Delving into the Latest Updates on Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Polycap, PolyPill, Polypill

+ [1]

Target

ACE x COX x HMG-CoA reductase x NCC x β1-adrenergic receptor

Mechanism

ACE inhibitors(Angiotensin-converting enzyme inhibitors), COX inhibitors(Cyclooxygenases inhibitors), HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication

Cardiovascular DiseasesStrokeCoronary Disease+ [2]

Inactive Indication-

Originator Organization

Cadila Pharmaceuticals Ltd.

Active Organization

Zydus Lifesciences Ltd.

Cadila Pharmaceuticals Ltd.

Inactive Organization

Tehran University of Medical Sciences

Drug Highest PhaseApproved

First Approval Date

IN (14 Jul 2009),

Coronary Disease

Regulation-

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Structure

Molecular FormulaC9H8O4

InChIKeyBSYNRYMUTXBXSQ-UHFFFAOYSA-N

CAS Registry50-78-2

View All Structures (5)

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.

Start Date01 Sep 2024

Sponsor / Collaborator

Northern California Institute for Research & Education

NCT03329599 / CompletedPhase 2IIT

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.

Start Date14 Feb 2019

Sponsor / Collaborator

Northern California Institute for Research & Education

NCT01646437 / CompletedPhase 3IIT

The International Polycap Study 3 (TIPS-3) is a Randomized Double-blind Placebo-controlled Trial for the Evaluation of a Polycap, Low Dose Aspirin and Vitamin D Supplementation in Primary Prevention

The randomized 2x2x2 factorial design placebo controlled trial will enroll 5000 participants (women 60 years or older and men 55 years or older) without known heart disease or prior stroke and without a clear indication or contraindication to any of the study medications. Eligible and consenting individuals will be randomized to receive either the active study medications or placebo (dummy pills) and will be monitored for an average of 5 years. The study will include people from at 10 countries, will be conducted by an international group of scientists and physicians and will be coordinated by the Population Health Research Institute at Hamilton Health Sciences.

Start Date01 Jun 2012

Sponsor / Collaborator

Population Health Research Institute

[+3]

100 Clinical Results associated with Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin

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100 Translational Medicine associated with Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin

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100 Patents (Medical) associated with Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin

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12

Literatures (Medical) associated with Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin

01 Nov 2022·International immunopharmacology

Protective and vaccine dose-sparing efficacy of Poly I:C-functionalized calcium phosphate nanoparticle adjuvants in inactivated influenza vaccination

Article

Author: Le, Chau Thuy Tien ; Ahn, So Yeon ; Jung, Jaehan ; Ko, Eun-Ju ; Lee, Jueun ; Lee, Dong-Ha

Adjuvants are required to increase the immunogenicity and efficacy of vaccination and enable vaccine dose sparing. Polyinosinic-polycytidylic acid (Poly I:C), a toll-like receptor 3 agonist, is a promising adjuvant candidate that can induce cell-mediated immune responses; however, it remains unlicensed owing to its low stability and toxicity. Calcium phosphate (CaP), a biocompatible and biodegradable nanoparticle, is widely used in biomedicine for stable and targeted drug delivery. In this study, we developed Poly I:C-functionalized CaP (Poly-CaP) and evaluated its vaccine adjuvant efficacy in vitro and in vivo. A half dose of Poly-CaP nanoparticles showed similar efficacy to a full dose of soluble Poly I:C in stimulating bone marrow-derived dendritic cells and macrophages to secrete proinflammatory cytokines and express their activation markers. Immunization with a half dose of inactivated influenza vaccine in the presence of Poly I:C or Poly-CaP adjuvants induced sufficient antigen-specific humoral responses after boost immunization. Immunization with Poly I:C, CaP, or Poly-CaP-adjuvanted with a half dose of influenza vaccine showed comparable protective efficacy against lethal virus infection, with lower weight loss and virus titer than a full dose of influenza vaccine. The Poly-CaP adjuvant was effective in stimulating antigen-specific CD4+ T cell proliferation in the lungs. Collectively, our results showed that the Poly-CaP adjuvant enhanced antigen-specific cell-mediated immunity and humoral immune responses with vaccine dose-sparing effects, suggesting its potential as a novel vaccine adjuvant candidate.

