PSORIATIC PATIENT-REPORTED OUTCOMES, ADHERENCE, AND SATISFACTION. / RESULTADOS COMUNICADOS POR EL PACIENTE, ADHERENCIA Y SATISFACCIÓN EN PACIENTES CON PSORIASIS.

BACKGROUND AND OBJECTIVES: Patient-reported outcomes (PROs) are outcomes evaluated by patients based on their perception of their disease and treatment. The objective of PROs is to determine antipsoriatic treatment-related adherence, quality of life (QoL) and satisfaction. MATERIALS AND METHODS: We conducted an observational cross-sectional, prospective, and single-center study in which PROs surveys were conducted on adherence (Morisky-Green [MG] test), treatment satisfaction (Spanish Questionnaire of Treatment Satisfaction in Psoriasis [CESTEP]) and QoL (Skindex-29 and DLQI). Additional variables include: PASI, BSA. STATISTICAL ANALYSIS: Jamovi®2.3.26. RESULTS: A total of 100 surveys were conducted. Based on the MG questionnaire, we found that 75% (75/100) of patients were adherent vs 94% (94/100) from the dispensation records. Regarding CESTEP, a mean score of 7.4 ± 7.7 (close to maximum satisfaction 0) was obtained, while DLQI yielded a score of 2.6 ± 4.6 (indicating a small effect on QoL), and SKINDEX-29 a score of 14.6 ± 15.4 (68% indicating mild (< 5) or very mild (6-17) impact according to Nijsten et al.). Based on CESTEP a p.Rho Spearman value of 0.338 (p = 0.004) was obtained in relation to PASI when the study was conducted with a BSA of 0.255 (p = 0.050), DLQI results of 0.508 (p < 0.001) and Skindex-29 results of 0.397(p < 0.001). At the time of the study, the correlation matrix between DLQI result and PASI was 0.365 (p = 0.002) with a BSA of 0.347 (p = 0.007). Skindex-29 results with PASI were 0.380 (p = 0.001) and with BSA, 0.295 (p = 0.022). CONCLUSIONS: Patients on therapy exhibit a good QoL, high adherence and satisfaction with their treatment. A significant correlation was seen among satisfaction, QoL, and PASI-BSA at the time of the study.

[Temporal evolution of antiretroviral therapy (2017-2021): analysis of treatment change and its economic impact]. / Evolución temporal de la terapia antirretroviral (2017-2021): análisis de la modificación del tratamiento y su impacto económico.

OBJECTIVE: To analyze the modifications of antiretroviral therapy (ART) and their economic impact on daily clinical practice. METHODS: Observational, retrospective study of patients who started ART between 01/2017-12/2021 (follow-up until 12/2022). Variables collected: prescribed ART, duration, the reason for the change, and treatment costs. RESULTS: A total of 280 patients initiated ART therapy. The median durability of 1st line was: 19.9 months in 2017 (95%CI 13.9-25.9), 12.2 months in 2018 (95%CI 4.7-19.7), 27.4 months in 2019 (95%CI 6.8-48.1) and the median was not reached for the years 2020 and 2021 (p<0.001). Triple therapy with protease inhibitors was changed in 63.8% (81/127) of cases, followed by integrase inhibitors 52.1% (159/305), while dual therapy (DTG/3TC) only in 8.3% (7/84). The main cause of discontinuation was simplification/optimization 47.5% (124/261), followed by adverse effects 21.8% (57/261), with 2017 being the only year where simplification/optimization was at the same level as adverse effects. The economic impact of ART changes resulted in an average cost reduction of 34.0€ [-391.4 to +431.4] per month per patient. The year 2019 stands out as the only year where these changes were associated with an increase in mean additional cost (23.4€ [-358.3 to +431.4]). CONCLUSIONS: Optimization/simplification accounts for almost half of the reasons for TAR change, with an economic impact that, despite the inflection point of 2019, each year manages to exceed the previous one, achieving a progressive cost reduction maintained over time.

[Adherence to treatment with erythropoiesis stimulating agents]. / Adherencia al tratamiento con agentes estimulantes de la eritropoyesis.

BACKGROUND: To establish adherence to treatment with erythropoiesis stimulating agents (ESA) in patients with anemia associated to chronic kidney disease (CKD), and analyze its relationship to response to ESA. METHODS: Retrospective study of a cohort of 198 patients with CKD who started treatment with epoetin-ß or darbepoetin-a, followed for two years. Basal characteristics, effectiveness (% of hemoglobin (Hb) target attainment, percentage increase of Hb) and adherence (medication possession rate) were registered. A non-adherent patient was one whose mean adherence was <90%. RESULTS: Average global adhesion was 89.6%, slightly higher in treatment with darbepoetin-a than with epoetin-ß; 8.6% of patients were non-adherents. Hb target was accomplished in 87% cases. Level of response to ESA treatment was independent of the degree of adherence to treatment. CONCLUSIONS: Adherence to ESA treatment was good, without differences related to degree of response.

