Alexithymia Increases Pericranial and Cervical Muscle Tenderness in Women with Migraine.

Background/Objectives: Alexithymia is characterized by a deficit in identifying and communicating feelings. Emerging evidence suggests that alexithymia is highly prevalent in migraine, in a complex interplay with psychiatric comorbidity. Pericranial/cervical muscle tenderness is a remarkable clinical feature in a large proportion of migraine patients. This pilot study aimed at investigating the relationship between alexithymia and pericranial/cervical muscle tenderness in female migraineurs. Methods: A total of 42 female patients fulfilling the diagnostic criteria for migraine were enrolled into this pilot, observational, cross-sectional study after informed consent was obtained. Each patient underwent a psychological assessment to identify any alexithymia by means of TAS-20, anxiety/mood comorbidity (by means of STAI-Y1 STAI-Y2, BDI-II), and migraine-related disability (by means of HIT-6), and a physical cranial/cervical musculoskeletal examination. Palpation of pericranial and cervical muscles was carried out in the standardized manner. A Cumulative Muscle Tenderness (CUM) score (0-6) was calculated for each patient. A multivariate analysis was performed to investigate any association amongst the TAS-20 score, the CUM score, and the following covariates: BDI-II, STAI-Y1, STAI-Y2, and HIT-6 scores, age, disease duration, monthly migraine days, and average head pain intensity in the previous three months. Results: Overall, 35.6% of the sample had alexithymia. The multivariate analysis detected a linear and independent relationship between the TAS-20 and CUM scores, with a statistically significant (p = 0.017) association. Conclusions: This pilot study suggests that alexithymia plays a role in increasing pericranial/cervical muscle tenderness in migraine, independently from psychiatric comorbidity. A novel therapeutical approach, targeting alexithymia, may well reduce muscular tenderness in female migraineurs.

Performance assessment across different care settings of a heart failure hospitalisation risk-score for type 2 diabetes using administrative claims.

Predicting the risk of cardiovascular complications, in particular heart failure hospitalisation (HHF), can improve the management of type 2 diabetes (T2D). Most predictive models proposed so far rely on clinical data not available at the higher Institutional level. Therefore, it is of interest to assess the risk of HHF in people with T2D using administrative claims data only, which are more easily obtainable and could allow public health systems to identify high-risk individuals. In this paper, the administrative claims of > 175,000 patients with T2D were used to develop a new risk score for HHF based on Cox regression. Internal validation on the administrative data cohort yielded satisfactory results in terms of discrimination (max AUROC = 0.792, C-index = 0.786) and calibration (Hosmer-Lemeshow test p value < 0.05). The risk score was then tested on data gathered from two independent centers (one diabetes outpatient clinic and one primary care network) to demonstrate its applicability to different care settings in the medium-long term. Thanks to the large size and broad demographics of the administrative dataset used for training, the proposed model was able to predict HHF without significant performance loss concerning bespoke models developed within each setting using more informative, but harder-to-acquire clinical variables.

General population screening for atrial fibrillation with an automated rhythm-detection blood pressure device.

BACKGROUND: Screening strategies to diagnose previously undetected atrial fibrillation (AF), especially silent AF (SAF), in at-risk populations may help reduce the number of strokes. We prospectively assessed the incidence rate of AF, including SAF, using an automated AF-detection capable sphygmomanometer in the General Practitioner (GP) setting. METHODS: This was a population-based prospective study of unselected general population of ≥65 years without prior AF. Participating GPs were requested, in the period February 2018-April 2019, to record all AF diagnoses including those derived from the AF-detection capable sphygmomanometer and confirmed by 12­lead ECG or ECG Holter in asymptomatic patients. RESULTS: Overall, 14,987 patients assisted by 76 GPs accumulated 16,838 patient-years of follow up. The incidence rate of AF was 2.25% patient-years (95%CI 2.03-2.48). AF was more frequently detected in male, older, overweight, and patients with prior stroke, congestive heart failure, and chronic kidney disease. One in four patients had device-detected SAF (0.56% patient-years, 95%CI 0.46-0.69). Age, overweight, and the number of annual visits, were independent predictors of both SAF and AF. In addition, congestive heart failure, mitral valve disease were independent predictors of AF. Due to the interaction between blood pressure and age the risk of AF increased exponentially after 75 years of age in patients with higher systolic blood pressure values. CONCLUSION: We found a higher than previously reported incidence rate of AF possibly by capturing SAF. Our simple protocol might be feasible in large-scale screening for AF and SAF in routine GP care.

