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Biomedical subjects

C Barbui

Publications and source records attributed to C Barbui.

At least 19 recordsLinked to original sources
PubMed2005

Fluoxetine versus other types of pharmacotherapy for depression.

BACKGROUND: Depression is common in primary care and it is associated with marked personal, social and economic morbidity, and creates significant demands on service providers in terms of workload. Treatment is predominantly pharmaceutical or psychological. Fluoxetine, the first of a group of antidepressant (AD) agents known as selective serotonin reuptake inhibitors (SSRIs), has been studied in many randomised controlled trials (RCTs) in comparison with tricyclic (TCA), heterocyclic and related ADs, and other SSRIs. These comparative studies provided contrasting findings. In addition, systematic reviews of RCTs have always considered the SSRIs as a group, and evidence applicable to this group of drugs might not be applicable to fluoxetine alone. The present systematic review assessed the efficacy and tolerability profile of fluoxetine in comparison with TCAs, SSRIs and newer agents. OBJECTIVES: To determine the efficacy of fluoxetine, compared with other ADs, in alleviating the acute symptoms of depression, and to review its acceptability. SEARCH STRATEGY: Relevant studies were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), the Cochrane Central Register of Controlled Trials (CENTRAL), Medline (1966-2004) and Embase (1974-2004). Non-English language articles were included. SELECTION CRITERIA: Only RCTs were included. For trials which have a crossover design only results from the first randomisation period were considered. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers using a standard form. Responders to treatment were calculated on an intention-to-treat basis: drop-outs were always included in this analysis. When data on drop-outs were carried forward and included in the efficacy evaluation, they were analysed according to the primary studies; when dropouts were excluded from any assessment in the primary studies, they were considered as treatment failures. Scores from continuous outcomes were analysed including patients with a final assessment or with the last observation carried forward. Tolerability data were analysed by calculating the proportion of patients who failed to complete the study and who experienced adverse reactions out of the total number of randomised patients. The primary analyses used a fixed effects approach, and presented Peto Odds Ratio (PetoOR) and Standardised Mean Difference (SMD). MAIN RESULTS: On a dichotomous outcome fluoxetine was less effective than dothiepin (PetoOR: 2.09, 95% CI 1.08 to 4.05), sertraline (PetoOR: 1.40, 95% CI 1.11 to 1.76), mirtazapine (PetoOR: 1.64, 95% CI 1.01 to 2.65) and venlafaxine (Peto OR: 1.40, 95% CI 1.15 to 1.70). On a continuous outcome, fluoxetine was more effective than ABT-200 (Standardised Mean Difference (SMD) random effects: - 1.85, 95% CI - 2.25 to - 1.45) and milnacipran (SMD random effects: - 0.38, 95% CI - 0.71 to - 0.06); conversely, it was less effective than venlafaxine (SMD random effect: 0.11, 95% CI 0.00 to 0.23), however these figures were of borderline statistical significance. Fluoxetine was better tolerated than TCAs considered as a group (PetoOR: 0.78, 95% CI 0.68 to 0.89), and was better tolerated in comparison with individual ADs, in particular than amitriptyline (PetoOR: 0.64, 95% CI 0.47 to 0.85) and imipramine (PetoOR: 0.79, 95% CI 0.63 to 0.99), and among newer ADs than ABT-200 (PetoOR: 0.21, 95% CI 0.10 to 0.41), pramipexole (PetoOR: 0.20, 95% CI 0.08 to 0.47) and reboxetine (PetoOR: 0.61, 95% CI 0.40 to 0.94). AUTHORS' CONCLUSIONS: There are statistically significant differences in terms of efficacy and tolerability between fluoxetine and certain ADs, but the clinical meaning of these differences is uncertain, and no definitive implications for clinical practice can be drawn. From a clinical point of view the analysis of antidepressants' safety profile (adverse effect and suicide risk) remains of crucial importance and more reliable data about these outcomes are needed. Waiting for more robust evidence, treatment decisions should be based on considerations of clinical history, drug toxicity, patient acceptability, and cost. We need for large, pragmatic trials, enrolling heterogeneous populations of patients with depression to generate clinically relevant information on the benefits and harms of competitive pharmacological options. A meta-analysis of individual patient data from the randomised trials is clearly necessary.

