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Document Reviewers: Luis Alcocer (Mexico), Christina Antza (Greece), Mustafa Arici (Turkey), Eduardo Barbosa (Brazil), Adel Berbari (Lebanon), Luís Bronze (Portugal), John Chalmers (Australia), Tine De Backer (Belgium), Alejandro de la Sierra (Spain), Kyriakos Dimitriadis (Greece), Dorota Drozdz (Poland), Béatrice Duly-Bouhanick (France), Brent M. Egan (USA), Serap Erdine (Turkey), Claudio Ferri (Italy), Slavomira Filipova (Slovak Republic), Anthony Heagerty (UK), Michael Hecht Olsen (Denmark), Dagmara Hering (Poland), Sang Hyun Ihm (South Korea), Uday Jadhav (India), Manolis Kallistratos (Greece), Kazuomi Kario (Japan), Vasilios Kotsis (Greece), Adi Leiba (Israel), Patricio López-Jaramillo (Colombia), Hans-Peter Marti (Norway), Terry McCormack (UK), Paolo Mulatero (Italy), Dike B. Ojji (Nigeria), Sungha Park (South Korea), Priit Pauklin (Estonia), Sabine Perl (Austria), Arman Postadzhian (Bulgaria), Aleksander Prejbisz (Poland), Venkata Ram (India), Ramiro Sanchez (Argentina), Markus Schlaich (Australia), Alta Schutte (Australia), Cristina Sierra (Spain), Sekib Sokolovic (Bosnia and Herzegovina), Jonas Spaak (Sweden), Dimitrios Terentes-Printzios (Greece), Bruno Trimarco (Italy), Thomas Unger (The Netherlands), Bert-Jan van den Born (The Netherlands), Anna Vachulova (Slovak Republic), Agostino Virdis (Italy), Jiguang Wang (China), Ulrich Wenzel (Germany), Paul Whelton (USA), Jiri Widimsky (Czech Republic), Jacek Wolf (Poland), Grégoire Wuerzner (Switzerland), Eugene Yang (USA), Yuqing Zhang (China)., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

The Vobarno Study represents the first observational study aimed to assess in a general population sample the relationship between parameters of cardiac and vascular structure (and function) and blood pressure values, measured in the clinic and during the 24 hours. In the frame of The Vobarno Study blood samples for hematochemistry and DNA extraction, clinic and 24-hour blood pressure measurements, cardiac and carotid ultrasound, and aortic stiffness were measured in all subjects, living in a small town (Vobarno) between Brescia and the Garda Lake (Italy), and randomly selected from electoral roles. In this sample of a general population an extensive evaluation of organ damage, including left ventricular (LV) mass and hypertrophy, LV systolic function, left atrial dimensions and aortic root diameters, carotid intima media thickness (IMT) and carotid plaques, carotid and aortic stiffness were performed. In this study subjects were included in a long follow-up, lasting 25 years, and cardiovascular morbility and mortality were assessed up to 2019. This will allow to update the information related to cardiovascular morbidity and mortality in the study cohort. The present paper will report the results of some analyses performed, exploring epidemiological and clinical aspects of target organ damage.

Introduction: Achieving hypertension control is beneficial regardless of age. Fixed-combination pills have the potential of increasing adherence to treatment, improving the benefit/risk ratio, and simplifying therapy, with resulting convenience especially in the elderly., Aim: We examined real-world antihypertensive treatment adherence and hypertension control rates in a cohort of Italian elderly individuals, enrolled in a prospective, pragmatic awareness-raising campaign on blood pressure (BP)., Methods: 13196 treated hypertensive elderly (mean age 73.2±7.5 years, 55.5% women) were recruited through opportunistic sampling, answered a brief questionnaire on antihypertensive therapy, and were followed-up for 6 months, when BP was measured as per routine care. Controlled hypertension was defined as BP < 140/90 mmHg. Real-world treatment adherence and hypertension control rates were evaluated at 6 months according to different treatment patterns (fixed-dose versus free combinations), using Yates correction for continuity to assess likelihood estimates for differences between treatments., Results: 10551 participants (80%) were on a single-pill therapy and 3445 were on a fixed combination therapy of two (24.8%) or three (1.3%) drugs. Individuals on a fixed combination therapy were more adherent to treatment than the counterparts (p < 0.001). Full adherence increased with the number of drugs/pill among single-pill users (47.5%, 68.5%, and 100% with 1, 2, or 3 drugs/pill; p < 0.001). Hypertension control rates were 70% and 65.2% (p = 0.001) according to fixed or free combinations of two drugs and 71% and 63.9% (p = 0.321) for fixed or free combinations of three drugs., Conclusions: Real-world data suggest that simplified treatment strategies and use of fixed combinations improve adherence to antihypertensive therapy and BP control in the elderly., (© 2021. The Author(s).)

