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Background and Objective: This study aimed to compare the prescribing patterns of paracetamol in COVID-19 with those for similar respiratory conditions and investigated the association between paracetamol use and COVID-19-related hospitalization/death., Methods: Using a primary care data source, we conducted a cohort study to calculate the incidence rate of paracetamol use in COVID-19 and for similar respiratory conditions in 2020 and 2019 (i.e. pre-pandemic phase), respectively. In the study cohort, we nested a case-control analyses to investigate the association between paracetamol use and COVID-19-related hospitalizations/deaths., Results: Overall, 1554 (33.4 per 1000) and 2566 patients (78.3 per 1000) were newly prescribed with paracetamol to treat COVID-19 or other respiratory conditions, respectively. Those aged 35-44 showed the highest prevalence rate (44.7 or 99.0 per 1000), while the oldest category reported the lowest value (17.8 or 39.8 per 1000). There was no association for early (OR = 1.15; 95% CI: 0.92-1.43) or mid-term (OR = 1.29; 95% CI: 0.61-2.73) users of paracetamol vs. non-users. Instead, the late users of paracetamol showed a statistically significant increased risk of hospitalization/death (OR = 1.75; 95% CI: 1.4-2.2)., Conclusions: Our findings provide reassuring evidence on the use and safety profile of paracetamol to treat early symptoms of COVID-19 as in other respiratory infections., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Background General practitioners often deal with patients suffering acute musculoskeletal disorders. Paracetamol, non-steroidal anti-inflammatory drugs, and opioids are the most prescribed medications, according to pain intensity and patient's features. Combinations of different analgesics can be adopted to enhance pain relief, but only one fixed-dose combination has been recently launched to treat acute musculoskeletal pain. Objective This study aimed to investigate the effectiveness of ibuprofen plus paracetamol (fixed-dose) combination compared to other analgesics in preventing musculoskeletal pain persistence. Setting Italian outpatients' data extracted from a national general practice database. Method A retrospective cohort study was conducted on the Health Search Database. Patients prescribed with analgesics for acute musculoskeletal painful conditions were considered (i.e., non-chronic painful conditions, identified using a query validated by two expert General Practitioners (GPs)). For each patient, the first prescription of an analgesic was defined as index date. A new GP's visit related to musculoskeletal disorders in the first 3 months following the index date was defined as "pain persistence". Main outcome measure Risk of pain persistence among users of the ibuprofen plus paracetamol combination compared to other systemic analgesics. Results Overall, 102,216 patients were treated with systemic analgesics for acute musculoskeletal disorders. Most patients were middle-aged or elderly women. 939 (0.92%) patients were prescribed with the fixed-dose ibuprofen plus paracetamol combination for a mean duration of 7.23 ± 2.68 days, mainly for low back pain and cervicalgia. Musculoskeletal pain persistence was found in 22,125 (21.65%) patients. Compared to other systemic analgesics, the ibuprofen plus paracetamol combination resulted significantly more effective in preventing pain persistence (adjusted hazard ratio 0.72, 95% confidence interval 0.61-0.85). Conclusion These findings suggest that the fixed-dose ibuprofen plus paracetamol combination might be effective in controlling musculoskeletal pain persistence., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature.)

