RU may lead to uncertainty in health economic evaluations, but few published studies report these data in the detail needed. The present analysis reports RU data by depression health state from an observational study. MethOds: PERFORM (Prospective Epidemiological Research on Functioning Outcomes Related to Major depressive disorder) is a 2-year prospective observational study conducted in 5 Western-European countries. Two-and six-month RU were estimated by health state: remitters, non-remitters, patients in relapse or not. RU included visits to different health care professionals, hospitalization and sick leave. Results are reported for the whole study population and are also available by country (including the UK, for which EQ5-D-derived utilities are also available) and for subgroups (e. g., patients who switched antidepressants at baseline). Results: Of the 819 analysable patients at 2 months, 29% were in remission. Among patients with at least one visit, the frequency of visits to general practitioners, psychiatrists and psychotherapists was consistently lower for remitters versus non-remitters (1.8 vs. 2.4, 2.2 vs. 2.4 and 2.6 vs. 3.1 respectively). Fourteen patients had at least one hospitalisation. Sick leave was less frequent (14% vs. 27%) and shorter (34 vs. 41 days) for remitters versus non-remitters respectively. At 6 months, 19.3% of patients relapsed. RU were higher with more visits to psychiatrists, psychotherapists (4.0 vs. 2.7, 7.8 vs. 5.5) for relapsed versus non-relapsed patients. cOnclusiOns: This first analysis provides European RU data in MDD. More information is expected at completion of the two-year follow-up and this study offers the possibility to describe RU by health states, countries and subgroups and assess their transferability to other countries.
ObjectiveTo assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder.MethodsThe relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989–2002) and up to 5 years later (1989–2007). Ranking probability outputs were presented for efficacy, using change from baseline to 8 weeks on Montgomery–Åsberg Depression Rating Scale total score, and tolerability, using withdrawals due to adverse events.ResultsThe relative efficacy and tolerability of some selected antidepressants, including escitalopram, varied considerably over the two time periods. The improved relative efficacy and tolerability of escitalopram over time, compared with citalopram, was demonstrated by greater separation of ranking probability curves for efficacy and tolerability. In 2002, escitalopram ranked low with 13.9% and 5.1% probability of being in the top four antidepressants’ relative efficacy and tolerability, respectively. In 2007, ranking probabilities for relative efficacy and tolerability of escitalopram increased to 52.5% and 82.1%, respectively.ConclusionsTime of marketing authorization may not be the most appropriate time to evaluate the relative efficacy and tolerability of a new antidepressant based on MTC approach due to the asymmetry of information between new and older compounds. However, the first evaluation of relative effect of a new drug for health technology assessment recommendations is commonly done at this time. Re-evaluation of a drug several years after its launch is likely to provide a more accurate indication of its relative efficacy and tolerability.
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