Aprovasc (amlodipine/irbesartan) / Simcere, Sanofi, Sumitomo Pharma, Shionogi - LARVOL DELTA

A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence. (PubMed, J Cardiovasc Dev Dis) - "In this work, VBC is applied to bioequivalence studies of three anti-hypertensive drugs: amlodipine, irbesartan, and hydrochlorothiazide. The results suggest that VBC is a reproducible, easily applicable method allowing for the discrimination and utilization of the endpoint component expressing different attributes. All clinical characteristics are assessed with increased statistical power, without inflation of type I error."

Journal

Estimated impact of guidelines-based initiation of dual antihypertensive therapy on long-term cardiovascular outcomes in 1.1 million individuals. (PubMed, Eur Heart J Cardiovasc Pharmacother) - "This study represents the first to investigate guidelines-based treatment in hypertensive patients and demonstrates the opportunity for considerable risk reduction by ensuring recommended dual therapy in clinical practice, particularly in the form of SPC with high persistence, relative to no treatment or monotherapy."

Journal • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Hematological Disorders • Hypertension • Ischemic stroke • Metabolic Disorders • Myocardial Infarction

Primary Hyperaldosteronism Leading to Aldosterone Deficiency (ENDO 2024) - "Patient has been on multiple agents and blood pressure remained elevated after trying triamterene/hctz, metoprolol, irbesartan, amlodipine...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Cardiovascular • Chronic Kidney Disease • Diabetes • Endocrine Disorders • Fatigue • Hypertension • Hypotension • Metabolic Disorders • Pain • Renal Disease

The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy. (PubMed, Clin Ther) - P3 | "The combination of IRB and AML has superior antihypertensive effects compared with IRB alone over an 8-week treatment period, with placebo-like tolerability."

Clinical • Combination therapy • Journal • Monotherapy • Acute Myelogenous Leukemia • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders

Impact of China's National Volume-Based Procurement on Medication Adherence and Clinical Outcomes Among Patients With Hypertension (ISPOR 2024) - "The study included users of originator antihypertensive medications covered by the first pilot NVBP, including amlodipine, irbesartan, losartan, and irbesartan hydrochlorothiazide combination formulations. NVBP had no negative effect on cardiovascular clinical outcomes in hypertensive patients and improved medication adherence."

Adherence • Clinical • Clinical data • Cardiovascular • Hypertension • Myocardial Infarction

Irbesartan-Induced Enteropathy: A Case Report Demonstrating Clinical and Histological Improvement With Medication Cessation (ACG 2023) - "At that time, his hypertension was being managed with irbesartan and amlodipine. Duodenal mucosa showing acute and chronic duodenitis with focal mucosal erosion (E, x 20). Squamous mucosa showing reactive epithelial changes, focal mucosal erosion, and inflamed granulation tissue (F, x 20)."

Clinical • Asthma • Cardiovascular • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammation • Peptic Ulcer • Pulmonary Disease • Respiratory Diseases

Irbesartan Induced Prolonged Perioperative Hypotension During Pleurectomy For Mesothelioma (ASA 2023) - "We present the case of a 79 year-old man with mesothelioma presenting for thoracotomy and pleurectomy who had not held his anti-hypertensives (Irbesartan, amlodipine, and hydrochlorothiazide) prior to surgery. Generally, ACEi and ARBs are held 24 hours prior to surgery regardless of half-life. Our case describes prolonged hypotension and management from continuation of a long acting ARB in the perioperative setting."

Anesthesia • Hypotension • Lung Cancer • Mesothelioma • Oncology • Solid Tumor

Estimated impact of timely guidelines-based initiation of dual-combination anti-hypertensive therapy on long-term cardiovascular outcomes in a population of 1.4 million individuals. (ESC 2023) - "In scenario 2, the simulated 10-year event rates for the primary endpoint were 15.8% (absolute risk reduction [ARR] 6.6%, number needed to treat [NNT] 15) and 15.2% (ARR 7.1%, NNT 14) for Ramipril plus Amlodipine (R+A) and Irbesartan plus Amlodipine (I+A), respectively. Results suggest substantial population attributable risk for behaviors of suboptimal adherence and persistence. The opportunity for risk reduction by optimal treatment, and attributable risk due to suboptimal treatment, were especially high for individuals with ASCVD or diabetes."

Clinical • Atherosclerosis • Cardiovascular • Congestive Heart Failure • Dyslipidemia • Heart Failure • Myocardial Infarction

Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients (clinicaltrials.gov) - P3 | N=157 | Completed | Sponsor: Handok Inc. | Recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Handok Inc. | Active, not recruiting ➔ Completed

Trial completion

Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients (clinicaltrials.gov) - P3 | N=271 | Completed | Sponsor: Handok Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2023 ➔ Jun 2023

Trial completion • Trial completion date • Cardiovascular • Hypertension

Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Handok Inc. | Active, not recruiting ➔ Completed

Trial completion

Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Handok Inc. | Active, not recruiting ➔ Completed

Trial completion

Coronary Spasm in a Patient With Argininosuccinic Aciduria (AHA 2022) - "Therapeutic drugs including, L-arginine, sodium phenylbutyrate and antiepileptic drugs had been administered...The patient was started on amlodipine and irbesartan, however, he continued to complain of chest discomfort at rest...Chest discomfort was disappeared after additional administration of isosorbide mononitrate.ASA is a genetic disorder of the urea cycle, caused by deficiency of argininosuccinate lyase (ASL)...The precise mechanisms of coronary spasm remain to be elucidated. Our case report might support the significance of endothelial function in the pathogenesis of coronary spasm."

