The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy
This study aimed to evaluate the efficacy and tolerability of irbesartan (IRB) and amlodipine (AML) combination therapy in patients with essential hypertension whose blood pressure (BP) was not controlled by IRB monotherapy.METHODS: Two multicenter, randomized, double-blind, placebo-controlled, phase III studies were conducted in Korea (the I-DUO 301 study and the I-DUO 302 study). After a 4-week run-in period with either 150 mg IRB (I-DUO 301 study) or 300 mg IRB (I-DUO 302 study), patients with uncontrolled BP (ie, mean sitting systolic BP [MSSBP] ≥140 mmHg to <180 mmHg and mean sitting diastolic BP <110 mmHg) we...
Source: Clinical Therapeutics - May 4, 2024 Category: Drugs & Pharmacology Authors: Hae-Young Lee Kyung Wan Min Kyung Ah Han Jeong Su Kim Jeong Cheon Ahn Moo Hyun Kim Jin Bae Lee Sung-Hee Shin Chong-Jin Kim Kye Hun Kim Deok-Kyu Cho Junghyun Choi Moo-Yong Rhee Sung-Ho Her Weon Kim Jin Oh Na Goo-Yeong Cho Seok Yeon Kim Gyung-Min Park Bong- Source Type: research
Antiretroviral Stewardship: Top 10 Questions Encountered by Stewardship Teams and Solutions to Optimize Therapy
Clin Ther. 2024 May 3:S0149-2918(24)00081-X. doi: 10.1016/j.clinthera.2024.04.002. Online ahead of print.ABSTRACTPURPOSE: Infectious disease pharmacists and physicians overseeing antimicrobial stewardship programs possess expertise and often advanced certification in management of antiretrovirals to treat HIV. Stewardship programs are responsible for managing facility formularies and must stay up to date with the latest antiretrovirals, including once daily formulations and depot injectables. Furthermore, stewardship program members need to understand drug-interactions, short-, and long-term toxicities of these regimens, i...
Source: Clinical Therapeutics - May 4, 2024 Category: Drugs & Pharmacology Authors: Mei H Chang Yi Guo Antoinette Acbo Hongkai Bao Terrence McSweeney Christopher A Vo Priya Nori Source Type: research
Mechanism of Action of Ropeginterferon Alfa-2b in Polycythemia Vera Treatment
Clin Ther. 2024 May 1:S0149-2918(24)00072-9. doi: 10.1016/j.clinthera.2024.03.005. Online ahead of print.NO ABSTRACTPMID:38697872 | DOI:10.1016/j.clinthera.2024.03.005 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - May 2, 2024 Category: Drugs & Pharmacology Authors: Albert Qin Source Type: research
Zuranolone: A Narrative Review of a New Oral Treatment for Postpartum Depression
Clin Ther. 2024 May 1:S0149-2918(24)00079-1. doi: 10.1016/j.clinthera.2024.04.001. Online ahead of print.ABSTRACTPURPOSE: Postpartum depression is a prevalent and overlooked mental disorder. Pathophysiology is thought to originate from a combination of biological and social factors, including hormones, and genetics. The consequences of untreated postpartum depression can be severe and negatively impact maternal and infant health. Zuranolone was approved as an oral agent in August 2023 for the treatment of postpartum depression in adults. The purpose of this article is evaluating the clinical aspects of zuranolone, includin...
Source: Clinical Therapeutics - May 2, 2024 Category: Drugs & Pharmacology Authors: Emily M Hitt Source Type: research
Mechanism of Action of Ropeginterferon Alfa-2b in Polycythemia Vera Treatment
Clin Ther. 2024 May 1:S0149-2918(24)00072-9. doi: 10.1016/j.clinthera.2024.03.005. Online ahead of print.NO ABSTRACTPMID:38697872 | DOI:10.1016/j.clinthera.2024.03.005 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - May 2, 2024 Category: Drugs & Pharmacology Authors: Albert Qin Source Type: research
Zuranolone: A Narrative Review of a New Oral Treatment for Postpartum Depression
Clin Ther. 2024 May 1:S0149-2918(24)00079-1. doi: 10.1016/j.clinthera.2024.04.001. Online ahead of print.ABSTRACTPURPOSE: Postpartum depression is a prevalent and overlooked mental disorder. Pathophysiology is thought to originate from a combination of biological and social factors, including hormones, and genetics. The consequences of untreated postpartum depression can be severe and negatively impact maternal and infant health. Zuranolone was approved as an oral agent in August 2023 for the treatment of postpartum depression in adults. The purpose of this article is evaluating the clinical aspects of zuranolone, includin...
Source: Clinical Therapeutics - May 2, 2024 Category: Drugs & Pharmacology Authors: Emily M Hitt Source Type: research
Bioequivalence of Related GelShield < sup > Ⓡ < /sup > Sustained-Release Formulations of Metformin: A Pooled Pharmacokinetic Analysis
Clin Ther. 2024 Apr 29:S0149-2918(24)00077-8. doi: 10.1016/j.clinthera.2024.03.011. Online ahead of print.ABSTRACTPURPOSE: GlucophageⓇ (Merck Healthcare KGaA, Darmstadt, Germany) is the originator brand of metformin hydrochloride, an oral antidiabetic drug. Metformin is recommended in guidelines as first-line treatment of type 2 diabetes mellitus and increasingly in related insulin-resistant conditions, such as prediabetes and polycystic ovary syndrome. The GelShieldⓇ sustained-release formulation tablet of GlucophageⓇ has been improved from the historic version marketed in 2000. Bioequivalence has been demonstrated ...