Background: Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents., Methods: The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses., Results: Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings., Conclusion: Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

Introduction: The aim of the study was to assess the age-specific, sex-specific, and region-specific average sodium and potassium intake and its association with anthropometric characteristics in a sample of the Italian adult hypertensive population., Methods: A total of 1232 hypertensive patients were recruited consecutively by 47 centers recognized by the Italian Society of Hypertension. The enrolled participants were on stable antihypertensive treatment. Anthropometric indices, blood pressure, 24-h urinary sodium, and potassium excretion were measured and used as proxy for the average daily sodium and potassium intake., Results: The average sodium intake was 172  mmol (or 10.1  g of salt/day) among men and 138 (or 8.1) among women, with no difference among geographical areas. Over 90% of men and 81% of women had a consumption higher than the recommended standard dietary intake of 5  g/day. The average potassium intake was 63 and 56  mmol, respectively in men and women, again without geographical differences, nearly 92% of men and 95% of women having an intake lower than the recommended intake (100  mmol/day or 3.9  g/day). There was a significant trend to a gradual decrease in sodium intake with age in both sexes (P <0.001). There was also a direct association between BMI and sodium intake in both sexes, this association being independent of age (P < 0.001)., Conclusion: In this national sample of the Italian hypertensive population, dietary sodium intake was largely higher and potassium intake much lower than the recommended intakes, and this was true for all geographical areas. Overweight and obese hypertensive patients had particularly high sodium intakes.

Unlabelled: The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet., Methods: We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04., Results: The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines., Conclusions: Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the National Health Service and patients, considering that the price difference between brand and generic drugs is completely charged on patients.

Observational studies demonstrate that the proportion of treated hypertensive patients who attain the recommended blood pressure goals (140/90 mmHg) does not exceed 30-40%. Conversely, clinical trials have consistently shown that effective blood pressure control within the recommended targets can be achieved in 70-80% of treated hypertensive patients with different cardiovascular risk profile, especially when appropriate, effective and well tolerated combination therapies are used. In order to bridge the gap between current and optimal blood pressure control rates and to achieve a more effective cardiovascular prevention, the Italian Society of Hypertension has recently developed an interventional strategy that aims to approximate 70% of treated controlled patients by 2015. This ambitious goal can be realistically achieved by the appropriate use of modern aids and tools, also including the implementation of combination therapy, especially if this approach can be simplified into a single pill, now available in Italy. At present, 70-80% of hypertensive patients require combination therapies based on at least two classes of antihypertensive drugs to achieve the recommended blood pressure goals. It is therefore of paramount importance to implement this strategy in routine clinical practice. Among the different combination therapies, the use of combination strategies based on drugs inhibiting the renin-angiotensin system, such as angiotensin receptor blockers and angiotensin-converting enzyme inhibitors, combined with diuretics and/or calcium-channel blockers, have demonstrated to significantly reduce the rates of major cardiovascular events and discontinuations from prescribed therapies, resulting in higher antihypertensive efficacy and better tolerability than monotherapy. The present document of the Italian Society of Hypertension aims to provide main indications for implementing combination therapy in the clinical management of hypertension in order to improve blood pressure control in Italy.

Aim: To perform a genetic screening for the multiple endocrine neoplasia type 1 (MEN1) gene mutations in patients affected by an apparently sporadic form of the disease, referred to an internal medicine unit of a large general hospital., Subjects and Methods: In a group of 12 consecutive patients presenting clinical features of MEN type 1 syndrome, we performed a genetic screening for germline MEN1 gene mutations, including complete sequencing of the coding region (exons 2 to 10) and multiplex ligation-dependent probe amplification analysis for large deletion detection., Results: Among these patients affected by apparently sporadic MEN type 1 syndrome, a targeted clinical history could detect indirect support for a diagnosis of familial condition only in 2 cases. The genetic screening identified pathogenic germline MEN1 gene mutations in 3 patients (25%). A previously unknown 18 base-pair deletion within exon 3, c.564&#95;581delCAATGGGGAGCAGACAGC, resulting in loss of 6 amino acids (pAsp189&#95;Ala194del), was found in heterozygosis in a woman affected by primary hyperparathyroidism and multifocal pancreatic neoplasia., Conclusions: Our results underscore the importance of performing genetic testing also in apparently sporadic MEN1 patients and extend the list of molecular variants leading to inactivation of the MEN1 gene.

