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Aim: To evaluate the pattern of use of statins in the Emilia Romagna Region, with a focus on the therapeutic regimens and the patient's risk profile as predictors of adherence to therapy., Methods: All patients from Emilia Romagna (4,027,275 inhabitants) receiving statin prescriptions in January-February 2005 were selected and observed for 12 months in terms of their statin regimen and use of other drugs for cardiovascular risk prevention. Previous hospital admissions for major cardiovascular events were also obtained. Adherence to statins was evaluated in terms of coverage (covered: >or=300 tablets/year). The relationship between coverage and risk profile (age, sex, other cardiovascular drugs, previous cardiovascular events and choice of drugs/dosages) was analysed by multivariate logistic regression., Results: Among the 137,217 patients receiving at least one prescription in the observation period, the rate of coverage was 46%. Coverage was statistically higher in patients with a previous hospital admission (secondary prevention) [Odds ratio (OR) 1.19; 95% confidence interval (95% CI) 1.16, 1.22], in those concomitantly treated with three to four different cardiovascular drugs (OR 2.77; 95% CI 2.66, 2.89). The coverage was also statistically higher in patients aged 50-69 years (OR 1.14; 95% CI 1.08, 1.20) and among males (OR 1.21; 95% CI 1.18, 1.23)., Conclusions: Less than half of patients receiving statin therapy took their medication daily, with a coverage only slightly higher in patients at higher cardiovascular risk. Three-quarters of the patients received statin therapy in primary prevention, whereas the benefits of statins are documented mostly for patients in secondary prevention. These findings strengthen the need to sensitise physicians and patients to the correct use of statins.

Background: Misuse of antimicrobial agents in hospitals may cause the emergence of resistant microorganisms, as well as increased costs and unnecessary exposure of patients to drugs. We investigated the pattern of antibiotic consumption in 2002-04 in a sample of Italian hospitals, and compared this with antibiotic consumption data in primary healthcare in the Emilia-Romagna region., Methods: The study was carried out in five hospitals of the Emilia-Romagna region and 2002-04 drug use data were obtained from the pharmacy services. Data were analysed by clinical areas and single wards and were expressed by ATC classification and defined daily doses (DDD)/100 bed days. Prescription data of antibacterials in primary care in the same period were also analysed., Results: Antibiotic consumption increased by 18% in the 3 year period. Combinations of penicillins and beta-lactamase inhibitors were the most used drugs, followed by fluoroquinolones and third-generation cephalosporins. Penicillins plus beta-lactamase inhibitors increased in all the clinical areas by over 40%, and fluoroquinolones sharply increased in medical units (+29%). Third-generation cephalosporins remained fairly stable in paediatrics and surgery, but increased in medicine (+18%). Glycopeptides accounted for 4.3% of total antibiotic consumption with a peak of 10% in intensive care units. Antibacterial prescription in primary care showed a pattern similar to that of hospitals., Conclusions: We found a considerable increase in antibiotic use over time and a marked preference for wide-spectrum antibiotics such as penicillins plus beta-lactamase inhibitors, fluoroquinolones and third-generation cephalosporins; thus raising concern about appropriate use. These results could represent the basis for educational initiatives aimed at rationalizing the use of antibiotics in hospitals.

Aim: To evaluate adherence to chronic cardiovascular drug treatments, in terms of long-term persistence and dose coverage., Methods: General practice prescription data of antihypertensives, lipid-lowering agents, oral hypoglycaemic agents and nitrates were collected over a 5-year period (1998-2002) in a Northern Italian district (Ravenna, 350,000 inhabitants). We selected subjects (>40 years) receiving at least one prescription of the above drugs in December 1999. For each patient, we documented the regimen at the time of selection and evaluated adherence to treatment during the following 3 years in terms of persistence (at least one prescription per year) and daily coverage (recipients of an amount of medication consistent with daily treatment)., Results: Fewer than 10% of the 32 068 selected subjects were naive to treatment. Antihypertensives were the most represented therapeutic category. Among patients already on treatment in December 1999, persistence was virtually complete, whereas >40% of naive patients withdrew within 1 year, except for nitrates. The rates of coverage were always much lower than the corresponding values of persistence. Coverage was significantly higher in older patients (chi(2) for trend 69.41; P < 0.001), males (odds ratio 1.30; 95% confidence interval 1.25, 1.36) and users receiving more than one therapeutic category., Conclusions: Lack of adherence to chronic cardiovascular treatments represents an important matter of concern: although most people continued treatment over the years, less than 50% received an amount of drugs consistent with daily treatment, thus jeopardizing the proved beneficial effects of available medications.