Antidepressive Agents↗
PubMed2005

Side-effect profile of fluoxetine in comparison with other SSRIs, tricyclic and newer antidepressants: a meta-analysis of clinical trial data.

BACKGROUND: In the last ten years, SSRIs have increasingly replaced TCAs as comparators of newer antidepressants (ADs), because of their better tolerability profile. In particular, fluoxetine has become a reference drug for the treatment of depression, but the occurrence of individual side effects in depressed subjects treated with fluoxetine and each comparator AD have not been systematically investigated. METHODS: This meta-analysis investigated the frequency of side effects induced by fluoxetine or alternative ADs and compared the occurrence of individual side effects in depressed subjects. All randomised clinical trials (RCTs) comparing fluoxetine with any other AD drug in patients with major depression were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Controlled Trials Register. Two reviewers independently extracted information. RESULTS: Significantly less percentage of patients treated with fluoxetine experienced any side effects in comparison with TCAs (50.9 % vs 60.3 %, 29 RCTs; RR = 0.84, p = 0.003), but not in comparison with other SSRIs (59.4 % vs 59.3 %, 15 RCTs; RR = 1.00, p = 0.902). In addition, fluoxetine was better tolerated in comparison with TCAs and related ADs (RR 0.61, 95 % CI 0.52, 0.71), but not in comparison with other SSRIs. Regard to individual side effects, activating (insomnia, agitation, tremor and anxiety) and gastrointestinal adverse events (nausea, vomiting, diarrhoea, weight loss and anorexia) were significantly more frequent in fluoxetine-treated patients, whereas cholinergic side effects were significantly less frequent. CONCLUSIONS: Fluoxetine compared to other ADs had more activating and gastrointestinal adverse effects, which often require additional pharmacotherapy or other managements strategies, leading to discontinuation and non-compliance and increasing the costs. This information is relevant to base on evidence the prescription of ADs in everyday clinical practice.

Antidepressive Agents, Tricyclic↗
PubMed2005

Epidemiology of first- and second-generation antipsychotic agents in Lombardy, Italy.

INTRODUCTION: This study investigated the age and gender distribution of antipsychotic prescribing in Lombardy, a region of nine million inhabitants in northern Italy. METHODS: From the Regional Administrative Database of Lombardy, all ambulatory prescriptions of antipsychotics dispensed during 2001 were extracted and prevalence data were calculated by dividing users by the total number of male and female residents in each age group. RESULTS: During the study period 86,187 subjects were dispensed antipsychotic agents, yielding a prevalence of use of 0.87 (95 % CI: 0.86, 0.88) per 100 males and 1.01 (95 % CI: 1.00, 1.02) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old subjects. The prevalence of use of first-generation antipsychotics progressively increased with age and dramatically increased in old and very old subjects; in contrast, the prevalence of use of second-generation antipsychotics remained substantially stable or slightly decreased up to 65 years of age and increased thereafter. CONCLUSION: Antipsychotic agents are prescribed widely in the general population, and very high rates were observed in those aged 80 years or more.

Adolescent↗
PubMed2004

Amitriptyline for inpatients and SSRIs for outpatients with depression? Systematic review and meta-regression analysis.

