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
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
SGLT2 Inhibitors to Slow Chronic Kidney Disease Progression: A Review
Clin Ther. 2023 Nov 9:S0149-2918(23)00406-X. doi: 10.1016/j.clinthera.2023.10.014. Online ahead of print.ABSTRACTPURPOSE: One in seven Americans is at risk for chronic kidney disease (CKD). For decades, the only treatment proven to slow progression of CKD was the use of renin-angiotensin-aldosterone system inhibitors. Based on promising secondary kidney outcomes in the cardiovascular outcome trials with sodium-glucose co-transporter-2 inhibitors, kidney outcome trials in patients with CKD were published for canagliflozin, dapagliflozin, and empagliflozin.METHODS: A literature search was conducted of PubMed using the MeSH t...
Source: Clinical Therapeutics - November 11, 2023 Category: Drugs & Pharmacology Authors: Rebecca Maxson Jessica Starr Jeanna Sewell Claretha Lyas Source Type: research
SGLT2 Inhibitors to Slow Chronic Kidney Disease Progression: A Review
Clin Ther. 2023 Nov 9:S0149-2918(23)00406-X. doi: 10.1016/j.clinthera.2023.10.014. Online ahead of print.ABSTRACTPURPOSE: One in seven Americans is at risk for chronic kidney disease (CKD). For decades, the only treatment proven to slow progression of CKD was the use of renin-angiotensin-aldosterone system inhibitors. Based on promising secondary kidney outcomes in the cardiovascular outcome trials with sodium-glucose co-transporter-2 inhibitors, kidney outcome trials in patients with CKD were published for canagliflozin, dapagliflozin, and empagliflozin.METHODS: A literature search was conducted of PubMed using the MeSH t...
Source: Clinical Therapeutics - November 11, 2023 Category: Drugs & Pharmacology Authors: Rebecca Maxson Jessica Starr Jeanna Sewell Claretha Lyas Source Type: research
Predictors of a Good Diuretic Response and Administration Methods for Carperitide in Patients With Acute Heart Failure
Clin Ther. 2023 Nov 7:S0149-2918(23)00397-1. doi: 10.1016/j.clinthera.2023.10.006. Online ahead of print.ABSTRACTPURPOSE: In Japan, carperitide has been recommended for the treatment of pulmonary congestion in patients with acute heart failure. Identifying useful indicators to support the decision to administer carperitide and the optimal timing of administration may lead to better improvement of pulmonary congestion. Therefore, we investigated the factors associated with good diuretic response to carperitide in patients with acute heart failure and the optimal timing of carperitide administration.METHODS: This retrospecti...
Source: Clinical Therapeutics - November 9, 2023 Category: Drugs & Pharmacology Authors: Mayumi Inamoto Noriko Kohyama Hiroshi Suzuki Mio Ebato Mari Kogo Source Type: research
Selexipag for the Treatment of Pediatric Pulmonary Hypertension: A Systematic Review
Clin Ther. 2023 Nov 7:S0149-2918(23)00391-0. doi: 10.1016/j.clinthera.2023.09.026. Online ahead of print.ABSTRACTPURPOSE: To systematically evaluate the safety, dosing regimen, and efficacy of selexipag for pediatric patients with pulmonary hypertension (PH).METHODS: A literature search of the electronic databases of PubMed, Embase, Web of Science, Cochrane Library, and Google Scholar was performed from inception through February 28, 2023. Two reviewers independently searched and evaluated the quality of the studies and pooled data when appropriate. Full-text articles of studies of children diagnosed with PH and treated wi...
