PROBLEM OF TREATMENT WITH STATINS IN RUSSIA: WILL GENERICS HELP?

The article underlines necessity of statins treatment for patients with high risk of cardio-vascular events. It is noted that in our country these drugs are used extremely seldom. The problem of generic-statins equivalence to original drugs is considered

CAMELLIA TRIAL: COMPARISON IN THERAPIES BASED ON CARVEDILOL AND METOPROLOL IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT AND OBESITY

Therapy of arterial hypertension in patients with overweight and obesity has peculiarities. Reasons for comparable study of efficacy and safety of therapies based on β-blockers (carvedilol and metoprolol) in this type of patients are presented. Study aims and design, efficacy and safety criteria are described

PHARMACOECONOMIC ANALYSIS OF CARVEDILOL THERAPY IN PATIENTS WITH ARTERIAL HYPERTENSION AND METABOLIC RISK FACTORS (ACCORDING TO THE CAMELLIA STUDY)

Aim. To perform cost-effectiveness analysis of 24 weeks antihypertensive therapy based on carvedilol or metoprolol in patients with arterial hypertension (HT) 1-2 degrees and overweight/obesity. To assess effects of carvedilol therapy on 10-year expected risk of cardiovascular complications (CVC).Material and methods. Patients with HT and overweight/obesity (n=320) were included into the study and randomly split in two groups. Patients of the first group (n=160) received carvedilol as a basic therapy and patients of the second group (n=160) — metoprolol. Both groups of the patients were comparable on key clinical characteristics.Results. In 24 weeks of treatment systolic and diastolic blood pressure (BP) decreased significantly in comparison with the baseline level (p<0.0001). Dose doubling of beta-blockers was required more often in patients treated with carvedilol. At the same time a combined antihypertensive therapy of the patients treated with carvedilol was required less (p>0.05). Target BP levels were achieved in carvedilol and metoprolol groups in 96.2and 95.5% of patients respectively (p=0.85). Carvedilol had better effect on plasma metabolic indicators such as glucose (p<0.01), lipid profile, uric acid level. Reduction in expected 10-year risk of death was more pronounced in 24 weeks carvedilol treatment. Cost of target BP level achievement was approximately 2.5 times higher in carvedilol group than this in metoprolol group. However cost of additional therapy was higher in metoprolol group. 1% reduction of the 10-year expected risk of CVC death cost 1 847 rubles in carvedilol therapy.Conclusion. Carvedilol therapy (vs metoprolol one) has a higher cost under comparable efficacy. Additional expenses are compensated with the favorable effect on metabolic indices and a more pronounced effect on reduction in the 10-year expected risk of CCO death. That is why carvedilol can be recommended to patients with HT and metabolic risk factors. Longer studies are necessary to assess an effect of carvedilol therapy on prognosis in patients with HT and concomitant metabolic disorders

Changes in Long-term Mortality in Patients with Myocardial Infarction History According to the LIS Luberetskiy registry

Aim. The aim of the research was to study the dynamics of distant cases of the disease that underwent AMI in 2005-2007 (LIS registry) and in 2014 and 2018 (LIS-3 registry), discharged from the same hospital of the Lyubertsy District Hospital (LDH).Material and methods. The study was conducted on the basis of two registries - a retrospective-prospective register LIS (Lyubertsy investigation of death), which was conducted in the Lyubertsy district of the Moscow region, all cases of check-ups in the AMI hospital for a 3-year period (2005- 2007) and the prospective register LIS-3 (11/01/2013 – to the present), which included patients admitted to the cardiology department of the Lyubertsy District Hospital No. 2 with the correct diagnosis of Acute coronary syndrome with and without ST segment elevation. With patients discharged from the hospital, a telephone contact was established no earlier than 1 year after discharge to clarify the life status, and in case of death – to find out its causes. Search for patients who did not answer the phone call, was using by the study of the archive of the polyclinic, with database statistics. Longterm cases of the LIS were compared with LIS-3 registers, clinical demographic characteristics and risk indicators in patients in the LIS and LIS-3 registers were also compared, differences in drug therapy before the onset of AMI and after discharge from the hospital register between LIS and LIS3 were analyzed.Results. Out of 327 patients, the registry included 104 (31.8%) patients discharged in 2014 and 223 (68.2%) in 2018. When comparing the longterm mortality curves of the LIS and LOS-3 registers, a significant difference was noted. The LIS-3 study revealed more frequent referrals for antiplatelet agents (20% vs 16%), statins (11.6% vs 2.0%). Less commonly, diuretics began to be prescribed at the prehospital level. After discharge from the hospital in the LIS-3 registry, a decrease compared to the LIS registry, more frequent prescription of antiplatelet agents (97.5% vs 85.0%), anticoagulants (1.1% vs 0%), statins (96.5% vs 67.0%), beta-blockers (93.3% vs 81.0%). Less commonly, diuretics are prescribed at discharge from the hospital.Conclusion. The present study of the LIS-3 registry showed a significant decrease in the incidence of those who had AMI, which occurred 15-20 years after the LIS registry was conducted