Background: Iron deficiency is a major cause of anemia in older people. Increasing the knowledge on the predictors of iron-deficiency anemia (IDA) may facilitate its timely diagnosis., Aim: To investigate the predictors of IDA in older people in four European countries., Design and Setting: Retrospective longitudinal study. Primary care patients aged 65 or older (N = 24,051) in four European countries., Methods: IDA predictors were estimated using multivariate Cox regression based on information gathered from national primary care databases: Italy (years 2002-2013), Belgium, Germany and Spain (years 2007-2012). Adjusted hazard ratios (aHR) with 95% confidence intervals (CIs) were estimated., Results: In Spain and Belgium, men were at greater risk of IDA than women, while they had a lower risk in Italy. Weakness, irritability, alopecia and xerostomia were signs and symptoms significantly associated with IDA. Concurrent diseases, potential causes of anemia, positively associated with IDA were small bowel polyposis, stomach cancer, obesity, gastritis and peptic ulcer, esophagitis, Crohn's disease, celiac disease, lymphangiectasis, gastrectomy or gastric atrophy, gut resection or bypass, and cardiac prosthetic valve. Aspirin users had a 12-35% higher hazard of IDA than non-users. Similarly, corticosteroids and anti-acids were positively associated with IDA. A higher level of comorbidity was associated with an increased hazard of IDA in all countries., Conclusions: Specific signs and symptoms, chronic conditions, a greater comorbidity burden, and specific pharmacological treatments registered in primary care databases represent relevant predictors and correlates of incident IDA in older people in Europe. General practitioners might employ this information to obtain early diagnosis of IDA in community-dwelling older adults.

Idiopathic pulmonary fibrosis (IPF) is a chronic disease with unknown etiology and poor prognosis. Little is known about the epidemiology of this disease; most of the studies are limited by small and restricted cohort studies. We aim to investigate the epidemiology of IPF in the Italian primary care setting using the Health Search Database (HSD) between January 2002 and June 2017. In an attempt to define cases of IPF we adopted iterative combinations of International Classification of Diseases Ninth Revision (ICD-9-CM) and other clinical investigations according to three different operational Algorithms. Incidence and prevalence rate, according to the three Algorithms defining IPF, were calculated and the association with candidate determinants [sex, age, gastro-esophageal reflux (GERD) and smoking status] was evaluated. We identified 1,104,307 eligible patients. The prevalence rate of IPF varies between 2.6 to 24.3 per 100.000 person-year, using algorithm 1 and from 0.8 to 7 using algorithm 3. The incidence rate of IPF varies between 1.25 and 3.77 per 100.000 person-years, using algorithm 1 and from 0.10 to 1.61 using algorithm 3. The mean adjusted incidence rate ratio of IPF, using algorithm 1, is 2.33 (95% CI 2.11-2.57) per 100.000 person-years. Over the study years, the trend of prevalence was statistically significantly increasing while the incidence rate started to increase in the last 3 years. The analyses on candidate determinants showed that patients aged 61 years or older, those suffering from GERD, and former smokers were statistically significantly at greater risk of incurring IPF. To our knowledge, this is one of the first European IPF epidemiological studies conducted in primary care. The increase of the incidence rates is likely due to a growing awareness for IPF among General Practitioners, while the increase of prevalence rates may be due to an increase of survival, a result of recent advances in the diagnosis, management and therapies for the disease.

Objectives: To describe NSAID utilization for musculoskeletal conditions in a large cohort of Italian elderly with cerebro/cardiovascular disease, a population in which NSAIDs should be generally avoided due to the prothrombotic potential., Methods: Administrative data from five Italian geographic areas were analyzed. Patients aged ≥ 65 with a cerebro/cardiovascular event recorded between 2008 and 2011 (cohort entry) were selected. Prescription NSAIDs reimbursed for musculoskeletal conditions and dispensed during 1 year follow-up were retrieved to describe (i) prevalence of use, (ii) average amount of defined daily doses of NSAIDs claimed by users per day of follow-up, and (iii) distribution of the received daily dose (RDD) among patients with ≥ 2 dispensings. Among new users, i.e., patients without NSAID dispensings during 2 years before cohort entry, the first dispensed NSAID molecule was observed., Results: Overall, 511,989 patients were selected. Across the five geographic areas, prevalence of use ranged from 48 to 21% and average consumption ranged between 30 and 67 DDD/1000 users/day. Around 10% of patients in the overall cohort had a RDD > 1. Nimesulide (9.6%) and diclofenac (7.5%) had the highest prevalence of use. The most consumed NSAIDs were nimesulide and coxibs with 10.6 and 7.5 DDD/1000 users/day, respectively. Among new users recruited in 2011, 30% had diclofenac or a coxibs as the first prescription., Conclusions: NSAID use was common in the study cohort, particularly in central-southern areas. In contrast with current recommendations, coxibs and diclofenac were among the most prescribed active principles, even in new users. Interventions to promote appropriateness of use are warranted.

