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OBJECTIVE: This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS). RESEARCH DESIGN AND METHODS: The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12). RESULTS: TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA₁c: treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate. CONCLUSIONS: Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.

Menopause is a risk factor for cardiovascular disease (CVD) because estrogen withdrawal has a detrimental effect on cardiovascular function and metabolism. The menopause compounds many traditional CVD risk factors, including changes in body fat distribution from a gynoid to an android pattern, reduced glucose tolerance, abnormal plasma lipids, increased blood pressure, increased sympathetic tone, endothelial dysfunction and vascular inflammation. Many CVD risk factors have different impacts in men and women. In postmenopausal women, treatment of arterial hypertension and glucose intolerance should be priorities. Observational studies and randomized clinical trials suggest that hormone replacement therapy (HRT) started soon after the menopause may confer cardiovascular benefit. In contrast to other synthetic progestogens used in continuous combined HRTs, the unique progestogen drospirenone has antialdosterone properties. Drospirenone can therefore counteract the water- and sodium-retaining effects of the estrogen component of HRT via the renin-angiotensin-aldosterone system, which may otherwise result in weight gain and raised blood pressure. As a continuous combined HRT with 17β-estradiol, drospirenone has been shown to significantly reduce blood pressure in postmenopausal women with elevated blood pressure, but not in normotensive women. Therefore, in addition to relieving climacteric symptoms, drospirenone 17β-estradiol may offer further benefits in postmenopausal women, such as improved CVD risk profile.

BackgroundExercise training, delivered within a cardiac rehabilitation program, improves both quality of life and clinical outcomes in patients with cardiovascular diseases (CVDs). Assessing heart rate variability (HRV) during training sessions has been shown to assist in tailoring exercise programs and optimizing their therapeutic effects. In this study, we investigated how the discontinuation of the betablocker bisoprolol affects HRV assessed during exercise in CVDs patients.MethodsWe present a case series of eight CVDs patients, (age: 71.3±5.7; BMI: 27.4±1.8 ), seven male and one female in stable clinical conditions, who performed cycle-ergometer exercise at a constant pedaling cadence. During the exercises: i) the HR (mean over instantaneous HR values) was meaningfully regulated, through a variable control load, to a piecewise constant reference, with the aim of meeting stationarity conditions for a 3-minutes short-term analysis of HRV; ii) the first HR reference value, within each exercise bout, was set close to the HR resting value of the patients, thus making room for the HRV baseline measure. Each patient performed three HR-controlled training bouts, at a non-decreasing rate of perceived exertion, in two different experimental sessions: A) while taking bisoprolol; B) 48-hours after discontinuation of the bisoprolol therapy. HRV recordings were made during all the phases of the bouts in which a constant HR reference was imposed. They led to the evaluation of low frequency (LF) and high frequency (HF) components, all of them normalized with respect to the total power.ResultsIn most phases, the use of bisoprolol non-negatively affects the HR regulation performance. On the other hand, when the analysis, over a proper subset of patients, is restricted to the phases for which a direct comparison – with and without bisoprolol – can be made at the same HR (almost constant) level, it is uniformly observed that: i) normalized HF was higher with bisoprolol in A session than in the B session, ii) normalized LF was lower with bisoprolol (A session) than in the B session, and consequently, iii) the LF/HF ratio is lower with bisoprolol (A session) than in the B session. Such modifications are stronger in a patient whose HR is more largely reduced by the effect of bisoprolol.ConclusionsThe experimental data of this paper go beyond previous studies showing that betablockers affect HRV (at rest) in patients with CVDs. Indeed, they extend those findings to an HR-controlled exercise framework that is, in our view, feasible and potentially advantageous in the cardiac rehabilitation field, since it provides quantitative variables (namely, the integral of the HR regulation error over the 3-minute-long time window at constant HR reference, as well as the normalized HF, LF, respectively): i) to characterize the HR regulation performance whose accuracy is necessary for measuring the HRV; ii) the subject’s functional response to the training level assessed during the exercise, which might allow for a precision approach to rehabilitation.Previous findings regarding temporary discontinuation of betablockers and HRV are extended to HRV recordings madeduring exercises at piecewise constant HR reference.Stopping betablocker bisoprolol led to signs of higher sympathetic nervous activity at the same perceived effort, based onHRV measures.When patients were taking beta-blockers, their heart rate was more stable during exercise sessions.A reliable measurement framework (with HR-regulation-performance-based thresholds) is provided, in which the HRVanalysis can be fruitfully carried out and used as a complementary tool for exercise intensity adjustments in order to gettailor safer and more effective training for people with heart disease.

