A simple informative intervention in primary care increases statin adherence.

PURPOSE: To assess the effectiveness of an informative intervention on general practitioners aimed at improving patients' adherence to statin therapy. METHODS: In the local health unit (LHU) of Bergamo, Lombardy (Italy), each general practitioner received a synthetic scientific document on dyslipidaemia and statins and aggregated data on adherence in 2006 for his/her patients compared to the means in the LHU and in his/her working district. Furthermore, a sample of seven districts received also a table of adherence levels for single patients. Patient's level data were retrieved from the health care utilisation databases of the LHU. Adherence parameters (proportion of patients with only one prescription, medication possession ratio [MPR] and proportion of non-persistent patients) were assessed after 1 year of follow-up. RESULTS: Overall, 5833 and 4788 new statin users were enrolled before and after the intervention, respectively. The percentage of patients with only one prescription decreased from 28.0 to 23.9 % (p < 0.001). MPR increased from 70.3 to 76.0 % (p < 0.001), and proportion of patients with MPR ≥ 80 % increased from 45.4 to 56.4 % (p < 0.001). The persistence also showed an improvement, both in terms of decreasing proportion of non-persistent (from 51.9 to 41.4 %, p < 0.001) and of increasing duration of continued therapy (from 235 to 264 mean days of persistent therapy, p < 0.001). There were not significant differences between the two types of intervention. CONCLUSIONS: This intervention resulted in an overall improvement of the short-term adherence to therapy. This tool can be replicated in other local contexts and with other chronic therapies.

Adherence, persistence and treatment switching in psoriasis.

Aim: This study aims to investigate drug utilization patterns in the treatment of psoriasis (PsO) from 1 to 5 years in a real-life setting with Adalimumab (Ada), Etanercept (Eta), Ustekinumab (Ust), Golimumab (Gol), Ixekizumab (Ixe), Secukinumab (Sec) and Apremilast (Apr). Materials & methods: Data from an observational study were used to calculate adherence using the Proportion of Days Covered (PDC) method and persistence. Results & conclusion: Treatment adherence was found to be good for all the drugs studied across all years of analysis, while persistence was suboptimal, showing a marked decrease from the third year of study onward. In the treatment of PsO, greater attention needs to be paid to treatment persistence.

This summary explains that when a patient follows their doctor's medication instructions and continues using the same medication over time to treat a condition like psoriasis, they can expect safer and more effective outcomes. This study examined these aspects to assess how different medications perform over the long term and to explore ways to improve their prescription. The findings highlight that the main issue is not so much in following instructions but in continuing to use the same medication throughout the treatment duration. Raising awareness among healthcare professionals about these issues is crucial to help patients maintain consistent therapy over time and improve their care pathway.

ADA_ETA_BIO2021: real-world evaluation of adherence, persistence, and cost-effectiveness of originator and biosimilar biologic drugs in the treatment of rheumatoid arthritis: a multicenter study in Italy.

OBJECTIVES: The objective was to assess the adherence, persistence, and costs of bDMARDs through a multicentre study of nine Italian hospital pharmacies. METHODS: The drugs analysed were Abatacept, Adalimumab, Certolizumab, Etanercept, Golimumab and Tocilizumab.Adult subjects with Rheumatoid Arthritis were considered in the analysis.In this study, we calculated the following metrics: Adherence to treatment was evaluated as dose-intensity, which is the ratio between the amount of medication received and probably taken by the patient at home (Received Daily Dose, RDD) and the amount prescribed by the clinician (Prescribed Daily Dose, PDD). Persistence was calculated as the number of days between the first and last dispensing of the same drug. Lastly, costs were assessed based on persistence to treatment and normalized for adherence. RESULTS: Adherence to treatment was found to be above 0.8 for all drugs studied. The median persistence for a 5-year treatment period was 1.4 years for Abatacept, 1.7 years for Adalimumab, 1.8 years for Certolizumab, 1.4 years for Etanercept, 1.3 years for Golimumab, and 1.6 years for Tocilizumab. CONCLUSIONS: This multicentre retrospective observational study of bDMARDs used in the treatment of RA showed that, for all the drugs studied, there was no problem with adherence to treatment but rather a difficulty in maintaining treatment with the same drug over time.

Healthcare Resource Consumption and Related Costs of Patients Estimated with Treatment-Resistant Depression in Italy.