[Safety and effectiveness of salvage therapy in HIV patients]. / Efectividad y seguridad de la terapia de rescate en pacientes VIH.

INTRODUCTION: The treatment used after failure of at least two lines of antiretroviral treatment in HIV patients is called salvage therapy. The study aims to describe the characteristics of HIV patients subjected to such a regimen, and determine the safety and effectiveness of treatment with tipranavir (TPV), darunavir (DRV), enfuvirtide (ENF) and etravirine (ETR) combined with an optimised antiretroviral regimen. PATIENTS AND METHODS: HIV patients treated with ENF, TPV, DRV or ETR in a tertiary hospital infectious diseases department subjected to at least 12 weeks treatment. The patient characteristics are described and the effectiveness, durability and adherence to the treatment analysed. RESULTS: There were 28 patients studied, with an average of 10 treatment regimens prior to starting salvage therapy (SD=3.5; 95% CI, 8.9-11.1). A total of 85.7% patients had treatment adherence >90%. For ENF, 70.8% of the treatment lines were suspended during follow-up. After salvage therapy, the percentage of patients with viral load (VL) <400 copies/ml doubled, and cases with undetectable CV (<50 copies/ml) almost tripled. The treatments used did not change the liver or kidney profiles; however, they changed the lipid profile and increased the percentage of patients with hyperglycaemia. CONCLUSIONS: The salvage therapy studied was effective. Good adherence to the therapy is critical for its effectiveness.

[Discontinuation and long-term adherence to beta interferon therapy in patients with multiple sclerosis]. / Discontinuación y adherencia a largo plazo en la terapia con interferón beta en pacientes con esclerosis múltiple.

OBJECTIVE: To determine discontinuation rate and degree of adherence to first-line treatment with interferon-beta (INFß) in patients with multiple sclerosis (MS), identifying causes and associated factors. MATERIAL AND METHOD: A retrospective observational study that included patients with MS treated with INFß during 2001. The patients were followed-up from the beginning of treatment until the end of 2006. The data sources used were a computer database compiled in the outpatients' area, medical records and application protocols for beginning and monitoring treatment for MS. Patient characteristics at baseline, treatment and continuity were included in the information collected. RESULTS: The study included 131 patients. Mean follow-up was 74 ± 26 years. 641% of the patients were treated with only one drug during the study. At 2 years follow-up 99% of patients had discontinued INFß therapy and at 5 years 412% had done so. Men, patients with relapsing-remitting MS and those treated with INFß1a i.m. continued treatment for a longer period, but this was statistically significant only in patients with 10 years or less of disease progression at the beginning of therapy. Main causes of discontinuation were lack of efficacy (388%) and adverse effects (328%). Compliant patients presented lower discontinuation rates (558% vs. 75%). CONCLUSIONS: treatment of MS patients with IFNß is discontinued mainly due to lack of efficacy and adverse effects. Greater understanding of patients' views can help to identify those at greatest risk of lack of adherence, thereby helping to improve treatment.

[A study of initial antiretroviral therapy effectiveness, survival and safety in HIV+ patients]. / Estudio de la efectividad, supervivencia y seguridad de las terapias antirretrovirales de inicio en pacientes VIH+.

OBJECTIVE: To study initial antiretroviral therapies indicated for HIV-infected patients during the 2001-2003 period regarding effectiveness, survival and safety. METHOD: A descriptive, retrospective study of clinical and drug-related variables of naïve HIV-infected patients through pharmacotherapeutic history. RESULTS: Mean CD4+ lymphocytes counts were 209.6 cells/mm3. Pneumonia by Pneumocystis carinii was the most commonly found condition at antiretroviral treatment onset. Most commonly used therapies included those based on a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors (NRTIs). The longest mean survival was achieved by using combinations of three nucleoside reverse transcriptase inhibitors. The primary reason for initial antiretroviral therapy discontinuation were adverse effects, with stavudine exhibiting the poorest tolerability. CONCLUSIONS: Therapies based on non-nucleoside reverse transcriptase inhibitors and protease inhibitors (PIs) have shown similar effectiveness to increase CD4+ cell counts. Regarding viral load decreases, protease inhibitors were most effective. Therapies using three nucleoside reverse transcriptase inhibitors resulted in peak survival.

[Influence of gender on clinical research]. / Influencia del género en investigación ckínica.

OBJECTIVE: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. MATERIAL AND METHODS: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. DATA SOURCES: protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. RESULTS: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. CONCLUSIONS: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.