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

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Cardiovascular Diseases

Inactive Indication

Acute myocardial infarctionST Elevation Myocardial Infarction

Originator Organization

Grupo Ferrer Internacional SA

Active Organization

Grupo Ferrer Internacional SA

Inactive Organization

Ferrer Internacional SA

License Organization-

Drug Highest PhaseApproved

First Approval Date

Mexico (01 Jan 2012),

Cardiovascular Diseases

Regulation-

Structure/Sequence

Molecular FormulaC9H8O4

InChIKeyBSYNRYMUTXBXSQ-UHFFFAOYSA-N

CAS Registry50-78-2

View All Structures (3)

Clinical Trials associated with Simvastatin/Ramipril/Aspirin

NCT06930885

/ Not yet recruitingPhase 3IIT

Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial

The EPOCA study (Evaluation of a POlypill and Colchicine for risk reduction in patients with established Atherosclerotic cardiovascular disease) will be a randomized, superiority, parallel, 2x2 factorial, multicenter clinical trial which will include at least 7713 and up to a maximum of 10797 participants with established atherosclerotic cardiovascular disease.

Start Date01 May 2025

Sponsor / Collaborator-

NCT02596126

/ CompletedPhase 3IIT

Secondary Prevention of Cardiovascular Disease in the Elderly Trial

The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

Start Date01 Jul 2016

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

[+6]

NCT02791958

/ Unknown statusPhase 2

Pharmacodynamic Equivalence Study of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular Fixed Dose Combination Pill AAR as Compared to Monotherapy With the Reference Products Altace® 10 mg and Lipitor® 40 mg

This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.

Start Date01 Mar 2016

Sponsor / Collaborator

Ferrer Internacional SA

100 Clinical Results associated with Simvastatin/Ramipril/Aspirin

100 Translational Medicine associated with Simvastatin/Ramipril/Aspirin

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

314

Literatures (Medical) associated with Simvastatin/Ramipril/Aspirin

01 May 2025·LANCET INFECTIOUS DISEASES

Albendazole–ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial

Article

Author: Bedane, Dereje ; Mwandawiro, Charles ; de Jesus, Áuria ; Messa, Augusto ; Gelaye, Woyneshet ; Kepha, Stella ; Algorta, Jaime ; Gandasegui, Javier ; Rono, Martin ; Mwahanje, Jusper ; Novela, Valdemiro ; Degarege, Dawit ; Mandomando, Inácio ; Enbiale, Wendemagegn ; Muñoz, José ; van Lieshout, Lisette ; Fleitas, Pedro E ; Krolewiecki, Alejandro

BACKGROUND:

Treatments for soil-transmitted helminthiases face challenges, especially in addressing Trichuris trichiura. Combination regimens, particularly of ivermectin and albendazole, are promising. We aimed to assess the safety, efficacy, and palatability of a combination tablet for the treatment of T trichiura, hookworm, and Strongyloides stercoralis infections among school-aged children in Ethiopia, Kenya, and Mozambique.

METHODS:

We conducted an adaptive phase 2/3, randomised, parallel-group, active-controlled, superiority trial in 15 schools in Ethiopia, Kenya, and Mozambique. Eligible participants for both phases were aged 5-18 years, weighed at least 15 kg, and were infected with T trichiura, hookworms, or S stercoralis. Participants were randomly assigned via a computer-generated sequence to either a single dose of a fixed-dose combination (FDC×1) of albendazole (400 mg) plus ivermectin (9 mg or 18 mg), three consecutive daily doses of an FDC (FDC×3) of albendazole (400 mg) plus ivermectin (9 mg or 18 mg), or a single dose of albendazole alone (400 mg) via block randomisation, stratified by soil-transmitted helminth species. Participants and those administering the treatments were not masked to treatment assignment, but those assessing the outcomes were masked. The primary outcome of phase 2 (conducted in Kenya only) was safety during the first 3 h after the intervention and for 7 days, and the primary outcome of phase 3 was efficacy (ie, the proportion of individuals cured at day 21 out of the total number infected at baseline) for T trichiura; both primary outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT05124691, and is terminated.

