Prevalence and impact of polypharmacy in older patients with type 2 diabetes

Background: Polypharmacy is a prevalent condition in older adults, especially those with multiple chronic diseases, and has been largely associated with adverse outcomes, including disability, hospitalizations, and death. Aims: This systematic review focused on diabetes and aimed to investigate the prevalence and impact of polypharmacy in older adults affected by such disease. Methods: Observational (either cross-sectional or longitudinal) or experimental studies investigating the frequency and impact of polypharmacy in older adults with diabetes were identified from scientific databases and grey literature until August 2021. The prevalence and the 95% Confidence Interval (95% CI) of polypharmacy in older people with diabetes were summarized by a random-effects meta-analysis. Results: From a total of 1465 records, 9 were selected for the qualitative synthesis, and 8 for the quantitative synthesis. Most studies defined polypharmacy using a cut-off for the minimum number of medications ranging from 4 to 6 drugs/day. The pooled prevalence of polypharmacy in older people with diabetes was 64% (95% CI 45–80%). Considering studies that used the same definition of polypharmacy (i.e. ≥ 5 drugs/day), the pooled prevalence was 50% (95% CI 37–63%). The between-studies heterogeneity was high. Across the selected studies, polypharmacy seemed to negatively influence both diabetes-specific (poor glycemic control and risk of hypoglycemia) and health-related (risk of incident falls, syncope, hospitalization, and death) outcomes. Conclusion: This systematic review confirms the high prevalence of polypharmacy in older people with diabetes and its strong impact on several health-related outcomes, including mortality. These results strengthen the need to improve care strategies for management of these patients

ASSOCIATION OF CALCIFEDIOL LEVELS WITH VERTEBRAL FRACTURES, VASCULAR CALCIFICATIONS AND MORTALITY.

The best biomarker of Vitamin D status is calcifediol [25(OH)D]. We investigated the relationship between serum calcifediol levels and vertebral fractures (VF), vascular calcifications (VC) and mortality in hemodialysis patients. Within a multicenter, cross-sectional study in 18 hospital based dialysis centers in Italy, we included 387 hemodialysis patients (143 F, 37% ; 244 M, 63%), mean age 64±14 (SD) years, median dialytic age 49 months, BMI 25± 4 Kg/m2. We determined total 25(OH)D using the LIASON® 25 OH Vitamin D kit (DiaSorin Inc., Stillwater MN, USA). We evaluated VF with a computerized analysis of scanned L-L vertebral X-rays (T4 to L5). Reduction of > 20% of vertebral body height was considered a VF, while reductions between 15% and 20% were considered borderline fractures (BF). Fracture severity was estimated as mild, moderate or severe (reduction: 20–25%, 25–40% or >40%, respectively). VC assessments were also centralized. Witteman's method (Lancet, 1994) was used for blinded assessments in duplicate. VC were quantified by measuring the length of calcific deposits along the anterior and posterior wall of the aorta (mild 0.1-5 cm, moderate 5.1-10 cm and severe >10 cm). We also evaluated the presence or absence of calcifications of the iliac arteries in the same radiograph (mild 0.1-3 cm, moderate 3.1-5 cm and severe >5cm). Any differences in VC were resolved by consensus. Follow up was 2.7±0.5 years. Bone markers were: Ca 9.15±0.68 mg/dl, P 4.8± 1.28 mg/dl, median ALP 83 U/L and median PTH 244 pg/ml. We found a median 25(OH)D level of 28.9 ng/ml. Nine ( 2.3%) patients had vitamin D deficiency (30 ng/ml). We found that 55% of patients had VF and 30.9% of patients had BF. Prevalence of VC was 80.6% (mild 20.1%, moderate 30.8%, severe 29.7%) in the aorta and 55,1% in the iliac arteries. Males had more VF than Females (60% versus 48%, P=0.019). No associations were found between VF and biochemical parameters including calcifediol levels (p=0.662), while we found an association between low calcifediol levels and a higher prevalence of severe aortic calcifications (36.8 vs 28.2, p=0.0044). Furthermore, we found a OR 1.85 (1.04-3.29 CI, p=0.0367) for Aortic Calcification in patients with calcifediol levels lower than the median value of 29 ng/ml. During follow-up (2.7±0.5 years) mortality was of 19.9%. No association was found between mortality and calcifediol levels (p=0.5394). In conclusion, despite good control of bone and mineral metabolism parameters, hemodialysis patients showed high prevalence of VF and VC. Our study suggests that high calcifediol levels could be protective against progression of severe aortic calcificatio