Prevalence of frailty in older people in Veneto (Italy).

Context: Both frailty and multimorbidity are strong predictors of clinical endpoints for older people. In Italy, the interventions targeting chronicity are mainly based on the treatment of diseases: sufficient epidemiological literature is available about these strategies. Less is known about the territorial distribution of the frailty status. Aims: To estimate the prevalence of frailty in older people (65+) and to evaluate the relationship between frailty and multimorbidity. Methods and material: A group of general practitioners working in Veneto (Italy) was enrolled on a voluntary basis. Older individuals were both community dwelling and institutionalized patients, that is, the older people normally followed by Italian general practitioners. A centrally randomized sample was extracted from the pool of physician-assisted elderly. Each doctor evaluated the frailty status through the CSHA Clinical Frailty Scale and the multimorbidity status through the Charlson score (Frailty = CSHA Clinical Frailty Scale's score >4; serious multimorbidity = Charlson score ≥4). Prevalence and its confidence interval (CI) 95% were evaluated through the Agresti's method for proportions. The relation between frailty and multimorbidity was studied through a logistic regression model adjusted for age and sex. Results: Fifty-three physicians were enrolled, whose population of elderly individuals (N = 82919) was highly representative of the population of Veneto. The prevalence of frailty in the randomized sample of 2407 older people was 23.18% (CI 95%: 21.53%-24.91%). Sex was shown to be a strong predictor of frailty (female status OR = 1.58 p < .0001) and multimorbidity was shown to be an independent predictor only for individuals <85 years of age. Conclusions: In Veneto, more than 20% of elderly people are frail. Physicians should pay close attention to frailty and multimorbidity because both are important prognostic factors toward clinical endpoints relevant to territorial care. The CSHA Clinical Frailty Scale (easy and quick) should become part of their professional routine.

The burden of frailty in older people visiting GPs in Veneto and Sicily, Italy.

Context: In Italy, little is known about the territorial distribution of the frailty status. Aims: To compare frailty- and multimorbidity-prevalence in the elderly population of two Italian regions. Methods: This study examined randomized samples of elderly (both community dwelling and institutionalized) assisted by general practitioners. Frailty was evaluated through the CSHA-Scale, multimorbidity through the Charlson-Score. The relation between frailty and multimorbidity was studied through a logistic model. Both crude and standardized prevalences were calculated. Results: One hundred and sixteen physicians assisted 176,503 patients highly representative of Italian people. In a randomized sample of 4,531 older people, the sex-age-standardized prevalence of Frailty (standard population: Italy) was 25.74% (24.63-26.85%). Age-standardized prevalence for males was 20.08% (18.46-21.71%) and 30.00% (28.54-31.57%) for females. Using the sex-age-standardization pooled sample, the prevalence of frailty was significantly higher in Sicily than Veneto (28.74% [27.03-30.46%] vs 22.30% [20.94-23.67%]. This study did not find differences in the prevalence of multimorbidity: Veneto 20.76% (19.21-22.31%); Sicily 22.05% (20.33-23.77%). Both "to be female" and "to live in Sicily" were shown to be predictors of frailty OR for being female = 1.64 (1.42-1.88); OR for living in Sicily = 1.27 (1.11-1.46). Multimorbidity was an independent frailty-predictor only for those aged < 85: OR of Charlson Index ≥ 4 for ages < 85 = 3.44 (2.88-4.11), OR for ages ≥ 85 = 1.44 (0.97-2.12). Limitations: (1) This study considered patients assisted by doctors, not a random sample of the general population. (2) The cross-sectional nature of the study limits the interpretation of the relationships between frailty and multi-morbidity. (3) Few covariates were available for our multivariate models. Conclusions: More than 1/4 of elderly persons are shown to be frail (1/5 of males and 1/3 of females). Frailty is more frequent in Sicily, while multimorbidity does not differ between the two regions. This could be due to regional differences in the organization of care networks dedicated to elderly patients.

The systematic review of randomized controlled trials of PCSK9 antibodies challenges their "efficacy breakthrough" and the "lower, the better" theory.

