WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced results of two pooled analyses involving a lot more compared to 4,600 patients along with type 2 diabetes. Both analyses, which represent AstraZeneca’s ongoing commitment to fully learning the effects of dapagliflozin across subsets of patients along with type 2 diabetes, will certainly be presented at the 76th Scientific Sessions of the American Diabetes Association (ADA) in Brand-new Orleans, June 10-14, 2016.
In one analysis of patients along with type 2 diabetes and renal impairment (Poster 1095-P), FARXIGA reasonable physique weight and systolic blood stress regardless of baseline estimated glomerular filtration fee (eGFR), once compared to placebo. Additionally, FARXIGA reasonable urine albumin to creatinine ratio (UACR) in patients along with a baseline UACR ≥30 mg/g once compared to placebo, including in patients along with mild renal impairment (eGFR ≥60 to <90 mL/min/1.73m2). As seen in previous trials, the A1C lowering effects of FARXIGA® (dapagliflozin) decreased as renal function declined. FARXIGA ought to not be used in patients along with eGFR <60 mL/min/1.73 m2.1
Hiddo Lambers Heerspink, Pharm.D., Ph.D., Clinical Pharmacologist in the Department of Clinical Pharmacy Pharmacology at the University Medical Focus Groningen, the Netherlands and lead investigator of the study said: “Approximately 1 in 3 adults along with diabetes has actually renal impairment. This study is essential as it helps further the learning of dapagliflozin in type 2 diabetes patients along with varying degrees of renal impairment.”2
FARXIGA is indicated as an adjunct to diet plan and workout to enhance glycemic regulate in adults along with type 2 diabetes mellitus. It is not recommended for patients along with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. FARXIGA is not indicated for fat loss or the treatment of hypertension.3
The second analysis examined the effects of FARXIGA versus placebo in patients treated along with potassium-sparing agents (Poster 1094-P). once co-administered along with potassium-sparing agents, FARXIGA resulted in lower A1C, physique weight and systolic blood pressure, along with no evidence of improve in serum potassium.4
Jim McDermott, Head of Medical, US Medical Affairs, Diabetes, AstraZeneca said: “Physicians are regularly faced along with difficult decisions on exactly how to most effectively treat patients along with type 2 diabetes along with significant complications and comorbidities. For example, patients along with kidney and cardio illness are regularly being treated along with concomitant medications, including potassium-sparing diuretics, to treat higher blood stress or heart failure. These analyses offer essential insights and support the demand for research in to treating these patients.”
The very first analysis assessed a lot more compared to 4,400 patients along with type 2 diabetes (n=2,22six and 2,178 for FARXIGA and placebo groups, respectively) using pooled data from 11 Phase 3 clinical trials along with varying degrees of renal function as measured by eGFR (eGFR ≥45 to <60; eGFR ≥60 to <90; eGFR ≥90 mL/min/1.73m2) over 24 weeks. Results showed a difference of -0.27%, -0.47% and -0.57% in A1C, -2.1, -1.8 and -2.3 kilograms in physique weight, -4.3, -2.six and -3.4 mmHg in systolic blood stress and -38.3%, -23.3% and -16.1% in UACR along with FARXIGA compared to placebo for patients along with the lowest to highest eGFR, respectively. Side events occurred a lot more often in patients along with the lowest eGFR in the 2 the FARXIGA and placebo groups. In patients treated along with dapagliflozin along with varying degrees of renal function (eGFR ≥45 to <60; eGFR ≥60 to <90; eGFR ≥90 mL/min/1.73m2) 68.3%, 58.3%, and 59.4% respectively reported at least one Side event.1
The second analysis assessed a lot more compared to 200 patients along with type 2 diabetes treated along with potassium-sparing agents (n=108 and 119 for FARXIGA and placebo groups, respectively) using pooled data from 14 Phase 2b/3 clinical trials of up to 24 weeks. Results showed a difference of -0.39% in A1C, -2.2 kg in physique weight, -5.2 mmHg in systolic blood pressure, -3.2 mL/min/1.73m2 in eGFR, and -0.12 mEq/L in serum potassium along with FARXIGA compared to placebo. Potassium levels ≥six mEq/L throughout follow up were observed in two patients versus nine patients for the FARXIGA and placebo groups, respectively. The fee of Side events was similar between the FARXIGA and placebo groups, including Side events of renal impairment/failure (3.7% vs. 6.7%); hypotension/volume reduction (2.8% vs. 1.7%), and potassium ≥six mEq/L (1.9% vs. 7.6%).4
Effects of Dapagliflozin on cardio Risk Factors at Varying Degrees of Renal Function (Poster 1095-P), and Safety and Efficacy of Dapagliflozin (DAPA) in Combination along with Potassium (K)-sparing Agents (Poster 1094-P) will certainly be presented throughout a poster session along with a moderated discussion on June 12, 2016.