This study aimed to investigate the psychological impact of the COVID-19 pandemic on healthcare workers (HCWs) in geriatric settings. Online cross-sectional survey. 394 geriatric HCWs in Italy. The survey was developed by a multidisciplinary team and disseminated in April 2022 to the members of two geriatric scientific societies (Italian Society of Geriatrics and Gerontology and Italian Association of Psychogeriatrics). The survey examined the experiences related to the COVID-19 pandemic, as well as psychological burden and support. Work-related anxiety and distress related to the pandemic were studied using the SAVE-9 scale (Stress and Anxiety to Viral Epidemics). Three hundred sixty-four participants (92.4%) changed their job activity during the pandemic and about half (50.9%) failed to cope with this change, 58 (14.7%) had increased work-related anxiety, and 39 (9.9%) work-related stress levels. Three hundred forty (86.3%) participants reported acute stress reaction symptoms, including irritability, depressed mood, headache, anxiety, and insomnia, and 262 (66.5%) required psychological support, mainly from friends/relatives (57.9%) and/or colleagues (32.5%). Furthermore, 342 participants (86.8%) recognized they would benefit from informal and formal psychological support in case of future similar emergencies. This study highlights the high psychological burden experienced by geriatric HCWs in Italy during the COVID-19 pandemic and emphasizes the need for supportive interventions.

Statins are extensively used to treat dyslipidemia, but, because of their low tolerability profile, they are discontinued in a significant proportion of patients. Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated. A single-blind, single-center, randomized, prospective, and parallel group trial comparing a combination of nutraceuticals (red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin), called Armolipid Plus, and ezetimibe for 3 months in terms of efficacy and tolerability. Patients who did not achieve their therapeutic target (low-density lipoprotein cholesterol <100 mg/dl) could add the alternative treatment on top of randomized treatment for another 12 months: 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled (ezetimibe n = 50, nutraceutical n = 50). Efficacy (lipid profile) and tolerability (adverse events, transaminases, and creatine kinase) were assessed after 3 and 12 months. After 3 months, 14 patients in the nutraceutical group achieved their therapeutic target, whereas none of the patients in the ezetimibe group did. At 1-year follow-up, 58 patients (72.5%) of the combined therapy group (n = 86) and 14 (100%) of the nutraceutical group reached the therapeutic goal. No patients experienced important undesirable effects. In conclusion, nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease. Further studies are needed to assess long-term effects of nutraceuticals on mortality.

Historically, high androgen levels have been linked with an increased risk for coronary artery disease (CAD). However, more recent data suggest that low androgen levels are associated with adverse cardiovascular risk factors, including an atherogenic lipid profile, obesity and insulin resistance. The aim of the present study was to evaluate the relationship between plasma sex hormone levels and presence and degree of CAD in patients undergoing coronary angiography and in matched controls. We evaluated 129 consecutive male patients (mean age 58±4 years, range 43–72 years) referred for diagnostic coronary angiography because of symptoms suggestive of CAD, but without acute coronary syndromes or prior diagnosis of hypogonadism. Patients were matched with healthy volunteers. Out of 129 patients, 119 had proven CAD; in particular, 32 of them had one, 63 had two and 24 had three vessel disease, respectively. Patients had significantly lower levels of testosterone than controls (9.8±6.5 and 13.5±5.4 nmol/l, P <0.01) and higher levels of gonadotrophin (12.0±1.5 vs 6.6±1.9 IU/l and 7.9±2.1 vs 4.4±1.4, P <0.01 for follicle-stimulating hormone and luteinizing hormone, respectively). Also, both bioavailable testosterone and plasma oestradiol levels were lower in patients as compared to controls (0.84±0.45 vs 1.19±0.74 nmol/l, P <0.01 and 10.7±1.4 vs 13.3±3.5 pg/ml, P <0.05). Hormone levels were compared in cases with one, two or three vessel disease showing significant differences associated with increasing severity of coronary disease. An inverse relationship between the degree of CAD and plasma testosterone levels was found ( r =−0.52, P <0.01). In conclusion, patients with CAD have lower testosterone and oestradiol levels than healthy controls. These changes are inversely correlated to the degree of CAD, suggesting that low plasma testosterone may be involved with the increased risk of CAD in men.

OBJECTIVE To investigate the contribution of apoptosis in the development of the skeletal myopathy in chronic heart failure. DESIGN The electrophoretic pattern of myosin heavy chains (MHC), fibre cross sectional area, number of in situ nick end labelling (TUNEL) positive apoptotic myocyte nuclei, and the tissue levels of caspase-3, Bcl-2, and ubiquitin were determined in biopsies taken from the vastus lateralis muscle. The study involved nine patients with severe chronic heart failure caused by ischaemic heart disease and hibernating myocardium and five controls. RESULTS In chronic heart failure patients the vastus lateralis showed a significant increase of MHC2a and MHC2b and a greater degree of fibre atrophy, as demonstrated by the decreased cross sectional area. There was also an increased number of TUNEL positive apoptotic myocyte nuclei. Tissue concentrations of Bcl-2 were decreased, while those of caspase-3 and ubiquitin were increased. Peak oxygen consumption (Vo 2) was negatively correlated with the number of TUNEL positive nuclei and the fibre cross sectional area. There was a correlation between the number of apoptotic nuclei and the fibre cross sectional area, but no correlation between myosin heavy chains and number of apoptotic nuclei. CONCLUSIONS Myocyte apoptosis occurs in the skeletal muscle of patients with chronic heart failure, and its magnitude is associated with the severity of exercise capacity limitation and the degree of muscle atrophy. Muscle atrophy contributes to the limitation of exercise capacity, together with the increased synthesis of fast, more fatiguable myosin heavy chains.

