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Home > Health Conditions > Diabetes > Jardiance (empagliflozin)

Jardiance (empagliflozin)

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News & Research:

  • Empagliflozin's HFpEF Efficacy Catalyzes Redefinition of HF - Medscape, 9/22/21 - "This new consensus essentially throws out left ventricular ejection fraction (EF) as the key metric for matching patients to heart failure treatments. Experts have instead begun suggesting a more unified treatment approach for all heart failure patients regardless of their EF ... We encourage you to forget about ejection fraction ... We certainly encourage you to forget about an ejection fraction of less than 40%" as having special significance ... The 40% ejection fraction divide is artificial. It was created in 2003 as part of a trial design, but it has no physiological significance ... A much better way to distinguish systolic and diastolic heart failure is by strain assessment rather than by ejection fraction. "Strain is a measure of myocardial shortening, a measure of what the heart does. Ejection fraction is a measure of volume," ... Wouldn't it be easier if we said that every patient with heart failure needs to receive one agent from each of the four [pillar] drug classes, and put them in a polypill ... The four pillar drug classes, recently identified as essential for patients with HFrEF but until now not endorsed for patients with HFpEF, are the sodium-glucose cotransporter 2 (SGLT2) inhibitors, such as empagliflozin (Jardiance); an angiotensin receptor blocker neprilysin inhibitor compound such as sacubitril/valsartan (Entresto); beta-blockers; and mineralocorticoid receptor antagonists such as spironolactone and eplerenone ... The consequence is that clinicians should feel comfortable prescribing empagliflozin to most patients with heart failure without regard to EF, even patients with EF values in the mid-60% range ... The EMPEROR-Preserved results showed a clear signal of attenuated benefit among patients with an EF of 65% or greater "on a population basis," ... Recently, data from a third trial that tested sacubitril/valsartan in patients with HFpEF, PARAGON-HF, showed benefit among patients with EFs below the study median of 57%"
  • FDA Okays Empagliflozin for HFrEF - Medscape, 8/19/21 - "The FDA based its decision on results from the EMPEROR-Reduced study, first reported in August 2020, that showed treatment of patients with HFrEF with empagliflozin on top of standard therapy for a median of 16 months cut the incidence of cardiovascular death or hospitalization for worsening heart failure by 25% relative to placebo, and by an absolute 5.3%, compared with placebo-treated patients ... Patients enrolled in EMPEROR-Reduced had chronic heart failure in New York Heart Association functional class II-IV and with a left ventricular ejection fraction of 40% or less, the standard ejection fraction criterion for defining HFrEF. Half the enrolled patients had diabetes, and analysis showed no heterogeneity in the primary outcome response based on diabetes status at enrollment ... Subsequent to the report of results from the EMPEROR-Reduced trial nearly a year ago, heart failure experts declared that treatment with an agent from the SGLT2 inhibitor class had become a "new pillar of foundational therapy for HFrEF," and they urged rapid initiation of an SGLT2 inhibitor (along with other appropriate medications) at the time of initial diagnosis of HFrEF"
  • Tips for Navigating Prior Authorization and Out-of-Pocket Costs for HFrEF Medications - Medscape, 5/11/21 - "Moreover, in the past decade, a series of large randomized trials have shown the efficacy of newer classes of medications in improving health outcomes of patients with HFrEF. These newer medications include the I f inhibitor ivabradine (SHiFT study); the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril-valsartan (PARADIGM-HF and PIONEER-HF trials); the sodium-glucose transporter 2 (SGLT2) inhibitors dapagliflozin (DAPA-HF study) and empagliflozin (EMPEROR-Reduced trial); and the soluble guanylate cyclase activator vericiguat (VICTORIA trial) ... Although these new treatment options for HFrEF are proven to be safe and well tolerated across a wide range of patients, there are obstacles to their widespread use — namely, the high cost of these drugs, prior authorization requirements, and out-of-pocket fees. Not only must patients often first obtain approval from their insurance companies for these prescriptions, but they are also required to pay greater out-of-pocket costs for them than generic drugs. Perhaps not surprisingly, the use of generic ACE inhibitors and beta-blockers for HFrEF remains high, whereas uptake of ivabradine and sacubitril-valsartan continues to be slow and SGLT2 inhibitors are only just beginning to be prescribed." - See dapagliflozin at ReliableRXPharmacy.  They don't carry empagliflozin, which in my view is better.  I read somewhere that India would no longer sell generic versions after a certain patent date until that drug goes generic.  I think that's the problem with buying generic empagliflozin from India.
