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The need for new clinical trials of old cardiovascular drugs

Nature Reviews Cardiology volume 20, pages 71–72 (2023)Cite this article

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While there is understandable excitement about the development of new cardiovascular drugs, an unmet and equally important need is to perform new clinical trials of old drugs, including to determine their longer-term effects and if and when they should be discontinued after years of use. New trials of old drugs can inform clinical practice and are much needed.

Most clinical practice guideline recommendations on important care decisions are not supported by evidence from large, randomized clinical trials1. Even when randomized trials have been performed in the past, many were conducted in the context of historical care, which makes it uncertain whether the original trial results are still relevant to current clinical practice, given evolving background therapy and changes in populations related to ageing, more comorbidities and higher levels of polypharmacy than in the historical trial populations. Moreover, the magnitude of previously demonstrated effects on safety and efficacy might not apply in contemporary clinical practice, given the improvements in pharmacological and invasive therapies and their favourable effect on prognosis. Given that most large, randomized trials are funded by industry, relatively few resources are directed to large trials of older, generic drugs. In addition, very few trials have asked the question of whether and when drugs can be stopped, which might be especially important in the context of polypharmacy and its negative effect on adherence to all drugs prescribed to a patient. Therefore, an unmet need exists for new, large, randomized trials of old cardiovascular drugs (Table 1).

Table 1 Examples of new trials of old cardiovascular drugs
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Authors and Affiliations

  1. Duke University School of Medicine, Durham, NC, USA

    Christopher B. Granger

  2. London School of Hygiene and Tropical Medicine, London, UK

    Stuart J. Pocock

  3. Mayo Clinic College of Medicine and Science, Rochester, MN, USA

    Bernard J. Gersh

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  1. Christopher B. Granger
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  2. Stuart J. Pocock
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  3. Bernard J. Gersh
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Correspondence to Christopher B. Granger.

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Competing interests

C.B.G. has received consulting fees from AbbVie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer Corporation, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cardionomics, CeleCor Therapeutics, Janssen Pharmaceutical, Medtronic, Merck, Novo Nordisk, Novartis Pharmaceutical Company, PLX Pharma, Pfizer and Philips. C.B.G. also has salary funded by Duke University grants sponsored by Boehringer Ingelheim, the Food and Drug Administration, Novartis Pharmaceutical Company and Philips. C.B.G. has equity in Tenac.io. The other authors declare no competing interests.

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Granger, C.B., Pocock, S.J. & Gersh, B.J. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol 20, 71–72 (2023). https://doi.org/10.1038/s41569-022-00819-1

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