Diabetes is a leading cause of death worldwide, partially because of its close association with cardiovascular (CV) conditions. Although US and EU regulators require drugs for type 2 diabetes to show CV safety, the methodology of CV outcome trials are not fool proof and could be improved, as demonstrated by some recent exceptions to the usual approach.
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Metformin is the standard of care for type 2 diabetes. Credit: Shutterstock.
CV disease is one of the most common causes of death and adverse events in type 2 diabetes patients. Credit: Shutterstock.
Metformin is the standard of care for type 2 diabetes. Credit: Shutterstock.
CV disease is one of the most common causes of death and adverse events in type 2 diabetes patients. Credit: Shutterstock.
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Diabetes remains among the world’s most serious and pervasive public health issues. According to the World Health Organisation, the population living with diabetes worldwide reached 422 million in 2014, the global prevalence among adults at 8.5%. In 2016, diabetes was the direct cause of 1.6 million deaths globally, but what is the diabetes and cardiovascular connection?
Almost 3.7 million people in the UK have been diagnosed with diabetes, according to Diabetes UK. This number is more than double the amount 20 years ago.
Prescriptions for diabetes were estimated by NHS Digital to cost NHS England more than £1bn a year; this represents an increase of more than £422m in the past decade and approximately one in 20 prescriptions written by GPs.
The recent NHS National Diabetes Audit report found that 500 people with diabetes die prematurely each week in England and Wales. Type 1 diabetes patients between the ages of 35 and 62 are three to four times more likely to die than those of the same age without the condition. For the same age range, type 2 diabetes patients are twice as likely to die prematurely.
To raise awareness of this prevalent disease, the International Diabetes Federation chose November as World Diabetes Month and designated 14 November as World Diabetes Day. The theme for this year’s World Diabetes Day is family and diabetes.
Understanding the connection between diabetes and CV conditions
There are two main types of diabetes: the most common is type 2 – according to Diabetes UK, it represents approximately 90% of cases. This type differs from type 1 in a variety of ways, including diagnosis later in life and treatment, but also it is closely associated with high blood pressure and cholesterol at diagnosis.
Having diabetes increases a patient’s risk of developing cardiovascular (CV) disease; the American Heart Association says adults with diabetes are between two and four times more likely to die from cardiovascular disease than adults without diabetes.
A 2017 study by many US government groups, including the National Centre for Chronic Disease Prevention and Health Promotion, the Centres for Disease Control and Prevention and the National Centre for Health Statistics, found that more than 60% of type 2 diabetes patients died from CV disease, and even more suffer from severe CV-associated complications.
This is because having high blood sugar levels means it sticks to red blood cells and begins to build up, which can block and damage vessels carrying blood to and from the heart.
There is also a positive association between hypertension and high cholesterol with insulin resistance.
As a result of the proven association between CV and diabetes, the US Food and Drug Administration (FDA) requires all new type 2 diabetes drugs to undergo CV outcome trials, which show that the drug demonstrates CV safety.
This was first enforced in 2008, but the regulator’s Endocrinologic and Metabolic Advisory Committee (EMDAC) voted in October to retain the rule regardless of the presence of a CV risk signal during development.
This decision was based upon testimony from experts in the field who spoke about benefits and drawbacks of CV outcomes trials.
The European Medicines Agency (EMA) has similar regulations in place. These originally came into effect in 2002 and were most recently updated in 2016.
Its guidance notes: "A new glucose-lowering agent should preferably show a neutral or beneficial effect on param...
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