Informing drug development in cardiovascular disease

Cardiovascular disease is the leading cause of death globally according to the WHO.  An estimated 17.7 million people died from cardiovascular disease in 2015.  This represents 31% of all global deaths.  Most cardiovascular diseases can be prevented by addressing behavioral risk factors such as tobacco use, unhealthy diet, obesity, physical inactivity, and harmful use of alcohol.  People with cardiovascular disease or who are at high risk due to the presence of one or more risk factors require management using medicines as appropriate. 

AdisInsight can help you keep up with the rapid pace of development in cardiovascular disease.  AdisInsight ( is an integrated database of profiles authored by Springer Nature editors sourced from publicly available information from journals, conferences, trial registries, media releases, company websites, and government filings about pharmaceutical development programs, clinical trial studies, and published individual case safety reports.  Information in AdisInsight is updated daily to keep you informed of the latest information impacting your research.


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Global Drug Pipeline

According to AdisInsight, the global drug pipeline for cardiovascular disease currently contains 4,959 unique drug programs that are either marketed, in regulatory approval, in clinical development, in preclinical development, or have been discontinued for the treatment of cardiovascular disease.

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A gap analysis of the global drug pipeline reveals a potential unmet medical need for the treatment of Giant Cell Arteritis.  Current treatment options are limited mostly consists of the administration of high doses of a corticosteroid drug such as prednisone.  There are 7 drug programs in late stage development to fill this need.  

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Tocilizumab, a drug for the treatment of Rheumatoid Arthritis originated by Chugai Pharmaceutical and Osaka University, leads the pack.  In May 2017, the US FDA approved Actemra® (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA). In July 2017, CHMP recommended approval of tocilizumab for Giant cell arteritis in European Union.  Below is an example of the AdisInsight drug profile for tocilizumab.

Global Clinical Trial Map

AdisInsight shows 10,115 clinical studies investigating pharmaceutical treatment of cardiovascular disease being conducted in 144 countries.  Some of these studies will be active in either the planning, recruitment, or administration stage while other will be inactive either completed or discontinued.  The clinical trial map shown below aggregates information across all trials researching cardiovascular disease to show where active clinical studies are taking place at a regional level.

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One of those clinical studies taking place in Austria, Belgium, Canada, Denmark, England, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Scotland, Spain, Sweden, United Kingdom, and USA is a phase III, multicenter, rRandomized, double-blind placebo-controlled study to assess the efficacy and safety of tocilizumab in subjects with giant cell arteritis. This trial sponsored by Roche is active and no longer recruiting subjects.  Results from this study were presented at the American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting and published in the New England Journal of Medicine.  The trial met the primary endpoint with a significant increase in the proportion of patients achieving sustained remission at one year (56% in the weekly treatment group [QW; p < 0.0001] and 53.1% in the bi-weekly treatment group [Q2W; p < 0.0001]) versus 14% in a six-month steroid taper regimen given alone. The secondary endpoint were also met with a significant increase in the proportion of patients achieving sustained remission at one year (56% [QW; p < 0.0001] and 53.1% [Q2W; p = 0.0002]) compared to 17.6% with a 12-month steroid taper regimen given alone.  The study also demonstrated that tocilizumab had a generally well tolerated adverse events (AEs) profile and the safety profile of the tocilizumab groups was generally consistent with the documented safety profile of tocilizumab in other indications. Incidence of AEs was similar in the 4 treatment arms. No deaths or new vision loss incidents were reported over the period of observation. Fewer patients reported serious adverse events in the tocilizumab weekly (15%) and biweekly groups (14.3%) than in the placebo combined with a 26-week steroid taper regimen (22%) and placebo combined with a 52-week steroid taper regimen groups (25.5%).  Below is an excerpt from the AdisInsight trial profile for this study.

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Organizations Active in Studying CD

According to AdisInsight there are 3,283 organizations involved in researching drug development programs for the treatment of cardiovascular disease.  The table below shows the top 15 organizations ranked according by the number of drug programs in development for cardiovascular disease. 

Many of these organizations use AdisInsight to inform their strategic decisions as they work to advance drug therapies for the treatment of cardiovascular disease.  Whether they are identifying unmet clinical needs, monitoring the therapy area landscape, researching innovative disease targets, or planning clinical trial programs, AdisInsight is making drug development more efficient. 

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Biomarkers for CD

Biomarker selection is becoming an essential part of clinical development. Successful use of biomarkers can accelerate the pace of development by predicting drug efficacy more quickly, identifying optima patient populations, and early detection of safety signals.   

AdisInsight catalogs 852 biomarkers associated with the drugs being studied to treat cardiovascular disease.  382 of biomarkers are being used as outcome measures, 223 are being used to detect safety issues, 222 are being used for patient inclusion, and 170 are being used for patient exclusion.  The top 15 biomarkers being used in cardiovascular disease drug research are shown below. 

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