Triplixam (perindopril arginine/amlodipine/indapamide) / Servier - LARVOL DELTA

Application of spectrophotometry in novel simultaneous dissolution profiling of a single pill triple therapy of amlodipine, perindopril and indapamide; whiteness evaluation. (PubMed, BMC Chem) - "Simple, diverse univariate spectrophotometric methods were developed and validated for the determination of amlodipine besylate (AM), perindopril arginine (PE), and indapamide (ID). These methods were successfully applied to determine AM, PE, and ID in bulk powder, as well as in Triplixam® tablets, without interference from excipients and in different used dissolution media. The whiteness of the method was evaluated, demonstrating its excellent environmental, analytical and practical efficiency."

Journal

TOPSPIN- A Three-arm Randomized Trial For Treatment Optimisation Of Blood Pressure With Single-pill Combinations In India (AHA 2024) - P4 | "Participants were randomized 1:1:1 to receive a SPC of starting doses of either - amlodipine and perindopril or perindopril and indapamide or amlodipine and indapamide...The results of this trial may have major clinical implications for improving BP control in India and the South Asian diaspora. (CTRI/2022/04/042106 & NCT05683301)"

Clinical • Late-breaking abstract • Cardiovascular • CNS Disorders • Diabetes • Hypertension • Metabolic Disorders • Renal Disease • Vascular Neurology

TOPSPIN: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India (clinicaltrials.gov) - P4 | N=1981 | Completed | Sponsor: Centre for Chronic Disease Control, India | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

TOPSPIN: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India (clinicaltrials.gov) - P4 | N=1981 | Active, not recruiting | Sponsor: Centre for Chronic Disease Control, India | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Aug 2024

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Hypertension

Efficacy and safety of a single-pill versus free combination of perindopril/indapamide/amlodipine: a multicenter, randomized, double-blind study in Chinese patients with hypertension. (PubMed, J Hypertens) - "Per/Ind/Aml is an effective substitute for Per/Ind + Aml, providing at least equivalent BP control over 24 h in a single pill, with comparable safety."

Clinical • Journal • Acute Myelogenous Leukemia • Cardiovascular • Hypertension

OPTIMAL-HT: Optimal Medical Treatment of Difficult-to-treat Hypertension (clinicaltrials.gov) - P4 | N=2500 | Recruiting | Sponsor: National Institute of Cardiology, Warsaw, Poland

New P4 trial • Cardiovascular • Hypertension

Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH) (clinicaltrials.gov) - P=N/A | N=375 | Not yet recruiting | Sponsor: Servier Russia

Adherence • New trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

Efficacy and Organoprotection of Triple Combinations in the Treatment of Arterial Hypertension (PubMed, Kardiologiia) - "Combination antihypertensive therapy with a renin-angiotensin-aldosterone system inhibitor, amlodipine, and thiazide/thiazide-like diuretics provides a better blood pressure control compared to other antihypertensive drug combinations. The use of the triple combination of amlodipine/indapamide/perindopril is associated with a better metabolic profile than any other considered combination of antihypertensive drugs and a more pronounced organ-protective effect."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension

A real-world analysis of outcomes and healthcare costs of patients on perindopril/indapamide/amlodipine single-pill vs. multiple-pill combination in Italy. (PubMed, J Hypertens) - "The SPC of PER/IND/AML, compared with multiple-pill combination, is associated with higher adherence to medication, lower incidence of CV events and mortality, and reduced healthcare costs."

HEOR • Journal • Real-world • Real-world evidence • Retrospective data • Acute Myelogenous Leukemia • Cardiovascular

Marginal Zone B Cell Lymphoma and Non-HCV Associated Type II Cryoglobulinemic Vasculitis: A Rare Presentation (EADV 2023) - "She was taking atorvastatin, methylprednisolone (MP) 15 mg, levothyroxine, perindopril arginine, indapamide, amlodipine, vildagliptin, metformin, insulin, colchicine, pregabalin, alpha lipoic acid...A rituximab-bendamustine regimen for NMZL was planned. Entecavir treatment was started for prophylaxis of hepatitis B reactivation... Type I CG consists of monoclonal IgM or IgG; Type II consists of monoclonal IgM/polyclonal IgG immune complexes; Type III consists of polyclonal IgM and IgG. In Type II and III Mixed Cryoglobulinemia (MC), the IgM fraction has RF activity. Type I CG is usually associated with monoclonal gammopathies, whereas MC is associated with infections (HCV, HBV), autoimmune diseases, B-cell lymphomas, or solid neoplasms."

Anemia • Cardiovascular • Complement-mediated Rare Disorders • Diabetes • Diabetic Neuropathy • Endocrine Disorders • Fatigue • Fibrosis • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Lupus Nephritis • Lymphoma • Marginal Zone Lymphoma • Metabolic Disorders • Monoclonal Gammopathy • Musculoskeletal Pain • Myositis • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Pain • Rheumatoid Arthritis • Scleroderma • Solid Tumor • Systemic Sclerosis • Thrombocytosis • Type 2 Diabetes Mellitus • Vasculitis

Efficacy and safety of perindopril/indapamide/amlodipine single-pill combination in essential hypertension (ESC 2023) - "Perindopril/Indapamide/Amlodipine SPC is as effective and safe as the free combination in hypertensive patients uncontrolled with dual therapy of Perindopril/Indapamide. The uptitration to higher dosages of the triple-drug SPC provided additional benefit on BP lowering and BP control without increasing pill burden."

