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BackgroundAlirocumab and evolocumab (PCSK9-Inhibitors), are new drugs incorporated into the therapeutic arsenal for the treatment of hypercholesterolaemia, having shown effectiveness and safety in the performed clinical trials.PurposeTo assess the effectiveness and safety of PCSK9-Inhibitors, to evaluate if both drugs are equally effective and to evaluate if there is any efficacy difference when using them as monotherapy agents or plus other lipid-lowering therapies (OLLT).Material and methodsObservational, retrospective and analytical study of patients in treatment with PCSK9-Inhibitors between February 2016 and August 2017. Patients’ selection, demographic and clinical parameters (sex, age, diagnosis, prescribed PCSK9-Inhibitors, OLLT, adverse events(AE)), analytical data (LDL-Cholesterol (LDL-C) and transaminases at week 0, 24 and 48) were obtained from Farmatools®and MambrinoXXI®.Effectiveness was defined as the percent change in LDL-C from baseline to week 24 or 48. Safety was assessed by analysing AE andincrease in transaminases during treatment.Effectiveness difference between groups were analysed (alirocumab vs evolocumab and PCSK9-Inhibitors vs PCSK9-Inhibitors plus OLLT) using t-test with SPSS®v23.ResultsThirty-nine patients were included: 62% male, between 34 and 78 years’ old. Diagnosis were 77% primary hypercholesterolaemia (97% heterozygous, 3% homozygous) and 23% mixed dyslipidaemia, with mean basal LDL-C of 165.13±45.37 mg/dl. Evolocumab was prescribed in 59% of patients and alirocumab 41%. Only six patients were on PCSK9-Inhibitors monotherapy (33 plus OLLT).The percentage change in LDL-C from baseline to week 24 were −41% and to week 48 were −61%.The percentage change in LDL-C from baseline to week 24 in the evolocumab group were −50% and −46% in the alirocumab group (p=0.736). The percentage change in LDL-C in the monotherapy group were −36% and −51% in the group plus OLLT (p=0.283).No EA were reported, however, 5% of patients presented elevation of transaminases at 12 weeks. There were no cases of patients requiring suspension or interruption of the treatment.ConclusionOur study has shown a reduction in LDL-C that is comparable with that shown in clinical trials, with a greater tendency for reduction in the evolocumab group and in patients with OLLT combined, probably associated with the synergistic effect of both drugs. We must continue to study whether this is related to a reduction in morbidity and mortality.No conflict of interest

BackgroundThe Andalusian Health Service insulinisation protocol for the non-critical patient is applied through a subcutaneous ‘Basal-Bolus-Correction’ technique. Our previous pilot study of glycaemic control in diabetic patients admitted to the hospital, revealed how 41%, with only insulin correction regimen without basal insulin and/or bolus (ICRw), presented at some time during their admission fasting glycaemia >140 mg/dl, and of these 10%>180 mg/dl. It is important to maintain at all times optimal glycaemic control.PurposeTo measure the impact of a multidisciplinary intervention to rationalise the use of ICRw in diabetic patients admitted to the hospital, analysing the-number-of-changes-of-regimen due to hyperglycaemia per 100 prescriptions of ICRw during and after the intervention.Material and methodsIntervention periodDaily selection during 1 month of diabetic patients with 3 days of ICRw and glycaemia >150 mg/dl, of the total of patients with ICRw prescription, using the electronic prescription program and electronic clinical history.Daily intervention of the PROI group (group–for–the–optimisation–of–insulin–therapy) –endocrinology–pharmacy – in all selected patients, through a note with recommendations, in the electronic prescription program.After 2 months, analysis post-interventionfollowing the same procedure.ResultsWe analysed 337 patients with ICRw prescription in the intervention period and 182 in the post-intervention:Percentage of diabetics patients with ICRw in the intervention period: 29% (97/337) and in the post–intervention: 22% (44/182).Percentage of regimen–changes in patients with glycaemia >150 mg/dl and ICRw: 35% in the intervention period – 23 recommendations for change of insulin therapy and 11 follow–ups and posterior change – accepted 87%; and 9% in the post–intervention, all accepted.Odds ratio: 0.1872 (CI 0.04486 to 0.583), Fisher’s Exact Test-, P:0.001. (OPEN-EPI 3.0.)In the intervention period most prescriptions were in patients with home-based insulin therapy or with more than one oral antidiabetic: only 14% were patients with a single oral antidiabetic at home. In the post-intervention period, all were prescriptions in patients with a single oral anti-diabetic at home.ConclusionAfter the intervention of the PROI group, ICRw prescription in the hospital was applied only to patients with single low doses of oral antidiabetics at home. The glycaemia in such cases is usually maintained below 150 mg/dl. The intervention of the multidisciplinary group PROI is considered effective.No conflict of interest