Saul Genuth, MD: Clinical Researcher and Leader in Developing Modern Diabetes Treatment

Jacobson, Alan M.; Nathan, David M.

doi:10.2337/dc14-1396

Cited by 2 publications

(1 citation statement)

References 25 publications

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“…The Committee also considered ethical issues. Saul Genuth (10) recommended "not to allow any participant in the trial to be…continuously above some ethically acceptable level that exposes them to microvascular risk...We can't let people go for four or five years with hemoglobin A1cs above…8% for sure" (7,8). Thirty years earlier, the Belmont Report concluded that risks to human subjects in biomedical research should be reduced to those necessary to achieve the research objective (11).…”

Section: Recommendations Of the Advisory Committeementioning

confidence: 99%

Cardiovascular outcome trials of diabetes drugs: lessons learned

Taylor

Leslie

2018

Journal of Clinical Investigation

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Diabetes mellitus is a risk factor for coronary heart disease, ischemic stroke, and peripheral arterial occlusion (macrovascular disease), as well as chronic kidney disease, neuropathy, and retinopathy (microvascular disease). Antihyperglycemic treatments reduce the risk of microvascular conditions, but their effect on macrovascular events is uncertain (1, 2). Years ago, the University Group Diabetes Program suggested that sulfonylureas and phenformin might increase the risk of major adverse cardiovascular events (3). After similar concerns were raised about two PPAR-γ agonists (4, 5), the FDA convened an Advisory Committee in 2008 to discuss how to evaluate the cardiovascular safety of diabetes drugs (6-8).

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Section: Recommendations Of the Advisory Committeementioning

confidence: 99%