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  • American Heart Association Scientific Sessions

Heart AssociationExtended-Release Niacin/Statin Combination for Atherosclerotic Patients with Coronary Heart Disease

Speaker: Allen J. Taylor, MD, Director of Cardiovascular Research, Cardiology Service, Walter Reed Medical Center, Washington, DC

Results from the ARBITER-2 (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol) trial indicate that the combination of prescription extended-release (ER) niacin (Niaspan®, Kos) and statin therapy slows the progression of atherosclerosis in individuals with coronary heart disease (CHD) and moderately low high-density lipo-protein-cholesterol (HDL-C) by 68%, compared with statin monotherapy, as measured by plaque buildup in the carotid artery.

The ARBITER-2 trial enrolled 167 patients with known CHD and low HDL-C levels (below 45 mg/dl). All patients were already receiving treatment with statin monotherapy at the start of the trial, when they were randomly assigned to add either ER niacin tablets at a daily oral dose of 500 mg for 30 days (which was then increased to 1,000 mg/day for the rest of the 12-month study period) or a matched control. canada drugs online

There were no differences in cardiac risk factors or in the use of other cardiovascular medications between groups. Disease progression was measured by the change in carotid intima-media thickness (CIMT), a sanctioned marker in which a submillimeter increase in arterial wall thickness (i.e., plaque buildup) predicts an increased risk of heart disease.

A total of 149 patients completed the 12-month study period and were included in the primary endpoint analysis.

At 12 months of treatment, CIMT increased significantly, by 0.44 mm in the placebo group of patients, and remained unchanged in the patients taking ER niacin. Although the difference in CIMT between these two groups was not significant, a subgroup analysis showed that CIMT progression in patients without insulin resistance was significantly reduced in the ER niacin group compared with the placebo patients. In fact, placebo-treated patients experienced the greatest CIMT progression, regardless of insulin resistance status.

HDL-C levels rose significantly, by 21% in the ER niacin patients (from 39 to 47 mg/dl) but remained unchanged in the placebo group. Triglyceride levels decreased significantly in the ER niacin patients in contrast to the patients receiving statin monotherapy only, from 154 ± 82 mg/dl at the baseline evaluation to 134 ± 87 mg/dl at 12 months for ER niacin versus 172 ± 104 mg/dl at baseline to 164 ± 83 mg/dl at 12 months for placebo.

Furthermore, in a population in which all patients had CHD, clinical cardiovascular events declined by 60% among patients taking ER niacin compared with those on statin monotherapy, although this was not a specified endpoint. Clinical cardiovascular events occurred in three patients (3.8%) taking ER niacin versus seven patients (9.6%) taking placebo.

Telmisartan in Hypertensive Patients with the Metabolic Syndrome

Speaker: Giuseppe M. Rosano, MD, Cardiologist, San Raffaele Hospital, Rome, Italy

In a study of two well-known angiotensin II type-1 receptor blockers (ARBs), telmisartan (Micardis®, Boehringer Ingel-heim) improved glucose metabolism in patients with the metabolic syndrome and hypertension, and it significantly reduced 24-hour mean ambulatory blood pressure (BP) compared with losartan potassium (Cozaar®, Merck).

The glycemic effects of these two ARBs were compared in patients with the metabolic syndrome in a double-blind, parallel-group study. Forty patients with newly diagnosed arterial hypertension, metabolic syndrome, impaired glucose tolerance, insulin resistance, or type-2 diabetes were randomly assigned to receive telmisartan 80 mg daily or losartan 50 mg daily for three months. Patients were assessed at baseline and after three months of treatment for levels of glycosylated hemoglobin (HbA1c), ambulatory BP, and free plasma glucose and free plasma insulin levels. A homeostasis model (HOMA-1R) was used to measure insulin resistance. Patients also underwent an oral glucose tolerance test (OGTT) and were evaluated for the incidence and severity of adverse drug effects (ADEs).

Telmisartan significantly decreased free plasma glucose by 18%, free plasma insulin by 10%, insulin resistance by 26%, and HbA1c by 9%. Losartan did not have a meaningful effect on any of these parameters. Levels of glucose and insulin following the OGTT were also significantly reduced with telmisartan in comparison with losartan. silagra 100

After three months, although both ARBs reduced BP, telmi-sartan showed a significantly greater reduction in 24-hour mean systolic BP and diastolic BP. No significant correlation between a decrease in BP and a change in glucose or insulin levels was observed.

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