Source: Clinical Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Axel Krebs-Brown Kerstin M G Brand Marco A F Nogueira Filho Sumedh Gaikwad Yvonne Schnaars Source Type: research
Bioequivalence of Related GelShield < sup > Ⓡ < /sup > Sustained-Release Formulations of Metformin: A Pooled Pharmacokinetic Analysis
Clin Ther. 2024 Apr 29:S0149-2918(24)00077-8. doi: 10.1016/j.clinthera.2024.03.011. Online ahead of print.ABSTRACTPURPOSE: GlucophageⓇ (Merck Healthcare KGaA, Darmstadt, Germany) is the originator brand of metformin hydrochloride, an oral antidiabetic drug. Metformin is recommended in guidelines as first-line treatment of type 2 diabetes mellitus and increasingly in related insulin-resistant conditions, such as prediabetes and polycystic ovary syndrome. The GelShieldⓇ sustained-release formulation tablet of GlucophageⓇ has been improved from the historic version marketed in 2000. Bioequivalence has been demonstrated ...
Source: Clinical Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Axel Krebs-Brown Kerstin M G Brand Marco A F Nogueira Filho Sumedh Gaikwad Yvonne Schnaars Source Type: research
Bioequivalence of Related GelShield < sup > Ⓡ < /sup > Sustained-Release Formulations of Metformin: A Pooled Pharmacokinetic Analysis
Clin Ther. 2024 Apr 29:S0149-2918(24)00077-8. doi: 10.1016/j.clinthera.2024.03.011. Online ahead of print.ABSTRACTPURPOSE: GlucophageⓇ (Merck Healthcare KGaA, Darmstadt, Germany) is the originator brand of metformin hydrochloride, an oral antidiabetic drug. Metformin is recommended in guidelines as first-line treatment of type 2 diabetes mellitus and increasingly in related insulin-resistant conditions, such as prediabetes and polycystic ovary syndrome. The GelShieldⓇ sustained-release formulation tablet of GlucophageⓇ has been improved from the historic version marketed in 2000. Bioequivalence has been demonstrated ...
Source: Clinical Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Axel Krebs-Brown Kerstin M G Brand Marco A F Nogueira Filho Sumedh Gaikwad Yvonne Schnaars Source Type: research
Strategic Partnerships in Pharmacovigilance: Business, Legal, and Regulatory Domains
Clin Ther. 2024 Apr 26:S0149-2918(24)00074-2. doi: 10.1016/j.clinthera.2024.03.007. Online ahead of print.ABSTRACTPharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In genera...
Source: Clinical Therapeutics - April 27, 2024 Category: Drugs & Pharmacology Authors: Ashraf Youssef Nancy L Blanchard Tarek A Hammad Source Type: research
Strategic Partnerships in Pharmacovigilance: Business, Legal, and Regulatory Domains
Clin Ther. 2024 Apr 26:S0149-2918(24)00074-2. doi: 10.1016/j.clinthera.2024.03.007. Online ahead of print.ABSTRACTPharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In genera...
Source: Clinical Therapeutics - April 27, 2024 Category: Drugs & Pharmacology Authors: Ashraf Youssef Nancy L Blanchard Tarek A Hammad Source Type: research
Strategic Partnerships in Pharmacovigilance: Business, Legal, and Regulatory Domains
Clin Ther. 2024 Apr 26:S0149-2918(24)00074-2. doi: 10.1016/j.clinthera.2024.03.007. Online ahead of print.ABSTRACTPharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In genera...
Source: Clinical Therapeutics - April 27, 2024 Category: Drugs & Pharmacology Authors: Ashraf Youssef Nancy L Blanchard Tarek A Hammad Source Type: research
Lessons Learned From Clinical Studies in Centronuclear Myopathies: The Patient Perspective-A Qualitative Study
CONCLUSION: The acknowledgment and inclusion of patients' perspectives and efficient and effective communication is expected to improve patient recruitment and retention in future clinical studies, as well as more accurate assessment of the patient performance related to suitable planning of the study visits.PMID:38670885 | DOI:10.1016/j.clinthera.2024.03.008 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Lizan Stinissen Johann B öhm Sietse Bouma Jeno van Tienen Holger Fischer Zak Hughes Anne Lennox Erin Ward Marie Wood A Reghan Foley Wija Oortwijn Heinz Jungbluth Nicol C Voermans Source Type: research
Spinal Muscular Atrophy: Expanded Access as an Instrument of Fairness
Clin Ther. 2024 Apr 25:S0149-2918(24)00076-6. doi: 10.1016/j.clinthera.2024.03.010. Online ahead of print.NO ABSTRACTPMID:38670886 | DOI:10.1016/j.clinthera.2024.03.010 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Paul Beninger Source Type: research
Knowledge Graphs in Pharmacovigilance: A Step-By-Step Guide
Clin Ther. 2024 Apr 25:S0149-2918(24)00071-7. doi: 10.1016/j.clinthera.2024.03.006. Online ahead of print.ABSTRACTPURPOSE: This work aims to demystify Knowledge Graphs (KGs) in pharmacovigilance (PV). It complements the scoping review within this issue. By bridging knowledge gaps and stimulating interest, further engagement with this topic by pharmacovigilance professionals will be facilitated.METHODS: We elucidate fundamental KGs concepts and terminology, followed by delineating a sequence of implementation steps: use case definition, data type selection, data sourcing, KG construction, KG embedding, and deriving actionab...
Source: Clinical Therapeutics - April 26, 2024 Category: Drugs & Pharmacology Authors: Manfred Hauben Mazin Rafi Source Type: research