Aims: In a previous paper, we proposed an algorithm to assess the degree of therapeutic innovation of the agents approved by the European centralized procedure, which must be followed by biotechnological products and is optional for drugs claimed as innovative. A low overall degree of therapeutic innovation (about 30%) was found. This figure may be an underestimate of the actual level of innovation, because common biotechnological products, such as recombinant human insulins, must follow this procedure. To test the hypothesis that therapeutic innovation prevails among nonbiotechnological products, we evaluated separately the degree of therapeutic innovation of biotechnological vs. nonbiotechnological agents in the first decade of European Medicines Agency activity, also studying a possible time trend., Methods: We assessed, for each drug: (i) the seriousness of the target disease, (ii) the availability of previous treatments, and (iii) the extent of therapeutic effect according to the previously proposed algorithm., Results: Our analysis considered 251 medicinal products corresponding to 198 active substances, classified according to four main areas as therapeutic agents (88.9%), diagnostics (5.5%), vaccines (5.1%) and life-style drugs (0.5%). Among all therapeutic agents, 49 out of 176 agents (28%) were classified as having an important degree of therapeutic innovation. Fifteen out of 60 biotechnological therapeutic agents were considered important therapeutic innovations (25%), whereas this figure was 29% for nonbiotechnological agents., Conclusions: Among active substances claimed as innovative by the manufacturers, only a minority deserve this definition according to our algorithm.

Background: In a previous questionnaire-based survey, we found extensive use of nonsteroidal anti-inflammatory drugs (NSAIDs) in subjects with risk factors for serious gastrointestinal complications., Aim: This study focused on the use of NSAIDs in subjects who reported either (a) pre-existing disorders which would have required caution in using NSAIDs (e.g. dyspepsia/heartburn or peptic ulcer) or (b) co-medication with drugs having a high risk of interacting with NSAIDs., Methods: Between March and September 2002, 65 general practitioners (GPs) submitted a validated self-administered questionnaire on health status and drug use to 3,250 subjects (age >or=18 years, stratified by sex and age). The questionnaire was divided into three parts: (1) sociodemographic information, (2) symptoms/illnesses (in the previous 6 months) and (3) drugs taken during the previous week., Results: Of the 2,738 subjects who filled in the questionnaire (84% of responders), 633 (23%) used NSAIDs and, among them, 114 (18%) were chronic users. Among the subjects reporting dyspepsia/heartburn or ulcer (n=909 of 2,738), 24% were occasional NSAID users and 6% chronic users. Of the chronic NSAID users reporting gastrointestinal symptoms, 35% also used a drug for acid-related disorders, but only 14% used daily a proton pump inhibitor (PPI). One hundred six subjects used concomitantly more than one NSAID. Eighteen percent of the subjects using corticosteroids also reported NSAID use; similar proportions were seen in subjects using selective serotonin reuptake inhibitor (SSRI) antidepressants or calcium channel blockers, whereas 6% of the subjects with oral anticoagulants used NSAIDs., Conclusions: Our study shows that NSAIDs are frequently used in patients with upper gastrointestinal complaints or in combination with potentially interacting medications. Adverse effects and untoward drug interactions should be monitored in patients treated with NSAIDs in order to minimise their occurrence.