BACKGROUND: A Cochrane review with meta-analysis showed controversial results about the efficacy of PCSK9 antibodies in the prevention of cardiovascular diseases. This review gives the opportunity to test the relationship between LDL-C levels and cardiovascular events. METHODS: The authors analyzed the relationship between the calculated LDL-C lowering and the risk of all-cause mortality, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, any adverse event, cardiovascular events and cardiovascular disease mortality. RESULTS: No beneficial relationship was found between LDL-C lowering and cardiovascular events explored by meta-regression; instead, there was a trend toward harm. For any of the other outcomes there was no significant association between LDL-C lowering and risk. Furthermore, the authors calculated the efficacy that would be expected through the LDL-C lowering showed in the meta-analysis, considering widely accepted predictions. These were respected only for stroke, while the observed efficacy on other cardiovascular events was significantly lower than the expected, and no significant result was observed at all for fatal outcomes. A separate meta-analysis of trials recruiting familial hypercholesterolemia patients have showed a tendency to harm for almost all outcomes. CONCLUSIONS: The relationship between LDL-C lowering and cardiovascular events has not showed any significant association (and even a tendency toward harm), challenging the "lower the better" theory. A separate meta-analysis of trials recruiting familial hypercholesterolemia patients has showed a tendency to harm for all outcomes with PCSK9 antibodies. Therefore, at the moment, the data available from randomized trials does not clearly support the use of these antibodies.

[A cross-sectional survey to evaluate the cardiovascular risk profile in subjects referred to the Verona-ASL 20 general practitioners]. / Indagine trasversale per la valutazione del profilo di rischio cardiovascolare nella popolazione di soggetti assistibili afferenti ai medici di medicina generale nell'area della ASL 20 di Verona.

BACKGROUND: Most of the studies on the identification of cardiovascular risk factors have been conducted either in northern Europe or in the United States. However, genetic as well as dietary factors may vary across different countries and geographical areas and there are few data about the cardiovascular risk profile in our country. METHODS: A sample of 3144 subjects (1463 males, 1681 females aged 35-74 years) were randomly selected among the population qualifying for healthcare assistance, registered with 170 general practitioners. Demographic data, clinical information, lab tests and current pharmacological treatments were collected using an electronic case report form. RESULTS: The prevalences of cardiovascular risk factors in the population were: smoking habit 22.7%, obesity 12.8%, hypertension 39.2%, hypercholesterolemia 25.5%, hyperglycemia and diabetes 5.5%. Thirty-five point four percent of the subjects presented a low absolute 10-year cardiovascular risk level (< 5%), 31.1% an intermediate risk (5-9%), 24.9% a moderate risk (10-19%), and 8.6% a high risk (> or = 20%) of developing cardiovascular diseases. CONCLUSIONS: In the area of Verona approximately 20,000 out of 231,592 subjects, aged 35-74 years, may present an absolute 10-year cardiovascular risk level > or = 20%. These results represent the epidemiological basis for planning and implementing preventive interventions toward cardiovascular diseases.