FINDINGS:

Between Jan 20, 2022, and March 24, 2023, 1001 participants were recruited (465 [46%] were female and 536 [54%] were male). 636 (64%) were infected with T trichiura, 360 (36%) with hookworm, and 104 (10%) with S stercoralis; 94 (9%) of 1001 participants had co-infections and were included in the analysis of each infecting species. A total of 243 participants were allocated to the albendazole group, 381 to the FDC×1 group, and 377 to the FDC×3 group. In both phase 2 and 3, gastrointestinal symptoms were the most common mild-to-moderate adverse events in the FDC groups, but resolved within 48 h without intervention. At least one treatment-related adverse event occurred in 34 (14%) of 243 participants in the albendazole group, 75 (20%) of 381 participants in the FDC×1 group, and 88 (23%) of 377 participants in the FDC×3 group. No serious adverse events occurred. For T trichiura, both FDC groups had a higher cure rate (97·2% [95% CI 95·2- 99·3] for FDC×3 and 82·9% [78·2-87·5] for FDC×1) than albendazole (35·9% [27·7-44·1]), with absolute differences of 61·3% (98% CI 50·2-71·2) and 47·0% (34·7-58·1), respectively. For hookworms, FDC×3 had a higher cure rate (95·0% [95% CI 91·1-98·9]) than albendazole (65·1% [56·0-74·2]), with absolute differences of 29·9% (98% CI 17·2-42·4), whereas FDC×1 had a similar cure rate (79·8% [72·8-86·9]) to albendazole. The sample size for efficacy evaluation of S stercoralis was not met.

INTERPRETATION:

An FDC of albendazole plus ivermectin has a similar safety profile but superior efficacy to albendazole alone against T trichiura infection and hookworms. These findings open opportunities for control of all soil-transmitted helminth species of interest, including potentially S stercoralis. Evaluation of safety in larger populations and implementation scenarios are the next steps for this innovation to promote its incorporation into programmatic activities.

FUNDING:

European and Developing Countries Clinical Trials Partnership.

TRANSLATION:

For the Portuguese translation of the abstract see Supplementary Materials section.

01 May 2025·LANCET

Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial

Article

Author: Davidson, Michael ; Kastelein, John ; Goldberg, Anne C ; Nicholls, Stephen J ; Hayden, Kierstyn ; Michos, Erin D ; Ditmarsch, Marc ; Stronczek, Amanda ; Mason, Denise ; Neild, Annie L ; Brennan, Danielle ; Tercek, Grace ; Sarraju, Ashish ; McGuire, Darren K ; Nissen, Steven E ; Kling, Douglas

BACKGROUND:

Reducing LDL cholesterol prevents atherosclerotic cardiovascular disease (ASCVD) events. The aim of this study was to evaluate the LDL cholesterol-lowering efficacy of a fixed-dose combination (FDC) of obicetrapib, a CETP inhibitor, and ezetimibe.

METHODS:

This randomised, double-blind trial across 48 US sites including hospitals, private and group practices, and independent research centres included participants at least 18 years old with pre-existing or high risk for ASVCD or heterozygous familial hypercholesterolaemia with LDL cholesterol concentrations of 1·8 mmol/L (70 mg/dL) or greater despite maximally tolerated lipid-lowering therapy excluding ezetimibe, or having statin intolerance. Participants were randomly assigned (1:1:1:1) to obicetrapib 10 mg plus ezetimibe 10 mg FDC, obicetrapib 10 mg monotherapy, ezetimibe 10 mg monotherapy, or placebo administered daily for 84 days. The co-primary endpoints in the intention-to-treat population were the percent LDL cholesterol changes in the FDC group compared with placebo, ezetimibe monotherapy, and obicetrapib monotherapy, and the placebo-adjusted change in the obicetrapib monotherapy group. The trial was prospectively registered (NCT06005597) and is completed.

FINDINGS:

Between March 4 and July 3, 2024, 407 participants were randomly assigned. The median age was 68·0 years (IQR 62·0-73·0) and 177 (43%) were female. Mean baseline LDL cholesterol was 2·4 mmol/L, 2·5 mmol/L, 2·6 mmol/L, and 2·5 mmol/L in the placebo (n=102), ezetimibe monotherapy (n=101), obicetrapib monotherapy (n=102), and FDC groups (n=102), respectively. At day 84, percent differences in LDL cholesterol reduction with the FDC were -48·6% (95% CI -58·3 to -38·9) versus placebo, -27·9% (-37·5 to -18·4) versus ezetimibe, and -16·8% (-26·4 to -7·1) versus obicetrapib. Obicetrapib monotherapy decreased LDL cholesterol by 31·9% (22·1 to 41·6) versus placebo. Adverse event rates were similar in the FDC (52 [51%] of 102), obicetrapib (55 [54%] of 102), and ezetimibe (54 [53%] of 101) groups and lowest with placebo (38 [37%] of 102). Serious adverse event rates were generally similar across FDC (three [3%] of 102), obicetrapib (six [6%] of 102), ezetimibe (seven [7%] of 101), and placebo (four [4%] of 102) groups. Deaths occurred in one [1%] of 102 participants with FDC, one [1%] of 102 with obicetrapib, one [1%] of 101 with ezetimibe, and none with placebo.

