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[Oral antidiabetic drugs. How to begin and combine without cardiovascular risk]
1Médico Diabetologista da APDP, Lisbon, Portugal. ruisduarte@mail.telepac.pt
Abstract:
Diabetes is recognized to be a major cardiovascular risk factor, and cardiocerebrovascular disease is the main cause of death of diabetic patients. Over the past decade, randomized controlled trials in type 2 diabetes have failed to demonstrate a clear association between glycemic control and a reduction in cardiovascular events and mortality, and have actually suggested that reducing glycemia to near normal levels may be harmful in some patients, increasing overall mortality. A meta-analysis showed that one of the most promising drugs for the treatment of hyperglycemia in type 2 diabetics, namely rosiglitazone, increases the incidence of ischemic cardiovascular events, and this led to the drug's suspension in Europe and drastically restricted it's use in the US. Consequently, over the recent years, any new drug for the treatment of hyperglycemia is obliged to present pre-clinical studies that prove it's cardiovascular safety, besides its efficacy, in order to receive approval by the regulatory authorities. Hence, the issue of how to treat type 2 diabetes in a cardiovascular safe manner is a current and very relevant concern.
Insights
Type 2 diabetes poses significant cardiovascular risks. New hyperglycemia drugs require cardiovascular safety data due to past drug concerns, making safe treatment a key concern.
Area of Science:
- Endocrinology and Metabolism
- Cardiovascular Medicine
- Pharmacology
Context:
- Diabetes mellitus is a major risk factor for cardiovascular disease (CVD), which is the leading cause of mortality in diabetic patients.
- Recent trials show glycemic control in type 2 diabetes does not consistently reduce cardiovascular events and may increase mortality.
- Concerns about cardiovascular safety have led to restrictions on drugs like rosiglitazone, highlighting the need for safer treatments.
Purpose:
- To address the critical need for cardiovascularly safe treatments for hyperglycemia in type 2 diabetes.
- To emphasize the regulatory requirement for pre-clinical cardiovascular safety data for new antidiabetic drugs.
- To underscore the ongoing challenge of managing type 2 diabetes while minimizing cardiovascular risk.
Summary:
- Randomized controlled trials have yielded inconclusive results regarding the cardiovascular benefits of glycemic control in type 2 diabetes.
- A meta-analysis revealed increased ischemic cardiovascular events associated with rosiglitazone, leading to regulatory actions.
- Current regulatory standards mandate rigorous cardiovascular safety assessments for all new hyperglycemia medications.
Impact:
- This highlights the urgent necessity for developing and approving antihyperglycemic agents with proven cardiovascular safety.
- Ensures that new diabetes medications prioritize patient well-being by mitigating cardiovascular risks.
- Advances the field of diabetes management by focusing on a dual approach of efficacy and safety.
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