In addition to the prevention and treatment of macro- and microvascular complications, management goals for patients with type 2 diabetes include reducing the risk of cardiovascular events with a view to improving quality of life. A number of epidemiological and observational cohort studies have been published in Italy and France in an effort to determine the patient profile of individuals with type 2 diabetes in these countries and to gather data on current clinical practice and prescribing patterns. The results of the studies confirm that cardiovascular risk factors, such as hypertension and elevated cholesterol, commonly occur in patients with type 2 diabetes and that these co-morbid conditions are not well controlled. As a consequence, both macro- and microvascular complications are prevalent in this patient population. It is clear that the management of type 2 diabetes in France and Italy is suboptimal. In both primary and specialist care, treatment guidelines need to be reinforced and a more aggressive approach needs to be adopted in the treatment of modifiable cardiovascular risk factors and in particular hypertension. Collectively, the available data highlight the importance of managing global cardiovascular risk within the context of diabetes care. Greater adherence to therapeutic targets recommended in guidelines will ensure that greater proportions of patients attain these treatment goals thereby reducing diabetes-related morbidity and mortality.

Unlabelled: The association of headache and arterial hypertension is still controversial, although headache is usually considered a symptom of hypertension. The aim of this study is to evaluate the prevalence of headache in a general population sample and the relationship with arterial hypertension, as diagnosed by office measurements and ambulatory monitoring of blood pressure (BP)., Patients and Methods: In the randomized sample of the Vobarno population, 301 subjects (126 males, 175 females, age range 35-50 years) underwent a structured standardized headache questionnaire, office and 24-h ambulatory BP monitoring., Results: Prevalence of lifetime headache and of migraine was greater in females than in males. Office and 24-h BP values did not differ between subjects without headache and subjects with headache. No differences in headache prevalence (58% vs 55%), migraine prevalence (32% vs 28%) and use of analgesic drugs in the presence of headache (82% vs 78%) were observed between hypertensive patients (93.5% newly diagnosed, 6.5% treated) and normotensive subjects., Conclusions: In a general population sample, hypertension (diagnosed by office and/or 24-h BP) is not associated with headache.

Background and Aim: The need to update tools for the estimate of cardiovascular risk prompted the "Gruppo di Ricerca per la Stima del Rischio Cardiovascolare in Italia" to produce a new chart and new software called Riskard 2005., Methods and Results: Data from 9 population studies in 8 Italian regions, for a grand total of 17,153 subjects (12,045 men and 5,108 women) aged 35-74 and for a total exposure of about 194,000 person/years were available. A chart for the estimate of cardiovascular risk (major coronary, cerebrovascular and peripheral artery disease events) in 10 years was produced for men and women aged 45-74 free from cardiovascular diseases. Risk factors employed in the estimate were sex, age (6 classes), systolic blood pressure (4 classes), serum cholesterol (5 classes), diabetes, and cigarette smoking (4 classes). Estimates were produced for absolute risk and for relative risk, the latter against levels expected in the general population that produced the risk functions. Software was produced for the separate estimate of major coronary, cerebrovascular and cardiovascular events (the latter made by coronary, cerebrovascular and peripheral artery disease of atherosclerotic origin) for follow-up at 5, 10 or 15 years, in men a women aged 35-74 years at entry and free from cardiovascular diseases. Risk factors employed here were sex, age, body mass index, mean physiological blood pressure, HDL cholesterol, non-HDL cholesterol, cigarette smoking, diabetes and heart rate. The output is based on several indicators: absolute risk, relative risk (as defined above), ideal risk (for a very favourable risk profile), biological age of risk, comparisons among the above indicators, the percent contribution of risk factors to the excess of estimated risk above the level of the ideal risk, and the description of trends in risk estimate in relation to repeated measurements., Conclusions: These tools represent progress compared to similar tools produced some years ago by the same Research Group.

The angiotensin II type 1 (AT1) receptor has a key role in mediating the vasoconstrictor and growth-promoting effects of angiotensin II. It has been reported that a polymorphism of the AT1 receptor gene (an A/C transversion at position 1166) may be associated with cardiovascular phenotypes, such as arterial blood pressure and aortic stiffness, that underlie a condition of increased cardiovascular risk. We examined a sample of 212 subjects randomly selected from a general population in northern Italy to investigate the role of AT1 receptor gene polymorphism, in the regulation of blood pressure and cardiovascular growth. We measured blood pressure (both clinic and 24-hour ambulatory recording), left ventricular mass (echocardiography), and carotid artery wall thickness (B-mode ultrasound); we assessed the AT1 receptor genotype by polymerase chain reaction and allele-specific oligonucleotide hybridization. Blood pressure values were lower in CC homozygotes than in heterozygotes and AA homozygotes; the difference was statistically significant for clinic measurements (mean difference for mean blood pressure, -6.6 mm Hg, P = .01; 95% confidence interval, -1.6 to -11.7 mm Hg) but not for ambulatory blood pressure measurements. CC homozygotes also presented a lower incidence of a positive family history of hypertension (P = .027). No statistically significant differences among AT1 receptor A/C1166 genotypes were observed for left ventricular mass or carotid artery wall thickness. We conclude that the present study does not support a major role of the AT1 receptor gene A/C1166 polymorphism as a marker of conditions associated with increased cardiovascular risk.