Electronic cigarette use as an aid to quit smoking in the representative Italian population PASSI survey.

This study explored electronic cigarette (e-cigarette) use as an aid to quit smoking and compared abstinence rates for different quitting methods in a representative sample of the Italian population. In the 2014-2015 PASSI survey, the ongoing Italian behavioural risk factor surveillance system, 6112 adults who smoked and made at least one quit attempt in the previous 12months, were categorized into three groups according to the method used in their most recent quit attempt: e-cigarette only, no aid, other quitting methods (medications; programmes delivered in smoking cessation services; other unspecified methods). The primary outcome was self-reported abstinence for a period ≥6months, adjusted for potential confounders. Eleven percent used e-cigarettes only, 86% no aid, 3% other quitting methods. Smoking abstinence was reported among 9% of those using no aid; 8% of e-cigarette users; 15% of those using other methods. No significant differences in abstinence were observed for e-cigarette users compared with those reporting no aid (adjusted Prevalence Ratio [aPR]=0.81; 95%Confidence Interval (CI)=0.58-1.14). Changing the reference group to e-cigarette users, those using other quitting methods were significantly more likely to report abstinence than e-cigarette users (aPR=1.76; 95%CI=1.07-2.88). One out of ten smokers who attempted to quit in 2014-2015 in Italy used e-cigarettes. E-cigarettes users were as likely to report abstinence as those using no aid, but were less likely to report abstinence than users of established quitting methods. Further studies are needed to understand the relationship between e-cigarette types used to quit and abstinence rates.

Quit attempts and smoking cessation in Italian adults (25-64 years): factors associated with attempts and successes.

Background: Over the past 50 years there was a substantial decrease in the prevalence of smoking in Italy. The objective of this work is to describe attempts to quit and cessation success in Italian smokers. Methods: A surveillance on health-related behaviors (PASSI) was conducted in 2007-13 on a sample of 203 610 Italian adults 25-64 years of age. An analysis of smokers' characteristics and behaviors was performed, focusing on attempts to quit and quit success. Data from national surveys (ISTAT) from 1983 to 2013 (Italian adults, 25-64 years of age, 1983: 46 634; 1987: 40 915; 1990: 36 622; 2000: 77 531; 2005: 71 032; 2013: 64 205) were used to explore if a cessation trend in Italy exists. Results: Smokers who quit in the previous year and were still abstinent when interviewed increased from 1990 to 2013. In the years 2011-13, 38% of people who had smoked in the last 12 months reported at least a quit attempt during the same period and 7% were still abstinent when interviewed. An association of successful recent quit attempts with higher educational level, absence of economic difficulties and younger age was found. In the years 2007-13, the great majority tried to stop unaided. Having received assistance from a cessation program did not increase the probability of enduring abstinence. Conclusions: In Italy interventions to drive more smokers to quit should be focused in particular on disadvantaged groups. Initiatives have to be studied not only to incentive more smokers to try to quit, but also to maintain abstinence over time.

[Behavioural risk factors in L'Aquila (Central Italy) 3-5 years after the 2009 earthquake]. / Fattori di rischio comportamentali all'Aquila 3-5 anni dopo il terremoto del 2009.

OBJECTIVES: to evaluate the long-term impact on the health of the general population of L'Aquila earthquake that occurred on April 6th, 2009. DESIGN, SETTING AND PARTICIPANTS: three consecutive surveys were performed on samples of the population of 18-69 years resident in L'Aquila and in the other towns affected by the earthquake. Data on health-related quality of life, depressive disorders, behaviour risk factor, and adoption of preventive measures were collected through telephone interviews in 2007-2008, in 2010, and in 2011-2014. RESULTS: the prevalence of individuals who declared to have economic difficulties increased after 3-5 years from the earthquake (8% in 2010 vs. 14% in 2011-2014). Nevertheless, health-related quality of life improved (decrease of unhealthy days: 7 in 2010 vs. 5 in 2011-2014), while the prevalence of depressive symptoms decreased so that it reached the national average rates (16% in 2010 vs. 7% in 2011-2014). Lack of physical activity, a serious consequence of the first period after the earthquake, became less habitual (39% in 2010 vs. 27% in 2011-2014), probably due to an improvement in the urban redevelopment. The prevalence of smoking and harmful use of alcohol is high (34% and 21%), mostly among young adults. CONCLUSIONS: 3-5 years after the earthquake of L'Aquila, compared to 2010 the quality of life related to health is improved (except in people with at least one chronic disease), and the frequency of depressive symptoms decreased, a sign of an extended recovery from conditions caused by the earthquake, despite of an increasing economic difficulties. On the other hand, we must emphasize critical elements, such as the high prevalence of smoking and consumption of alcoholic beverages other than as part of the meals, especially among young people, and very frequent physical inactivity, particularly among the elderly, although lower than in 2010. Finally, adherence to preventive measures and screening for cancer, and adoption of road safety devices could be improved.