  • Diabetes Drug Can Treat and Reverse Heart Failure and Reduce Hospitalizations - mountsinai.org - "Roughly 80 percent of the patients treated with empagliflozin showed significant improvement, and their hearts returned to near normal, the researchers found. This group had a 16.6 percent improvement in left ventricular ejection fraction at the six-month mark and their hearts pumped blood in a stronger way. Their hearts became smaller, less dilated because of less congestion and less fluid accumulation in the body, meaning that their heart failure became less severe, and the walls of the heart were less thick, meaning that the left ventricle could pump blood more easily"
  • Which Antidiabetic Drug Class is Most Renoprotective? - Medscape, 12/2/20 - "All three of the newer drug classes performed better than the sulfonylureas. Both SGLT2i and GLP-1a offered greater renoprotection than DPP-4i, but neither was notably better than the other, according to the analysis. These findings held for patients at various levels of early and advanced chronic kidney disease and were independent of whether the patients were taking metformin" - Note: Jardiance is a SGLT2 inhibitor.
  • SCORED and FIDELIO-DKD: Time for Cardiologists to Help, Not Hurt, the Kidney - Medscape, 11/20/20 - 20 minute video on empagliflozin (Jardiance).  I doubt if most cardiologists are even aware of this yet. - "In terms of heart failure with reduced EF, these are really well-tolerated medicines. I've been using dapagliflozin and empagliflozin in my patients and found them to have good clinical outcomes and to be clinically well tolerated, with minimal side effects"
  • Diabetes drug can treat and reverse heart failure and reduce hospitalizations - Science Daily, 11/16/20 - "Empagliflozin, a recently developed diabetes drug ... this medication can improve the heart's size, shape, and function, leading to better exercise capacity and quality of life, which will reduce hospitalizations for heart failure patients" - Note:  It's a $500/month medication.
  • EMPEROR-Reduced: Empagliflozin's HFrEF Benefit Holds Steady on Top of Sacubitril/Valsartan - Medscape, 10/7/20 - "When there are two very effective treatments, it's common for people to ask: Which should I use?' The goal of my presentation was to emphasize that the answer is both. We shouldn't choose between neprilysin inhibition [sacubitril inhibits the enzyme neprilysin] and SGLT2 [sodium-glucose transporter 2] inhibition; we should use both"

Abstracts:

  • Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial - J Am Coll Cardiol 2021 Sep 28 - "In EMPEROR-Reduced, higher baseline NT-proBNP concentrations were associated with greater risk for adverse heart failure or renal outcomes, but empagliflozin reduced risk regardless of baseline NT-proBNP concentration"
  • Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME tri - Diabetes Obes Metab 2021 Sep 24 - "Empagliflozin reduced UA levels and the composite of gout episodes or prescription of antigout medication. These clinically important findings expand the utility of empagliflozin as a potential antigout treatment in patients with T2D, beyond its well-established cardio-renal benefits"
  • EMPEROR-Preserved: Empagliflozin Scores HFpEF Breakthrough - Medscape, 8/27/21 - "The SGLT2 inhibitor empagliflozin achieved in EMPEROR-Preserved what no other agent could previously do: unequivocally cut the incidence of cardiovascular death or hospitalization in patients with heart failure and preserved ejection fraction (HFpEF) ... Treatment with empagliflozin (Jardiance) led to a significant 21% relative reduction in the rate of cardiovascular death or hospitalization for heart failure (HHF), compared with placebo, among 5,988 randomized patients with HFpEF during a median 26 months of follow-up, proving that patients with HFpEF finally have a treatment that gives them clinically meaningful benefit, and paving the way to an abrupt change in management of these patients, experts said ... A second sodium-glucose cotransporter 2 (SGLT2 ) inhibitor, dapagliflozin (Farxiga), is also an option for treating HFrEF based on results in the DAPA-HF trial, and the DELIVER trial, still in progress, is testing dapagliflozin as a HFpEF treatment in about 6,000 patients, with results expected in 2022 ... This showed a consistent and robust benefit from empagliflozin for reducing HHF across a wide spectrum of patients with heart failure, ranging from patients with left ventricular ejection fractions of less than 25% to patients with ejection fractions as high as 64% ... patients with reduced ejection fractions showed a significant 49% relative reduction in the incidence of serious renal outcomes" - Note:  If you can't get empagliflozin, ReliableRxPharmacy sells dapagliflozin.
