APONTIS PHARMA: SECURE study and START study add-on analysis confirm superior efficacy of Single Pill
 

• SECURE study and START study add-on analysis results presented at European Society of Cardiology Congress (ESC) in Barcelona
• Single Pill made up of ASA, Atorvastatin, and Ramipril led to a 24% relative reduction in cardiovascular events (MACE) and a 33% relative reduction in cardiovascular death among post-myocardial infarction patients
• SECURE study published in the New England Journal of Medicine (NEJM)
• START study add-on analysis: Single Pill concept significantly superior to identical loose combinations in all event rates

Monheim am Rhein, 1 September 2022. APONTIS PHARMA AG (ticker / ISIN ), a leading pharmaceutical company specializing in Single Pills in the German market, continues to work successfully on the dissemination of the Single Pill therapy concept. The prospective SECURE study, presented at the European Congress of Cardiology (26–29 August, Barcelona) by Prof. Valentin Fuster (among others General Director of the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, and Physician-in-Chief at Mount Sinai Medical Center, New York) and funded by the European Union, proves the efficiency of the Single Pill. The SECURE study and its results were published in the prestigious concurrent with its presentation at the Congress.

In this randomized phase 3 study that was supported by a grant from the European Union Horizon 2020 research and innovation program, 2,499 patients from 113 centers in seven countries including Germany with a myocardial infarction suffered within the previous six months, were prospectively assigned for up to 48 months to receive either Single Pill therapy with the active ingredients ASA, Atorvastatin and Ramipril, treatment with a loose, substance-matched tablet combination or usual standard therapy of comparable drug groups. Here, Single Pill therapy had a 24% relative risk reduction in cardiovascular events (primary combined endpoint) and a 33% relative risk reduction in median cardiovascular-related mortality after three years. Specifically, Single Pill therapy resulted in a significantly lower risk of serious adverse cardiovascular events than usual care within six months of myocardial infarction. Clinical study leader J. M. Castellano (Spain) assesses this study as a game-changer: “The single pill Ramipril/Atorvastatin/ASS (Iltria®) must now be seen as a new molecule in the secondary prevention of cardiovascular disease!”

Additional analysis to START study shows lower all-cause mortality

Prof. Dr. Burkhard Weisser (Kiel, Germany) presented the results of the add-on analysis to the START study conducted in Germany. In the study, data from more than 50,000 people medically insured at a large German health insurance company were analyzed to determine whether fewer events occur in cardiovascular patients when a combination of substances is given as a single pill than when the individual substances are given identically. As a result, significantly fewer myocardial infarction, stroke, transient ischemic attack, coronary heart disease, heart failure, and acute and chronic kidney disease were observed when patients were treated with Single Pills. In addition, patients in the Single Pill group were incident-free longer. Overall, this group had lower gestational mortality. The results were seen by the audience as an important advance in knowledge and as proof that Single Pills ensure higher adherence on the part of the patients.

“The results were even better than expected. The effect was stronger than in most landmark studies of recent years for new cardiovascular medications,” commented Prof. Dr. Burkhard Weisser from Kiel University.

“SECURE and START are the proof of principle of the Single Pill concept in a prospective study. These results must clearly influence our therapeutic actions in the future,” concluded Prof. Dr. Georg Predel (Cologne, Germany) on the practical consequence of these results.

“We are meeting with strong interest from the research community with our Single Pill therapy concept. The results of the SECURE study, which have now been published, clearly support and extend the findings of a further evaluation of the START study, which also attracted a great deal of attention at the ESC in Barcelona. Our goal is and remains to provide patients with Single Pills with an efficient therapy and to save lives. That is why we want to establish Single Pills as the gold standard and exploit the full potential of the active ingredients through therapy simplification and substitution, as has been impressively demonstrated in the START and SECURE studies. This is what drives us; every day,” said Karlheinz Gast, Chief Executive Officer of APONTIS PHARMA AG.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pills in Germany. Single Pills combine two to three generic active ingredients in a single dosage form. APONTIS PHARMA develops, promotes and sells a broad portfolio of Single Pills and other pharmaceutical products, with a special focus on cardiovascular diseases. Since 2013, APONTIS PHARMA successfully launched several Single Pill products alone for cardiovascular indications such as hypertension, hyperlipidemia and secondary prevention. With its headquarters in Monheim am Rhein, APONTIS PHARMA is located in one of Europe's leading pharmaceutical and chemical region. From here, the company maintains a broad network with research-based pharmaceutical companies and a customer target group of approx. 23,000 physicians in Germany. For additional information about APONTIS PHARMA, please visit .

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