Recent studies show that the risk of cardiovascular adverse events for certain traditional non-steroidal anti-inflammatory drugs (NSAIDs) is similar to that of rofecoxib. While these results are focused on ischemic cardiomyopathy, there is little evidence concerning the risk of ischemic stroke/transient ischemic attack and hemorrhagic stroke. Additionally, there is no information on nimesulide and ketoprofen, the most frequently prescribed NSAIDs in Italy, along with diclofenac. This study aims to determine whether the use of NSAIDs is associated with an increased risk of cerebrovascular events in Italy. We performed a case-control analysis nested in a cohort of patients with osteoarthritis between 2002 and 2011 who were newly treated with NSAIDs. The patients were followed until December 31, 2012. Conditional logistic regression was used to estimate odds ratios (ORs) with 95% confidence intervals (95% CI) of cerebrovascular events (index date) associated with current (until 30 days before the index date), recent (31-365 days) and past (>365 days) use of NSAIDs. Within a cohort of 29,722 patients, 1566 cases (1546 matched with controls) were identified (incidence rate = 11.0/1000 person-years). The overall rate of cerebrovascular event was not elevated with current NSAIDs overall when compared with past use. Among individual NSAIDs, diclofenac and ketoprofen were the molecules significantly associated with an increased rate of cerebrovascular events (OR = 1.53; 95% CI 1.04-2.24; OR = 1.62; 95% CI 1.02-2.58, respectively). The most frequent event was hemorrhagic stroke following the use of ketoprofen (OR = 2.09; 95% CI 1.05-4.15). Diclofenac and ketoprofen seemed to increase the risk of cerebrovascular events. These findings might influence the choice of NSAIDs according to patient characteristics.

Purpose: Osteoporosis is a chronic disease of the bone, whose incidence increases progressively with aging. The main consequences of osteoporosis are fragility fractures, which have considerable medical, social, and economic implications. Adequate treatment of osteoporosis must be considered as a compelling public health intervention. Bisphosphonates (BPs) represent the most significant advance in this field in the past decade, and they are widely used in the treatment of osteoporosis. However, evidence for their effectiveness is limited to secondary prevention, whereas their effect in primary prevention is uncertain and needs further investigation., Methods: Using administrative data collected in the "Biphosphonates Efficacy-Safety Tradeoff" (BEST) study, a nested case-control study was conducted by including 56,058 participants, aged 55 years who were started on oral BPs from 2003 to 2005. Cases were the 1,710 participants who were hospitalized for osteoporotic fractures until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio of fracture associated with categories of treatment duration., Results: Compared with participants assuming BPs for less than 1 year, those who remained on therapy for at least 2 years had a 21% (95% confidence interval (CI) 7 to 33%) fracture risk reduction., Conclusion: This study provides evidence that BPs, dispensed for primary prevention of osteoporotic fractures, are associated with a reduced risk of osteoporotic fractures after at least 2 years of treatment.

