PCSK9 inhibitors as an add on for the treatment of dislipemia in real clinical practice

This article describes the rationale for methodology of comprehensive assessment of drug consumption in real clinical practice. The proposed methodology includes three stages: 1) epidemiological monitoring – disease epidemiology assessment; assessment of the role of factors leading to the disease; 2) pharmacoepidemiological monitoring – assessment of pharmacotherapy in real clinical practice; clinical efficacy analysis of drugs; cost-effectiveness analysis; 3) long-term clinical and economical evaluation of various treatment options. Comprehensive assessment of drug consumption should result in optimal pharmacotherapy regimens, decrease of the drug load, increasing of the therapy effectiveness and cost reduction. The scheme of comprehensive assessment of drug consumption is universal and can be used for clinical guidelines development, treatment standards, for the optimal formation of drugs lists at the federal level. Separate stages and sub-steps of an integrated assessment also can be used at the territorial and local levels, medical institution, to optimize pharmacotherapy.

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Pharmacoepidemiological Analysis of Pharmacotherapy for Burn Injuries in Real Clinical Practice

Medical Technologies Assessment and Choice (Медицинские технологии Оценка и выбор) ◽

10.31556/2219-0678.2020.39.1.070-079 ◽

2020 ◽

pp. 70-79

Author(s):

Olga Vyacheslavovna Zhukova ◽

Ekaterina Sergeevna Nekaeva ◽

Elena Sergeevna Khoroshavina ◽

Ekaterina Alexeevna Kozlova ◽

Yulia Alexandrovna Dudukina ◽

...

Keyword(s):

Clinical Practice ◽

Average Cost ◽

Burn Injury ◽

General Structure ◽

Burn Injuries ◽

Antimicrobial Drugs ◽

Positive Tendency ◽

Defined Daily Doses ◽

Duration Of Hospitalization ◽

Real Clinical Practice

Objective: to conduct pharmacoepidemiological analysis and analysis of the costs of pharmacotherapy, taking into account the actual consumption of drugs in the real inpatient clinical practice at the federal center in Russia. Materials and methods. Data from the medical records of 14 patients with burn injury, who were hospitalized in 2018, was analyzed. Patients’ age was from 23 to 67 years (44,93 ± 14,66). Duration of hospitalization was from 17 to 62 days (35,93 ± 14,17). We calculated rate of prescription foe each drug and its share in general structure of all utilized drug courses (n = 460). We performed frequency analysis of prescription structure, DDD (defined daily doses) analysis, DU90% (Drug Utilization 90%) analysis, ABC-analysis and analysis of average cost of pharmacotherapy. Results. Most frequently used drugs, prescribed in 75-100% of all hospital cases, included 15 names, e.g. 2 antimicrobial drugs (vancomycin and amikacin), 19 were used commonly, including 4 antimicrobial drugs (co-trimoxazole, cefoperazone/sulbactam, tigecyclin and cefepime). Other drugs were used in less than 25% of cases. 33 drugs made 90% of all consumed NDDD, including 5 antimicrobial drugs (vancomycin, amikacin, co-trimoxazole, cefoperazone/sulbactam and tigecyclin). These drugs comprised 70,24% in the prescription structure. The cost of one DDD in DU90% segments (512,33 rubles) is 1,4 higher than in DU10% segment (649,34 rubles). Average cost of drugs included in DU90% group was 4735,89 rubles vs 4966,80 rubles for drugs from DU10% group. This finding shows positive tendency of burn injuries pharmacological treatment. Conclusion. We obtained the data, which can be used for comparison of real clinical practice costs with a current payment rates for medical care.

