Publications by authors named "Phillip Banks"

Article Synopsis
  • The study assessed the effectiveness of LX9211 in alleviating pain from diabetic peripheral neuropathy by conducting a double-blind trial with 319 participants over 6 weeks.
  • Results indicated that the 10 mg dose of LX9211 significantly reduced pain compared to placebo, while the 20 mg dose showed improvement that was not statistically significant.
  • Participants reported side effects like dizziness and nausea, but overall, the study suggests LX9211 warranting further research in larger trials for DPNP treatment.
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  • Sodium glucose cotransporter inhibitors like sotagliflozin can raise beta-hydroxybutyrate (BHB) levels in people with type 1 diabetes who require insulin, leading to potential risks of diabetic ketoacidosis (DKA).
  • In a study comparing sotagliflozin 400 mg to a placebo over 6 months, median BHB levels increased slightly, with about 67% of patients experiencing no significant change.
  • Key factors affecting BHB levels and DKA risk included baseline BHB, age, and use of insulin pumps, emphasizing the need for careful monitoring and personalized education about DKA management.
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  • The SCORED trial examined the effects of sotagliflozin on cardiovascular and kidney-related events in patients with type 2 diabetes and moderate kidney impairment but was initially affected by early termination and data reconciliation issues.
  • An exploratory analysis utilized laboratory eGFR data to evaluate the impact of sotagliflozin on kidney and cardiorenal outcomes, revealing a significant reduction in the risk of serious kidney-related events compared to placebo.
  • Results showed that sotagliflozin lowered the risk of sustained kidney decline and related composite outcomes, with hazard ratios indicating substantial benefits, making it an effective treatment option for patients at cardiovascular risk.
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Article Synopsis
  • The SCORED and SOLOIST-WHF trials showed that sotagliflozin, a medication for type 2 diabetes, improved health outcomes in patients with heart failure or kidney disease.
  • The study analyzed 11,744 adults, revealing that those on sotagliflozin had significantly lower rates of harmful heart failure events compared to those receiving a placebo, regardless of their starting blood sugar levels (HbA1c).
  • Overall, sotagliflozin was effective at reducing heart failure-related complications in type 2 diabetes patients with varying HbA1c levels, demonstrating consistent benefits across different groups.
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Article Synopsis
  • - Sotagliflozin (SOTA) improves glycemic control and has beneficial effects on body weight, blood pressure, and cardiovascular risk in adults with type 1 diabetes (T1D), potentially outweighing the risk of diabetic ketoacidosis.
  • - A study involving 2,980 adults with T1D showed that SOTA significantly decreased the predicted 5- and 10-year cardiovascular disease (CVD) risk and the risk of end-stage kidney disease (ESKD) compared to a placebo.
  • - The findings support the idea that the benefits of using SOTA in T1D may provide a favorable risk-benefit balance for patients, especially those with higher body mass index (BMI).
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Article Synopsis
  • The study aimed to evaluate the effectiveness and safety of sotagliflozin, a medication for adults with type 2 diabetes and stage 3 chronic kidney disease, focusing on its impact on HbA1c levels over 26 weeks.
  • In a trial involving 787 participants, sotagliflozin 400 mg significantly reduced HbA1c compared to placebo, while the 200 mg dose did not show a significant difference.
  • Both doses of sotagliflozin led to reduced urine albumin-creatinine ratios in patients with higher albuminuria after 26 weeks, but these effects weren’t maintained at 52 weeks; safety profiles were similar across treatment groups.
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  • The study examines the effects of two different types of SGLT inhibitors, sotagliflozin (dual SGLT1 and SGLT2 inhibitor) and empagliflozin (selective SGLT2 inhibitor), on type 2 diabetes and hypertension in 40 patients over 8 weeks.
  • Both medications yielded similar improvements in glycemic control and cardiovascular outcomes; however, sotagliflozin showed significant reductions in post-meal glucose and insulin levels during breakfast, suggesting its unique effect on intestinal SGLT1.
  • No serious side effects were reported, indicating that both treatments are safe, but sotagliflozin might have additional benefits in managing postpr
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  • The study aimed to evaluate the effectiveness and safety of sotagliflozin, a medication for type 2 diabetes (T2D), in patients with severe chronic kidney disease (CKD4) over 52 weeks.
  • Results showed that after 26 weeks, sotagliflozin did not significantly reduce glycated hemoglobin (HbA1c) compared to a placebo, though some improvements in weight and blood pressure were noted.
  • The safety profile of sotagliflozin was largely consistent with previous studies, with a notable percentage of patients experiencing adverse events, but serious cardiovascular issues were less common in those receiving the drug.
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Article Synopsis
  • - The SOLOIST-WHF trial investigated the effects of sotagliflozin, a medication for patients with type 2 diabetes and heart failure, finding it reduced cardiovascular-related events by 33% compared to a placebo.
  • - The study was designed as a randomized, double-blind trial with 1,222 participants across 306 sites in 32 countries, assessing the efficacy of sotagliflozin on outcomes like days alive and out of the hospital (DAOH).
  • - Results showed while hospitalization rates were similar between both groups, those on sotagliflozin experienced fewer repeated hospitalizations and a 3% higher rate of DAOH due to a significant decrease in days lost to death.
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Introduction: Telotristat ethyl is indicated for use in combination with somatostatin analogs (SSAs) to treat carcinoid syndrome (CS) diarrhea uncontrolled by SSAs alone in adults, but long-term safety and efficacy data beyond 48 weeks are needed.

Objectives: The aims of the study were to evaluate the long-term safety and tolerability of telotristat ethyl and its effect on quality of life (QOL) in patients with CS.

Methods: In this phase 3, nonrandomized, multicenter, open-label, long-term extension study (TELEPATH), patients who participated in phase 2 or 3 trials of telotristat ethyl continued treatment at their present dose level (250 or 500 mg thrice daily) for 84 weeks.

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  • The study aimed to evaluate the occurrence and risk factors of diabetic ketoacidosis (DKA) in adults with type 1 diabetes who were treated with sotagliflozin alongside insulin.
  • During the research, 191 ketosis-related adverse events were reported, with 37 adjudicated as DKA, showing a higher DKA incidence for patients taking sotagliflozin compared to those on placebo.
  • After a risk mitigation plan was implemented, the incidence of DKA decreased in patients taking sotagliflozin, indicating that patient education can help manage this risk.
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  • Diabetes-related distress is prevalent among individuals with diabetes and negatively impacts both glycemic control and overall health, making it an important patient-reported outcome (PRO).
  • A study analyzing data from adults with type 1 diabetes (T1D) using sotagliflozin alongside insulin found that a higher percentage of patients reported significant improvements in treatment satisfaction compared to those on placebo.
  • Overall, patients taking sotagliflozin experienced notable reductions in both diabetes distress and improvements in treatment satisfaction, highlighting its potential benefits in diabetes management.
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Article Synopsis
  • Young adults with type 1 diabetes (T1D) often have higher A1C levels and face greater risks of diabetic ketoacidosis (DKA), prompting a study to explore the use of sotagliflozin, an oral adjunct to insulin, in this population.
  • In a 12-week study, participants aged 18-30 with A1C levels of 9.0% or higher were given either sotagliflozin or a placebo alongside insulin; results indicated that sotagliflozin led to greater decreases in A1C levels and improved postprandial glucose and weight compared to the placebo.
  • The findings showed that more patients taking sotagliflozin achieved an A1C
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Background: Telotristat ethyl is approved to treat carcinoid syndrome diarrhea in combination with somatostatin analogs. In TELESTAR and TELECAST phase III studies, patients with carcinoid syndrome received telotristat ethyl 250 or 500 mg 3 times per day (tid) or placebo tid in addition to somatostatin analogs. The aim of this prespecified analysis was to examine the time to reductions in bowel movements (BMs) in the TELESTAR and TELECAST studies using survival analysis methods.

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Article Synopsis
  • The study investigates the impact of sotagliflozin, a drug that inhibits sodium-glucose cotransporters, on how the body absorbs glucose after eating.
  • It involved 24 healthy participants who were given single doses of either sotagliflozin, canagliflozin, or a placebo, and their glucose absorption was measured using a specialized tracer method.
  • Results showed that sotagliflozin significantly reduced glucose absorption and insulin levels after meals, suggesting it could effectively manage post-meal blood sugar spikes.
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  • Carcinoid syndrome significantly impacts quality of life, primarily due to symptoms like diarrhea and fatigue, prompting this study to assess bowel movement frequency changes in patients.
  • The research utilized an anchor-based method to establish meaningful change thresholds, comparing changes in bowel movements to various quality of life questionnaires and patient-reported outcomes from a clinical study.
  • Results indicated a notable reduction in bowel movement frequency among patients, with large effect sizes suggesting significant improvement for those experiencing adequate relief, highlighting the importance of understanding meaningful changes in patient outcomes for effective treatment evaluation.
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Article Synopsis
  • This study evaluated the effects of sotagliflozin, a medication, on adults with type 1 diabetes over 12 weeks in a double-blind trial comparing different doses to a placebo.
  • The results showed that sotagliflozin helped reduce glycated hemoglobin (HbA1c), particularly at the 200 mg and 400 mg doses, and led to a reduction in weight and increased glucose excretion.
  • Overall, the medication improved glycemic control without significantly increasing the risk of severe low blood sugar or diabetic ketoacidosis, indicating it could be a beneficial addition to insulin therapy for type 1 diabetes patients.
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Article Synopsis
  • The study investigates the effects of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in adults with type 1 diabetes when used alongside insulin, focusing on improved glucose time in range (TIR) and other glycemic metrics.
  • Data from two randomized, double-blind clinical trials were pooled, comparing the effects of different doses of sotagliflozin (200 mg and 400 mg) with a placebo on glucose levels over 24 weeks using continuous glucose monitoring.
  • Results showed that both doses of sotagliflozin significantly improved glucose TIR and reduced postprandial glucose levels without increasing the risk of hypoglycemia, demonstrating better glycemic control in participants.
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Article Synopsis
  • The study aimed to assess the safety and effectiveness of sotagliflozin, a dual sodium-glucose cotransporter inhibitor, in adult T1D patients when combined with optimized insulin treatment compared to a placebo.
  • Conducted over 52 weeks, the trial involved randomizing adults with T1D into three groups: placebo, 200 mg, and 400 mg of sotagliflozin, with the main focus on changes in HbA levels at 24 weeks.
  • Results showed that sotagliflozin significantly reduced HbA levels, improved glycemic control, lowered weight and insulin doses, and decreased the incidence of severe hypoglycemia, along with positive treatment satisfaction outcomes, especially in the
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Article Synopsis
  • The inTandem1 trial tested the effectiveness and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in adults with type 1 diabetes (T1D) alongside optimized insulin therapy over 52 weeks.
  • Results showed that patients taking sotagliflozin experienced significant reductions in HbA1c levels, weight loss, and lower insulin doses compared to those on placebo, with 40.3% reaching an HbA1c target of less than 7% at 24 weeks.
  • While sotagliflozin showed positive outcomes, it was associated with a higher incidence of adverse effects like genital infections and diabetic ketoacidosis, but overall, patients reported
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Article Synopsis
  • - The study aimed to test the safety and effectiveness of sotagliflozin, an oral medication, when combined with insulin therapy in patients with type 1 diabetes who often struggle to control their blood sugar levels.
  • - In a phase 3 trial involving 1402 patients over 24 weeks, the group taking sotagliflozin showed a significantly higher success rate in achieving target blood sugar levels without severe hypoglycemia compared to the placebo group.
  • - Results indicated improvements in additional health metrics, such as weight loss and lower blood pressure in the sotagliflozin group; however, there was an increased rate of diabetic ketoacidosis in that group compared to the placebo.
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