Italian Guidelines for the Management of Non-Functioning Benign and Locally Symptomatic Thyroid Nodules.

AIM: This guideline (GL) is aimed at providing a reference for the management of non-functioning, benign thyroid nodules causing local symptoms in adults outside of pregnancy. METHODS: This GL has been developed following the methods described in the Manual of the National Guideline System. For each question, the panel appointed by Associazione Medici Endocrinology (AME) identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as "critical" and "important" were considered in the systematic review of evidence and only those classified as "critical" were considered in the formulation of recommendations. RESULTS: The present GL contains recommendations about the respective roles of surgery and minimally invasive treatments for the management of benign symptomatic thyroid nodules. We suggest hemithyroidectomy plus isthmectomy as the first-choice surgical treatment, provided that clinically significant disease is not present in the contralateral thyroid lobe. Total thyroidectomy should be considered for patients with clinically significant disease in the contralateral thyroid lobe. We suggest considering thermo-ablation as an alternative option to surgery for patients with a symptomatic, solid, benign, single, or dominant thyroid nodule. These recommendations apply to outpatients, either in primary care or when referred to specialists. CONCLUSION: The present GL is directed to endocrinologists, surgeons, and interventional radiologists working in hospitals, in territorial services, or private practice, general practitioners, and patients. The available data suggest that the implementation of this GL recommendations will result in the progressive reduction of surgical procedures for benign thyroid nodular disease, with a decreased number of admissions to surgical departments for non-malignant conditions and more rapid access to patients with thyroid cancer. Importantly, a reduction of indirect costs due to long-term replacement therapy and the management of surgical complications may also be speculated.

Recommendations for Cardiovascular Prevention During the Sars-Cov-2 Pandemic: An Executive Document by the Board of the Italian Society of Cardiovascular Prevention.

In 2020, the Sars-Cov-2 pandemic is causing a huge and dramatic impact on healthcare systems worldwide. During this emergency, fragile patients suffering from other comorbidities, especially patients susceptible to or affected by cardiovascular disease, are the ones most exposed to the poorer outcomes. Therefore, it is still mandatory to continue to strictly adhere to the rules of cardiovascular prevention. This document aims to provide all doctors with simple and clear recommendations in order to spread useful messages to the widest number of subjects in order to continue the battle against cardiovascular diseases even in times of pandemic.

Treatment with Free Triple Combination Therapy of Atorvastatin, Perindopril, Amlodipine in Hypertensive Patients: A Real-World Population Study in Italy.

INTRODUCTION: Polytherapy is often required to treat the comorbidity of hypertension and hyperlipidemia. Fixed-dose co-formulation, rather than free combinations, simplifies medication taking and also improves adherence to medication, which is the key for a successful management of these conditions. AIM: To determine the number of patients potentially eligible for treatment with triple fixed-dose atorvastatin/perindopril/amlodipine (CTAPA), and to estimate if an unmet medical need exists among CTAPA free combination treated patients. METHODS: This observational retrospective study was based on administrative databases of 3 Italian Local Health Units. The cohort comprised adult patients with at least one prescription of amlodipine and perindopril (either as free combination or co-formulated) and atorvastatin during 2014. Follow-up period started on the date of prescription of the 3 molecules (index date) and lasted 1 year. Adherence to CTAPA was analyzed during follow-up, by using the proportion of days covered (PDC). RESULTS: 2292 patients (9.1 per 10,000 beneficiaries) had a prescription for CTAPA as free combination. Only 1249 (54.5%) were adherent to the therapy (PDC ≥ 80%); among them, a small percentage required dosage modification. The number of patients with CTAPA increased during the study period. Discontinuation of drugs prescribed the year before interested 582 patients in 2014, and 522 in 2015. Considering the Italian national population (n = 60,782,668), it was estimated that 69,542 hypertensive patients could be eligible for fixed-dose CTAPA during 2014. CONCLUSIONS: Real-world analysis among patients with free combination therapy can be applied to estimate the eligible population for fixed combination, and to evaluate the appropriateness of their prescriptions. Moreover, fixed-dose CTAPA could effectively improve adherence, which was calculated to be low in the free combination cohort.