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How many CCS- and ACS-patients might reach the newly recommended LDL-C-target <55mg/dl in clinical practice if guidelines were applied – an estimate from the DYSIS II study population

European Heart Journal ◽

10.1093/ehjci/ehaa946.1445 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

A.K Gitt ◽

M Horack ◽

D Lautsch ◽

R Zahn ◽

J Ferrieres

Keyword(s):

Clinical Practice ◽

Real Life ◽

Statin Treatment ◽

Lipid Lowering ◽

High Risk Population ◽

High Dose ◽

Funding Source ◽

Pcsk9 Inhibitors ◽

Target Values ◽

Coronary Syndromes

Abstract Background The 2019 ESC guidelines for the management of dyslipidemia even further lowered the LDL-C-target values for the very high-risk population from <70mg/dl to <55mg/dl. Population based studies already had shown that the previous target was difficult to reach. It is yet unclear how many patients in clinical practice might be treated to the new target. Methods The Dyslipidemia International Study (DYSIS II) prospectively collected data of patients with chronic coronary syndromes (CCS) and acute coronary syndromes (ACS) (all on statins) in 18 countries in Europe, the Middle East, South- and East Asia to document patient characteristics, medication and a current lipid profile from 2012 to 2014 under real life conditions in physicians' offices and hospitals. We took these real-life lipid profiles and data on the kind/dose of used statins to estimate how treatment escalation such as changing statin treatment to a high dose (atorvastatin ≥40mg / rosuvastatin≥20mg), adding ezetimibe and adding a PCSK9-inhibitor might help to bring LDL-C-levels to the recommended <55mg/dl target. Results A total of 7,865 patients were enrolled into DYSIS II, 6,794 had CCS and 1,071 ACS. Under the documented statin treatment in DYSIS only 12.7% of patients reached an LDL-C <55mg/dl. Putting all patients on high dose statins in combination with ezetimibe, 64.1% would reach the target. If PCSK9-inhibitors would be used in the remaining patients not at goal a total of 94.0% would match the goal. Conclusion Our analysis indicates that in real life practice the use available lipid-lowering medications would substantially increase the percentage of CCS- and ACS-patients reaching the newly recommended 2019 ESC guideline LDL-C-target of <55 mg/dl from less than 20% to more than 90% of the population. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): MSD

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Insulin doses requirements in patients with type 1 diabetes using glargine U300 or degludec in routine clinical practice

Journal of Investigative Medicine ◽

10.1136/jim-2020-001633 ◽

2021 ◽

pp. jim-2020-001633

Author(s):

Florentino Carral San Laureano ◽

Mariana Tomé Fernández-Ladreda ◽

Ana Isabel Jiménez Millán ◽

Concepción García Calzado ◽

María del Carmen Ayala Ortega

Keyword(s):

Type 1 Diabetes ◽

Clinical Practice ◽

Retrospective Study ◽

Real World ◽

Glycosylated Hemoglobin ◽

Routine Clinical Practice ◽

Insulin Analogs ◽

Total P ◽

Real Clinical Practice

There are not many real-world studies evaluating daily insulin doses requirements (DIDR) in patients with type 1 diabetes (T1D) using second-generation basal insulin analogs, and such comparison is necessary. The aim of this study was to compare DIDR in individuals with T1D using glargine 300 UI/mL (IGlar-300) or degludec (IDeg) in real clinical practice. An observational, retrospective study was designed in 412 patients with T1D (males: 52%; median age 37.0±13.4 years, diabetes duration: 18.7±12.3 years) using IDeg and IGla-300 ≥6 months to compare DIDR between groups. Patients using IGla-300 (n=187) were more frequently males (59% vs 45.8%; p=0.004) and had lower glycosylated hemoglobin (HbA1c) (7.6±1.2 vs 8.1%±1.5%; p<0.001) than patients using IDeg (n=225). Total (0.77±0.36 unit/kg/day), basal (0.43±0.20 unit/kg/day) and prandial (0.33±0.23 unit/kg/day) DIDR were similar in IGla-300 and IDeg groups. Patients with HbA1c ≤7% (n=113) used significantly lower basal (p=0.045) and total (p=0.024) DIDR, but not prandial insulin (p=0.241), than patients with HbA1c between 7.1% and 8% and >8%. Patients using IGla-300 and IDeg used similar basal, prandial and total DIDR regardless of metabolic control subgroup. No difference in basal, prandial and total DIDR was observed between patients with T1D using IGla-300 or IDeg during at least 6 months in routine clinical practice.

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