PURPOSE: To analyse the healthcare resource consumption and related costs for the Italian National Health System of patients estimated to be affected by treatment-resistant depression (TRD) in Italy. PATIENTS AND METHODS: This was an observational retrospective study based on administrative databases, including those related to residential/semiresidential structures, of Veneto Region and the Local Health Unit of Bergamo in Italy (for a total of around 6 million health-assisted subjects). Between July 2011 and December 2017, all adult patients with a third antidepressant (AD) after ≥2 AD (each one with at least ≥4 weeks duration, ≥1 prescription at maximum dosage reported in datasheets, a grace period ≤30 days when switching AD and treatment maintained ≥9 months) were included. Overall and psychiatry-related healthcare resources consumption and related costs were estimated on a 12-months based analysis. Data were re-proportioned to the Italian population. RESULTS: We have previously estimated a total of 101,455 patients with TRD in Italy (130,049 considering the mean maximum dosage of AD). Of them, 44.2% had at least a psychiatric hospitalization/visit or accessed a residential/semiresidential structure, and 31% added another AD or a mood stabilizer/antipsychotic drug. Patients with at least one psychiatry-related hospitalization increased over the number of antidepressant lines from 12.0% during first line up to 24.5% during fourth line. Direct healthcare costs increased from €4,405 for first line to €9,251 from fifth line onwards. Psychiatry-related costs went from €1,817 (first line) to €4,606 (fifth line onwards) and were mainly driven by residential/semiresidential structures and hospitalizations. CONCLUSION: An upward trend with number of AD lines was observed for all healthcare resource utilization and consequently for all direct costs, thus indicating an increasing burden for patients as they move forward AD lines.

Treatment with Free Triple Combination Therapy of Atorvastatin, Perindopril, Amlodipine in Hypertensive Patients: A Real-World Population Study in Italy.

INTRODUCTION: Polytherapy is often required to treat the comorbidity of hypertension and hyperlipidemia. Fixed-dose co-formulation, rather than free combinations, simplifies medication taking and also improves adherence to medication, which is the key for a successful management of these conditions. AIM: To determine the number of patients potentially eligible for treatment with triple fixed-dose atorvastatin/perindopril/amlodipine (CTAPA), and to estimate if an unmet medical need exists among CTAPA free combination treated patients. METHODS: This observational retrospective study was based on administrative databases of 3 Italian Local Health Units. The cohort comprised adult patients with at least one prescription of amlodipine and perindopril (either as free combination or co-formulated) and atorvastatin during 2014. Follow-up period started on the date of prescription of the 3 molecules (index date) and lasted 1 year. Adherence to CTAPA was analyzed during follow-up, by using the proportion of days covered (PDC). RESULTS: 2292 patients (9.1 per 10,000 beneficiaries) had a prescription for CTAPA as free combination. Only 1249 (54.5%) were adherent to the therapy (PDC ≥ 80%); among them, a small percentage required dosage modification. The number of patients with CTAPA increased during the study period. Discontinuation of drugs prescribed the year before interested 582 patients in 2014, and 522 in 2015. Considering the Italian national population (n = 60,782,668), it was estimated that 69,542 hypertensive patients could be eligible for fixed-dose CTAPA during 2014. CONCLUSIONS: Real-world analysis among patients with free combination therapy can be applied to estimate the eligible population for fixed combination, and to evaluate the appropriateness of their prescriptions. Moreover, fixed-dose CTAPA could effectively improve adherence, which was calculated to be low in the free combination cohort.

Non-persistence risk and health care resource utilization of Italian patients with non-valvular atrial fibrillation

The aim of this study is to compare discontinuation risk and health care resource utilization between vitamin K antagonists (VKAs) and non-vitamin K antagonist oral anticoagulants (NOACs) in newly treated patients with non-valvular atrial fibrillation (NVAF). Based on administrative databases of five Italian Local Healthcare Units, all patients with a discharge diagnosis of NVAF between 2011 and 2014 were selected. Among them, the incident users of NOACs and VKAs in 2014 were followed-up to from the first prescription date to the occurrence of anyone of the following events: a 90-day gap in therapy, switch to a different molecule or add-on of a different molecule into the regimen, death of patient, end of follow-up (December 2015). All-cause hospitalizations, outpatient visits and examinations within the persistence period were also evaluated. The final cohort was composed of 2909 and 765 incident users of VKA and NOACs, respectively. Cox regression to model time to non-persistence within 12 months showed a 62% reduction in risk of drug discontinuation in NOAC patients compared to VKA patients (HR,0.38 [0.33-0.44]). In the adjusted analyses with warfarin as reference, apixaban patients (HR, 0.35 [0.24-0.50]) had the lowest risk of non-persistence, followed by rivaroxoban (HR, 0.42 [0.33-0.54]) and dabigatran users (HR, 0.51 [0.43-0.61]). The mean total numbers of all-cause hospitalization records in 12-month persistent patients were significantly less in NOACs users compared with VKA users (0.36 vs 0.47, p-value:0.03). Similarly, the differences in the mean numbers of all-cause visits and examinations were statistically significant between VKA and NOAC patients, who registered on average 2.33 vs 1.84 visits (p-value: 0.01) and 24.4 vs 9.2 exams referrals (p-value: <0.0001), respectively. NOACs showed a better profile in terms of both resource utilization and persistence compared with VKAs. In particular, apixaban returned the lowest risk of discontinuation than dabigatran and rivaroxaban.

Modifications in drug adherence after switch to fixed-dose combination of perindopril/amlodipine in clinical practice. Results of a large-scale Italian experience. The amlodipine-perindopril in real settings (AMPERES) study.