Background: In this study, we aimed at comparing the effects of three different exercise modalities on post-exercise hypotension (PEH) in elderly hypertensive patients and at investigating whether PEH responses to the same exercises are affected by their training status. Methods: Thirty-six male sedentary hypertensive patients over 60 years old, were included. They were divided into three groups each one corresponding to a different exercise modality, i.e., aerobic continuous exercise (ACE), high-intensive interval exercise (HIIE), and combined (aerobic and resistance) exercise (CE). PEH was assessed in each group by ambulatory blood pressure monitoring (ABPM) in two different conditions as follows: (1) sedentary status and (2) trained status, at the end of a 12 week of ACE training program. A cardiopulmonary test was performed before and at the end of the training program. Results: In the sedentary status, 24-h and nocturnal systolic and diastolic blood pressure (BP) decreased in all groups as compared with top pre-exercise, with a greater but not significant reduction in the ACE and CE groups as compared with HIIE. ACE and HIIE groups presented a more sustained PEH than CE. In the trained status, 24-h and nighttime systolic and diastolic BP decreased significantly only after HIIE, but were unchanged as compared with pre-exercise in the ACE and CE groups. Conclusions: ACE and CE produced greater PEH than HIIE in sedentary elderly hypertensive patients. However, after training, HIIE produced the greater and more sustained PEH. The training status appears to exert significant effects on PEH produced by different exercise modalities.

Bacteria are able to adapt to heavy metals in contaminated environments, by developing specific mechanisms of resistance. A mercury (Hg)-resistant bacterial community was isolated from polluted sediments of the Orbetello Lagoon, Italy. The members of the Hg-resistant bacterial community showed high levels of resistance both to the inorganic and to the organic forms of Hg. 16S rRNA gene sequencing showed the presence of different genera, and a bacterial strain resistant to Hg belonging to the genus Luteimonas was evidenced for the first time. The merA gene coding for mercury-reductase conferring resistance to inorganic Hg, and the merB gene coding for mercury-lyase enzymes, for resistance to the organic forms of Hg, were detected in the tested bacterial strains. The community showed the presence of bacteria belonging to the genera Pseudomonas and Psychrobacter that highlighted the capability to reduce Hg2+ to the volatile form of Hg0. Experiments carried out with immobilized cells of the Hg-resistant strains removed 96% of Hg in sediments leachates in a bioremediation laboratory scale pilot plant. A methylating activity of the sulphate-reducing bacteria of the same polluted sediments was moreover evidenced. These results evidenced the presence of microbial communities highly adapted to the presence of Hg into the sediments of the lagoon. The use of the isolated autochthonous bacterial strains for bioremediation of the native sediments contaminated by Hg is suggested.

Both clinical and experimental evidence shows that iron deficiency (ID) correlates with an increased incidence of heart failure (HF). Moreover, data on iron supplementation demonstrating a beneficial effect in subjects with HF have mostly been collected in patients undergoing HF with reduced ejection fraction (HFrEF). Relatively poor data, however, exist on the potential of iron supplementation in patients with HF with preserved ejection fraction (HFpEF). Here, we report on data emerging from a multicentric, double-blind, randomized, placebo-controlled study investigating the effect of IV supplementation with a placebo or ferric carboxymaltose (FCM) on 64 subjects with HFpEF. ID was detected by the measurement of ferritin levels. These data were correlated with cardiac performance measurements derived from a 6 min walking test (6MWT) and with echocardiographic determinations of diastolic function. Moreover, an EndoPAT analysis was performed to correlate cardiac functionality with endothelial dysfunction. Finally, the determination of serum malondialdehyde (MDA) was performed to study oxidative stress biomarkers. These measurements were carried out before and 8 weeks after starting treatment with a placebo (100 mL of saline given i.v. in 10 min; n = 32) or FCM at a dose of 500 mg IV infusion (n = 32), which was given at time 0 and repeated after 4 weeks. Our data showed that a condition of ID was more frequently associated with impaired diastolic function, worse 6MWT and endothelial dysfunction, an effect that was accompanied by elevated MDA serum levels. Treatment with FCM, compared to the placebo, improved ferritin levels being associated with an improved 6MWT, enhanced cardiac diastolic function and endothelial reactivity associated with a significant reduction in MDA levels. In conclusion, this study confirmed that ID is a frequent comorbidity in patients with HFpEF and is associated with reduced exercise capacity and oxidative stress-related endothelial dysfunction. Supplementation with FCM determines a significant improvement in diastolic function and the exercise capacity of patients with HFpEF and is associated with an enhanced endothelial function and a reduced production of oxygen radical species.