Clinical efficacy and safety of Ezetimibe on major cardiovascular endpoints: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Randomized clinical trials (RCTs) about Ezetimibe's efficacy on patient-oriented outcomes have given discordant results. The aim of this study was to determine the net effect of Ezetimibe and of the widely marketed combination, Ezetimibe+simvastatin, on mortality and morbidity outcomes. METHODS AND FINDINGS: We searched for RCT on Ezetimibe using MEDLINE, CCTR, EMBASE, ClinicalTrials.gov databases up to December 2013, Merck and Novartis online registers, and personal communications. Two authors independently selected trials fulfilling these criteria: RCTs comparing Ezetimibe±statin or another lipid-lowering drug against placebo, or against the same lipid-lowering drug at the same dosage, with a follow-up at least 24 weeks and one or more of these outcomes: all-cause mortality, cardiovascular (CV) mortality, stroke, myocardial infarction (MI), cancer, serious adverse events (SAEs); we assessed the risk of bias using the Cochrane checklist. We extracted the data for major clinical events as a dichotomous measure, with the patient the unit of analysis. Pooled analysis was done with random and fixed effect based models. Trials comparing Ezetimibe plus a lipid-lowering drug against the same lipidlowering drug representing the net effect of Ezetimibe, showed a nonsignificant tendency toward damage for cancer, MI, stroke and SAEs. Ezetimibe+simvastatin vs. simvastatin alone showed a stronger tendency towards a higher risk for all-cause death (2.52; 0.65-9.74), CV death (3.04; 0.48-19.21), non-CV death (3.03; 0.12-73.50), MI (1.91; 0.42-8.70), stroke (2.38; 0.46-12.35), cancer (RR 11.11; 0.62-198.29), and SAEs (1.45; 0.95-2.23). Limitations include small numbers of events and inadequate power of the pooling. Trials comparing Ezetimibe+simvastatin vs placebo showed non-significant effects: MI (0.81; 0.66-1.00 p = 0.051), all-cause death (1.02; 0.95-1.09), CV death (0.91; 0.80-1.04), non-CV death (108; 0.99-1.18), stroke (0.86; 0.72-1.04), cancer (1.18; 0.80-1.74), SAEs (1.01; 0.96-1.06). CONCLUSIONS: Ezetimibe±simvastatin had inconsistent effects on important outcomes. No firm conclusions are possible, but findings indicative of damage suggest much more selective use of Ezetimibe±simvastatin.

[Patients with heart failure in the last year of their life: the primary care perspective]. / I pazienti con scompenso cardiaco nell'ultimo anno di vita: il punto di vista della Medicina Generale.

BACKGROUND: The care of end-stage patients with heart failure (HF) represents a substantial cost and a relevant workload for health professionals and caregivers. Studies performed in out-of-hospital settings are limited. We aimed to provide data about management in primary care and professional needs of general practitioners (GPs). METHODS: One hundred fifty-one GPs provided information about patients with HF who died (whatever the cause) in the previous 365 days: a) where they died, b) cause of death, c) number and cause of hospital admission, d) who was mainly in charge of the patient during the year preceding death, e) place where patients were mainly cared for, f) relevant diseases other than HF. GPs were also requested to express their personal opinion about their professional needs. RESULTS: GPs identified 245 patients (mean age 83.8 ± 8.76 years, range 48-103, 53.9% female). The place of death was hospital (46.5%), home (42.9%), nursing home (4.9%), hospice (1.6%). Fifty percent of patients died of worsening HF, 14% of sudden death, 23% of noncardiovascular diseases. In the last year of life, 193 (78.8%) patients were hospitalized, 149 (60.8%) for HF. GPs were responsible for care in the majority of patients. Total number of hospitalizations was the only variable significantly associated with death in hospital. GPs reported clinical or organizational problems in 58.4% of cases. CONCLUSIONS: The care of HF patients is mostly home-based and provided by families and GPs. GPs often need simple and inexpensive cardiological and organizational support.

The care for chronic heart failure by general practitioners. Results from a clinical audit in Italy.

BACKGROUND: In Italian primary care, chronic heart failure (CHF) patients are mainly managed by general practitioners (GPs). However, there are few studies analysing CHF management challenges in primary care and identifying opportunities for improvement. OBJECTIVES: To describe CHF care as implemented by GPs in the Veneto Region and to identify opportunities for improvement. METHODS: In 2008, using an audit process, 114 Venetian GPs analysed their electronic health records, identified CHF patients and collected clinical and care related information: prevalence, co-morbidity, caring conditions, diagnostic and therapeutic management, and hospitalization. After two training sessions, data on pharmacotherapy were analysed again in 2009. RESULTS: The prevalence of CHF was 1.2% (95% CI: 1.1-1.3%). Diagnostic echocardiography was used in 57% of cases. At baseline, the proportions of patients that used specific medication were: diuretics 88%; angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) 77%, beta-blockers 46% and anti-aldosterone agents 32%. After two training sessions, the use of ACE inhibitors/ARB and beta-blockers increased to 80% and 56%, respectively. Renal failure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and dementia were the most prevalent concomitant diseases, posing specific management problems. Half of the patients were generally visited at home; they were dependent on some kind of care given. CONCLUSION: In Veneto a large number of CHF patients are mainly managed by GPs. Further improvements are necessary to meet standards of care with regard to diagnosis, medication, follow-up and home care. The care situation affected hospitalization and the quality of follow-up visits.