  • Effects of Empagliflozin on Erythropoiesis in Patients with Type 2 Diabetes - data from a randomized, placebo controlled study - Diabetes Obes Metab 2021 Aug 11 - "Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been shown to significantly reduce heart failure hospitalization (HHF) and cardiovascular (CV) mortality in various cardiovascular outcome trials in patients with and without type 2 diabetes mellitus (T2D). SGLT2 inhibition further increased haemoglobin concentration and hematocrit by a yet unknown mechanism and this increase proved as an independent predictor for the CV benefit of these agent ... 44 patients with T2D were randomized into 2 groups and received empagliflozin 10 mg or placebo for a period of 3 months ... Empagliflozin increased hemoglobin concentrations and hematocrit with a delayed time kinetic which was most likely attributable to increased erythropoiesis with augmented iron utilization and not hemoconcentration. This might be attributable to reduced tubular glucose reabsorption in response to SGLT2 inhibition possibly resulting in diminished cellular stress as a mechanism for increased renal erythropoietin secretion"
  • Effects of empagliflozin on lipoprotein subfractions in patients with type 2 diabetes: data from a randomized, placebo-controlled study - Atherosclerosis 2021 Jun 25 - "Empagliflozin treatment of patients with T2D increased LDL-C and LDL apolipoprotein B levels but had no effect on calculated LDL particle size"
  • Usefulness of Sodium-Glucose Cotransporter 2 Inhibitors for Primary Prevention of Heart Failure in Patients With Type 2 Diabetes Mellitus - Am J Cardiol 2021 May 15 - "The sodium-glucose cotransporter 2 inhibitors (SGLT2i) empagliflozin, canagliflozin, and dapagliflozin reduce the risk of heart failure (HF) events in patients with diabetes mellitus (DM) at high risk for HF. Differences in HF outcomes between SGLT2i were demonstrated in a recent-published meta-analysis ... Our findings suggest that between the available SGLT2i, the cost of primary prevention of HF in patients with DM at high risk for HF is lowest with empagliflozin" - See dapagliflozin at ReliableRXPharmacy.  They don't carry empagliflozin, which in my view is better.  I read somewhere that India would no longer sell generic versions after a certain patent date until that drug goes generic.  I think that's the problem with buying generic empagliflozin from India.