Source: Clinical Therapeutics - November 9, 2023 Category: Drugs & Pharmacology Authors: Meng Li Lin Liu Cong Liu Zebin Chen Weibin Li Xuejuan Li Xiaopeng Ma Yumao Zhang Source Type: research
Predictors of a Good Diuretic Response and Administration Methods for Carperitide in Patients With Acute Heart Failure
Clin Ther. 2023 Nov 7:S0149-2918(23)00397-1. doi: 10.1016/j.clinthera.2023.10.006. Online ahead of print.ABSTRACTPURPOSE: In Japan, carperitide has been recommended for the treatment of pulmonary congestion in patients with acute heart failure. Identifying useful indicators to support the decision to administer carperitide and the optimal timing of administration may lead to better improvement of pulmonary congestion. Therefore, we investigated the factors associated with good diuretic response to carperitide in patients with acute heart failure and the optimal timing of carperitide administration.METHODS: This retrospecti...
Source: Clinical Therapeutics - November 9, 2023 Category: Drugs & Pharmacology Authors: Mayumi Inamoto Noriko Kohyama Hiroshi Suzuki Mio Ebato Mari Kogo Source Type: research
Selexipag for the Treatment of Pediatric Pulmonary Hypertension: A Systematic Review
Clin Ther. 2023 Nov 7:S0149-2918(23)00391-0. doi: 10.1016/j.clinthera.2023.09.026. Online ahead of print.ABSTRACTPURPOSE: To systematically evaluate the safety, dosing regimen, and efficacy of selexipag for pediatric patients with pulmonary hypertension (PH).METHODS: A literature search of the electronic databases of PubMed, Embase, Web of Science, Cochrane Library, and Google Scholar was performed from inception through February 28, 2023. Two reviewers independently searched and evaluated the quality of the studies and pooled data when appropriate. Full-text articles of studies of children diagnosed with PH and treated wi...
Source: Clinical Therapeutics - November 9, 2023 Category: Drugs & Pharmacology Authors: Meng Li Lin Liu Cong Liu Zebin Chen Weibin Li Xuejuan Li Xiaopeng Ma Yumao Zhang Source Type: research
Peripheral Artery Disease: Underappreciated Impact and Residual Cardiovascular Risk Despite Revascularization
Clin Ther. 2023 Nov 6:S0149-2918(23)00384-3. doi: 10.1016/j.clinthera.2023.09.021. Online ahead of print.ABSTRACTThis Commentary highlights the under-recognized prevalence and heavy burden of peripheral artery disease (PAD) and its important role as a harbinger of complications of atherosclerotic cardiovascular disease. Although increasing in prevalence globally, PAD is being further accelerated with diabetes, and patients with advanced PAD are at high risk for chronic limb-threatening ischemia. The need for (repeated) revascularization and amputation places a heavy social burden on patients and family, and a heavy financi...
Source: Clinical Therapeutics - November 8, 2023 Category: Drugs & Pharmacology Authors: Shirley Jansen Gert J de Borst Robert Hinchliffe Martin Teraa Source Type: research
Effectiveness of High-Dose Clonazepam Versus Low-Dose Clonazepam With Cognitive Behavioral Therapy in Older Adults With Moderately Severe Insomnia: A Prospective Cohort Study
Clin Ther. 2023 Nov 6:S0149-2918(23)00402-2. doi: 10.1016/j.clinthera.2023.10.010. Online ahead of print.ABSTRACTPURPOSE: To evaluate the effectiveness of high-dose clonazepam (1 mg) versus low-dose clonazepam (0.5 mg) with cognitive behavioral therapy for insomnia (CBT-i) in older adults with moderately severe insomnia.METHODS: A prospective cohort study was conducted in patients who did not respond to low-dose clonazepam for insomnia secondary to chronic medical conditions. After starting with 0.25 mg of clonazepam, their dose was increased to 0.5 mg, then to 1 mg (Group A), or to the same dose with additional CBT-i (Gro...
Source: Clinical Therapeutics - November 8, 2023 Category: Drugs & Pharmacology Authors: Karthik Sankar Natrajan Shanmugasundram Balaswetha Baskaran Deepika Anabalagan Varadharajan Sivaraman Xavier Santhiyagu Rajanandh Muhasaparur Ganesan Source Type: research