Background: Despite the high use of antidepressants (ADs) among the elderly, there is limited information about the prescribing pattern of these drugs in the Italian elderly population. The aim of this study was to analyze the trend in the use of ADs in the Italian elderly patients in the years 2003-2009, and specifically, to evaluate rates and predictors of AD treatment discontinuation in depressed older patients., Methods: The nationwide general practice Health Search Database (HSD) was used to identify AD users aged 65 years old and over from 2003 to 2009. ADs were categorized as (1) selective serotonin reuptake inhibitors (SSRIs); (2) serotonin-norepinephrine reuptake inhibitors (SNRIs); (3) tricyclic antidepressants (TCAs); (4) noradrenergic and specific serotonergic antidepressants (NaSSAs); and (5) other ADs. Incidence and prevalence of AD use per 1,000 inhabitants was calculated by drug class and single compound. We also measured rates and predictors of AD discontinuation (i.e., treatment gap ≥ 60 days) during the first year of therapy., Results: Overall, 39,557 AD users ≥65 years (17 % of the total HSD elderly population) were included in the study. SSRIs were increasingly and most frequently prescribed ADs (102.7-195.3 per 1,000 over seven years). The most common indications for AD use were depression and anxiety. Overall, 14 % of AD users continued their AD medication without treatment gaps, 27 % were intermittent AD users and 58 % discontinued their ADs during the first year of follow-up. Specific AD classes such as TCAs and 'other ADs were found to be predictors of discontinuation. In depressed patients, the use of NaSSas, TCAs and 'other ADs as well the concomitant use of >5 drugs (other than ADs) and living in Southern Italy were more likely to predict discontinuation., Conclusion: ADs, especially SSRIs, are widely and increasingly prescribed in elderly Italian patients in recent years. The observed high AD discontinuation rates are likely to impact the achievement of a therapeutic endpoint in depressed patients. Patients who are at high risk of AD discontinuation such as those receiving multi-drug therapy or living in Southern Italy should be monitored more closely to improve benefits of AD treatments.

Background and Aims: Poor adherence to medications is a major health concern especially among older subjects. To plan future studies to improve adherence, an epidemiological study, called "Fiesole Misurata", was conducted. The aim of the present paper was to verify the representativeness of the database in evaluating the AntiHyperTensives (AHTs)-taking behaviour., Methods: Demographic records of all subjects aged ≥65 years (n = 2,228) living in the community of Fiesole (Florence, Italy) was retrieved from the Registry Office of Fiesole Municipality. The corresponding healthcare records were obtained from administrative archives of the Local Health Authority (claim dataset). Moreover, a cohort of subjects aged ≥65 years (n = 385) living in the community was screened by means of a multidimensional geriatric evaluation (cross-sectional dataset)., Results: In claim dataset, biyearly prevalences of hospitalization for ischemic cardiomyopathy, heart failure, and stroke were 3.7, 3.0, and 3.2%, respectively. In the cross-sectional dataset, prevalences were 11.2, 6.7, and 7.1%, respectively. The most used drugs were angiotensin-converting enzyme inhibitors (43.6% in the claim dataset, 45.3% in the cross-sectional dataset) and diuretics (35.6% and 47.0%, respectively). Among the incident users of AHTs, 63.5% was highly adherent (≥80%) over the first 6 months of follow-up, while 14.3 and 22.2% were intermediate (40-79%) and low (<40%) adherent. The percentage of high adherers decreased with time and reached 31.2% at the 24th month., Conclusions: These findings indicate that "Fiesole Misurata" study database can be used to develop future strategies aimed at improving the adherence to AHTs in older individuals.

Guidelines Towards a Pain-Free Hospital, published in 2001 in Italy, determined an increasing spread of No-Pain Hospital Committees across the country and supported a more effective pain control in hospital. However, few hospitals adopted such protocols. To date, a thorough investigation on quality of pain management documentation is lacking. The present survey aimed to evaluate the quality of pain management documentation reported in medical and hospital discharge records. The study reviewed records of 2,459 patients discharged every Wednesday of November 2006 in 29 Tuscany hospitals. Among 2,459 patients, 51.5 % were males. Patients were aged between 0 and 90 years or above and were mostly (24.93 %) between 70 and 79 years; most of them (47.1 %) were hospitalized in Medicine ward. At hospital admission, less than half of examined records (40.3 %) reported pain-related items, and only 8.1 % reported how it was treated. During hospitalization, 39.6 % of the records reported the use of scales for measuring pain intensity and 49.7 % reported the pharmacological therapy. The present study highlights the lack of an exhaustive documentation of pain recording and management in the hospital setting. Therefore, healthcare providers should pay close attention to this relevant issue, and the quality of such documentation should be constantly monitored.