Longevity and health expectancy in an ageing society: implications for public health in Italy

Summary. Introduction. While the prolongation of life expectancy is due to medical, economic, social and public health advancements, longevity may not necessarily be an indicator of real development. Epidemiologic data indicate, in fact, that advanced age carries the risk of multiple diseases, disability and loss of autonomy. Materials and methods. How the years gained are lived need to be assessed evaluating quality of life, health status, and disability. Results and conclusions. Good health care planning should aim to ensure that the years of life gained are lived in good health conditions in the light of the World Health Organization's declaration that "increased longevity without quality of life is an empty prize. Health expectancy is more important than life expectancy"

Long-term beneficial impact of the randomised trial 'Train the Brain', a motor/cognitive intervention in mild cognitive impairment people: effects at the 14-month follow-up

: No treatment options are currently available to counteract cognitive deficits and/or delay progression towards dementia in older people with mild cognitive impairment (MCI). The 'Train the Brain' programme is a combined motor and cognitive intervention previously shown to markedly improve cognitive functions in MCI individuals compared to non-trained MCI controls, as assessed at the end of the 7-month intervention. Here, we extended the previous analyses to include the long-term effects of the intervention and performed a data disaggregation by gender, education and age of the enrolled participants. We report that the beneficial impact on cognitive functions was preserved at the 14-month follow-up, with greater effects in low-educated compared to high-educated individuals, and in women than in men

Metabolic Syndrome and All-Cause and Cardiovascular Mortality in an Italian Elderly Population: The Progetto Veneto Anziani (Pro.V.A.) Study

OBJECTIVE—The purpose of this study was to explore the association of metabolic syndrome and each of its components with all-cause and cardiovascular mortality in a general Italian elderly population

Early results of PRO-EPI: PROspective multicenter observational study on elective pelvic nodes irradiation in patients with intermediate/high/very high-risk non-metastatic prostate cancer submitted to radical, adjuvant, or salvage radiotherapy with or without concomitant androgen deprivation therapy

Simple Summary: Although radiotherapy plays a fundamental role in the management of intermediate/high/very high-risk non-metastatic prostatic cancer (IHR-nmPca), there is still no consensus on the optimal treatment strategy in this setting. Remarkably, the role of elective nodal irradiation (ENI) is still highly controversial. The PROspective multicenter observational study on Elective Pelvic nodes Irradiation (PRO-EPI) was designed to provide "real life" data regarding the patterns of care for IHR-nmPca.Forty-three Italian Radiation Oncology centers participated in the PROspective multicenter observational study on Elective Pelvic nodes Irradiation (PRO-EPI) project, with 1029 patients enrolled. In this preliminary analysis, we longitudinally evaluated the impact of Elective Nodal Irradiation (ENI) and radiotherapy features on toxicity and quality of life (QoL). Six months follow-up data were available for 913 patients and 12 months data for 762 patients. Elective Nodal Irradiation was given to 506 patients (48.9%). Volumetric Intensity-Modulated Radiation Therapy (IMRT) was adopted in more than 77% of patients and Image-Guided Radiation Therapy (IGRT) in 84.4%. Androgen deprivation therapy (ADT) was administered to the majority of patients (68.3%), and it was associated to ENI in 408 cases (81.1%). Toxicity was mostly mild and reversible and IGRT resulted in a significant reduction of rectal toxicity, although a non-significant trend toward increased urinary toxicity was observed. No statistically significant differences in QoL and toxicity were seen in patients treated with or without ENI. The adoption of IGRT is widespread and increasing and could reduce treatment toxicity. ENI is not yet the standard treatment, but it is performed in a growing fraction of cases and not resulting into an increase in toxicity or in a deterioration of QoL. Further analyses are needed to clarify the long-term toxicity profile and the impact of ENI on survival

