Multifactorial Treatment Is Essential For Type 1 and Type 2 Diabetic Patients With Cardiovascular Disease
Diabetes is an epidemic, but promising medications are in the pipeline.
Patients with type 1 or type 2 diabetes need multifactorial management, said Michael E. Farkouh, MD, MSc, director of the Mount Sinai Heart Clinical Trials Unit.
According to Farkouh, diabetes has reached epidemic proportions in this country. Diabetic cardiovascular patients are different from those without diabetes and need to be treated accordingly, he said. They may have hyperlipidemia, inflammatory challenges, accelerated atherosclerosis and worse clinical outcomes than other cardiac patients.
Initial trials
The BARI trial, which evaluated patients with coronary disease who were initially revascularized by coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty, found no statistical difference between the two treatments among the entire cohort of patients, but a subset of diabetes patients fared better with CABG.
Moving into the stent era, Farkouh said the ARTS-1 trial illustrated that patients receiving stents had a mortality rate 1.6 times lower than those in the surgery group, findings that warrant further study.
Discussing the SIRIUS and TAXUS-IV trials, Farkouh said there was a 70% reduction in target lesion revascularization among diabetic patients with drug-eluting stents compared with controls. In the DIABETES trial, which specifically evaluated diabetes patients, there was a 26% reduction in the rate of major adverse cardiovascular events with drug-eluting stents vs. bare-metal stents, he said.
BARI 2D
The BARI 2D trial will use a 2 x 2 factorial design and will enroll 2,800 patients, randomizing them to elective revascularization with aggressive medical therapy or aggressive medical therapy alone, while simultaneously randomizing patients to an insulin-providing or an insulin-sensitizing strategy for glycemic control.
The goal of BARI 2D is for patients to reach the recommended target value for HbA1c of < 7.0%.
Farkouh said the data show that microvascular complications are reduced when HbA1c levels are below 7%, but macrovascular complications are not.
Drugs in development
Farkouh said there are a number of medications in the pipeline for cardiovascular patients with diabetes: vildagliptin (Galvus, Novartis), muraglitazar (Pargluva, Bristol Myers) and tesaglitazar (Galida, AstraZeneca). Sitagliptin (Januvia, Merck) was recently approved by the FDA; inhaled insulin (Exubera, Pfizer), protein kinase C inhibitors and cannabinoid-1 receptor antagonists will also make a difference in treatment.
Insulin treatment
Discussing how insulin-treated patients differ from non-insulin-treated patients, Farkouh said insulin-treated patients typically have higher HbA1c levels, are more often women, are more likely to have hypertension, and have to significantly longer lesions. However, insulin dependence should not influence revascularization strategy, according to Farkouh.
Multifactorial approach
Data from STENO-2 illustrate that intensive multifactorial intervention had a definite effect on reducing incidence of MI and death in patients with type 2 diabetes. Intensive treatment was associated with a 53% reduction in the composite primary outcome compared with usual care.
Farkouh concluded his presentation by stressing the importance of teamwork between interventional cardiologists and their colleagues in diabetes health care.