BACKGROUND: Although the selective serotonin reuptake inhibitors (SSRIs) are widely used as first-line agents in depression, amitriptyline, a reference tricyclic (TCA) agent, has the edge in terms of efficacy over control antidepressants (ADs), but it is not clear whether this advantage can be attributed to a more favourable profile in inpatients, but not in outpatients, with depression. The aim of this study was to investigate the contribution of study setting on outcome in clinical trials comparing amitriptyline with any other AD. METHODS: A systematic review and meta-regression analysis of amitryptiline randomised clinical trials was carried out. The electronic search yielded 181 randomised clinical trials, 47% enrolling inpatients and 53% outpatients with depression. RESULTS: Both on a dichotomous and continuous out-come, amitriptyline was more effective than control agents in in-patients [Peto odds ratio (OR): 1.22, 95%, Confidence Interval (CI): 1.04, 1.42; Standardised Mean Difference (SMD): 0.28, 95 %,Cl: 0.08, 0.46], but not in outpatients (Peto OR: 1.01, 95%, CI: 0.88,1.17; SMD: 0.10,95% CI: -0.02,0.23). Among inpatients amitriptyline was significantly more effective than TCA and nonsignificantly more effective than the SSRIs. Among outpatients no statistically significant differences emerged between amitriptyline and TCA and between amitriptyline and the SSRIs. Amitriptylinewas less well tolerated than control agents in outpatients (Peto OR: 0.90, 95%, CI: 0.81, 0.99), but not in inpatients (Peto OR:1.09, 95% CI: 0.95, 1.25). CONCLUSIONS: These data suggest that a reasonable approach could be the first-line prescription of newer agents in the routine outpatient care of depressive subjects, and the use of amitriptyline in inpatients with severe depression.

Adrenergic Uptake Inhibitors↗
PubMed2004

Off-label and non-classical prescriptions of antipsychotic agents in ordinary in-patient practice.

OBJECTIVE: To estimate the proportion of off-label prescriptions of antipsychotics (APs) in ordinary in-patient practice. METHOD: From the South-Verona Psychiatric Case Register all admissions to the in-patient unit during 2001-02 were extracted. Prescriptions of APs were defined off-label when dispensed outside the licensed indications. In addition, the proportion of "non-classical prescriptions" was calculated. RESULTS: During the 2 years surveyed AP agents were prescribed in 311 cases. Nearly 50% of second-generation AP prescriptions were for an off-label indication. In contrast, <15% of first-generation AP prescriptions were for an off-label indication. About 30% of first- and second-generation agents were prescribed for a non-classical indication. CONCLUSION: Approved labels for second-generation AP agents cover a much narrower range of indications than any of the first-generation agents, and this explains the higher proportion of off-label prescriptions. In contrast, the everyday use of first- and second-generation APs cover a similar range of clinical indications.

Antipsychotic Agents↗
PubMed2003

Major depression in multiple sclerosis: a population-based perspective.

OBJECTIVE: To determine the prevalence of major depression in multiple sclerosis (MS) in a population-based sample controlling for nonspecific illness effects. METHODS: This study used data from a large-scale national survey conducted in Canada: the Canadian Community Health Survey (CCHS). The analysis included 115,071 CCHS subjects who were 18 years or older at the time of data collection. The CCHS interview obtained self-reported diagnoses of MS and employed a brief predictive interview for major depression: the Composite International Diagnostic Interview Short Form for Major Depression. The 12-month period prevalence of major depression was estimated in subjects with and without MS and with and without other long-term medical conditions. RESULTS: The prevalence of major depression was elevated in persons with MS relative to those without MS and those reporting other conditions. The association persisted after adjustment for age and sex (adjusted odds ratio = 2.3, 95% CI 1.6 to 3.3). Major depression prevalence in MS for those in the 18- to 45-year age range was high at 25.7% (95% CI 15.6 to 35.7). CONCLUSIONS: The prevalence of major depression in the population with MS is elevated. This elevation is not an artifact of selection bias and exceeds that associated with having one or more other long-term conditions.

Adolescent↗
PubMed2003

Low dosage tricyclic antidepressants for depression.