INTERPRETATION:

Combination therapy of obicetrapib and ezetimibe significantly reduced LDL cholesterol. This oral, single-pill therapy could improve LDL cholesterol management in patients with pre-existing or high risk for ASCVD.

FUNDING:

NewAmsterdam Pharma.

22 Apr 2025·JOURNAL OF MEDICAL MICROBIOLOGY

Targeted ‘knock out’ therapy with a combination antimicrobial regimen restores treatment options in the management of extensively drug-resistant carbapenemase-producing organisms

Article

Author: Donoghue, Orla ; McDermott, Sinead ; Ali, Saied

Introduction. Cefiderocol (FDC) and the combination of ceftazidime-avibactam and aztreonam (CZA+ATM) are emerging therapeutic options to combat carbapenemase-producing organisms (CPOs) that exhibit resistance due to multiple β-lactamases.Hypothesis/Gap Statement. Molecular diagnostics and specialized antimicrobial susceptibility testing (AST) are infrequently available in most clinical laboratories, and outputs from reference laboratories are not always timely. Practical methods must be explored to provide meaningful advice to treat infections due to CPOs in real time.Aim. To evaluate the in vitro efficacy of FDC and CZA+ATM against CPOs and to compare colistin (CST) MICs obtained locally with those from the reference laboratory.Methodology. CPOs isolated from 2017 to 2023 inclusive were retrieved. AST for FDC was performed using disc diffusion, CZA and ATM individually by E-tests and the E-test superposition method for the combination CZA+ATM. CST AST was performed locally using the VITEK2 system, and MICs were compared with those attained from the reference laboratory where manual broth microdilution is performed.Results. Fifty-eight CPOs were analysed. OXA-48 was the most frequently detected carbapenemase (37.9%, n=22). Co-existing β-lactamases of Ambler classes A and C were present for 79.3% of CPOs (n=46). Twenty-nine isolates (50%) were found to be susceptible to FDC. Fifty-seven isolates (98.3%) were susceptible to CST according to the VITEK2, compared to 44 of 47 tested isolates (93.6%) by the reference broth microdilution. Essential agreement was found to be 78.7%, and categorical agreement was 91.5% with one major error and three very major errors (VMEs) reported. CZA+ATM was tested against 26 CPOs, all of which harboured metallo-β-lactamases. Synergy was detected for all except one isolate where additivity was noted. Of the 32 isolates where combination therapy was not assessed, 29 (90.6%) possessed serine-β-lactamases and were susceptible to CZA monotherapy, whilst three (9.4%) possessed an isolated metallo-β-lactamase and were susceptible to ATM monotherapy.Conclusions. FDC appears to perform favourably against CPOs harbouring serine-β-lactamases, but not metallo-β-lactamases. The VITEK2 may provide presumptive categorical information for CST susceptibility, but MICs must be confirmed by broth microdilution as VMEs can lead to treatment failures. Moreover, our study confirms potent in vitro activity of CZA+ATM against CPOs expressing multiple β-lactamases.