Sex differences in the efficacy and safety of SARS-CoV-2 vaccination in residents of long-term care facilities: insights from the GeroCovid Vax study

Despite the reported sex-related variations in the immune response to vaccination, whether the effects of SARS-CoV-2 vaccination differ by sex is still under debate, especially considering old vulnerable individuals, such as long-term care facilities (LTCFs) residents. This study aimed to evaluate COVID-19 infections, adverse events, and humoral response after vaccination in a sample of LTCF residents. A total of 3259 LTCF residents (71% females; mean age: 83.4 +/- 9.2 years) were enrolled in the Italian-based multicenter GeroCovid Vax study. We recorded the adverse effects occurring during the 7 days after vaccine doses and COVID-19 cases over 12 months post-vaccination. In a subsample of 524 residents (69% females), pre- and post-vaccination SARS-CoV-2 trimeric S immunoglobulin G (Anti-S-IgG) were measured through chemiluminescent assays at different time points. Only 12.1% of vaccinated residents got COVID-19 during the follow-up, without any sex differences. Female residents were more likely to have local adverse effects after the first dose (13.3% vs. 10.2%, p = 0.018). No other sex differences in systemic adverse effects and for the following doses were recorded, as well as in anti-S-IgG titer over time. Among the factors modifying the 12-month anti-S-IgG titers, mobility limitations and depressive disorder were more likely to be associated with higher and lower levels in the antibody response, respectively; a significantly lower antibody titer was observed in males with cardiovascular diseases and in females with diabetes or cognitive disorders. The study suggests that, among LTCF residents, SARS-CoV-2 vaccination was effective regardless of sex, yet sex-specific comorbidities influenced the antibody response. Local adverse reactions were more common in females

The Association between Influenza and Pneumococcal Vaccinations and SARS-Cov-2 Infection : Data from the EPICOVID19 Web-Based Survey

The present study aims to evaluate whether influenza and pneumococcal vaccinations are associated with positive nasopharyngeal swab (NPS) testing to detect SARS-CoV-2. Data from the Italian cross-sectional web-based survey (EPICOVID19), based on a self-selection sample of individuals aged 6518, were considered. The probability of a positive SARS-CoV-2 NPS test result as a function of influenza or anti-pneumococcal vaccination was evaluated using multivariable logistic regression, stratifying analysis by age (<65 years, 6565 years). From April 2020, 170,731 individuals aged <65 years and 28,097 6565 years filled out the EPICOVID19 questionnaire. Influenza and anti-pneumococcal vaccinations were received, respectively, by 16% and 2% of those <65 years, and by 53% and 13% of those 6565 years. SARS-CoV-2 NPS testing was reported by 6680 participants. Anti-pneumococcal and influenza vaccinations were associated with a decreased probability of a SARS-CoV-2 NPS positive test in the younger participants (OR = 0.61, 95% CI 0.41\u20130.91; OR = 0.85, 95%CI 0.74\u20130.98; respectively). A significantly lower probability of a positive test result was detected in the individuals 6565 years who received anti-pneumococcal vaccination (OR = 0.56, 95%CI 0.33\u20130.95). These results need to be confirmed by further investigations, but they are relevant given the probable coexistence of influenza, bacterial infections, and COVID-19 over the coming autumn\u2013winter season

Clinical profile of trazodone users in a multisetting older population: data from the Italian GeroCovid Observational study