Cancer screening uptake: association with individual characteristics, geographic distribution, and time trends in Italy.

BACKGROUND: In Italy, organized screening programmes invite the vast majority of the population for cervical and breast cancer, and about one half of the population for colorectal cancer. Programme activity and quality are closely monitored. Nevertheless, there is a vast spontaneous activity, both public and private, for which information on service and coverage is missing. To estimate actual population coverage for the three types of screening the extent of spontaneous screening needs to be known. METHODS: PASSI is a national telephone-interview surveillance system that continuously collects information about behavioural health risk factors and the diffusion of preventive health interventions. From 2010 to 2013, more than 151,000 18- to 69-year-olds were interviewed. During 2013, 136 out of 147 Italian local health authorities participated in the survey. Information about screening includes: test uptake (Pap smear, HPV, mammography, faecal occult blood test, colonoscopy), date of the last test, provider of the last test (whether paid or for free, proxy of the organized screening programme), reason for not participating in screening, and screening promotion/recommendation received. Individual information on socio-economic characteristics is available. RESULTS: Seventy-seven percent of the 25-64 year-old women interviewed said they had undergone a Pap smear or HPV test in the three years before the interview, 40%within the screening programme, 37% spontaneously and paying. Seventy percent of the 50-69 year-old women interviewed reported having had a mammography in the two years before the interview, 51% within the screening programme, 19% spontaneously and paying. Thirty-eight percent of the 50-69 year olds interviewed reported having undergone colorectal screening in the two years before the interview, 31% within the screening programme, 7% spontaneously and paying. All three screening programmes showed a decreasing North-South trend in coverage. From 2010 to 2013, coverage increased for all types of screening; the trend was stronger in the South; the increase was mostly due to the tests performed within the organized programmes. People with low education, economic problems, and immigrants from high migration pressure countries had lower coverage levels. In regions with well-implemented organized screening programmes, test coverage was higher and differences for socio-economic factors were smaller than in regions with incomplete programme activation.

Impact of trazodone once-a-day on quality of life and functional recovery in adults with major depressive disorder: A prospective, observational study.

BACKGROUND: Health-related quality of life (HRQL) is an important goal for patients with major depressive disorder (MDD), but whether antidepressants improve HRQL in these patients is unclear. Here, we describe the real-world effects of trazodone once-a-day (TzOAD) and selective serotonin reuptake inhibitor (SSRI) treatments on HRQL and functioning in adults with MDD. METHODS: This 8-week prospective, observational, open-label, multicenter study was conducted in adults with moderate or severe MDD for whom TzOAD or SSRI were prescribed as monotherapy. The primary outcome was life enjoyment and satisfaction assessed via the patient-reported Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to week 8. Secondary outcomes included change in Q-LES-Q-SF from baseline to weeks 1 and 2; severity of depressive symptoms using the Montgomery Åsberg Depression Rating Scale (MADRS) and sleep disturbance via the PROMIS SF-SD 8b questionnaire at weeks 1, 2, and 8; and overall functioning via the Sheehan Disability Scale (SDS), hedonic capacity using the Snaith-Hamilton Pleasure Scale (SHAPS), and cognitive dysfunction using the Perceived Deficits Questionnaire (PDQ-5) at baseline and week 8. RESULTS: The study included 208 adults with MDD (mean [SD] age = 50.2 [14.3] years; 68.6% female; 98.4% White). Life enjoyment and satisfaction improved from baseline to week 8 for both treatment groups: Q-LES-Q-SF mean (SD) scores were 27.5 (20.4) for the SSRI group and 39.0 (22.1) for the TzOAD group. Depressive symptoms and sleep disturbances also reduced from baseline to week 8: MADRS (SSRI, -15.7 [8.3]; TzOAD, -21.0 [9.8]); PROMIS SF-SD 8b (SSRI, -9.9 [12.6]; TzOAD, -22.0 [12.6]). Mean change scores in Q-LES-Q-SF, MADRS, and PROMIS SF-SD 8b improved as early as week 1 in both groups. Mean scores also improved from baseline to week 8 on SDS (SSRI, -9.2 [7.4]; TzOAD, -14.3 [7.5]), SHAPS (SSRI, -6.6 [4.3]; TzOAD, -8.3 [4.4]), and PDQ-5 (SSRI, -5.8 [4.5]; TzOAD, -7.7 [5.0]). CONCLUSIONS: In adults with MDD who received TzOAD or SSRIs, overall and individual HQRL domains improved rapidly and in parallel with improvements in depressive symptoms, with a slightly greater improvement observed in the TzOAD group.

Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study.

INTRODUCTION: Up to 50% of diabetic patients with neuropathy suffer from chronic pain, namely painful diabetic neuropathy (PDN), an unmet medical need with significant impact on quality of life. Gabapentin is widely used for PDN, albeit with frequent dose-limiting effects. Trazodone, an antidepressant with multi-modal action, has shown promising results when given at low doses as an add-on to gabapentin. Upon previous clinical trials and experimental evidence, a fixed-dose combination (FDC) of both compounds, at low doses, was developed for neuropathic pain. METHODS: This was a phase II, randomized, double-blind, placebo and reference controlled, dose-finding, multicenter, international, prospective study. Male and female diabetic patients aged 18-75 years and affected by PDN were eligible for enrolment. Patients were randomized (1:1:1:1:2 ratio) to trazodone and gabapentin (Trazo/Gaba) 2.5/25 mg t.i.d. for 8 weeks, Trazo/Gaba 5/50 mg t.i.d. for 8 weeks, Trazo/Gaba 10/100 mg t.i.d. for 8 weeks, gabapentin (Gaba), or placebo (PLB). The aim of the study was to collect preliminary information on the effect of the 3 different FDCs of Trazo/Gaba on pain intensity based on the 11-point numeric rating score (NRS) after 8 weeks of treatment. The secondary objectives were the evaluation of the percentage of responders, neuropathic pain symptoms, anxiety, sleep, quality of life, safety, and tolerability. The primary efficacy endpoint was evaluated with last observation carried out forward (LOCF), using an analysis of covariance (ANCOVA), including treatment and centers as factors and baseline as covariate and applying linear contrast test, excluding the active treatment. Only if the linear contrast test was significant (p < 0.05), the step-down Dunnett test would be used to determine the minimum effective dose significantly different from PLB. If linearity was not verified, an adjusted ANCOVA model and comparisons with Dunnett test were performed. Before the application of the ANCOVA model, the non-significance of interaction treatment per baseline was verified. RESULTS: A total of 240 patients were included in the modified intention-to-treat (m-ITT) population: 39 in Trazo/Gaba 2.5/25 mg, 38 in Trazo/Gaba 5/50 mg, 37 in Trazo/Gaba 10/100 mg, 83 in PLB, and 43 in Gaba. After 8 weeks of treatment, changes of the average daily pain score based on the 11-point NRS from baseline were - 2.52 ± 2.31 in Trazo/Gaba 2.5/25 mg group, - 2.24 ± 1.96 in Trazo/Gaba 5/50 mg group, - 2.46 ± 2.12 in Trazo/Gaba 10/100 mg group, - 1.92 ± 2.21 in Gaba group, and - 2.02 ± 1.95 in the PLB group. The linear contrast test did not result in significant differences (p > 0.05) among treatment groups. Consequently, the minimum effective dose against PLB was not determined. The multiple comparison with Dunnett adjustment did not show any statistically significant differences vs. PLB after 8 weeks of treatment: Trazo/Gaba 2.5/25 mg (95% confidence interval (CI) - 1.2739, 0.2026; p = 0.1539); Trazo/Gaba 5/50 mg (95% CI - 0.9401, 0.5390; p = 0.5931); Trazo/Gaba 10/100 mg (95% CI - 1.0342, 0.4582; p = 0.4471). However, patients receiving the lowest dose of Trazo/Gaba 2.5/25 mg showed a statistically significant difference to PLB after 6 weeks of treatment (95% CI - 1.6648, - 0.2126; p = 0.0116). Positive results were also found for responder patients, other items related to the pain, anxiety, depression, sleep, and quality of life, consistently in favor to the lowest Trazo/Gaba FDC. Two serious adverse events (SAEs) occurred but were judged unrelated to the study treatment. Treatment-emergent adverse events (TEAEs) were mainly mild-to-moderate in intensity and involved primarily nervous system, gastrointestinal disorders, and investigations. CONCLUSIONS: The primary end point of the study was the change from baseline of the average daily pain score based on the 11-point NRS after 8 weeks of treatment. While the primary endpoint was not reached, patients treated with Trazo/Gaba 2.5/25 mg t.i.d. showed statistically significant improvement of pain and other scores after 6 weeks and reported consistent better results in comparison to PLB on primary and secondary endpoints for the overall study duration. According to these results, the lowest dose of Trazo/Gaba FDC may be the best candidate for further clinical development to confirm the potential benefits of the FDC drug for this condition. CLINICAL TRIAL REGISTRATION: NCT03749642.

