4 research outputs found
Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes
BACKGROUND
The cardiovascular effects of ertugliflozin, an inhibitor of sodium–glucose cotransporter 2, have not been established.
METHODS
In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose
groups pooled for analysis, the primary objective was to show the noninferiority of
ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper
boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was
a composite of death from cardiovascular causes or hospitalization for heart failure.
RESULTS
A total of 8246 patients underwent randomization and were followed for a mean
of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin
or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients
(11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11;
P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization
for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group
and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI,
0.75 to 1.03; P=0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from
renal causes, renal replacement therapy, or doubling of the serum creatinine level
was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%)
who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received
the 15-mg dose, as compared with 45 patients (1.6%) who received placebo.
CONCLUSIONS
Among patients with type 2 diabetes and atherosclerotic cardiovascular disease,
ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular
events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov
number, NCT01986881.)
Effects of ertugliflozin on kidney composite outcomes, renal function and albuminuria in patients with type 2 diabetes mellitus: an analysis from the randomised VERTIS CV trial
Aims/hypothesis In previous work, we reported the HR for the risk (95% CI) of the secondary kidney composite endpoint (time
to first event of doubling of serum creatinine from baseline, renal dialysis/transplant or renal death) with ertugliflozin compared
with placebo as 0.81 (0.63, 1.04). The effect of ertugliflozin on exploratory kidney-related outcomes was evaluated using data
from the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes (VERTIS CV) trial (NCT01986881).
Methods Individuals with type 2 diabetes mellitus and established atherosclerotic CVD were randomised to receive ertugliflozin
5 mg or 15 mg (observations from both doses were pooled), or matching placebo, added on to existing treatment. The kidney
composite outcome in VERTIS CV (reported previously) was time to first event of doubling of serum creatinine from baseline,
renal dialysis/transplant or renal death. The pre-specified exploratory composite outcome replaced doubling of serum creatinine
with sustained 40% decrease from baseline in eGFR. In addition, the impact of ertugliflozin on urinary albumin/creatinine ratio
(UACR) and eGFR over time was assessed.
Results A total of 8246 individuals were randomised and followed for a mean of 3.5 years. The exploratory kidney composite
outcome of sustained 40% reduction from baseline in eGFR, chronic kidney dialysis/transplant or renal death occurred at a lower event
rate (events per 1000 person-years) in the ertugliflozin group than with the placebo group (6.0 vs 9.0); the HR (95% CI) was 0.66
(0.50, 0.88). At 60 months, in the ertugliflozin group, placebo-corrected changes from baseline (95% CIs) in UACR and eGFR were
−16.2% (−23.9, −7.6) and 2.6 ml min−1 [1.73 m]−2 (1.5, 3.6), respectively. Ertugliflozin was associated with a consistent decrease in
UACR and attenuation of eGFR decline across subgroups, with a suggested larger effect observed in the macroalbuminuria and
Kidney Disease: Improving Global Outcomes in Chronic Kidney Disease (KDIGO CKD) high/very high-risk subgroups.
Conclusions/interpretation Among individuals with type 2 diabetes and atherosclerotic CVD, ertugliflozin reduced the risk for
the pre-specified exploratory composite renal endpoint and was associated with preservation of eGFR and reduced UACR.
Trial registration ClinicalTrials.gov NCT0198688
Regional features of climate of national park ”Prypjat-Stokhid”
В статті приведено результати дослідження кліматичних показників за даними спостережень на метеостанції Любешів, яка знаходиться на території національного природного парку «Припʼять-Стохід». Проаналізовано багаторічний хід температури повітря та кількості опадів, визначено відхилення середніх місячних та середніх річних значень температури повітря та суми опадів від багаторічних і кліматичної норми. Вирахувані показники
укладено в таблиці, динаміка температури повітря та кількості опадів впродовж року та в багаторічному ходу відображена графічно. Встановлено, що на території національного парку спостерігається стійка тенденція до потепління, яке супроводжується підвищенням річної температури повітря та збільшенням річної суми опадів.The article presents the results of the study of climatic indicators based on observation data at the Lyubeshov Meteorological Station, which is located on the territory of the National Nature Park "Pripyat-Stokhid". The long-term course of air temperature and rainfall has been analyzed, deviations of average monthly and average annual values of air temperature and rainfall amounts from the perennial and climatic norm. Calculated values are summarized in the table, the dynamics of air
temperature and precipitation amount throughout the year and in the long run is graphically represented. It is established that in the territory of the national park there is a stable tendency to warming, which is accompanied by an increase in the annual temperature of the air and an increase in the annual amount of precipitation