Heart failure is a chronic and debilitating condition that affects over six million individuals across the United States, and even more globally. In patients with this condition, the heart muscle becomes weak and is unable to pump enough blood well enough to meet the body’s needs. As a result, the body does not receive enough oxygen and nutrients, leading to symptoms such as fatigue, shortness of breath, and fluid retention. Heart failure can be caused by a variety of factors, including high blood pressure, coronary artery disease, and heart valve disease.

Heart failure is a serious condition that requires lifelong management; in 2012 alone, the disease cost the U.S. healthcare system nearly US$31 billion in healthcare services, medicinal treatments, and missed days of work. For this reason, many sponsors and contract research organizations (CROs) around the world are working to provide more therapeutic options for these patients. While there is no cure for heart failure, there are currently some treatments available to help manage the symptoms and slow the progression of the disease via drug therapies, diet or lifestyle changes, and surgery. In this article, we highlight Inpefa, one of the newest available heart failure medications recently approved by the U.S. Food and Drug Administration.

Introducing Inpefa: A Drug for Heart Failure

Inpefa, or sotagliflozin, is a new medication that was approved for the treatment of heart failure on May 26, 2023. Sotagliflozin is a dual inhibitor of the glucose-regulating proteins, selective sodium-glucose transporters 1 and 2 (SGLT1/SGLT2), the first of its kind to reach the market. By blocking the activity of SGLT1, there is less intestinal absorption of glucose and sodium, whereas blocking SGLT2 simultaneously downregulates their reabsorption in the kidneys; the result is an improvement in fluid retention, heart function, and the accompanying symptoms of heart failure. The dual action of this drug makes Inpefa’s approval a notable step forward in the treatment of heart failure.

Its ability to target both SGLT1 and SGLT2 is significant because type 2 diabetes mellitus (T2DM), chronic kidney disorder (CKD), and cardiovascular disease (CVD) are well-known risk factors for developing heart failure. Therefore, patients in any of these disease populations can benefit from the dual action of a single treatment regimen with Inpefa, which could potentially increase treatment convenience and administration compliance. Earlier this year, the American College of Cardiology also revised its guidelines for heart failure therapies this past year in patients who have preserved ejection fraction, including sotagliflozin as one of three SGLT2 drugs to be recommended.

Inpefa: Clinical Safety and Efficacy Results

Inpefa was demonstrated to decrease the risk of heart failure, heart-related hospital visits, and related mortality by 33% and 25% when tested against a placebo in the phase 3 randomized double-blind clinical trials, SOLOIST and SCORED, respectively. Combined with data from the SCORED clinical trial, the FDA’s approval decision was based on sotagliflozin’s efficacy being evaluated in nearly 12,000 patients, including 5900 patients randomized to Inpefa and 5906 patients randomized to placebo. This patient population included both individuals with a history of heart failure, as well as those at elevated risk for the disease, such as those with T2DM, CKD, or CVD. In addition to improving symptoms and reducing the risk of hospitalization for heart failure, Inpefa was also shown to have a cost-effectiveness ratio of US$75,510 per quality-of-life year gained, which is below the expected threshold of US$100,000, within the SOLOIST study.

Considerations Before Using Inpefa

Inpefa has been approved by the FDA as a safe and effective treatment for heart failure. This means that patients can trust that the drug has undergone rigorous testing and has been deemed safe for use. However, it is important to note that Inpefa is not a cure for heart failure; although it can improve heart function and reduce symptoms, patients are encouraged to follow their healthcare provider’s recommendations for managing their condition. Individuals diagnosed with or at significant risk of heart failure should discuss with their healthcare provider if Inpefa is an appropriate treatment option for them. Additionally, those who are taking Inpefa should be monitored closely by their healthcare provider to ensure that they are not experiencing any adverse effects. The most common side effects reported in clinical trials at an incidence of 5% or greater were urinary tract infections, volume depletion, diarrhea, and hypoglycemia. Patients who experience any of these side effects should contact their healthcare provider immediately.

Inpefa: A New Hope for Heart Failure Patients

In conclusion, Inpefa is a new FDA-approved drug for heart failure that promises to improve the lives of patients with this condition, as well as high-risk patients with a history of diabetes, CKD, or CVD comorbidities. With its combined inhibitory action against the SGLT1/2 proteins, Inpefa is the first dual therapy of this kind approved for heart failure, setting it apart from existing drug therapies currently on the market. Patients with heart failure should discuss with their healthcare provider if Inpefa is an appropriate treatment option for them, and work together to manage their condition. With the advent of Inpefa, there is hope for millions of people living with heart failure to have an improved quality of life at cost-effective prices.

Vial: Your Trusted Partner in Cardiology Clinical Trials

Vial is a full-service tech-first CRO that recognizes the growing burden of heart failure in the U.S. and across the globe, necessitating effective new drug approvals like Inpefa. Vial CRO’s expert teams are dedicated to supporting leading sponsor companies and paving the way for modernized clinical research through the latest innovations in trial technology.

Visit our website to discover how we can optimize your next study, or contact a team member today to learn more!