Objectives: To evaluate the type, frequency, severity and predictors of potential Drug-Drug Interactions (DDIs) in a cohort of patients undergoing radiodiagnostic procedures., Setting: Eight Radiology wards located in Tuscany (Italy)., Methods: All participants exposed to at least two medications were included in the analysis. DDIs were grouped according to their severity as 'minor', 'moderate' or 'major'. A logistic model was used to estimate Odds Ratios and 95% Confidence Intervals for all predictors of potential DDI., Main Outcome Measures: Type and predictors of potential DDI in a cohort of patients undergoing radiodiagnostic procedures., Results: One-thousand-and-two subjects (57.6% females; mean age: 67.3 +/- 12.2) entered the analysis, and 46.1% of them incurred in a potential DDI (78.9% 'moderate' in severity). The combination of allopurinol and ACE-inhibitors was the most frequent (21/153) among major potential DDIs, while steroids were involved in all cases of potential DDI due to premedication. Co-morbidity, number of co-medications, advanced age and premedication use increased the risk of potential DDI; a protective role was found for positive history of allergy. When the analysis was restricted to subjects with premedication (n = 93), only 12.9% of them reported a potential DDI directly attributable to premedication drugs., Conclusions: Among patients undergoing radiological examination, types and predictors of potential DDIs appeared in agreement with other kind of in-hospital populations. Premedication revealed to be a proxy predictor for potential DDIs. Considering the poor capability of the prescriber in recognizing interactions, their systematic evaluation (using an informatics tool) in patients undergoing radiological examination might be helpful in preventing the occurrence of clinically relevant DDIs.

Background: More than 380,000 angiographic procedures are performed every year in Italian hospitals, with an increase rate of 8% per year. Although contrast media (CM) are considered relatively safe, adverse drug reactions (ADRs) remain an important issue., Objectives: The objective of this study was to quantify the incidence of immediate and delayed nonrenal ADRs to iodinated CM in an Italian cohort and to evaluate whether their different physicochemical properties are able to affect the incidence of immediate or delayed ADRs., Methods: A prospective intensive monitoring study was conducted on a cohort of patients undergoing radiodiagnostic procedures with iodinated CM enrolled in two hospitals in Tuscany, Italy. To evaluate both immediate (within 1 h after CM administration) and delayed (>1 h to 1 week after CM administration) ADRs to CM, two questionnaires were administered. Adverse events (AEs) were analyzed to check the causality assessment between CM and ADR. If more than one symptom occurred in the same patient, they were treated as a single event., Results: One thousand five hundred and fourteen subjects who were exposed to iodinated CM completed the questionnaires. Mean age [standard deviation (SD)] was 65.4 (13.3) years, and 57.9% were male patients. A total of 178 [11.8%; 95% confidence interval (CI) 10.1-13.4] ADRs were reported. Thirty-four (2.2%; 1.5-3.1) and 144 (9.5%; 8.0-11.1) developed immediate and delayed ADRs, respectively. Both types of ADRs were experienced by six subjects (0.4%; 0.1-0.8). One hundred and seventy-six cases (98.8%; 96.0-99.8) were classified as possible and two (1.1%; 0.1-3.9) as probable ADRs. Monomeric low-osmolal (iopromide, iomeprol, iobitridol) and dimeric iso-osmolal (iodixanol) groups mainly reported delayed allergy-like ADRs of mild severity. Only one immediate reaction was severe. Multivariate analysis confirmed a higher risk of immediate reactions occurring for monomeric CM (OR 4.3; 95% CI 1.2-15.7), whereas the risk of delayed ADRs was significantly higher for the dimeric group (OR 1.8; 1.1-2.5)., Conclusions: Monomeric CM were more frequently involved in immediate ADRs, whereas dimeric CM were involved in delayed reactions. Although severe life-threatening ADRs to CM were confirmed to be rare, due to the large use of these drugs, they still retain clinical and epidemiological significance.