BACKGROUND: Tricyclic antidepressants are still extensively prescribed worldwide. Evidence for the recommended dosage of tricyclics, however, is poor. OBJECTIVES: To compare the effects and side effects of low dosage tricyclic antidepressants with placebo and with standard dosage tricyclics in acute phase treatment of depression. SEARCH STRATEGY: Electronic search of the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), incorporating results of group searches of MEDLINE (1966-), EMBASE (1980-), CINAHL (1982-), PsycLIT (1974-), PSYNDEX (1977-) and LILACS (1982-1999) and hand searches of major psychiatric and medical journals. Reference search and SciSearch of the identified studies. Personal contact with authors of significant papers. SELECTION CRITERIA: All randomised controlled trials 1) comparing low dosage TCA (=< 100 mg/d on average at the end of trial) with placebo or 2) comparing low and standard dosages of the same TCA, in acute phase treatment of depressive disorder DATA COLLECTION AND ANALYSIS: Two independent reviewers examined eligibility of the identified studies, and extracted data for outcomes at 1 week, 2 weeks, 4 weeks, 6-8 weeks and later. Main outcome measures were relative risk of response in depression (random effects model), according to the original authors' definition but usually defined as 50% or greater reduction in severity of depression according to the last-observation-carried-forward intention-to-treat method, and relative risks of overall dropouts and dropouts due to side effects. Other outcome measures included worst-case-scenario intention-to-treat analysis of response as defined above (in which dropouts were considered non-responders in the active treatment group and as responders in the comparison group), and standardised weighted mean scores of continuous depression severity scales (usually calculated by last-observation-carried-forward method). MAIN RESULTS: 35 studies (2013 participants) compared low dosage tricyclics with placebo, and six studies (551 participants) compared low dosage tricyclics with standard dosage tricyclics. Low dosage tricyclics, mostly between 75 and 100 mg/day, were 1.65 (95% confidence interval 1.36 to 2.0) and 1.47 (1.12 to 1.94) times more likely than placebo to bring about response at 4 weeks and 6-8 weeks, respectively. Standard dosage tricyclics failed, however, to bring about more response but produced more dropouts due to side effects than low dosage tricyclics. REVIEWER'S CONCLUSIONS: Treatment of depression in adults with low dose tricyclics is justified. However, more rigorous studies are needed to definitively establish the relative benefits and harms of varying dosages.

Antidepressive Agents, Tricyclic↗
PubMed2003

Amitriptyline versus other types of pharmacotherapy for depression.

BACKGROUND: For many years amitriptyline has been considered one of the reference compounds for the pharmacological treatment of depression. However, new tricyclic drugs, heterocyclic compounds and the selective serotonin reuptake inhibitors have been introduced on the market with the claim of a more favourable tolerability/efficacy profile. OBJECTIVES: The aim of the present systematic review was to investigate the tolerability and efficacy of amitriptyline in comparison with the other tricyclic/heterocyclic antidepressants and with the selective serotonin reuptake inhibitors. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (2002-3) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched. Key journals and conference abstracts were handsearched. Pharmaceutical companies were contacted for information on unpublished materials. SELECTION CRITERIA: Only randomised controlled trials were included. Study participants were of either sex and any age with a primary diagnosis of depression. Included trials compared amitriptyline with another tricyclic/heterocyclic antidepressant or with one of the selective serotonin reuptake inhibitors. DATA COLLECTION AND ANALYSIS: Data were extracted using a standardised form. The number of patients undergoing the randomisation procedure, the number of patients who completed the study and the number of improved patients were extracted. In addition, group mean scores at the end of the trial on Hamilton Depression Scale or any other depression scale were extracted. In the tolerability analysis, the number of patients failing to complete the study and the number of patients complaining of side-effects was extracted. MAIN RESULTS: The estimate of the overall odds ratio for responders showed that more subjects responded to amitriptyline in comparison with the control antidepressant group (odds ratio 1.12, 95% confidence interval 1.01, 1.23, number needed to treat 50). The estimate of the efficacy of amitriptyline and control agents on a continuous outcome revealed an effect size which also significantly favoured amitriptyline (Standardised Mean Difference 0.13, 95% confidence interval 0.04, 0.23). Whilst these differences are statistically significant, their clinical significance is less clear. When the efficacy analysis was stratified by drug class, no difference in outcome emerged between amitriptyline and either tricyclic or selective serotonin reuptake inhibitor comparators. The dropout rate in patients taking amitriptyline and control agents was similar; however, the estimate of the proportion of patients who experienced side-effects significantly favoured control agents in comparison with amitriptyline (odds ratio 0.63, 95% confidence interval 0.56, 0.71). When the tolerability analysis was stratified by drug class, the dropout rate in patients taking amitriptyline and the selective serotonin reuptake inhibitors significantly favoured the latter (odds ratio 0.84, 95% confidence interval 0.75,0.95, number needed to harm 40). When the responder analysis was stratified by study setting amitriptyline was more effective than control ADs in inpatients (odds ratio 1.22, 95% confidence interval 1.04, 1.42, number needed to treat 24), but not in outpatients (odds ratio 1.01, 95% confidence interval 0.88, 1.17, number needed to treat = 200). REVIEWER'S CONCLUSIONS: This present systematic review indicates that amitriptyline is at least as efficacious as other tricyclics or newer compounds. However, the burden of side-effects in patients receiving it was greater. In comparison with the selective serotonin reuptake inhibitors amitriptyline was less well tolerated, and although counterbalanced by a higher proportion of responders, the difference was not statistically significant.