News (Medical) associated with Simvastatin/Ramipril/Aspirin

27 Sep 2024

·www.businesswire.com

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid

MUNICH--( BUSINESS WIRE )--For EU media only Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study. 1 The study evaluated the real-world use of bempedoic acid, marketed as NILEMDO ® ▼ and its FDC with ezetimibe, NUSTENDI ® ▼, in patients with primary hypercholesterolaemia or mixed dyslipidaemia. The results, presented in Hamburg, Germany at DGK Hertztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. 1 Raised LDL-C is a key modifiable contributor to risk of major cardiovascular events, with studies showing that every 1 mmol/L reduction in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. 5,6 The German cohort of MILOS study comprising 973 patients from 125 sites in Germany, is one of the most comprehensive assessments of bempedoic acid in a real-world clinical setting to-date in Germany. 1 Patients were followed-up for two years, with LDL-C levels assessed at pre-treatment, one year (1Y) and two years (2Y). Overall, 638 of 973 patients (65.6%) completed 2Y follow up, with LDL-C values at pre-treatment, 1Y and 2Y available for 451 patients. In these 451 patients, a mean reduction of LDL-C levels from 3.1 mmol/L (121.4 mg/dL) at pre-treatment, to 2.0 mmol/L (77.2 mg/dL) was observed, representing an average relative reduction of 30.3% in the overall population. 1 Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. 1 The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively. 1 Overall, more than 80% of patients received bempedoic acid in combination with other LLTs at pre-treatment and 2Y, including statins and ezetimibe. The safety profile of bempedoic acid in this real-world population was assessed at 1Y and 2Y and was consistent with that observed in the CLEAR clinical trial programme. 2,3,4 “By significantly lowering LDL-C levels toward guideline goals, we are taking a vital step in reducing the risk of cardiovascular events, which can have a profound impact on a person’s long-term health and quality of life,” said Professor Ioanna Gouni-Berthold, University of Cologne, Center for Endocrinology, Diabetes, and Preventive Medicine and Executive Board Member of the International Atherosclerosis Society . “Cardiovascular disease remains Europe’s leading cause of death, yet the majority of premature CV events are preventable,” 7,8 said Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe GmbH . “ The findings from this cohort reinforce the benefit provided by bempedoic acid for reducing LDL-C levels. Our long-term goal is to empower the medical community with real-world insights to improve CVD prevention and, ultimately, improve patient care.” -ENDS- About MILOS MILOS (NCT04579367) is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia. The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe FDC. Patients in the German cohort were recruited from 125 sites between January 2021 and January 2022 and were followed up for 2 years after baseline measurements. 1 Change in LDL-C levels and the proportion of patients achieving LDL-C goal were assessed in patients at pre-treatment, 1Y and 2Y visits. Analyses were stratified by investigator-assessed CV risk, based on the ESC/EAS dyslipidaemia guidelines. 1 Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and the UK. 9 About Bempedoic Acid and its Fixed-Dose Combination with Ezetimibe Bempedoic acid (NILEMDO ® ) is a first-in-class, oral, once-daily treatment to lower cholesterol, and can be combined with other oral treatments to help lower cholesterol even further. 10 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver. 10 Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, which allows additional LDL-C lowering when added to statin or other LDL-C-lowering therapies. 11 Bempedoic acid is not activated in skeletal muscle. 10 Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 10 in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, 10 alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. 10 Bempedoic acid is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 10 in patients on a maximum tolerated dose of statin with or without ezetimibe or, 10 alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated. 10 The bempedoic acid / ezetimibe FDC (NUSTENDI ® ) combines two complementary ways of reducing cholesterol in a once-daily tablet. Bempedoic acid / ezetimibe FDC is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 12 in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, 12 alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. 12 Bempedoic acid / ezetimibe FDC is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 12 in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or, 12 in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with ezetimibe treatment or, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets. 12 Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and its FDC with ezetimibe (marketed as NILEMDO ® and NUSTENDI ® ) in the European Economic Area, UK, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit https://www.daiichi-sankyo.eu/ ▼ This medicinal product is subject to additional monitoring. References 1 DGK Hertztage 2024 Abstract. Real-world effectiveness and safety of bempedoic acid in Europe: final 2-year results from the MILOS German cohort. Gouni-Berthold, I et al. 2 Nissen SE, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med . 2023;388:1353–64 3 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019; 380:1022–32 4 Ballantyne CM, et al . Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol . 2020; 27(6): 593–603 5 Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet. 2010. 376(9753): 1670–1681 6 NHS England. Improving lipid management to reduce cardiovascular disease and save lives. Available at: https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year . Last accessed September 2024. 7 Eurostat. (2023) Causes of death statistics. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Causes_of_death_statistics#Major_causes_of_death_in_the_EU_in_2020 . Last accessed September 2024. 8 World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/#:~:text=An%20estimated%2080%25%20of%20cardiovascular,and%20“knowing%20your%20numbers ”. Last accessed September 2024 9 ClinicalTrials.gov. Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367#contacts-and-locations . Last accessed September 2024. 10 European Medicines Agency. Nilemdo – Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf . Last accessed September 2024. 11 Pinkosky, S.L., et al . Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun . 2016. 7: 13457. 12 European Medicines Agency. Nustendi –Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf . Last accessed September 2024 HQ/BIL/09/24/0001

Drug ApprovalClinical ResultAHAClinical StudyLicense out/in

26 Aug 2022

·www.biospace.com

The Polypill Reduces Cardiovascular Mortality by 33% in Patients Treated After Myocardial Infarction