01 Dec 2018·TrialsQ4 · MEDICINE

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Q4 · MEDICINE

ArticleOA

Author: Voeks, Jennifer ; Ovbiagele, Bruce ; Sarfo-Kantanka, Osei ; Tagge, Raelle ; Obese, Vida ; Sarfo, Fred Stephen ; Sethi, Vipin ; Adamu, Sheila

BACKGROUND:

There is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA). Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges. We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC).

METHODS:

The Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is a phase 2, open-label, evaluator-blinded trial involving 120 Ghanaian recent-ischemic-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated 1:1 into either the intervention arm or UC. Patients in the intervention arm will receive Polycap DS® (containing aspirin, 100 mg; atenolol, 50 mg; ramipril, 5 mg; thiazide, 12.5 mg; simvastatin, 20 mg) taken as two capsules once daily. Patients in the UC will receive separate, individual secondary preventive medications prescribed at the physician's discretion. Both groups will be followed for 12 months to assess changes in carotid intimal thickness regression - a surrogate marker of atherosclerosis - as primary outcome measure. Secondary outcome measures include adherence to therapy, safety and tolerability, health-related quality of life, patient satisfaction, functional status, depression and cognitive dysfunction.

DISCUSSION:

An efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, parallel-group, randomized controlled trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in SSA.

TRIAL REGISTRATION:

ClinicalTrials.gov , ID: NCT03329599 . Registered on 11 February 2017.

01 Dec 2018·American heart journalQ2 · MEDICINE

The International Polycap Study-3 (TIPS-3): Design, baseline characteristics and challenges in conduct

Q2 · MEDICINE

Article

Author: Karen Yeates ; Habib Gamra ; Anwar Santoso ; Jessica Tyrwhitt ; Salim Yusuf ; Denis Xavier ; Peggy Gao ; Koon Teo ; Shamim Talukder ; Philip Joseph ; Patricio Lopez-Jaramillo ; Antonio L Dans ; Khalid Yusoff ; Paul Camacho Lopez ; Jackie Bosch ; Prem Pais

BACKGROUND:

It is hypothesized that in individuals without clinical cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction in CVD risk could be achieved using fixed dose combination (FDC) therapy (usually comprised of multiple blood-pressure agents and a statin [with or without aspirin]) in a single "polypill". However, the impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial.

METHODS:

TIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events.

RESULTS:

The study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk.

CONCLUSION:

Results of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.

100 Deals associated with Aspirin/Atenolol/Hydrochlorothiazide/Ramipril/Simvastatin

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	IN	Cadila Pharmaceuticals Ltd.	30 Jan 2014
Stroke	IN	Cadila Pharmaceuticals Ltd.	17 Jul 2009
Coronary Disease	IN	Cadila Pharmaceuticals Ltd.	14 Jul 2009
Coronary Artery Disease	-	Zydus Lifesciences Ltd.	-
Hypertension	-	Zydus Lifesciences Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01404078 (TIPSK, CTgov)	Not Applicable	Peripheral Vascular Diseases \| Diabetes Mellitus, Type 2 \| Ischemic stroke ... View more	518	statin+Polycap+aspirin (Two Doses of Low Strength Polycap)	kfwosjhkrx(ywmkyzhtum) = edfnoqswfz wpedqjihyw (ietevaftic, hfygnnowby - sgojfytaet) View more	-	01 Dec 2014
NCT01404078 (TIPSK, CTgov)	Not Applicable		518	Srength Polycap (One Dose of Low Srength Polycap)	kfwosjhkrx(ywmkyzhtum) = zqxonobmds wpedqjihyw (ietevaftic, gxbqbgwsrj - aapmcpwdoe) View more	-	01 Dec 2014
NCT00443794 (TIPS, Pubmed \| Lancet)	Phase 2	Cardiovascular Diseases	2,053	Polycap	pgezabtoow(yfmxaivlxn) = zearocvbpz hiwwhmuenb (lyonsarojk, 0.62 - 0.78)	-	18 Apr 2009