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Drug Trials Snapshots: INPEFA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the INPEFA Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

INPEFA (sotagliflozin)
In peh’ fah
Lexicon Pharmaceuticals, Inc.
Original Approval date
: May 26, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

INPEFA is a drug that reduces the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

  • heart failure or
  • type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

How is this drug used?

INPEFA is a tablet that is taken by mouth once daily.

Who participated in the clinical trials?

The FDA approved INPEFA based on evidence from two clinical trials of 11,806 total patients with heart failure or with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The trials were conducted at 322 sites in 32 countries (SOLOIST) and 750 sites in 42 countries (SCORED) primarily in Europe, South America, and North America. Both trials were used for primary determination of the benefits and side effects of the drug.

How were the trials designed?

The benefits and side effects of INPEFA were evaluated in two clinical trials of 11,806 total patients with heart failure (SOLOIST) or with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors (SCORED).

In both trials, patients were randomly assigned to receive either INPEFA or placebo by mouth once a day. Neither the patients nor the healthcare providers knew which treatment was being given until after the trial was completed.

The benefit of INPEFA was evaluated by measuring the number of predefined events (death from cardiovascular causes, need for hospitalization for heart failure, or urgent medical care visit for heart failure) occurring in the patient population receiving INPEFA versus placebo.

DEMOGRAPHICS SNAPSHOT

Figure 1, Figure 2, Figure 3, and Figure 4 display the percentage of patients by sex, race, age, and ethnicity enrolled in SOLOIST and SCORED trials, respectively.

Figure 1. Baseline Demographics by Sex in SOLOIST and SCORED Trials

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 6,640 (56%) male patients and 5,166 (44%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2. Baseline Demographics by Race in SOLOIST and SCORED Trials

Pie chart summarizing how many White, Black or African American, Asian or Pacific Islander, American Indian or Alaska Native, and other patients were in the clinical trial. In total, 9,851 (83%) White patients, 413 (4%) Black or African American patients, 741 (6%) Asian or Pacific Islander patients, 421 (4%) American Indian or Alaska Native, and 380 (3%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3. Baseline Demographics by Age in SOLOIST and SCORED Trials

Pie chart summarizing how many patients by age were in the clinical trial. In total, 3,588 (30%) patients younger than 65 years of age and 8,218 (70%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4. Baseline Demographics by Ethnicity in SOLOIST and SCORED Trials

Pie chart summarizing how many Hispanic, not Hispanic, and other patients were in the clinical trial. In total, 3,669 (31%) Hispanic or Latino patients, 8,067 (68%) not Hispanic or Latino patients, and 70 (1%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In patients with heart failure or those with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, INPEFA reduced the risk of dying from cardiovascular causes and need for hospitalization and urgent medical care visit for heart failure.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: INPEFA worked similarly in males and females.
  • Race: INPEFA worked similarly in White and Black patients. The number of patients of other races was too small; therefore , differences in how INPEFA worked among other races could not be determined .
  • Ethnicity: INPEFA worked similarly in patients regardless of ethnicity.
  • Age: INPEFA worked similarly in patients younger and older than 65 years of age.

What are the possible side effects?

In patients with type 1 diabetes mellitus, INPEFA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. Diabetic ketoacidosis is a serious, potentially life-threatening complication that occurs when the body produces high levels of acids called ketones in the blood. Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis.

The most common side effects with INPEFA are urinary tract infection, volume depletion, diarrhea, and low blood sugar levels.

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: More genital yeast infections and events of diarrhea were reported by females compared to males. In the trial, all patients treated with INPEFA had more genital yeast infections and diarrhea compared to patients given placebo.
  • Race: The majority of patients were White. The number of patients of other races was limited; therefore, differences in side effects among races could not be determined.
  • Age: Patients older than 65 years of age had more side effects related to volume depletion compared to younger patients.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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