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1 January, 2018 00:00 00 AM
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FDA approves Steglatro (ertugliflozin) for Type 2 Diabetes

drugs.com
FDA approves Steglatro (ertugliflozin) for Type 2 Diabetes

 Merck, known as MSD outside the United States and Canada, and Pfizer Inc., recently announced that the U.S. Food and Drug Administration (FDA) has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Steglatro is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Steglatro is contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, or with a history of a serious hypersensitivity reaction to ertugliflozin.

This FDA approval is supported by seven Phase 3 studies of approximately 4,800 patients. Steglatro was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment. “In clinical trials, treatment with Steglatro resulted in significant A1C reductions when used alone or in combination with sitagliptin,” said Juan Pablo Frias, M.D., president and principal investigator, National Research Institute, Los Angeles. “This is important, as A1C-lowering is a key component of diabetes management, and many of my adult patients may need multiple medications to help manage their condition.”

“Merck welcomes the opportunity to provide adult patients with type 2 diabetes and their physicians these new medicines to help lower A1C, building on over a decade of experience with our diabetes portfolio and reflecting our continued commitment to diabetes research and patient care,” said Keith Kaufman, M.D., vice president, global clinical development and therapeutic area head for diabetes, endocrinology and women’s health, Merck Research Laboratories.

Diabetes is a chronic, progressive disease affecting approximately 30 million Americans (90 to 95 percent have type 2 diabetes). About one-third of adults with type 2 diabetes in the U.S. are not at their A1C goal.

“There remains a need to help adults with type 2 diabetes improve their glycemic control, and as the prevalence of the disease continues to rise, we are pleased to offer additional treatment options to these patients and the healthcare providers who treat them,” said James Rusnak, M.D., Ph.D., senior vice president and chief development officer, internal medicine, Pfizer Global Product Development.

Selected important risk information about Steglatro

Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been reported in patients with type 1 and type 2 diabetes receiving SGLT2 inhibitors including Steglatro. Some cases were fatal. Assess patients with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, Steglatro should be discontinued, patient should be evaluated, and prompt treatment should be instituted. Before initiating Steglatro, consider risk factors for ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. In patients treated with Steglatro, consider monitoring for ketoacidosis and temporarily discontinuing Steglatro in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).

Steglatro causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors. Before initiating Steglatro, consider factors that may predispose patients to acute kidney injury. Consider temporarily discontinuing Steglatro in any setting of reduced oral intake or fluid losses; monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue Steglatro promptly and institute treatment.

Steglatro increases serum creatinine and decreases eGFR. Patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2) may be more susceptible to these changes. Renal function abnormalities can occur after initiating Steglatro. Renal function should be evaluated prior to initiating Steglatro and periodically thereafter. Use of Steglatro is not recommended when eGFR is persistently between 30 and less than 60 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2.

There have been postmarketing reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors. Cases of pyelonephritis also have been reported in patients treated with STEGLATRO in clinical trials. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

An increased risk for lower limb amputation has been observed in clinical studies with another SGLT2 inhibitor. Across seven Phase 3 clinical trials with Steglatro, non-traumatic lower limb amputations were reported in 1 (0.1%) patient in the comparator group, 3 (0.2%) patients in the Steglatro 5 mg group, and 8 (0.5%) patients in the Steglatro 15 mg group. A causal association between Steglatro (ertugliflozin) and lower limb amputation has not been definitively established. Before initiating Steglatro, consider factors that may predispose patients to the need for amputations. Counsel patients about the importance of routine preventative foot care. Monitor patients and discontinue Steglatro if complications occur.

Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. Steglatro may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Steglatro.

Steglatro increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately.

Dose-related increases in low-density lipoprotein cholesterol (LDL-C) can occur with Steglatro. Monitor and treat as appropriate.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Steglatro.

The most common adverse reactions associated with Steglatro (incidence ≥5%) were female genital mycotic infections.

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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