Incidence of herpes zoster and postherpetic neuralgia in Italian adults aged ≥50 years: A prospective study.

Herpes zoster (HZ) mainly affects older adults and immunocompromised individuals and is usually characterized by a unilateral painful skin rash. Its most common complication, postherpetic neuralgia (PHN), may cause chronic debilitating pain lasting for months or years. This study (ClinicalTrials.gov Identifier: NCT01772160) aimed to estimate the HZ incidence and the proportion of HZ patients with PHN in the Italian population aged 50 years or older. From 2013 to 2016, HZ-patients were recruited when presenting with acute HZ at 75 reporting general practitioners in Italy, covering 43,875 persons aged ≥50 years. PHN was defined as 'worst pain' rated ≥ 3 on the Zoster Brief Pain Inventory persisting or appearing over 90 days after rash onset. The overall HZ incidence rate per 1000 person-years (PY) was estimated as 6.46 (95% confidence interval [CI]: 5.99-6.95), increasing with age to 9.12/1000 PY (95% CI: 7.50-10.99) in 75-79 year-olds. Among 391 HZ-patients who completed the study, the overall proportion with PHN was 10.23% (95% CI: 7.41-13.67) and the highest proportion was 15.56% (95% CI: 6.49-29.46) for the 75-79 year-olds. Among the 128 patients (32.7%) who reported at least one pre-existing medical condition, 35.9% reported diabetes mellitus and 32.0% reported emotional problems, stress or depression. The study confirms previous findings that HZ and PHN cause an important clinical burden in older Italian adults. It also confirmed the age-related increasing risk of HZ and PHN.

Modifications in drug adherence after switch to fixed-dose combination of perindopril/amlodipine in clinical practice. Results of a large-scale Italian experience. The amlodipine-perindopril in real settings (AMPERES) study.

OBJECTIVE: The purpose of this study was to assess the changes in adherence to treatment, in patients who switched from perindopril and/or amlodipine as a monotherapy (single-pill therapy, SPT) or two-pill combinations to fixed-dose combination (FDC) therapy. METHODS: A large retrospective cohort study, in three Italian Local Health Units, was performed. All adult subjects who received at least one prescription of anti-hypertensive drugs between January 1, 2010 and December 31, 2014 were selected. The date of the first anti-hypertensive prescription was defined as the index-date (ID). For each patient, we evaluated the anti-hypertensive therapy and the adherence to treatment during the two 12-month periods preceding and following the ID. Changes in the level of adherence have been compared in patients who switched to the FDC of perindopril/amlodipine after the ID, as well as in patients who did not. RESULTS: A total of 24,020 subjects were initially included in the study. Subjects treated with the free dose combination switched more frequently to FDC of perindopril/amlodipine than subjects treated with SPT (p < .001). Adherence to treatment was found to be higher in the 3,597 subjects who switched to the perindopril/amlodipine FDC therapy, than in the 20,423 subjects who did not. A significant decrease in the number of concomitant anti-hypertensive drugs has been observed in patients treated with the same FDC. CONCLUSIONS: The results show that perindopril/amlodipine FDC increases the rate of stay-on-therapy and reduces the number of concomitant anti-hypertensive drugs in subjects previously treated with the same drugs as a two-pill combination or as SPT.

Hypertriglyceridemia, an Underestimated Cardiovascular Risk Factor: An Epidemiological Study of the Rome Area.