MADRID--(BUSINESS WIRE)-- The polypill developed by the CNIC and Ferrer, which includes three drugs (aspirin, an angiotensin-converting enzyme (ACE) inhibitor, and a statin), is effective at preventing secondary adverse cardiovascular events in people who have previously had a heart attack. The polypill reduces mortality from cardiovascular causes in this population by 33%. This press release features multimedia. View the full release here: Dr. Valentín Fuster, principal investigator of the SECURE study, CNIC General Director, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital Credit: Jordi Bardajil This is the finding of the SECURE study, coordinated by the Spanish National Center for Cardiovascular Research (CNIC). The study results were presented today in a Hot Line session at the European Society of Cardiology meeting (ESC 2022) in Barcelona and are published in The New England Journal of Medicine (NEJM)1. Dr. Valentín Fuster, principal investigator of the SECURE study, CNIC General Director, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital, said “the results of the SECURE study show for the first time that the polypill achieves clinically relevant reductions in the recurrent cardiovascular events among people who have recovered from a previous heart attack”. SECURE included 2499 patients from 7 European countries (Spain, Italy, Germany, the Czech Republic, France, Poland, and Hungary) recovering after a myocardial infarction. The study participants were randomly assigned to receive standard therapy or the CNIC polypill*. The average age of the participants was 76 years, and 31% were women. The study population included 77.9% with hypertension, 57.4% with diabetes, and 51.3% with a history of tobacco smoking. The SECURE trial analyzed the incidence of four major cardiovascular events: death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, and emergency coronary revascularization (the restoration of blood flow through a blocked coronary artery). The study followed patients for an average of 3 years and produced conclusive results: patients taking the polypill had a 24% lower risk of these four events than patients taking the three drugs separately. The standout finding of the study is the effect of the polypill on the key outcome of cardiovascular related death, which showed a relative reduction of 33%, from 71 patients in the group receiving standard treatment to just 48 in the polypill group. The study also found that patients in the polypill group had a higher level of treatment adherence than those in the control group, thus confirming the findings of the earlier FOCUS2 study, also funded by the European Union. According to Oscar Pérez, Chief Marketing, Market Access and Business Development Officer at Ferrer, “the 33% reduction in cardiovascular mortality demonstrates the efficacy of treatment with Trinomia compared to standard treatment and it represents an important step in our mission to provide significant and differential value to people who suffer from serious health conditions”. The SECURE trial was funded by the European Union Horizon 2020 research and innovation program (trial identifier NCT02596126). Polypill Strategy in Secondary Cardiovascular Prevention Castellano JM, Fuster V et al. New England Journal of Medicine (NEJM). 2022 Aug. Castellano JM, Sanz G, Peñalvo JL, Bansilal S, Fernández-Ortiz A, Alvarez L et al. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82 * Trinomia®, Sincronium®, Iltria® contains aspirin (100 mg), the ACE inhibitor ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg).

100 Deals associated with Simvastatin/Ramipril/Aspirin

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KEGG	Wiki	ATC	Drug Bank
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Approved

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	Mexico	Grupo Ferrer Internacional SA	01 Jan 2012

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	Czechia	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	France	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	Germany	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	Hungary	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	Italy	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	Poland	Ferrer Internacional SA	01 Jul 2016
Acute myocardial infarction	Phase 3	Spain	Ferrer Internacional SA	01 Jul 2016
ST Elevation Myocardial Infarction	Phase 3	Argentina	Ferrer Internacional SA	01 Jan 2012
ST Elevation Myocardial Infarction	Phase 3	Brazil	Ferrer Internacional SA	01 Jan 2012
ST Elevation Myocardial Infarction	Phase 3	Italy	Ferrer Internacional SA	01 Jan 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02596126 (SECURE, CTgov)	Phase 3	Myocardial Infarction \| Acute myocardial infarction	2,499	Treatment Prevention for Secondary CV (Treatment Prevention for Secondary CV)	syehexafcy = oyuzwmeowp evtylqqnhx (icqwdlhiwh, qcupnrtgrk - cyjrqfhoqp) View more	-	23 May 2025
NCT02596126 (SECURE, CTgov)	Phase 3	Myocardial Infarction \| Acute myocardial infarction	2,499	Cardiovascular Polypill (Cardiovascular Polypill)	syehexafcy = buxrjfjdfg evtylqqnhx (icqwdlhiwh, qrcdrbqaps - mnnsolmegz) View more	-	23 May 2025
Pubmed \| Arch Med Res	Phase 4	-	1,193	CNIC-Ferrer polypill	qmyyriliiw(efphjxnppl) = jfupuykrrw sydqaxwiuv (arcggnniae ) View more	Positive	01 Jan 2019
NCT01004705 (CTgov)	Phase 2	Hyperlipoproteinemias	36	simvastatin	rszgwpeboz(cxqmitjneb) = jzfrcrgxpa tgbleklmbu (kyanhonatt, 32.597) View more	-	31 Aug 2012

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Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation