Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis
This study assessed real-world HRU and costs of care among adult patients with R/R B-ALL by line of therapy (LoT) in the United States.METHODS: We selected patients from the MarketScanⓇ Database (January 1, 2016 through December 31, 2020) as follows: ≥1 claims of ALL-indicated first-line (1L) therapies, ≥1 diagnosis of ALL before the index date (1L initiation date), 6-month continuous enrollment before the index date, second-line (2L) therapy initiation, ≥18 years old at 2L, no clinical trial enrollment, no diagnosis of other forms of non-Hodgkin's lymphoma, and no claim for daratumumab or nelarabine during the stu...
Source: Clinical Therapeutics - November 19, 2023 Category: Drugs & Pharmacology Authors: Diane Ito Chaoling Feng Christine Fu Chong Kim James Wu David Dalton Josh Epstein Julia T Snider Adam S DuVall Source Type: research

Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis
This study assessed real-world HRU and costs of care among adult patients with R/R B-ALL by line of therapy (LoT) in the United States.METHODS: We selected patients from the MarketScanⓇ Database (January 1, 2016 through December 31, 2020) as follows: ≥1 claims of ALL-indicated first-line (1L) therapies, ≥1 diagnosis of ALL before the index date (1L initiation date), 6-month continuous enrollment before the index date, second-line (2L) therapy initiation, ≥18 years old at 2L, no clinical trial enrollment, no diagnosis of other forms of non-Hodgkin's lymphoma, and no claim for daratumumab or nelarabine during the stu...
Source: Clinical Therapeutics - November 19, 2023 Category: Drugs & Pharmacology Authors: Diane Ito Chaoling Feng Christine Fu Chong Kim James Wu David Dalton Josh Epstein Julia T Snider Adam S DuVall Source Type: research

Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis
This study assessed real-world HRU and costs of care among adult patients with R/R B-ALL by line of therapy (LoT) in the United States.METHODS: We selected patients from the MarketScanⓇ Database (January 1, 2016 through December 31, 2020) as follows: ≥1 claims of ALL-indicated first-line (1L) therapies, ≥1 diagnosis of ALL before the index date (1L initiation date), 6-month continuous enrollment before the index date, second-line (2L) therapy initiation, ≥18 years old at 2L, no clinical trial enrollment, no diagnosis of other forms of non-Hodgkin's lymphoma, and no claim for daratumumab or nelarabine during the stu...
Source: Clinical Therapeutics - November 19, 2023 Category: Drugs & Pharmacology Authors: Diane Ito Chaoling Feng Christine Fu Chong Kim James Wu David Dalton Josh Epstein Julia T Snider Adam S DuVall Source Type: research

Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis
This study assessed real-world HRU and costs of care among adult patients with R/R B-ALL by line of therapy (LoT) in the United States.METHODS: We selected patients from the MarketScanⓇ Database (January 1, 2016 through December 31, 2020) as follows: ≥1 claims of ALL-indicated first-line (1L) therapies, ≥1 diagnosis of ALL before the index date (1L initiation date), 6-month continuous enrollment before the index date, second-line (2L) therapy initiation, ≥18 years old at 2L, no clinical trial enrollment, no diagnosis of other forms of non-Hodgkin's lymphoma, and no claim for daratumumab or nelarabine during the stu...
Source: Clinical Therapeutics - November 19, 2023 Category: Drugs & Pharmacology Authors: Diane Ito Chaoling Feng Christine Fu Chong Kim James Wu David Dalton Josh Epstein Julia T Snider Adam S DuVall Source Type: research

Past, Present, and Future Therapies for Alcohol-Associated Hepatitis
Clin Ther. 2023 Nov 16:S0149-2918(23)00405-8. doi: 10.1016/j.clinthera.2023.10.013. Online ahead of print.ABSTRACTPURPOSE: Alcohol-associated hepatitis (AH) is a unique presentation of cholestatic steatohepatitis with liver dysfunction and malaise preceded by heavy alcohol intake. Although AH exists on a spectrum, in its most severe form, 28-day mortality approaches 50%. Clinical trials of therapeutic interventions over the last 50 years have yielded few durable therapies, none of which convey benefit beyond the short term.METHODS: A qualitative systematic review was performed via searches of PubMed, the International Clin...
Source: Clinical Therapeutics - November 18, 2023 Category: Drugs & Pharmacology Authors: Sally Condon Loretta L Jophlin Source Type: research

