Patienter med diabetes typ 2 som behandlas med läkemedlet Jardiance (Jardiance®) löpte 51 procent mindre risk att läggas in på sjukhus på grund av hjärtsvikt jämfört med dem som behandlas med DPP-4-hämmare, visar en ny studie med 35 000 patienter. Även antalet akuta vårdbesök på sjukhus var signifikant färre. (1)
Resultaten har nyligen presenterats vid två vetenskapliga konferenser i San Diego (AMCP) respektive New Orleans (ACC) i USA. (2, 3)
Den aktuella studien (EMPRISE) som startade 2016 är en pågående studie med syfte att jämföra behandling i klinisk vardag med Jardiance (empagliflozin) respektive DPP-4-hämmare hos patienter med diabetes typ 2. Resultaten som baseras på de två första åren visar:
- Behandling med Jardiance visade 39 procents mindre relativ risk för det sammansatta effektmåttet hospitalisering på grund av hjärtsvikt eller totalmortalitet jämfört med behandling med DPP-4-hämmare. (1)
- Behandling med Jardiance var associerad med signifikant färre akuta vårdbesök på sjukhus jämfört med patienter som fick DPP-4-hämmare. (2)
- Det fanns ingen ökad risk för frakturer eller amputation av underben vid behandling med Jardiance jämfört med DPP-4-hämmare. (3)
-Det är mycket glädjande att i den amerikanska studien EMPRISE kunna se en minskning av sjukhusinläggningar på grund av hjärtsvikt, en komplikation som dels är allvarlig för patienterna dels resurskrävande för vården. Det pågår ett arbete med en liknande studie som innefattar data från norden. Nordiska registerdata är en fantastisk källa till kunskap som ger oss möjlighet att undersöka hur ett läkemedel fungerar i klinisk vardag. De första resultaten förväntas redan nästa år, säger Rikard Amberntsson, medicinsk rådgivare vid Boehringer Ingelheim.
Den kliniska studien Empa-Reg-Outcome har tidigare visat att patienter med diabetes typ 2 och etablerad hjärt-kärlsjukdom och som behandlats med Jardiance har en 35 procent lägre risk för att drabbas av sjukhusinläggning på grund av hjärtsvikt samt en minskad risk för kardiovaskulär död. EMPRISE studien skall ses som ett komplement till denna studie.
S
(1) EMPRISE ACC 2019 poster_FINAL.pdf
(2)Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2019; March 25-28, 2019, San Diego, US
(3)American College of Cardiology´s (ACC) 68th Annual Scientific Session & Expo; 16-18 March 2019, New Orleans, Louisiana, US.
Ur Pressmeddelande • Apr 15, 2019
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From Circulation
https://www.ahajournals.org/doi/abs/10.1161/circ.138.suppl_1.14741?af=R
Abstract 14741: Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care: A First Analysis From the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study
Abstract
Introduction: The landmark EMPA-REG OUTCOME trial established a reduction of 38% for cardiovascular (CV) death and 35% for heart failure hospitalization (HHF) in patients with Type 2 diabetes (T2D) at high CV risk treated with Empagliflozin (EMPA), a SGLT2 inhibitor (SGLT2i), on top of standard of care.
Hypothesis: EMPRISE will evaluate the comparative effectiveness, safety and healthcare utilization of EMPA in routine care across a broad spectrum of CV risk using U.S. commercial and Medicare claims data (2014-2019).
Methods: In a first analysis in 2 commercial datasets (08/2014-09/2016) and Medicare (08/2014-09/2015), we identified a 1:1 propensity score-matched (PSM) cohort of T2D patients ≥18 years initiating EMPA or a DPP4 inhibitor (DPP4i), with no SGLT2i or DPP4i use in the prior year. The primary outcome was HHF, defined as a HF discharge diagnosis in the primary position (HHF-Primary); a secondary outcome was a HF discharge diagnosis in any position (HHF-Any). Hazard ratios (HR) and 95% confidence intervals (CI) were estimated controlling for >120 baseline characteristics in each dataset and pooled by fixed-effects meta-analysis. SGLT-2i vs DPP4i analyses were also performed.
Results: After PSM, we identified 14,414 patient pairs with similar characteristics (Table 1). Compared to DPP4i, EMPA decreased the risk of HHF-Primary by 48%, though this estimate was based on few events and not statistically significant [HR (95% CI) = 0.52 (0.22-1.22)], and the risk of HHF-Any by 49% [0.51 (0.34-0.78)]. Results were consistent in patients with and without CV disease. Results for the class of SGLT2i vs DPP4i (94,354 PSM pairs) were similar: HHF-Primary [0.42 (0.34-0.52)] and HHF-Any [0.68 (0.61-0.75)].
Conclusions: A first comprehensive assessment from EMPRISE showed that compared with DPP4i, EMPA was associated with a decreased HHF risk in routine clinical care, supporting the EMPA-REG OUTCOME trial results. Future analyses will include increasing numbers of patients to further assess relevant outcomes.
CREDENCE was a randomized, double-blind, placebo controlled study involving multiple clinical centers. It enrolled about 4400 patients with T2D, with estimated glomerular filtration rate (eFGR) ≥30 to <90 mL/min/1.73 m2, and albuminuria.
Artikeln i sin helhet utan lösenord och som pdf
https://www.nejm.org/doi/full/10.1056/NEJMoa1811744?query=featured_home
Abstract
BACKGROUND
Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.
METHODS
In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically.
RESULTS
The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture.
CONCLUSIONS
In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years. (Funded by Janssen Research and Development; CREDENCE ClinicalTrials.gov number, NCT02065791.)
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