STUDY OF THE PARAMETERS OF TOLERABILITY AND ADHERENCE TO THERAPY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND ARTERIAL HYPERTENSION ON THE BACKGROUND OF TREATMENT WITH FIXED COMBINATION OF RAMIPRIL AND AMLODIPINE (ACCORDING TO THE RESULTS OF OBSERVATIONAL STUDY "GRANAT-2")

Working group of the “GRANAT-2” study: Tula - Trubitsyn G.I., Ivanov Yu.V., Mirenkova O.K., Eskova R.A., Simonova R.P., Milon M.E., Telegina E.V., Kuznetsov A.M., Zhukova N.A., Zainullina I.K.; Rostov-on-Don - Budanov O.V., London E.M., Minosyan L.V., Nedashkovskaya N.G., Ter-Ananyants Ye.A.; Tomsk - Proskokova I.Yu., Permyakova O.V., Politova L.V., Maneeva I.D., Ivanova S.Yu.; Nizhny Novgorod - Larina O.V., Pokrovskaya I.N., Patselt E.A.; Moscow - Sladkova T.A., Zelenova Т.V. Aim. To study the tolerability and adherence to antihypertensive therapy in patients with hypertension and chronic obstructive pulmonary disease (COPD) using the fixed combination of ramipril and amlodipine in the observational program for patients with arterial hypertension and COPD (GRANAT-2). Material and methods. Patients with hypertension and COPD (n=52) with all inclusion criteria and without exclusion criteria who signed informed consent to participate in the GRANAT-2 program were included into the study. The use of a fixed combination of ramipril and amlodipine was recommended in all patients. The doses were determined by the treating physicians in accordance with the official drug instruction. The patients had 4 visits, and the duration of the study was 5 months. The Morisky-Green test was used to assess an adherence of patients to treatment. Assessments of blood pressure, adverse events were performed at all visits. Results. 50 of 52 patients completed the study: 45 patients used the studied fixed combination in the recommended doses, and 5 patients used other antihypertensive drugs, 2 patients withdrew from the study. Systolic blood pressure after 1 month of treatment decreased by an average of 20 mm Hg from the baseline, and diastolic blood pressure – by 10 mmHg. These rates after 5 months of therapy were 29 mm Hg and 15 mm Hg, respectively. Target blood pressure level was achieved in all patients. Increase in adherence of patients to treatment (according to the Morisky-Green test from 21.1% to 65.1%) was found. 2 cases of adverse events (dry cough) were registered. The discrepancy in adherence assessment was revealed between the results from the Morisky-Green test and the data from program case report forms. Conclusion. Regular patient visits to the doctor and the rapid achievement of an antihypertensive effect with good tolerability of a fixed combination of ramipril and amlodipine contributed to the increase in adherence of patients to treatment. Undesirable effects of the drug therapy are significant, but not leading factors that have a negative impact on the patient adherence to treatment

3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial

Background Liraglutide 3\ub70 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes. Methods In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3\ub70 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219. Findings The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2\ub77 times longer with liraglutide than with placebo (95% CI 1\ub79 to 3\ub79, p<0\ub70001), corresponding with a hazard ratio of 0\ub721 (95% CI 0\ub713\u20130\ub734). Liraglutide induced greater weight loss than placebo at week 160 (\u20136\ub71 [SD 7\ub73] vs 121\ub79% [6\ub73]; estimated treatment difference 124\ub73%, 95% CI 124\ub79 to 123\ub77, p<0\ub70001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group. Interpretation In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3\ub70 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes. Funding Novo Nordisk, Denmark

A randomized, controlled trial of 3.0 mg of liraglutide in weight management

BACKGROUND Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P&lt;0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P&lt;0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P&lt;0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.)

ROLE OF BETA-ADRENOBLOCKERS IN ARTERIAL HYPERTENSION TREATMENT. WHAT DO EVIDENCE BASED MEDICINE DATA SHOW?

The beta-blocker role in arterial hypertension treatment is surveyed from the positions of evidence based medicine and international clinical guidelines. Data of last randomized clinical trials and meta-analyses are discussed