Statin Use, Lipids, and 3-Hydroxy-3-Methyl-Glutaryl Coenzyme A Reductase Inhibition on Risk of Idiopathic Pulmonary Fibrosis
Clin Ther. 2023 Nov 15:S0149-2918(23)00427-7. doi: 10.1016/j.clinthera.2023.10.018. Online ahead of print.NO ABSTRACTPMID:37978012 | DOI:10.1016/j.clinthera.2023.10.018 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 17, 2023 Category: Drugs & Pharmacology Authors: Sizheng Steven Zhao Philip Alton Kira Rogers David M Hughes Source Type: research

Statin Use, Lipids, and 3-Hydroxy-3-Methyl-Glutaryl Coenzyme A Reductase Inhibition on Risk of Idiopathic Pulmonary Fibrosis
Clin Ther. 2023 Nov 15:S0149-2918(23)00427-7. doi: 10.1016/j.clinthera.2023.10.018. Online ahead of print.NO ABSTRACTPMID:37978012 | DOI:10.1016/j.clinthera.2023.10.018 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 17, 2023 Category: Drugs & Pharmacology Authors: Sizheng Steven Zhao Philip Alton Kira Rogers David M Hughes Source Type: research

Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis
This report aimed to assess the pharmacokinetics and safety of an edaravone oral suspension in patients with ALS after oral and percutaneous endoscopic gastrostomy (PEG) tube administration.METHODS: Two single-dose, open-label phase 1 clinical studies were conducted. Edaravone oral suspension (105 mg of edaravone in 5 mL aqueous suspension) was administered orally and via PEG tube to 9 and 6 Japanese patients with ALS, respectively. Plasma and urinary pharmacokinetics of unchanged edaravone and its metabolites (sulfate and glucuronide conjugates) were determined. Safety was also evaluated.FINDINGS: After reaching maximum p...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Hidetoshi Shimizu Yukiko Nishimura Youichi Shiide Makoto Akimoto Makiko Yashiro Masaki Ueda Manabu Hirai Hiide Yoshino Tomohiko Mizutani Kazuaki Kanai Osamu Kano Hideki Kimura Hisakuni Sekino Kimiko Ito Source Type: research

Crushing the Contents of Valbenazine Capsules for Potential Addition to Soft Foods or Administration via Gastrostomy Tube
Clin Ther. 2023 Nov 10:S0149-2918(23)00390-9. doi: 10.1016/j.clinthera.2023.09.024. Online ahead of print.ABSTRACTPURPOSE: One-capsule, once-daily valbenazine is approved for tardive dyskinesia and under evaluation for chorea associated with Huntington's disease, conditions in which patients often experience dysphagia. In vitro studies were conducted to assess the suitability of crushing the contents of valbenazine capsules (40 and 80 mg) for mixing with soft foods or liquids or administration via a gastrostomy tube (G-tube).METHODS: In study 1, the dissolution of whole valbenazine capsules and crushed capsule contents wer...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Martha Sajatovic Amita Patel Mello Hebert Alexander Mar Richard Moore Ali Bristow Khody Farahmand Scott Siegert Source Type: research

Combination Therapy Use and Associated Events in Clinical Practice Following Dissemination of Trial Findings: A De-Implementation Study Using Interrupted Time Series Analysis
This study followed 712,245 patients, 9297 of whom used combination therapy. Data were available from 428,535 and 283,710 patients pre- and post-intervention, respectively; among these, 8324 and 973 patients used combination therapy, the median ages were 66 and 68 years, and 96.92% and 98.82% were men. One month following communication from the PBM, the reductions in combination therapy users, acute kidney injury events, and hyperkalemia were 331.94 (95% CI, 500.27-163.32), 36.58% (95% CI, 31.90%-41.95%), and 25.49% (95% CI, 14.17%-36.07%) per 100,000 patients per month, respectively (all, P < 0.001), whereas before the...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Heather M Campbell Allison E Murata Adam M Henrie Todd A Conner Source Type: research

Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis
This report aimed to assess the pharmacokinetics and safety of an edaravone oral suspension in patients with ALS after oral and percutaneous endoscopic gastrostomy (PEG) tube administration.METHODS: Two single-dose, open-label phase 1 clinical studies were conducted. Edaravone oral suspension (105 mg of edaravone in 5 mL aqueous suspension) was administered orally and via PEG tube to 9 and 6 Japanese patients with ALS, respectively. Plasma and urinary pharmacokinetics of unchanged edaravone and its metabolites (sulfate and glucuronide conjugates) were determined. Safety was also evaluated.FINDINGS: After reaching maximum p...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Hidetoshi Shimizu Yukiko Nishimura Youichi Shiide Makoto Akimoto Makiko Yashiro Masaki Ueda Manabu Hirai Hiide Yoshino Tomohiko Mizutani Kazuaki Kanai Osamu Kano Hideki Kimura Hisakuni Sekino Kimiko Ito Source Type: research

Crushing the Contents of Valbenazine Capsules for Potential Addition to Soft Foods or Administration via Gastrostomy Tube
Clin Ther. 2023 Nov 10:S0149-2918(23)00390-9. doi: 10.1016/j.clinthera.2023.09.024. Online ahead of print.ABSTRACTPURPOSE: One-capsule, once-daily valbenazine is approved for tardive dyskinesia and under evaluation for chorea associated with Huntington's disease, conditions in which patients often experience dysphagia. In vitro studies were conducted to assess the suitability of crushing the contents of valbenazine capsules (40 and 80 mg) for mixing with soft foods or liquids or administration via a gastrostomy tube (G-tube).METHODS: In study 1, the dissolution of whole valbenazine capsules and crushed capsule contents wer...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Martha Sajatovic Amita Patel Mello Hebert Alexander Mar Richard Moore Ali Bristow Khody Farahmand Scott Siegert Source Type: research

Combination Therapy Use and Associated Events in Clinical Practice Following Dissemination of Trial Findings: A De-Implementation Study Using Interrupted Time Series Analysis
This study followed 712,245 patients, 9297 of whom used combination therapy. Data were available from 428,535 and 283,710 patients pre- and post-intervention, respectively; among these, 8324 and 973 patients used combination therapy, the median ages were 66 and 68 years, and 96.92% and 98.82% were men. One month following communication from the PBM, the reductions in combination therapy users, acute kidney injury events, and hyperkalemia were 331.94 (95% CI, 500.27-163.32), 36.58% (95% CI, 31.90%-41.95%), and 25.49% (95% CI, 14.17%-36.07%) per 100,000 patients per month, respectively (all, P < 0.001), whereas before the...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Heather M Campbell Allison E Murata Adam M Henrie Todd A Conner Source Type: research

Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis
This report aimed to assess the pharmacokinetics and safety of an edaravone oral suspension in patients with ALS after oral and percutaneous endoscopic gastrostomy (PEG) tube administration.METHODS: Two single-dose, open-label phase 1 clinical studies were conducted. Edaravone oral suspension (105 mg of edaravone in 5 mL aqueous suspension) was administered orally and via PEG tube to 9 and 6 Japanese patients with ALS, respectively. Plasma and urinary pharmacokinetics of unchanged edaravone and its metabolites (sulfate and glucuronide conjugates) were determined. Safety was also evaluated.FINDINGS: After reaching maximum p...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Hidetoshi Shimizu Yukiko Nishimura Youichi Shiide Makoto Akimoto Makiko Yashiro Masaki Ueda Manabu Hirai Hiide Yoshino Tomohiko Mizutani Kazuaki Kanai Osamu Kano Hideki Kimura Hisakuni Sekino Kimiko Ito Source Type: research

Crushing the Contents of Valbenazine Capsules for Potential Addition to Soft Foods or Administration via Gastrostomy Tube
Clin Ther. 2023 Nov 10:S0149-2918(23)00390-9. doi: 10.1016/j.clinthera.2023.09.024. Online ahead of print.ABSTRACTPURPOSE: One-capsule, once-daily valbenazine is approved for tardive dyskinesia and under evaluation for chorea associated with Huntington's disease, conditions in which patients often experience dysphagia. In vitro studies were conducted to assess the suitability of crushing the contents of valbenazine capsules (40 and 80 mg) for mixing with soft foods or liquids or administration via a gastrostomy tube (G-tube).METHODS: In study 1, the dissolution of whole valbenazine capsules and crushed capsule contents wer...
Source: Clinical Therapeutics - November 12, 2023 Category: Drugs & Pharmacology Authors: Martha Sajatovic Amita Patel Mello Hebert Alexander Mar Richard Moore Ali Bristow Khody Farahmand Scott Siegert Source Type: research