Important Safety Guide For FARXIGA®(dapagliflozin)
Contraindications
- History of a significant hypersensitivity reaction to FARXIGA
- Severe renal impairment, end stage renal disease, or patients on dialysis
Warnings and Precautions
Adverse Reactions
- In a pool of 12 placebo-controlled studies, the most common Side reactions (≥5%) associated along with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Individual Populations
- Pregnant Women: There are no adequate and well-controlled studies of FARXIGA in pregnant women. Think of proper alternative therapies, especially throughout the second and third trimesters.
- Nursing Mothers: It is not known whether FARXIGA is excreted in human milk. Due to the potential for significant Side reactions in nursing infants from FARXIGA, discontinue nursing or discontinue FARXIGA.
- Geriatric Use: A better proportion of patients ≥65 years treated along with FARXIGA had Side reactions related to volume depletion and renal impairment or failure compared to patients treated along with placebo. No FARXIGA dose modification is recommended based on age.
Indication and Limitations of Use for FARXIGA
FARXIGA is indicated as an adjunct to diet plan and workout to enhance glycemic regulate in adults along with type 2 diabetes mellitus.
FARXIGA is not recommended for patients along with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Please see US Full Prescribing Information and Medication Guide for FARXIGA.
NOTES TO EDITORS
About SGLT-2 inhibitors
Dapagliflozin (marketed as FARXIGA® in the US and FORXIGA® outside the US) is section of a class of medicines called sodium-glucose cotransporter 2 (SGLT-2) inhibitors, which remove glucose via the kidneys.3
About Type 2 Diabetes
Diabetes is estimated to affect 29.1 million people in the US5 and 415 million people worldwide.6 Type 2 diabetes accounts for approximately 90-95 percent of adults diagnosed along with diabetes in the US.5 The prevalence of diabetes is projected to reach a lot more compared to 642 million people international by 2040.6 Type 2 diabetes is a chronic and progressive illness characterized by multiple pathophysiologic defects leading to elevated glucose levels.6,7 Considerable unmet calls for still exist, as several patients stay inadequately controlled on their current glucose-lowering regimen.8 It is estimated that nearly half of people living along with type 2 diabetes are not achieving recommended A1C objectives based on guidelines established by professional societies and advocacy organizations for diabetes management.8,9
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science along with the target of creating life-changing medicines that aim to reduce the global burden and complications of diabetes. Our current portfolio includes the three newest classes of non-insulin, anti-diabetic treatments that support individualized treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.
As a strategic therapy area for the company, we are focusing our research and development efforts on diverse populations and patients along with Considerable co-morbidities, such as cardio disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.
Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing learning of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches to tips a lot more patients achieve treatment victory earlier in their illness progression. Our ambition is to reduce the long term impact of diabetes.
About AstraZeneca
AstraZeneca is a global, innovation-steered biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune illness (RIA), cardio and metabolic illness (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For a lot more Guide please visit: http://ift.tt/1sRp7EO
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References |
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| 2. | Centers for illness regulate and Prevention. National Chronic Kidney illness Naked truth Sheet, 2014. Atlanta, GA: US Department of Healthiness and Human Services; 2014. | |||
| 3. | FARXIGA (dapagliflozin) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2015. | |||
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Kosiborod M, Xu J, Sjöstrand M, Sjöström CD. “Safety and efficacy of dapagliflozin in combination along with potassium-sparing agents.” American Diabetes Association Scientific Sessions 2016. Abstract #1094-P. |
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Wong ND, Patao C, Wong K, et al. Trends in regulate of cardio risk factors among US adults along with type 2 diabetes from 1999 to 2010: comparison by prevalent cardio illness status. Diab Vasc Dis Res. 2013;10:505-513. |
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