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Home > Health Conditions > Diabetes > Farxiga (dapagliflozin)

Farxiga (dapagliflozin)

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News & Research:

  • Dapagliflozin Misses as Treatment for COVID-19 but Leaves Intriguing Signal for Benefit - Medscape, 5/18/21 - "At the end of 30 days, 11.2% of the dapagliflozin group and 13.8% of the placebo group had an event. By hazard ratio, dapagliflozin was linked to 20% nonsignificant relative protection from events (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10) ... The trend (P = .168) for the primary endpoint for prevention was reflected in the individual components. For dapagliflozin related to placebo, there were generally similar or greater reductions in new or worsening organ failure (HR, 0.80), cardiac decompensation (HR, 0.81), respiratory decompensation (HR, 0.85), and kidney decompensation (HR, 0.65). None were statistically significant, but the confidence intervals were tight with the upper end never exceeding 1.20 ... Moreover, the relative risk reduction for all-cause mortality moved in the same direction (HR, 0.77 ... In safety analyses, dapagliflozin consistently outperformed placebo across a broad array of safety measure, including any severe adverse event (65% vs. 82%), any adverse event with an outcome of death (32% vs. 48%), discontinuation caused by an adverse event (44% vs. 55%), and acute kidney injury (21% vs. 34%) ... These data show that these drugs are not going to lead to harm, but they might lead to benefit" - See dapagliflozin at reliablerxpharmacy.com.
  • 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.
  • FDA Approves Dapagliflozin (Farxiga ) for Chronic Kidney Disease - Medscape, 4/30/21 - "Dapagliflozin was approved in 2014 to improve glycemic control in patients with diabetes mellitus, and approval was expanded in 2020 to include treatment of patients with heart failure and reduced ejection fraction ... during a median of 2.4 years, treatment with dapagliflozin led to a significant 31% relative reduction compared with placebo in the study's primary outcome, a composite that included at least a 50% drop in estimated glomerular filtration rate (eGFR) compared with baseline, end-stage kidney disease, kidney transplant, renal death, or cardiovascular death ... Dapagliflozin treatment also cut all-cause mortality by a statistically significant relative reduction of 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization."
  • Dapagliflozin, Advanced Chronic Kidney Disease, and Mortality: New Insights From the DAPA-CKD Trial - Medscape, 4/28/21 - "Taken together, the data from DAPA-CKD, in conjunction with the results from other recently published SGLT2 inhibitor trials in patients with heart failure and reduced ejection fraction, position the class of SGLT2 inhibitors far beyond their original use in patients with type 2 diabetes (Graphical Abstract).[5,6,8] For the cardiovascular high-risk population of patients with CKD, SGLT2 inhibition with dapagliflozin provides for the first time a treatment option to significantly improve the prognosis and to reduce mortality—independent of the presence of diabetes. Within the next few years, additional studies with SGLT2 inhibitors in CKD patients will report (e.g. EMPA-KIDNEY with empagliflozin, NCT03594110), but now it is on us—nephrologists, cardiologists, and all healthcare providers treating patients with CKD—to ensure that these life-saving therapies are implemented. For the treatment of patients with diabetes, a subset of members of the writing groups of the 2019 American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) consensus document and the 2019 European Society of Cardiology (ESC) guidelines have recently published a call for action to ensure that clinical inertia no longer leads to the low prescription of evidence-based life-saving therapies in high risk patients"
  • New DAPA-CKD Analysis Hints at Dapagliflozin for IgA Nephropathy - Medscape, 4/20/21 - "Dapagliflozin may be a novel therapeutic option to slow kidney function decline in patients with IgA nephropathy"
  • 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"
  • Dapagliflozin Reduces Systolic Blood Pressure and Modulates Vasoactive Factors - Diabetes Obes Metab 2021 Mar 17 - "24 and 23 patients receiving dapagliflozin and placebo, respectively, completed the 12 weeks' study. Systolic BP fell significantly, compared to placebo, both after a single dose (by 7 ± 3 mmHg) and 12-week (by 7 ± 2 mmHg) treatment with dapagliflozin. Dapagliflozin suppressed angiotensin II and angiotensinogen (by 10.5 ± 2.1 pg/mL and 1.45 ± 0.42 μg/mL, respectively) and increased ANP and cGMP (by 34 ± 11 pg/mL and 29 ± 11 pmol/mL, respectively) compared to placebo group. cGMP levels also increased acutely following a single dose of dapagliflozin. Dapagliflozin also suppressed PDE5 expression by 26 ± 11% in MNC. There was no change in the other vasoactive mediators investigated."
  • More From DAPA-HF: Dapagliflozin Quickly Reduces Heart Failure Events - Medscape, 2/23/21 - "These findings were consistent with the timing of benefits for patients with heart failure with reduced ejection fraction (HFrEF) in recent studies of two other drugs from the same class, the sodium-glucose cotransporter (SGLT) inhibitors, including empagliflozin (Jardiance, which inhibits SGLT-2) in the EMPEROR-Reduced trial, and sotagliflozin (Zynquista, which inhibits both SGLT1 and -2) in the SOLOIST-WHF trial ... DAPA-HF randomized 4,744 patients with HFrEF and in New York Heart Association functional class II-IV at 410 sites in 20 countries. The incidence of the primary, combined endpoint fell by 26% with dapagliflozin treatment, compared with placebo, during a median 18-month follow-up. Among the study cohort 27% of patients had been hospitalized for heart failure within a year of their entry, 20% had been hospitalized for heart failure more than 1 year before entry, and 53% had no history of a hospitalization for heart failure."

Abstracts:

  • The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58 - Diabetes Care 2021 Jul 7 - "Urinary albumin-to-creatinine ratio (UACR) ... dapagliflozin demonstrated a favorable effect on UACR and renal-specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease" - See dapagliflozin at reliablerxpharmacy.com.
  • 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.
  • 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.
  • Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial - Diabetes Care 2021 Apr 15 - "SGTL2 inhibitors increase urinary glucose excretion and have beneficial effects on cardiovascular and renal outcomes. The underlying mechanism may involve caloric restriction-like metabolic effects due to urinary glucose loss ... Dapagliflozin treatment for 5 weeks resulted in major adjustments of metabolism mimicking caloric restriction, increased fat oxidation, improved hepatic and adipose insulin sensitivity, and improved 24-h energy metabolism"
  • Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD randomized controlled trial - Eur Heart J 2021 Mar 31 - "Mortality rates from chronic kidney disease (CKD) have increased in the last decade. In this pre-specified analysis of the DAPA-CKD trial, we determined the effects of dapagliflozin on cardiovascular and non-cardiovascular causes of death ... The relative risk reduction for all-cause mortality with dapagliflozin (31%, hazard ratio [HR] [95% confidence interval (CI)] 0.69 [0.53, 0.88]; P = 0.003) was consistent across pre-specified subgroups. The effect on all-cause mortality was driven largely by a 46% relative risk reduction of non-cardiovascular death (HR [95% CI] 0.54 [0.36, 0.82]). Deaths due to infections and malignancies were the most frequently occurring causes of non-cardiovascular deaths and were reduced with dapagliflozin vs. placebo ... In patients with CKD, dapagliflozin prolonged survival irrespective of baseline patient characteristics. The benefits were driven largely by reductions in non-cardiovascular death"