INTRODUCTION: Hypertriglyceridemia (triglycerides ≥200 mg/dL) is a major cardiovascular risk factor. Despite the high incidence of this condition in the Italian population, epidemiological information remains limited. AIM: To analyze a large database of clinical charts from general practitioners in the Rome area of Italy. METHODS: In this study, the DATAMEG database of patients treated in the Rome area between 2000 and 2015 was analyzed. The database was searched for information on (1) all patients diagnosed with hypertriglyceridemia, (2) all prescriptions for the treatment of hypertriglyceridemia, and (3) all patients who had an acute myocardial infarction. RESULTS: The overall prevalence of hypertriglyceridemia was 4.4% (3647/82,595). Among patients followed from January 1, 2015 onwards, 2786/55,345 (5.0%) were diagnosed with hypertriglyceridemia. Of these, 418 (15.0%) received at least one prescription of triglyceride-lowering treatment. Over the same period, 1653 patients had at least three measurements of triglycerides ≥200 mg/dL, with only 357 (21.6%) receiving at least one prescription of triglyceride-lowering drugs in the year following the last measurement. Furthermore, 513 patients had at least one measurement of ≥500 mg/dL. Of these, only 246 (48.0%) received at least one prescription of triglyceride-lowering drugs in the year following the last measurement. In total, 3485 patients had an acute myocardial infarction (prevalence, 4.3%) in 2015. Of these, only 288 (8.3%) received at least one prescription of triglyceride-lowering drugs in the year following this event. CONCLUSION: These findings confirmed a pattern of inadequate treatment of hypertriglyceridemia in the Rome area.

Prevalence and Control of Hypertension in Different Macro-Areas in Italy: Analysis of a Large Database by the General Practice.

INTRODUCTION: Limited data are available on the impact of hypertension in the different regions or urban areas in Italy. AIM: To evaluate hypertension prevalence and control among adult outpatients followed by general practitioners (GPs) in different regions and macro-areas in our Country. METHODS: We retrospectively analysed data extracted in 2013 from the national GP Health Search-CSD database and stratified into three groups, depending on their own regions (North, Center and South). Hypertension prevalence was estimated within the overall population sample of adult individuals, whereas control was assessed in hypertensive outpatients. Hypertension diagnosis was defined according to International Classification of Diseases 9. Clinic blood pressure (BP) levels were measured according to European guidelines. BP control was defined as BP <140/90 mmHg. RESULTS: Data from 940,806 individuals (52.0 % female) were scrutinized, among whom 363,324 (38.6 %) subjects were residents in the North, 276,643 (29.4 %) in the Center and 300,839 (32.0 %) in the South. Overall hypertension prevalence was higher in North (36.8 %) compared to South (33.8 %) and Center (29.3 %). Controlled BP levels were more frequently registered in the South (66.3 %) compared to Center (60.7 %) and North (55.6 %). In all these areas, prevalence and control of hypertension were higher in female than in male individuals. CONCLUSIONS: The present analysis demonstrates relevant differences in hypertension prevalence and control among different macro-areas and regions in Italy. Such analysis may be useful for promoting strategies aimed at ameliorating hypertension control at local levels.

H2020 and Beyond: Skip Discrepancy between Theory and Practice of Personalized Medicine. A Position Paper by the Italian Society of Personalized Medicine.

Many unsolved practical issues, from technical and scientific to ethical, legal and economic topics, are slowing down the translation of Personalized Medicine principles into medical practice. The Italian Society of Personalized Medicine exposes here its point of view, based on the real-world practice of precision medicine carried-out in Italian healthcare structures.

Prevalence of metabolic syndrome in the clinical practice of general medicine in Italy.