Clinical • Cardiovascular • Genetic Disorders • Hypertension • Myocardial Infarction

Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis. (PubMed, Clin Cardiol) - "The results of the network meta-analysis showed that a total of 11 single-pill combination antihypertensive drugs were included, namely: Amlodipine/valsartan, Telmisartan/amlodipine, Losartan/HCTZ, Candesartan/HCTZ, Amlodipine/benazepril, Telmisartan/HCTZ, Valsartan/HCTZ, Irbesartan/amlodipine, Amlodipine/losartan, Irbesartan/HCTZ, and Perindopril/amlodipine. Based on Ranking Plot of the Network, we can conclude that single-pill combination antihypertensive drugs are superior to monotherapy, and ARB/CCB combination has better advantages than other SPC in terms of systolic blood pressure, diastolic blood pressure, blood pressure control rate, and diastolic response rate. However, due to the small number of some drug studies, the lack of relevant studies has led to not being included in this study, which may impact the results, and readers should interpret the results with caution."

Journal • Retrospective data • Review • Cardiovascular • Hypertension

Pharmacokinetics of Irbesartan/Amlodipine High FDC and Co-administration of Irbesartan and Amlodipine High in Healthy Volunteers (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Handok Inc.

New P1 trial

: Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Handok Inc.

New P1 trial

Effect of administration of low-dose irbesartan and hydrochlorothiazide combined with levamlodipine at different times on the circadian rhythm of blood pressure and the levels of MMPs and TIMPs in non-dipper patients with grade 1 and 2 hypertension. (PubMed, J Clin Hypertens (Greenwich)) - "The percentage of the dipper type was higher in the night medication group than in the morning medication group, while the percentage of the non-dipper type was lower in the morning medication group (p < .05). Low-dose irbesartan and hydrochlorothiazide combined with levamlodipine at different times can effectively treat NDH, but bedtime dosing is more beneficial in reducing nocturnal blood pressure, reversing NDH, improving the circadian rhythm of blood pressure, left ventricular structure, regulating vascular endothelial function, increasing MMPs levels, and reducing TIMP levels."

Journal • Cardiovascular • Hypertension

Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Handok Inc.

New P1 trial

Giant Hepatic Hemangioma: Dulling the Blade of Ockham’s Razor (ACG 2022) - "She reported increased facial hair and acne which improved on spironolactone. Other medications included amlodipine, irbesartan, and progestin intrauterine device...Table: Table 1. Laboratory Data"

Acne Vulgaris • Cardiovascular • Endocrine Disorders • Hepatology • Hypertension • Long-acting Reversible Contraceptives • Oncology • Pain • Women's Health

Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients (clinicaltrials.gov) - P3 | N=273 | Recruiting | Sponsor: Handok Inc.

New P3 trial • Cardiovascular • Hypertension

Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients (clinicaltrials.gov) - P3 | N=168 | Recruiting | Sponsor: Handok Inc.

New P3 trial • Cardiovascular • Hypertension

Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension (clinicaltrials.gov) - P2 | N=440 | Completed | Sponsor: Handok Inc. | Recruiting ➔ Completed | Trial primary completion date: Jul 2021 ➔ Nov 2021

Trial completion • Trial primary completion date • Cardiovascular • Hypertension

Effects of Irbesartan and Amlodipine Besylate Tablets on the Intestinal Microflora of Rats With Hypertensive Renal Damage. (PubMed, Front Pharmacol) - " After the administration of irbesartan and amlodipine besylate, the disorder of intestinal flora in the rats with hypertensive renal damage improved. However, irbesartan was better than amlodipine besylate at improving the diversity of the intestinal flora in these rats."

Journal • Preclinical • Gastrointestinal Disorder

The antihypertensive effect of irbesartan in spontaneously hypertensive rats is associated with improvement of the leptin-adiponectin imbalance. (PubMed, Adipocyte) - "The antihypertensive effect of IRB in SHR rats was associated with its improvement of insulin resistance and correction of the LPN-APN imbalance. Abbreviations: ANOVA, one-way analysis of variance; SHR, Spontaneously hypertensive rats; WKY, Wistar kyoto rats; IRB, Irbesartan; AML, Amlodipine; LPN, Leptin; APN, Adiponectin; Ang-II, AngiotensinⅡ; HOMA-IR, Homoeostasis model assessment-insulin resistance; SBP, Systolic blood pressure; RT-PCR, Reverse transcription polymerase chain reaction; ARB, AngiotensinⅡreceptor blocker."

Journal • Acute Myelogenous Leukemia • LEP • PCR