Clinical evaluation of switching from immediate-release to prolonged-release lithium in bipolar patients, poorly tolerant to lithium immediate-release treatment: A randomized clinical trial.

AIM: The effect of switching from lithium immediate release (Li-IR) to lithium prolonged release (Li-PR) on lithium-induced tremor after 1 and 12 weeks of treatment was evaluated in a randomized, multicenter, open trial, in bipolar patients from the participating sites with a tremor severity ≥2 (Udvalg for Kliniske Undersøgelser [UKU] rating scale) despite optimal lithium titration. METHODS: The primary endpoint was the evaluation of tremor by means of the UKU scale after 1 week of treatment. Secondary endpoints included manic Young Mania Rating Scale (YMRS) and depressive symptoms (Montgomery-Asberg Depression Rating Scale), a global assessment of the patient's status (Clinical Global Impression), polyuria/polydipsia (UKU item 3.8) and patient-reported outcomes. RESULTS: Owing to difficulties in including suitable patients the enrollment phase was closed when 73 patients were randomized. Notwithstanding the lower number of patients, in the modified intention-to-treat population (n = 70) the primary endpoint was statistically significant: tremor improved after 1 week in 62.9% in Li-PR group against 20.0% of patients in Li-IR group (p = .0006; two-tailed Fisher's exact test). The difference remained statistically significant after 4 (p = .0031) and 12 weeks (p = .0128). The same analysis performed in the PP population confirmed these results. Among the secondary endpoints, only the factor convenience of the treatment satisfaction questionnaire showed a statistically significant difference between groups. There were no apparent differences in the safety profile of the two formulations. CONCLUSIONS: This study is the first comparative documentation of a potential benefit of the prolonged-release formulation in reducing the symptom tremor, a well-known adverse effect of lithium therapy. Indeed, the study results should be interpreted taking into account the sample size lower than planned.

Safety and tolerability of a novel oral nutritional supplement in healthy volunteers.

BACKGROUND AND OBJECTIVE: Foods for Special Medical Purposes (FSMPs) are formulated to support the nutritional needs of subjects with impaired capacity to ingest, digest or absorb ordinary food or nutrients. Polglumyt® is a proprietary highly purified, high quality glycogen obtained from mussels. Here we report the results of a single-center, single dose, open label, single arm study carried out to investigate acceptance (i.e. gastrointestinal tolerance and palatability), metabolic profile and safety of a low osmolarity, high-density energy Polglumyt®-based drink (the investigational product, IP) as a novel FSMP. METHODS: Twelve healthy subjects received a single oral administration of the IP under fasting conditions. The study endpoints were: changes in gastrointestinal system tolerability at 3 h, 6 h and 24 h after IP intake; IP palatability evaluation; metabolic evaluation through the kinetic profile of circulating glucose, insulin and C-peptide from 0 h to 6 h after IP intake and changes from baseline in circulating triglycerides at 3 h and 6 h after IP intake. RESULTS: The IP showed a good gastrointestinal tolerability and an acceptable palatability. The IP did not affect the physiological glycemic profile and the triglycerides levels 6 h after the intake. The IP was well tolerated by study subjects, with no or minor adverse events. CONCLUSIONS: The study results encourage additional clinical investigations on the IP as a novel FSMP in patients with impaired digestion or gastrointestinal absorption, unable to assume an ordinary diet, e.g. patients undergoing invasive gastrointestinal surgery, elderly or oncological patients, even with certain metabolic disorders.