BACKGROUND: Prevalence of metabolic syndrome (MS) in the clinical practice is still debated, due to different diagnostic criteria, target populations and clinical settings. Thus, the main purposes of the study were: (I) to evaluate prevalence of MS; (II) to estimate prevalence of additional cardiovascular (CV) risk factors and concomitant conditions in patients with MS followed by general practitioners (GPs) in Italy. METHODS: GPs from three different macro-areas were asked to evaluate the first and the last three outpatients, consecutively seen during 20 consecutive weeks in 2007, whatever the reason for clinical consultation. MS was defined according to Adult Treatment Panel (ATP) III definition. Clinical data were collected locally and centrally analysed. RESULTS: The overall population sample included 4,513 outpatients, among which 1,574 (34.9%) from Regione Lazio, 1,498 (33.2%) from Regione Piemonte, and 1,441 (31.9%) from Regione Umbria. The population analysis included 4,418 (97.9%) adult outpatients [52.1% females, (mean age, 58.0±11.8 years); mean body mass index (BMI), 26.7±4.7 kg/m(2)]. MS was diagnosed in 1,456 (33.0%) outpatients. High-normal blood pressure (BP) was the most common risk factor for MS (n=1,382; 94.9%), followed by abdominal obesity (n=1,229; 84.4%), hypertriglyceridemia (n=1,032; 70.9%), abnormal fasting glucose (n=819; 56.3%) and low high-density lipoprotein (HDL) cholesterol levels (n=730; 50.1%). CONCLUSIONS: Using this sample of outpatients followed by GPs in Italy, our study reports a relatively high prevalence of MS and a high prevalence of associated CV and metabolic risk factors in patients with than in those without MS.

Why is my hypertensive patient still not controlled?

UNLABELLED: Despite the well-known obstacles to blood pressure (BP) control, significant improvement can be obtained. Unfortunately more than a third of hypertensive patients remain non-controlled even after improving initiatives. We asked a group of General Practitioners (GPs) why their patients failed to reach the target despite their efforts. METHODS: After an audit the control rate increased from 50.8 % to 64.1 %. The 18 participating GPs analyzed the 2,674 patients who remained non controlled (no available BP recording in the last year or last available recorded value ≥140/90 mmHg -office BP-, ≥135/85 mmHg -home BP-, ≥130/80 mmHg -ambulatory BP-) and filled a questionnaire about the reasons for patients' non-attendance and for lack of BP control. RESULTS: BP values were missing in 1,769 (66.1 %) patients; reasons: contact impossible (19 %), contacted, but did not attend (29 %), forgot to check BP (19 %), BP checked at home, but not recorded (10 %), patients cared for by specialists (12 %), the patient is a doctor or a doctor's relative (4 %), other (12 %). Among the other 905 (33.9 %) non-controlled subjects (with recorded BP) 23 % were prescribed with ≥3, and 10 % with ≥4 drugs. Reasons not to increase therapy were: patient choice (29 %), wait and see strategy/patient not stable yet (26 %), increase inappropriate (20 %), others caring for hypertension (9 %), secondary hypertension (5 %), reached maximum possible therapy (4 %), "resistant hypertension" (4 %), forgot to increase therapy (3 %), other (5 %). CONCLUSIONS: The priorities for further improvement are the patients who do not see their doctors (regularly), followed by those unwilling to increase their therapy.

How many hypertensive patients can be controlled in "real life": an improvement strategy in primary care.

BACKGROUND: It is well known that hypertension control is non-satisfactory, but it is not clear how many hypertensive patients can be controlled in real life. We addressed this question implementing a simple, multifaceted improvement strategy in family practice. METHODS: Eighteen General Practitioner (GPs) agreed upon a simple improvement strategy including: 1) the use of occasional direct/indirect contacts (prescription refilling) to decrease missing blood pressure (BP) recording, and to increase therapeutic adherence, 2) the use of home BP measurements in non-controlled patients, 3) the addition of a new drug in non-controlled, but adequately adherent patients. Results were assessed after one year by automatic data extraction from the clinical records of all hypertensive subjects. RESULTS: The patients with a diagnosis of hypertension increased from 6.309 (age 58.5 +/- 12.4; M 45.5%) to 6.717 (age 58.6 +/- 12.9; M 45.7%): prevalence 25.3% to 27.0%. The BP recording increased: 4,305 patients (68.2%) vs 4,948 patients (78.4%) (+ 10.2%, ci 9.4%-10.9%; p < 0.001), as well as the BP control: 3,203 (50.8% of all the diagnosed hypertensive patients and 74.4% of the subjects with recorded BP value) vs 4,043 (64.1% of all the diagnosed hypertensive patients and 81.7% of the subjects with recorded BP value) (+ 13.3%, ci 12.5%-14.2%; p < 0.001 and + 7.3%, ci 6.7%-8.0%; p < 0.001). CONCLUSIONS: Almost 82% of hypertensive subjects who contact their doctors can be easily controlled. Most non-controlled patients simply don't see their GPs; in almost all the remaining non-controlled patients GPs fail to increase drug therapy. A further improvement is therefore possible.