OBJECTIVE: The purpose of this study was to assess the changes in adherence to treatment, in patients who switched from perindopril and/or amlodipine as a monotherapy (single-pill therapy, SPT) or two-pill combinations to fixed-dose combination (FDC) therapy. METHODS: A large retrospective cohort study, in three Italian Local Health Units, was performed. All adult subjects who received at least one prescription of anti-hypertensive drugs between January 1, 2010 and December 31, 2014 were selected. The date of the first anti-hypertensive prescription was defined as the index-date (ID). For each patient, we evaluated the anti-hypertensive therapy and the adherence to treatment during the two 12-month periods preceding and following the ID. Changes in the level of adherence have been compared in patients who switched to the FDC of perindopril/amlodipine after the ID, as well as in patients who did not. RESULTS: A total of 24,020 subjects were initially included in the study. Subjects treated with the free dose combination switched more frequently to FDC of perindopril/amlodipine than subjects treated with SPT (p < .001). Adherence to treatment was found to be higher in the 3,597 subjects who switched to the perindopril/amlodipine FDC therapy, than in the 20,423 subjects who did not. A significant decrease in the number of concomitant anti-hypertensive drugs has been observed in patients treated with the same FDC. CONCLUSIONS: The results show that perindopril/amlodipine FDC increases the rate of stay-on-therapy and reduces the number of concomitant anti-hypertensive drugs in subjects previously treated with the same drugs as a two-pill combination or as SPT.

Persistence, switch rates, drug consumption and costs of biological treatment of rheumatoid arthritis: an observational study in Italy.

OBJECTIVES: The aim of this analysis was to provide an estimate of drug utilization indicators (persistence, switch rate and drug consumption) on biologics and the corresponding costs (drugs, admissions and specialist care) incurred by the Italian National Health Service in the management of adult patients with rheumatoid arthritis (RA). METHODS: We conducted an observational retrospective cohort analysis using the administrative databases of three local health units. We considered all patients aged ≥18 years with a diagnosis of RA and at least one biologic drug prescription between January 2010 and December 2012 (recruitment period). Persistence was defined as maintenance over the last 3 months of the follow-up period of the same biological therapy administered at the index date. A switch was defined as the presence of a biological therapy other than that administered at the index date during the last 3 months of the follow-up period. Hospital admissions (with a diagnosis of RA or other RA-related diagnoses), specialist outpatient services, instrumental diagnostics and pharmaceutical consumption were assessed. RESULTS: The drug utilization analysis took into account only biologics with at least 90 patients on treatment at baseline (adalimumab n=144, etanercept n=236 and infliximab n=94). In each year, etanercept showed better persistence with initial treatment than adalimumab or infliximab. Etanercept was characterized by the lowest number of patients increasing the initial drug consumption (2.6%) and by the highest number of patients reducing the initial drug consumption (10.5%). The mean cost of treatment for a patient persisting with the initial treatment was €12,388 (€14,182 for adalimumab, €12,103 for etanercept and €11,002 for infliximab). The treatment costs for patients switching from initial treatment during the first year of follow-up were higher than for patients who did not switch (€12,710 vs. €11,332). CONCLUSION: Persistence, switch rate and drug consumption seem to directly influence treatment costs. In subjects not persisting with initial treatment, other health care costs were approximately three times higher than for persistent patients. This difference could suggest a positive effect on the quality of life for persistent patients. Etanercept showed the highest persistence with treatment.

Assessment and potential determinants of compliance and persistence to antiosteoporosis therapy in Italy.

OBJECTIVES: To analyze adherence to antiosteoporosis drugs (AODs) and to assess the influence of patient-related and drug-related factors. STUDY DESIGN: Observational, retrospective study. METHODS: Data on prescriptions for AODs from 2007 through 2008 were retrieved from administrative databases of 10 Italian local health units. Key measurements included compliance and persistence at 1 year. Multivariate regression analyses were performed to estimate adjusted risk ratios for compliance less than 80% and adjusted hazard ratios for no persistence. RESULTS: Of 40,004 new patients (89.9% women, mean age 69.8 years), 84.0% were treated with bisphosphonates and 74.6% of administration regimens were weekly. Overall, 75.1% of patients had suboptimal levels of compliance and 84.7% were not persistent; almost one-third had only 1 prescription. In regression analyses, younger age, change of drug, and concomitant corticosteroid therapy were significantly associated to compliance and persistence in both genders. In women, weekly and monthly regimens reduced the risk for poor compliance (sex-adjusted relative risks 0.729 [0.697-0.762], 0.846 [0.817-0.876], respectively) and no persistence (sex-adjusted hazard ratios 0.591 [0.541-0.646], 0.508 [0.461-0.560], respectively) compared with a daily regimen. CONCLUSIONS: In our study, 75% of subjects had discontinuous treatment and inadequate drug supply. Age and frequency of administration were strongly associated with adherence. Improvement is urgently needed, and occasional prescriptions represent the main target.