Amitriptyline↗
PubMed2003

How often do patients with psychosis fail to adhere to treatment programmes? A systematic review.

BACKGROUND: Studies that assess the rates of psychotic patients who fail to adhere to treatment programmes have generated heterogeneous results, with estimates ranging from 24 to 90%. This paper presents findings from a systematic review on adherence to treatment by patients with psychosis. Its purpose is to provide an overall estimate of treatment non-adherence in community psychiatric services, and to analyse and study patient characteristics explaining the between-study heterogeneity in rates of non-adherence. METHOD: A systematic review of published studies that report rates of non-adherence with medication and scheduled appointments by psychotic patients in community settings has been undertaken. RESULTS: A total of 103 studies were included in this systematic review. Eighty-six of these studies were suitable for data re-analysis. The overall weighted mean rate of non-adherence, calculated in a sample of 23 796 patients, was 25.78%. A linear regression analysis of non-adherence rates on background characteristics showed that sample size was negatively associated with non-adherence rates, while first-contact cases and low-adherence cases, in comparison with ongoing cases, were associated with higher non-adherence rates. Factors associated with poor compliance included: lack of insight; positive symptoms; younger age; male gender; history of substance abuse; unemployment; and low social functioning. CONCLUSIONS: Approximately one in four patients with psychosis fails to adhere with treatment programmes. Preventive evidence-based clinical interventions should be routinely implemented in community settings to reduce patient non-adherence.

Antipsychotic Agents↗
PubMed2002

Determinants of subjective quality of life in patients attending community-based mental health services. The South-Verona Outcome Project 5.

OBJECTIVE: Investigate the relationship of various domains of quality of life (QoL) with socio-demographics, clinical and social characteristics, service use and satisfaction in a representative sample of patients in contact with the South-Verona community mental health service. METHOD: Measures included: Lancashire Quality of Life Profile (LQOLP), demographics, diagnosis and service utilization data from the Case Register, Brief Psychiatric Rating Scale (BPRS), Disability Assessment Schedule (DAS), Global Assessment of Functioning (GAF) and Verona Service Satisfaction Scale (VSSS). Analyses were conducted using a block-stratified multiple regression model. RESULTS: Demographics, diagnosis, psychopathology, disability, functioning and service use together explained different amounts of variance in each LQOLP domain, but always less than 14%. VSSS explained more variance than any other indicator in health (13.1%), social relations (12.1%), leisure/participation (9.1%), and general wellbeing (9.0%). CONCLUSION: Different domains of QoL are predicted by different indicators. In some important domains, self-perceived satisfactory and effective care might have an impact on the QoL of patients.

