Cognitive Function with PCSK9 Inhibitors: A 24-Month Follow-Up Observational Prospective Study in the Real World-MEMOGAL Study.

INTRODUCTION: The cognitive safety of monoclonal antibody proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) has been established in clinical trials, but not yet in real-world observational studies. We assessed the cognitive function in patients initiating PCSK9i, and differences in cognitive function domains, to analyze subgroups by the low-density lipoprotein cholesterol (LDL-C) achieved, and differences between alirocumab and evolocumab. METHODS: This has a multicenter, quasi-experimental design carried out in 12 Spanish hospitals from May 2020 to February 2023. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). RESULTS: Among 158 patients followed for a median of 99 weeks, 52% were taking evolocumab and 48% alirocumab; the mean change from baseline in MoCA score at follow-up was + 0.28 [95% CI (- 0.17 to 0.73; p = 0.216)]. There were no significant differences in the secondary endpoints-the visuospatial/executive domain + 0.04 (p = 0.651), naming domain - 0.01 (p = 0.671), attention/memory domain + 0.01 (p = 0.945); language domain - 0.10 (p = 0.145), abstraction domain + 0.03 (p = 0.624), and orientation domain - 0.05 (p = 0.224)-but for delayed recall memory the mean change was statistically significant (improvement) + 0.44 (p = 0.001). Neither were there any differences in the three stratified subgroups according to lowest attained LDL-C level-0-54 mg/dL, 55-69 mg/dL and ≥ 70 mg/dL; p = 0.454-or between alirocumab and evolocumab arms. CONCLUSION: We did not find effect of monoclonal antibody PCSK9i on neurocognitive function over 24 months of treatment, either in global MoCA score or different cognitive domains. An improvement in delayed recall memory was shown. The study showed no differences in the cognitive function between the prespecified subgroups, even among patients who achieved very low levels of LDL-C. There were no differences between alirocumab and evolocumab. REGISTRATION: ClinicalTtrials.gov Identifier number NCT04319081.

Impact of a pharmaceutical intervention on influenza vaccination in patients receiving treatment with biological medicines.

OBJECTIVE: The aims of this study were twofold - to determine the impact of a health education intervention led by a hospital pharmacy department on influenza vaccination take-up in patients diagnosed with immune-mediated diseases. Patients were receiving treatment with biological medicines. Secondly, to compare those rates with the vaccination percentages of another hospital pharmacy with similar characteristics in which no educational intervention was conducted. METHODS: This was a retrospective cohort study of adult patients with immune-mediated diseases receiving treatment with biological medicines. The medicines were dispensed by the hospital pharmacy departments of two hospitals between 1 January 2019 and 31 December 2020. In Cohort A (intervention group), a health education strategy was implemented with regards to influenza vaccination. Cohort B acted as a control group. The influenza vaccination rates obtained in both cohorts during 2019 and 2020 were compared. RESULT: A total of 355 patients took part in the study - 148 (41.7%) in Cohort A and 207 (58.3%) in Cohort B. The hospital pharmacy department in Cohort A implemented a health education strategy after which the vaccination percentage during the 2020 campaign increased by 38 patients (45.7%), compared with a 10 patient (5.8%) increase in Cohort B (p<0.001). CONCLUSIONS: The health intervention by the pharmacy department had a positive impact. This included an opportunity to improve vaccination take-up and is a strategy to consider when implementing a vaccination programme. Health education is a fundamental objective of healthcare. In our case it led to an increase in vaccination and had a positive impact on public health. It also provides opportunities for pharmacists to work in a multidisciplinary way with other healthcare professionals.