Prevalence of 'borderline' values of cardiovascular risk factors in the clinical practice of general medicine in Italy: results of the BORDERLINE study.

INTRODUCTION: The prevalence of patients with 'borderline' levels of cardiovascular risk factors has been rarely investigated, being often reported in studies evaluating abnormal values of these parameters. The BORDERLINE study represents a pilot experience to primarily identify the prevalence of 'high-normal' conditions, such as pre-hypertension, lipid and glucose levels in the upper range of normality in the setting of general practice in Italy. AIM: The aim of this study was to evaluate the prevalence of patients with 'borderline' values of cardiovascular risk factors in Italy. METHODS: Involved physicians were asked to evaluate the first 20 outpatients, consecutively seen in June 2009. Data were collected in a study-designed case-report form, in which physicians identified thresholds rather than reported absolute values of several clinical parameters. High-normal values were defined as follows: blood pressure (BP) 130-140/85-90 mmHg; total cholesterol 180-200 mg/dL; low-density lipoprotein cholesterol (LDL-C) 130-150 mg/dL; high-density lipoprotein cholesterol (HDL-C) 30-40 mg/dL in males and 40-50 mg/dL in females; triglycerides 130-150 mg/dL and fasting glucose 100-110 mg/dL. RESULTS: Fifty-three Italian physicians provided valuable clinical data on 826 individual outpatients, among which 692 (83.7%, 377 women, mean age 60.9 ± 13.2 years, body mass index 26.6 ± 5.0 kg/m2) were included in the present analysis. Prevalence of borderline values of systolic BP and total cholesterol levels were at least comparable with those in the normal limits of the corresponding parameters, whereas prevalence of borderline diastolic BP, LDL-C, HDL-C, triglycerides and fasting glucose levels was significantly lower than that of normal values, but higher than that of abnormal values of the corresponding parameters. CONCLUSIONS: Using this sample of healthy subjects in the setting of general practice in Italy, our results demonstrated a relatively high prevalence of borderline values of cardiovascular risk factors, which was at least comparable with that of normal, but significantly higher than that of abnormal thresholds. These preliminary findings may prompt more extensive investigations in the area of 'borderline' cardiovascular risk. This information may, in fact, potentially enable the design of more effective prevention strategies in the future to limit the burden of cardiovascular disease in the general population in Italy. Received for publication 4 March 2011; accepted for publication 20 April 2011.

Venlafaxine-induced urinary incontinence resolved after switching to sertraline.

The authors report a case of urinary incontinence (UI) that occurred in a woman after administration of venlafaxine. UI resolved after discontinuation of the drug and did not reappear after switching to sertraline therapy. A 56-year-old white woman with a diagnosis of reactive depression developed severe UI after a 30 days' treatment with venlafaxine 75 mg/day. Symptoms resolved without consequence 48 hours after discontinuation of venlafaxine. The patient was then treated with sertraline without experiencing any incontinence episodes. Urinary incontinence is an important medical condition with clinical and social implications. Further studies need to be carried out to clarify the pharmacologic differences between dual and selective 5-HT and norepinephrine reuptake inhibitors on lower urinary tract function.