  • Effect of empagliflozin on cardiorenal outcomes and mortality according to body-mass index: A subgroup analysis of the EMPA-REG OUTCOME trial with a focus on Asia - Diabetes Obes Metab 2021 May 5 - "Overall, hazard ratios for empagliflozin versus placebo for all-cause mortality, HHF or CV death, and incident or worsening nephropathy were 0.68 (95% CI 0.57, 0.82), 0.66 (0.55, 0.79), and 0.61 (0.53, 0.70), respectively, and were consistent across BMI categories (P-values for interaction between treatment and BMI: 0.6772, 0.3087, and 0.6265, respectively). Results were similar in Asians using these BMI categories and < 24, 24 to <28, ≥28 kg/m2 categories. Thus, empagliflozin reduced cardiorenal and mortality risk regardless of BMI at baseline, including in Asians with lower BMI"
  • Are SGLT2 Inhibitors New Hypertension Drugs? - Circulation 2021 May 4 - Note:  See the table. Jardiance (empagliflozin) lowered systolic by about 10 points.  Farxiga (dapagliflozin) was 5.8.
  • Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function - Medscape, 3/29/21 - "Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: hazard ratio (HR)=0.78 (95% CI, 0.65–0.93) and HR=0.72 (95% CI, 0.58–0.90), respectively (interaction P=0.63). Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23–1.98) ml/min/1.73 m2/yr in patients with CKD and by 2.41 (1.49–3.32) ml/min/1.73 m2/yr in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95% CI, 0.31–0.91) and HR=0.46 (95% CI, 0.22–0.99), respectively. The effect of empagliflozin on the primary composite outcome and key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73 m2. Empagliflozin was well tolerated in CKD patients ... In EMPEROR-Reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD, and regardless of the severity of kidney impairment at baseline."
  • SGLT-2 inhibitors for prevention of cardiorenal outcomes in type 2 diabetes: an updated meta-analysis - Diabetes Obes Metab 2021 Mar 12 - "A total of 8 cardiorenal outcomes trials of SGLT-2i (empagliflozin, canagliflozin, dapagliflozin, ertugliflozin, sotagliflozin) were identified, with 66 601 patients ... Overall, SGLT-2i were associated with a 12% reduced risk of major adverse cardiovascular events (MACE, HR = 0.88; 95% CI, 0.83-0.93; Q statistic, P = 0.19), with no significant heterogeneity (p for interaction = 0.465) between subgroups of patients with or without cardiovascular disease (CVD). The risk of the composite renal outcome was significantly reduced by treatment with SGLT-2i (HR = 0.61, 95% CI, 0.54-0.70), with no significant heterogeneity of associations with outcome (I2 = 37%, P = 0.11), and no difference in the risk between patients with or without CVD (p for interaction = 0.665). SGLT-2i have moderate benefits on MACE and major benefits on the progression of diabetic kidney disease"
  • The role of SGLT-2 inhibitors in managing type 2 diabetes - Cleve Clin J Med 2020 Dec 31 - "Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are an exceptionally versatile class of medication, and their glycemic and nonglycemic benefits could help millions of patients with type 2 diabetes. Of note, they have been shown to improve cardiac and renal outcomes, much-needed benefits in patients with type 2 diabetes, who are at a higher risk for developing cardiac and renal dysfunction than those who do not have diabetes. The indications for SGLT-2 inhibitors may continue to expand as ongoing clinical trials provide more insight into these drugs"
  • Effects of SGLT2 inhibitors on eGFR in type 2 diabetic patients-the role of antidiabetic and antihypertensive medications - Hypertens Res 2020 Dec 14 - "metformin blunts the SGLT2i-induced decrease in eGFR, but coadministration of RASis ameliorates this response. Furthermore, the inability of CCBs to modify the SGLT2i-induced reduction in eGFR suggests that the SGLT2i-induced renal microvascular action is mediated predominantly by postglomerular vasodilation rather than preglomerular vasoconstriction" - Note:  Normal eGFR is >60.  I threw this in because the diabetes medication and SGLT2 inhibitor Jardiance (empagliflozin) is also being used to help repair the heart in heart failure patients.
  • Randomized Trial of Empagliflozin in Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction - J Am Coll Cardiol 2020 Nov 9 - "Empagliflozin administration to non-diabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for SGLT2 inhibitors in the treatment of HFrEF patients independently of their glycemic status"