Clinical • Cardiovascular • Hypertension • Hypotension

In the prevention of dementia, the focus should be on early and consistent treatment of hypertension. (PubMed, Vnitr Lek) - "To achieve rapid and effective hypertension control, a combination of antihypertensive drugs is usually required. Using a fixed-dose triple combination of perindopril, indapamide, and amlodipine, blood pressure targets of < 130/80 mm Hg can be achieved within three months in 93 % of patients."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Dementia • Hypertension

Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under Fasting Conditions (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Pharmtechnology LLC

New P1 trial

Vascular stiffness parameters as additional criteria for the effectiveness of antihypertensive therapy when switching from free combinations to a fixed triple combination (HEART FAILURE 2023) - "Conclusions. Indicators of vascular stiffness, together with target BP figures, can serve as criteria for monitoring the quality of blood pressure and have been used to assess the effectiveness of antihypertensive therapy when switching patients to TFC amlodipine/indapamide/perindopril."

Cardiovascular • Hypertension

Efficacy and Safety of Perindopril 5 mg / Indapamide 1.25 mg / Amlodipine 5 mg Fixed Combination in Hypertension (clinicaltrials.gov) - P3 | N=532 | Completed | Sponsor: Institut de Recherches Internationales Servier

New P3 trial • Cardiovascular • Hypertension

Adherence to Triple Single-Pill Combination of Perindopril/Indapamide/Amlodipine: Findings from Real-World Analysis in Italy. (PubMed, Adv Ther) - "This real-world analysis showed that switching to a triple single-pill combination could offer an opportunity to improve adherence to antihypertensive treatment in real-life clinical practice."

Adherence • Journal • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Cardiovascular • Hypertension

TOPSPIN: Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India (clinicaltrials.gov) - P4 | N=1968 | Recruiting | Sponsor: Centre for Chronic Disease Control, India

New P4 trial • Cardiovascular • Hypertension

In Vitro Dissolution Profile of Antihypertensive Mixture: Comparison between Multivariate Methods and Statistical and Graphical Representation of Different Univariate Spectrophotometric Data. (PubMed, J AOAC Int) - "The study was the first in vitro dissolution profiling of Perindopril, Amlodipine, and Indapamide. The developed methods were of excellent green methods without compromising the analytical criteria."

Journal • Preclinical

Cost-Effectiveness of Single-Pill Combination Versus Free-Equivalent Combination in the Management of Hypertension (ISPOR-EU 2022) - "For treatment acquisition costs, we used the price of Triplixam®, a triple single-pill combination of perindopril, indapamide and amlodipine... SPC is cost-effective versus its FEC in the management of hypertension and prevention of MaCEs and CV deaths."

HEOR • Cardiovascular • Hypertension

PREDICTORS OF BISOPROLOL ON-TREATMENT STATUS AT THE TIME OF INCLUSION OF HYPERTENSIVE PATIENTS IN THE STUDY: POST-HOC ANALYSIS OF THE TRICOLOR STUDY. (PubMed, J Hypertens) - P=N/A | "In the post-hoc analysis of the TRICOLOR study, patients receiving bisoprolol in addition to SPC at BL had predominantly more severe HTN, with presence of concomitant cardiovascular disease."

Journal • Retrospective data • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Dyslipidemia • Heart Failure • Hypertension • Metabolic Disorders • Myocardial Infarction

BASELINE CHARACTERISTICS, ANTIHYPERTENSIVE EFFECTIVENESS, AND TREATMENT ADHERENCE IN HYPERTENSIVE PATIENTS DEPENDING ON AGE: POST-HOC ANALYSIS OF THE TRICOLOR STUDY. (PubMed, J Hypertens) - P=N/A | "Treatment with perindopril/indapamide/amlodipine SPC showed high antihypertensive effectiveness and significantly increased adherence in both age-stratified groups of patients, despite more severe and comorbid conditions observed in patients > = 65 y.o. comparing to those under 65 y.o."

Journal • Retrospective data • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Metabolic Disorders • Myocardial Infarction

VASCULAR STIFFNESS AS AN TARGET OF OPTIMAL ANTIHYPERTENSIVE THERAPY. (PubMed, J Hypertens) - "In patients with HTN and previous uneffective antihypertensive therapy the FTC amlodipine / indapamide / perindopril provided high antihypertensive effectiveness. Parameters of vascular stiffness can serve as criteria for quality control of blood pressure and can be used to assess the effectiveness of antihypertensive therapy."

Journal • Cardiovascular • Hypertension • Hypotension

Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Darnitsa Pharmaceutical Company

New P1 trial

Use of Perindopril Arginine/Indapamide/Amlodipine in the Management of Hypertension in Two Sub-Saharan African Island Countries of Madagascar and Mauritius. (PubMed, Adv Ther) - "Triple fixed-dose therapy of perindopril arginine/indapamide/amlodipine continues to show additional blood pressure-lowering capacity even months after initiating the treatment in patients with hypertension in Madagascar and Mauritius. It is also well tolerated by patients with hypertension and assessed as safe to use by physicians."

Journal • Hypertension

Efficacy of Single-Pill, Triple Antihypertensive Therapy in Patients with Uncontrolled Hypertension: A Systematic Review and Meta-analysis. (PubMed, High Blood Press Cardiovasc Prev) - "perindopril/indapamide/amlodipine is effective in reducing systolic and diastolic blood pressures by 24 and 12 mmHg respectively. Over 24 h, the combination reduced systolic and diastolic blood pressures by 14 and 7 mmHg respectively."

Journal • Retrospective data • Review • Hypertension • Pulmonary Arterial Hypertension