Adult↗
PubMed2002

Prescribing second-generation antipsychotics and the evolving standard of care in Italy.

The present study was carried out to investigate the routine use of second-generation antipsychotic drugs in the Italian psychiatric care system. Seven outpatient psychiatric services enrolled a consecutive case series of patients who were being treated, or had started treatment, with clozapine, olanzapine, risperidone, or quetiapine. Information on sociodemographic and clinical variables, current psychotropic drug use, side-effects and past use of typical drugs was collected. In addition, patient symptoms and functional status were evaluated by the Health of the Nation Outcome Scale. Patients receiving off-label prescribing of second-generation antipsychotics were identified. A total of 209 patients were collected. In comparison with patients receiving other second-generation antipsychotics, living in residential facilities, unemployment, long psychiatric histories, and problems with activities of daily living and living conditions were more common in clozapine-treated patients. Nearly 80 % of patients receiving clozapine had schizophrenia compared to less than 50 % of those receiving other second-generation antipsychotics. Overall, 109 patients (52 %) received off-label prescriptions of second-generation antipsychotic drugs. This survey indicates that clozapine was mostly reserved for severe cases and poor responders; the high rate of off-label prescriptions highlights the gap existing between recommendations derived from randomised clinical trials and the current use of drugs.

Adolescent↗
PubMed2002

Clozapine-treated subjects with treatment-resistant schizophrenia: a systematic review of experimental and observational studies.

Randomized clinical trials have limitations because they focus on small samples of highly selected patients. Observational studies, which follow large cohorts of typical patients receiving pharmacological treatments, should overcome some of these trial limitations and provide information that cannot be generated with clinical trials. The present study aimed to compare experimental and observational studies of clozapine-treated subjects with treatment-resistant schizophrenia. A systematic review of experimental and observational studies evaluating clozapine-treated subjects in treatment-resistant schizophrenia was carried out. We identified 50 studies that met the inclusion criteria. Less than one-third of clinical trials enrolled more than 50 patients compared to 44% of prospective and nearly 90% of retrospective studies. In addition, 78% of prospective and 89% of retrospective observational studies lasted more than 12 weeks, while the majority of trials lasted less than 8 weeks. Most clinical trials defined treatment-resistant schizophrenia according to Kane's criteria, while the majority of observational studies adopted implicit criteria. In comparison with clinical trials, observational studies provided a higher weighted mean rate of clozapine-responders and a lower weighted mean rate of clozapine-dropouts. This literature survey suggests that the role of observational studies in the evaluation of medicines should be reconsidered. A new generation of observational studies should be developed to provide evidence on patient outcome in typical settings and under real-world circumstances, and on variables which may affect outcome.

Antipsychotic Agents↗
PubMed2001

Drug epidemiology in Italy: methods and ethical issues. The example of psychiatry.

PURPOSE: These notes aim at analysing current methods, ethical issues and major legislation changes related to drug epidemiology in Italy. METHODS: The design and conduct of two pharmacoepidemiological surveys carried out in the context of recent law dispositions on psychiatric care and confidentiality are presented. RESULTS: In 1978 law 180 stated that no more patients had to be admitted to psychiatric hospitals, and no more psychiatric hospitals had to be built. Chronic long-stay patients were allowed to remain in hospitals. In 1994, however, financial law 724 established a deadline for the final closure of Italian psychiatric hospitals. A survey of more than 1000 patients living in eight state psychiatric hospitals was carried out to describe the social and clinical characteristics of the inpatient population and to monitor their community placement. In 1996 law 675 established that private and confidential information could not be used for any purpose without the patient's informed consent. However, this law was not implemented that year. A survey of benzodiazepine use among general practice patients was conducted without written informed consent. CONCLUSIONS: The Italian legislation has been changing for some years, and regulations might still be modified in the near future. To increase ethical practices in pharmacoepidemiology scientists and clinical researchers should guarantee high standards in terms of research objectives, design and analyses. Potential conflict of interest should always be declared.

Anti-Anxiety Agents↗
PubMed2001

Antidepressant drug prescribing in Italy, 2000: analysis of a general practice database.

OBJECTIVE: Databases of subjects receiving antidepressants provide evidence on the use of drugs in typical patients and settings under real-world conditions. This study analysed a general practice database to estimate the prevalence of antidepressant drug use, describe the use of these compounds by gender and age and estimate the prevalence of occasional versus non-occasional users. METHODS: The general practice database of Chivasso, a city near Turin in Piedmont, was analysed. The database includes all community (i.e. outside hospitals) prescriptions reimbursed by the National Health System in the population living in the study area. From the database, the total number of units of antidepressant drugs prescribed over a 6-month period was extracted. Using the general practice patient code, all records were converted into a sample of patients receiving one or more prescriptions of one or more antidepressants. RESULTS: During the 6 months surveyed, 12,930 antidepressant prescriptions were dispensed to 3751 patients, resulting in a prevalence of use of 19 patients per 1000 inhabitants (confidence interval 18.3, 19.5). The prevalence of use progressively increased with age and was more than double in females than males (female/male ratio 2.16). Paroxetine was the most prescribed compound, followed by amitriptyline and fluoxetine. However, in older subjects, the top two antidepressants were trazodone and amitriptyline. Nearly one-fourth of all dispensed antidepressants were prescribed on one occasion only; occasional users were slightly younger than non-occasional users. CONCLUSIONS: In Italy, databases have been used to monitor the prescription of medicines, but they have always provided aggregate data on drug sales and consumption. In this study, a sample of typical patients receiving antidepressants under real-world conditions was analysed to help clarify what happens in clinical practice. Databases of patients receiving antidepressants should be adopted to suggest public health priorities and generate original research hypotheses to be formally tested with experimental studies.

Adolescent↗
PubMed2001

Forty years of antidepressant drug trials.

OBJECTIVE: This study was conducted to investigate whether the quality of antidepressant drug trials has improved during the last 40 years. METHOD: A sample of 314 randomized clinical trials published between 1962 and 1998 was analysed. RESULTS: From 1962 to 1970 the median number of patients per trial was 56 (range 24-137), from 1971 to 1980 was 50 (10-211) and from 1981 to 1990 was 51 (20-314). In the last 8 years the median sample size increased to 100 patients (20-1002). Trials had a median duration of 4 weeks in the first two decades of publication, and a median duration of 6 weeks in the following two decades. Patient selection criteria have become increasingly sophisticated and the median number of efficacy measures increased in the last 4 decades from 1 to 4. CONCLUSION: Stringent selection criteria and sophisticated outcome assessment tend to exclude typical patients from randomized controlled trials and made it more difficult to follow many patients in the long term.

Antidepressive Agents↗
PubMed2001

Psychotropic drug use in Italy, 1984-99: the impact of a change in reimbursement status.

After years of corruption surrounding drug reimbursement, in 1994, a change in drug reimbursement status was implemented in Italy according to cost-effectiveness criteria. The aim of this study was to assess the impact of these changes on the use of psychotropic drugs. National trends in antipsychotic, antidepressant and benzodiazepine prescriptions were analysed from 1984 to 1999. During the study period, prescriptions of antipsychotic drugs were stable from 1984 to 1994 but, in the subsequent 5 years, increased by 54%. Although the use of atypical compounds in 1999 accounted for only 6% of total antipsychotics sold, the cost of these new drugs accounted for almost one-half the total antipsychotic expenditure. The use of benzodiazepines increased by 53%. In 1999, the psychotropic drugs lorazepam and alprazolam were the most sold by value. From 1984 to 1999, the total antidepressants sold increased by 55%. Although the use of selective serotonin reuptake inhibitors and newer antidepressants in 1999 accounted for less than 50% of total antidepressants sold, the cost of these drugs accounted for 65% of total antidepressant expenditure. This analysis highlights specific areas of concern which should become the object of public health programs.

Cost-Benefit Analysis↗