Background: Antihypertensive agents are among the most used therapeutic classes. The approach to the pharmacological treatment of hypertension is guided by international recommendations and adherence to treatment is known to result in effective prevention of cardiovascular risk., Aim: The aim of this study was to evaluate the pattern of use of antihypertensive agents in general practice in terms of drug choice for the initial treatment of hypertension and adherence to treatments among newly recruited patients., Methods: We collected the data of all antihypertensive drugs prescribed by general practitioners (GPs) and reimbursed between January 1998 and December 2002 by a Local Health Authority of Emilia Romagna (Ravenna district, 350,000 inhabitants). We selected subjects aged 40 years and older, permanently living in the area during the whole period of the study, who received their first prescription of antihypertensives between January and December 1999, with no prescription of antihypertensive agents in the previous year. For each patient, we documented the starting regimen and evaluated adherence to treatment in terms of persistence during the years (patients were defined persistent if they received at least one prescription per year) and in terms of daily coverage (patients were defined covered if they received an amount of drugs consistent with a daily treatment). Finally, switches or addition of other therapeutic classes during the 3-year period were identified., Results: A cohort of 6,043 subjects receiving their first antihypertensive treatment in 1999 was obtained. Regarding the starting regimen, monotherapies with angiotensin converting enzyme inhibitors (n = 1,597; 26%) or calcium channel blockers (n = 1126; 19%) were the most frequently prescribed. Of the patients, 21% started with a drug combination regimen. Regarding adherence to treatment, 18% of the cohort received only one prescription throughout the 3 years, 13% received more than one prescription but stopped the therapy during the first year, 69% were persistent during the second year and 60% also during the third year. Only 34% were covered during the first year and 24% also during the second year, whereas only 20% of the patients resulted covered throughout the 3 years. Among persistent patients, 41% maintained the same antihypertensive regimen throughout the 3 years, 25% added other drugs to the initial treatment and 34% switched to completely different regimens., Conclusions: Our findings reflect the lack of convergence among guidelines on the drug class(es) to be considered as first choice in the initial treatment of hypertension. Although an intervention in this field may have important implications in terms of cost savings, the ongoing debate does not allow us to draw definite conclusions on whether measures should be taken by the National Health Authority. However, the lack of adherence to antihypertensive treatment is undoubtedly a matter of concern for public health and should be addressed with appropriate interventions.

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used medicines in the developed countries. The most important adverse reactions involve the upper gastrointestinal tract and can be life threatening. A detailed knowledge of the pattern of use of NSAIDs may help doctors in advising their patients about appropriateness and safety of use., Aim: The aim of the present survey was to evaluate the prevalence and pattern of NSAID use in the general population, as well as the main characteristics of NSAID users., Methods: Between March and September 2002, a self-administered questionnaire was submitted to a random sample, stratified by gender and age, representative of the Italian adult population (n=3,250). The questionnaire was divided into three parts regarding: (1) sociodemographic information, (2) symptoms/illnesses and (3) any drug taken during the previous week and the corresponding purpose. A statistical analysis (logistic regression) was performed., Results: Of the 2,738 subjects who filled in the questionnaire, 65% took at least one drug in the previous week and, among them, 35% used NSAIDs (top drug class; n=633). Of the NSAID users, 20% were >/=65 years of age and 18% were chronic users (daily or frequent use for more than 6 months). NSAID use was significantly higher in women, both for overall and chronic use. The older age groups showed an increasing risk of chronic NSAID use. Among NSAIDs, nimesulide was the most used compound (35%) followed by acetylsalicylic acid (14%) and ibuprofen (11%). The main reasons for NSAID use, as reported by subjects, were: headache (25%), osteoarticular pain (19%), unspecified pain (15%) and osteoarthrosis (9%). More than 50% of all the NSAIDs were prescribed by physicians (general practitioner, specialist, hospital physician), whereas about 44% were taken as self-treatment or following the advice of a pharmacist, relative/friend, etc., Conclusions: Our study confirms that NSAIDs are widely used in the Italian general population and that, in most cases, they are used in accordance with their approved indications. However, their large and often chronic use in the elderly, as well as the high frequency of self-treatment, recommends a higher awareness by all physicians.