Risultati per: Analisi sull’uso dei farmaci anti-osteoporotici in sette database europei

De Fiore contro declino di rigore e di incorruttibilità

This nonrandomized clinical trial examines whether matched-targeted therapy based on tumor mutation status with a PD-L1 inhibitor is associated with improved overall survival among patients with anaplastic thyroid carcinoma.

Objective
This study aimed to pool the prevalence of virological failure and associated factors.

Design
Systematic review and meta-analysis.

Primary outcome measure
Prevalence of virological failure.

Secondary outcome measure
Factors affecting virological failure.

Analysis
The extracted data were exported to STATA V.17 for statistical analysis. A random-effects DerSimonian-Laird model was used to compute the pooled prevalence of virological failure.

Setting
Ethiopia.

Participants
Patients receiving anti-retroviral therapy.

Results
A total of 51 primary studies with a sample size of 38, 789 participants were included in the final meta-analysis. The pooled prevalence of virological failure among patients receiving anti-retroviral therapy (ART) in Ethiopia was 15.95% (95% CI: 12.63, 19.27; I2=97.99%; p

Tre orfani, 7 nuovi e 6 estensioni delle indicazioni terapeutiche

In 7 anni spesa per medicinali aumentata di 2,5 miliardi

Introduction
Anti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk for harmful drug-drug interactions (DDI). In this trial, we aim to assess the efficacy of the combination doravirine, dolutegravir and lamivudine (DOR/DTG/3TC) among people with a history of virological failure who receive boosted ART.

Methods and analysis
B-Free is a multistage, randomised, multicentre, open-label, non-inferiority trial, embedded within the Swiss HIV Cohort Study and conducted in collaboration with cohorts of PWH in the Netherlands and France. Cohort participants with a history of ART change due to virologic failure and who maintain HIV virologic suppression with an ART regimen consisting of a pharmacological booster and at least two drugs from classes other than nucleoside reverse transcriptase inhibitors are included. Patients with major drug resistance mutations against DTG or DOR and individuals with chronic hepatitis B virus infection are not eligible for the study. Individuals are randomised 1:1 to either receiving co-formulated DTG/3TC and DOR once daily or continuing their boosted ART regimen. The primary outcome is the proportion of individuals lacking virologic control (HIV-RNA ≥50 cp/mL) at 48 weeks, according to the Food and Drug Administration snapshot algorithm. Changes in DDI burden (assessed using a DDI score), treatment satisfaction (assessed using the HIV Treatment Satisfaction Questionnaire), quality of life and mental health represent key secondary outcomes. Additional secondary outcomes include the proportion of individuals developing new resistance-associated mutations and changes in quality of life and mental health. In a qualitative substudy, we will conduct semistructured interviews with a subset of participants to assess their expectations and experiences towards HIV treatment and clinical research in general. Enrolling 210 individuals will provide 80% power to demonstrate non-inferiority, defined as less than 8% absolute increase in loss of viral suppression in individuals randomised to DOR/DTG/3TC (one-sided type I error rate of 0.025).

Ethics and dissemination
The study was approved by the competent ethics committees (reference number BASEC 2023–01060) and the regulatory authority Swissmedic (reference number 701655) in Switzerland before the enrolment of the first participant. Approval by the European Medicines Agency and local ethical committees in the Netherlands and France will be obtained prior to including participants in these countries. Participant’s written informed consent is obtained by the investigators before enrolment. The results of all major B-Free study outcomes will be submitted to peer-reviewed journals that enable Open Access publication.

Trial registration number
Swiss National Clinical Trials Portal (SNCTP000005686, registered on 06 November 2023) and Clinicaltrials.gov (NCT06037564, registered on 07 September 2023).

Objective
To estimate the herd effects of anti-microbial-based decontamination (ABD) interventions on bloodstream infections (BSIs) among groups of intensive care unit (ICU) patients in relation to group mean length of stay (LOS). To deduce which of three competing hypotheses of ABD effect mediation best accounts for the observed effects.

Design
Arms-based meta-regression of ICU-acquired BSI incidence against group mean LOS for control and interventions arms of ABD and non-ABD controlled trials each versus that in arms of observational studies.

Exposures
Within controlled trials of ABD, intervention, concurrent control (CC) and non-concurrent (NCC) groups are directly, indirectly and non-exposed, respectively.

Main outcomes and measures
BSI incidence, both overall and for BSI subtypes.

Results
In the arms-based meta-regression, the predicted BSI incidence per 100 patients in the ABD intervention arms increased from 4.6 (95% CI 3.8 to 5.5) at mean LOS 7 days to 13.0 (10.4–16.0) at mean LOS 20 days (n=60 arms) and CC arms 8.5 (6.7–11.0) increasing to 19.3 (14.8–24.8; n=52). These increases were double those in the observational (7.2; 6.1–8.5 increasing to 12.9; 10.4–16.7; n=99) and NCC arms and non-ABD arms. These results triangulate with the notional effect size observed in contrast-based meta-analyses.

Conclusions
The increased tempo of BSI acquisition, both overall and for various BSI subtypes, within intervention and CC groups of ABD randomised concurrent controlled trials versus other groups implicate rebound and spillover, respectively. Mechanisms other than colonisation resistance mediate ABD effects.

Objectives
To investigate the prevalence, associated factors, treatment status and burden of constipation in workers with depression or anxiety.

Study design
This was a retrospective observational study using a pre-existing database.

Setting
Claims data from October to November 2022 and data from the survey conducted in November 2022 were extracted from the database.

Participants
This study included self-reported workers who completed the survey, after excluding those with major mental disorders diagnosed as distinct from depression or anxiety and constipation due to organic diseases identified by International Classification of Diseases (ICD-10) codes.

Outcome measures
The subjects were divided into three groups: treated depression/anxiety, untreated depression/anxiety and no depression/anxiety. The prevalence of constipation, factors associated with constipation and medications prescribed for constipation were analysed. Work productivity and quality of life (QOL) were compared between three subgroups based on constipation status: treated constipation, untreated constipation and no constipation subgroup.

Results
Of the 18 585 respondents in the analysis population, 950 respondents (5.1%) were classified into the treated depression/anxiety group, 6035 respondents (32.5%) into the untreated depression/anxiety group and the remaining respondents into the no depression/anxiety group (11 600 (62.4%)). The prevalence of constipation was 22.5% in the treated group, 22.3% in the untreated group and 10.4% in the no depression/anxiety group, respectively. Depression and anxiety severity were independently associated with an increased risk of constipation. In all groups, the most commonly prescribed drug class was osmotic laxatives. Work productivity and QOL tended to indicate a greater burden in the untreated constipation subgroup than in the treated or no constipation subgroups.

Conclusions
The prevalence of constipation was twice as high if workers had depression/anxiety. Considering that the comorbidity of constipation with mental disorders may increase multiple burdens, appropriate medical interventions are required to treat both mental (depression/anxiety) and physical (constipation) conditions. This should be widely recognised by physicians and employers.

Schillaci: La resistenza è un’emergenza globale. No al fai da te’