An Italian survey of opioids misuse: Epidemiological and psychopathological aspects

© 2021 Published by Elsevier Ltd on behalf of International Society for the Study of Emerging Drugs. This is an open access article under the CC BY-NC-ND license, http://creativecommons.org/licenses/by-nc-nd/4.0/Objective Opioid abuse is a worrying reality especially in the US. The increase in the prescription of opioids in Europe poses the risk of a possible increase in the number of abusers also in Italy. The aim of the study is to evaluate the abuse of opioids in the youth population and to evaluate possible correlations with some psychopathological aspects. Methods A survey, conducted from July 2019 to March 2020, about the use of opioids was spread to a group of subjects aged between 18 and 40 years. A socio-demographical investigation and psychometric scales evaluating internet game addiction, gaming online, quality of life and general psychometric features were administrated. Results Nine-hundred and thirteen subjects completed the survey. Seventeen-five subjects (8.21%) have used one opioid at least once in their lifetime. Weak correlations were found between codeine and morphine intensity of use and sleep disturbance, cigarette smoked per day, while codeine correlates with the number of coffees taken per day and somatization. Conclusion Although the data of this survey do not show high percentages of use in Italy (8.21% of the sample have used one of the listed opioids at least once in their lifetime), the correlations founded confirm the literature data already present highlighting the need for constant monitoring of this phenomenon.Peer reviewedFinal Published versio

Impaired increase of plasma abscisic acid in response to oral glucose load in type 2 diabetes and in gestational diabetes

The plant hormone abscisic acid (ABA) is present and active in humans, regulating glucose homeostasis. In normal glucose tolerant (NGT) human subjects, plasma ABA (ABAp) increases 5-fold after an oral glucose load. The aim of this study was to assess the effect of an oral glucose load on ABAp in type 2 diabetes (T2D) subjects. We chose two sub-groups of patients who underwent an oral glucose load for diagnostic purposes: i) 9 treatment-naive T2D subjects, and ii) 9 pregnant women with gestational diabetes (GDM), who underwent the glucose load before and 8-12 weeks after childbirth. Each group was compared with matched NGT controls. The increase of ABAp in response to glucose was found to be abrogated in T2D patients compared to NGT controls. A similar result was observed in the women with GDM compared to pregnant NGT controls; 8-12 weeks after childbirth, however, fasting ABAp and ABAp response to glucose were restored to normal in the GDM subjects, along with glucose tolerance. We also retrospectively compared fasting ABAp before and after bilio-pancreatic diversion (BPD) in obese, but not diabetic subjects, and in obese T2D patients, in which BPD resulted in the resolution of diabetes. Compared to pre-BPD values, basal ABAp significantly increased 1 month after BPD in T2D as well as in NGT subjects, in parallel with a reduction of fasting plasma glucose. These results indicate an impaired hyperglycemia-induced ABAp increase in T2D and in GDM and suggest a beneficial effect of elevated ABAp on glycemic control

ABAp increases after an oral glucose load in healthy subjects, but not in T2D patients.

<p>After overnight fasting, a pre-test blood sample was taken from 7 healthy subjects and from 9 T2D patients, all of whom subsequently underwent a standard OGTT. The values of plasma ABA (A), glucose (B) and insulin (C) shown are the mean ± SD from the healthy controls (black rhombi) and from the T2D subjects (grey squares). * p<0.05 relative to time zero values.</p

Pre-partum impairment and post-partum restoration of the ABAp increase after oral glucose load in GDM subjects.

<p>The values of plasma ABA (A), glucose (B) and insulin (C) shown are the mean ± SD from seven NGT (black rhombi) and from nine GDM subjects (grey squares), who underwent a standard OGTT at the 24^th-28^th week (pre-partum) and again 2–3 months after childbirth (post-partum). Post-partum restoration of the ABAp increase during OGTT in the GDM subjects was accompanied by restoration of a normal glycemic profile. * p<0.05 compared to time zero values; ^§ p<0.05 compared to NGT.</p

Fasting ABAp in NGT subjects and T2D patients.

<p>Fasting ABAp was determined by HPLC-MS in 21 male T2D patients (squares) and in 27 sex-, age- and BMI-matched NGT subjects (rhombi). Results are ordered by increasing value. The circled areas indicate the possible existence of two sub-groups within the T2D patients, one with higher-than-normal ABAp levels and one with ABAp values similar to those of the NGT group. Inset: a box-and-whisker plot drawn from the same data sets. * p = 0.013</p

Higher fasting ABAp in T2D patients compared to NGT controls.

<p>Higher fasting ABAp in T2D patients compared to NGT controls.</p

Diminished increase of ABAp after oral glucose load in GDM and reversal to normal after childbirth.

<p>Diminished increase of ABAp after oral glucose load in GDM and reversal to normal after childbirth.</p

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trialResearch in context

Summary: Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the “2016 Call for Independent Drug Research”