Tool Predicts Added Disease-Free Life With Drug Changes in Diabetes

Marlene Busko

September 27, 2017

LISBON, PORTUGAL — Researchers have developed a model to predict changes in years of life free of cardiovascular disease (CVD) if a patient with type 2 diabetes starts or intensifies lifelong preventive therapy with lipid-lowering agents, aspirin, or antihypertensives.

"With easy-to-measure patient characteristics, we can estimate 10-year CVD risk and CVD-free life expectancy for patients with type 2 diabetes," Gijs Berkelmans, MD, University Medical Center Utrecht, the Netherlands, said in an oral session at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting.

This tool, which has been validated in cohorts from Asia, Europe, North America, and Oceania, facilitates shared decision-making and can help guide preventive treatment.

In contrast, "the Framingham risk calculator was not developed in a population consisting only of patient with type 2 diabetes, and it only estimates 10-year CVD risk," Dr Berkelmans told Medscape Medical News in an email.

"Our developed algorithm is able to estimate median life expectancy free of CVD and the treatment effects of lifelong preventive treatment in years/months gained without CVD...for patients between 30 and 95," he added.

"These results were fairly impressive," Jeremy Sussman, MD, University of Michigan, Ann Arbor, who was not involved with the study, told Medscape Medical News. The study links Framingham-type scores with clinical actions to predict what drugs a patient might benefit from, he said.

"One major need of doctors and patients is a more rigorous way to know 'If I take this drug, is there a good chance it will help me?' " he noted. "This study goes a long way to align big data with clinical decisions."

Lowering CVD Risk in Diabetes

Patients with type 2 diabetes are at high risk of CVD, and clinicians can estimate 5- or 10-year risk, "but a patient usually lives longer than those 5 or 10 years, so we wanted to know what the extent of [preventive] therapy is throughout their complete lives and what they gain from therapy," explained Dr Berkelmans.

Thus, the researchers developed and validated a treatment decision-support tool to help guide lipid-lowering, blood-pressure, and aspirin treatment to lower CVD risk in patients with type 2 diabetes.

They identified 389,366 patients with type 2 diabetes who were part of the Swedish National Diabetes Registry from 2002 to 2012 and were free of cancer and had an estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2.

They developed the model using data from 75% of the patients (292,024 patients) and validated it in the remaining patients.

The model inputs are parameters that would be readily available from a patient visiting the clinic: gender, smoking status, systolic blood pressure, BMI, HbA1c, eGFR, non-HDL cholesterol, albuminuria, duration of type 2 diabetes, insulin treatment or not, and history of CVD, Dr Berkelmans noted.

The CVD events logged were myocardial infarction (MI), stroke, and vascular mortality.

The model was validated in patients in the Swedish registry and in patients with type 2 diabetes living in four parts of the world who were part of six large trials:

  • North America: ACCORD (10,242 patients), ADVANCE (433), ALLHAT (3865).

  • Western Europe: EPIC NL (522), SMART (1876), ADVANCE (2921), ASCOT (2354).

  • Eastern Europe: ADVANCE (2126).

  • Asia and Oceana: ADVANCE (5580).

Two Typical Patients

Dr Berkelmans described two patient scenarios to illustrate how the decision tool could be used.

The first patient was a 55-year-old man with systolic blood pressure 150 mm Hg, HDL cholesterol 1.0 mmol/L, LDL cholesterol 3.0 mmol/L, and total cholesterol 6.0 mmol/L, who was currently taking aspirin (since he had a history of CVD) and 10 mg of simvastatin daily but no ezetimibe.

The model estimated that his 10-year risk of CVD was 27.1% and he would have 71.5 years of CVD-free life.

"We wondered whether it was a good idea to intensify treatment for this patient" by treating him with simvastatin 40 mg plus ezetimibe and lowering his target systolic blood pressure from 150 mm Hg to 140 mm Hg, Dr Berkelmans explained.

The model showed that with this intensified treatment, the patient had a 9.9% reduction in his 10-year CVD risk, and his estimated CVD-free life was 76.9 years.

The 5.4-year difference (between 76.9 years and 71.5 years) means that "this patient can gain 5.4 years [of CVD-free life] if he is willing to get his medication for 21 years."

In the second example, a 65-year-old woman had a 3.7% 10-year risk of CVD and an estimated CVD-free life of 85.2 years.

"When we are also intensifying her lipid-lowering treatment and her blood-pressure targets, her 10-year CVD risk reduces by 1.4%, [and] her estimated CVD-free life is 85.7 years" — a gain of 0.5 years, if the patient is willing to take treatment for 20 years.

"These are the numbers that we can discuss with our patients [in deciding] whether or not to intensify treatment," said Dr Berkelmans.

In addition to these three preventive therapies (lipid-lowering agents, aspirin, antihypertensives), "of course smoking and losing weight are important lifestyle changes that still need to be considered in the prevention of CVD," he agreed.

The manuscript for the decision-support tool and algorithm is due to be published at the end of this year.

The "next step" said Dr Berkelmans "would be to incorporate the 'new' preventive treatments in type 2 diabetes patients such as SGLT2 inhibitors and GLP-1 agonists — agents from both drug classes have shown benefit on cardiovascular outcomes in large trials in diabetes patients at high vascular risk."

The authors have no relevant financial relationships.

European Association for the Study of Diabetes 2017 Annual Meeting. September 14, 2017, Lisbon, Portugal. Abstract 167

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