Background and objectives: Depression is highly prevalent in older adults, especially in those with dementia. Trazodone, an antidepressant, has shown to be effective in older patients with moderate anxiolytic and hypnotic activity; and a common off-label use is rising for managing behavioral and psychological symptoms of dementia (BPSD). The aim of the study is to comparatively assess the clinical profiles of older patients treated with trazodone or other antidepressants. Methods: This cross-sectional study involved adults aged ≥ 60 years at risk of or affected with COVID-19 enrolled in the GeroCovid Observational study from acute wards, geriatric and dementia-specific outpatient clinics, as well as long-term care facilities (LTCF). Participants were grouped according to the use of trazodone, other antidepressants, or no antidepressant use. Results: Of the 3396 study participants (mean age 80.6 ± 9.1 years; 57.1% females), 10.8% used trazodone and 8.5% others antidepressants. Individuals treated with trazodone were older, more functionally dependent, and had a higher prevalence of dementia and BPSD than those using other antidepressants or no antidepressant use. Logistic regression analyses found that the presence of BPSD was associated with trazodone use (odds ratio (OR) 28.4, 95% confidence interval (CI) 18-44.7 for the outcome trazodone vs no antidepressants use, among participants without depression; OR 2.17, 95% CI 1.05-4.49 for the outcome trazodone vs no antidepressants use, among participants with depression). A cluster analysis of trazodone use identified three clusters: cluster 1 included mainly women, living at home with assistance, multimorbidity, dementia, BPSD, and depression; cluster 2 included mainly institutionalized women, with disabilities, depression, and dementia; cluster 3 included mostly men, often living at home unassisted, with better mobility performance, fewer chronic diseases, dementia, BPSD, and depression. Discussion: The use of trazodone was highly prevalent in functionally dependent and comorbid older adults admitted to LTCF or living at home. Clinical conditions associated with its prescription included depression as well as BPSD

Changes in sleep quality and sleep disturbances in the general population from before to during the COVID-19 lockdown: A systematic review and meta-analysis

IntroductionThis systematic review and meta-analysis aims to explore changes in sleep quality and sleep disturbances in the general population from before to during the COVID-19 lockdown.MethodsThe protocol was registered in PROSPERO (CRD42021256378) and the PRISMA guidelines were followed. The major databases and gray literature were systematically searched from inception to 28/05/2021 to identify observational studies evaluating sleep changes in the general population during the lockdown with respect to the pre-lockdown period. A random effects meta-analysis was undertaken for studies reporting (a) the means of the Pittsburgh Sleep Quality Index (PSQI) global scores or the means of the sleep onset latency (SOL) times (minutes - min) before and during the lockdown, (b) the percentages of poor sleep quality before and during the lockdown, or (c) the percentages of changes in sleep quality. Subgroup analysis by risk of bias and measurement tool utilized was carried out. A narrative synthesis on sleep efficiency, sleep disturbances, insomnia and sleep medication consumption was also performed.ResultsSixty-three studies were included. A decline in sleep quality, reflected in a pooled increase in the PSQI global scores (standardized mean difference (SMD) = 0.26; 95% CI 0.17–0.34) and in SOL (SMD = 0.38 min; 95% CI 0.30–0.45) were found. The percentage of individuals with poor sleep quality increased during the lockdown (pooled relative risk 1.4; 95% CI 1.24–1.61). Moreover, 57.3% (95% CI 50.01–61.55) of the individuals reported a change in sleep quality; in 37.3% (95% CI 34.27–40.39) of these, it was a worsening. The studies included in the systematic review reported a decrease in sleep efficiency and an increase in sleep disturbances, insomnia, and in sleep medication consumption.DiscussionTimely interventions are warranted in view of the decline in sleep quality and the increase in sleep disturbances uncovered and their potentially negative impact on health. Further research and in particular longitudinal studies using validated instruments examining the long-term impact of the lockdown on sleep variables is needed.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021256378, identifier CRD42021256378