A large-scale clinical trial comparing the ARB valsartan with the same ARB plus HCTZ revealed unexpected findings and raised new questions. The ARB/HCTZ combination lowered BP successfully but significantly increased the inflammatory marker hsCRP Professor Paul Ridker, MD, MPH, study author of the Val-MARC trial (POzlsartan: Managing BP Aggressively and Evaluating deductions in hsCRP) from Brigham and Women’s Hospital in Boston, had earlier shown that hsCRP interacts with elevated BP to increase cardiovascular risk, predicting incident hypertension, heart attacks, and strokes in normotensive individuals. Angiotensin II is also known to be a potent pro-inflammatory mediator, and ARBs have been reported to reduce hsCRP. However, he commented that biomarkers are a “difficult story,” particularly when it comes to “figuring out what is clinically useful.”
Aliskiren (Rasilez, Novartis), a direct renin inhibitor and the first in a new class of antihypertensive drugs to be introduced in a decade, has been submitted for approval by the Food and Drug Administration (FDA). In clinical trials presented at the American Society of Hypertension’s Annual Scientific Meeting and Exposition (ASH 2006), aliskiren provided uninterrupted blood pressure (BP) control over 24 hours in combination with hydrochlorothiazide (HCTZ), a diuretic. This year’s meeting took place from May 16 to May 20, 2006.
MULTIPLE SCLEROSIS SYMPOSIUM
Long-term efficacy data for glatiramer acetate (Copaxone, Teva Pharmaceuticals), which is indicated for patients with multiple sclerosis (MS), constituted a centerpiece among two days of presentations at the Fifth Teva and Sanofi-Aventis International Symposium on MS. Several hundred interested professionals attended the meeting, which took place from May 12-14, in Tenerife, Spain.
Our study showed baseline differences among the non-hypertensive and hypertensive AAASPS enrollees. Specifically, the non-hypertensive African American enrollees were more likely to be current cigarette smokers and have higher education, and less likely to have old CT/MRI-based infarcts. On the other hand, hypertensive AAASPS enrollees, in addition to having htn, were more likely to have other metabolic risk factors such as diabetes and trends for history of hypercholesterolemia, and other factors such as angina pectoris and history of prior stroke. The constellation of metabolic abnormalities that include dyslipidemia, glucose intolerance and htn may cluster in individuals and families and is known as Syndrome X. Syndrome X predicts cardiovascular disease risk and may also include such factors as hyperuricemia, impaired fibrinolysis and small dense LDL particles. Prevention and treatment of some of the risk factors that compromise Syndrome X reduce the risk of a first stroke.
Demographic and Factors (Table 1)
The mean age of hypertensive and non-hypertensive patients was 62.3 ± 10.4 and 59.1 ± 12.5 years (p=0.064), respectively. Women comprised 54% of the hypertensive and 41% of the non-hypertensive patients (p=0.030). The mean education of hypertensives was 11.1 ±3.1 compared to 11.7 ± 2.9 of non-hypertensives (p=0.024). A history of diabetes was identified in 41% and 25% of patients with and without htn, respectively (p=0.007). 41% of the hypertensives were classified as having a history of hypercholesterolemia compared to 32% of non-hypertensives (p=0.19). Of the 1012 patients identified as having htn, 11% had suffered a previous myocardial infarction compared to 8% of non-hypertensives (p=0.51); 13% of hypertensives compared with 7% of non-hypertensives had angina pectoris (p=0.13); 6% vs. 1% had a diagnosis of congestive heart failure (p=0.18); 2% vs. 0% had a history of atrial fibrillation (p=0.62); 2% vs. 4% had valvular heart disease (p=0.23) and 5% vs. 5% had leg claudication (p=0.77); 4% of hypertensives vs. 3% of non-hypertensives had previous cardiac surgery (p=0.74); and 1% vs. 0% had previous carotid endarterectomy (p=1.00). Peripheral arterial vascular surgery and thoracic or abdominal surgery was noted among 2% vs. 0% and 3% vs. 1% of hypertensive and non-hypertensive patients, respectively (p=0.39, 1.00). Some 37% of hypertensive vs. 41% of non-hypertensive patients exercised at least two times per week and enough to work up a sweat (p=0.49), and 41% vs. 38% had a family history of stroke (p=0.32).
MRI-based Infarcts and CT-based Infarcts
MRI and CT scans were reviewed by AAASPS local principal investigators and/or local radiolo gists for evidence, location and size of recent and old cerebral infarctions. MRI and CT results were classified according to TOAST criteria.
Demographics and Cardiovascular Factors
The database for this analysis was the AAASPS. AAASPS is an ongoing NIH-spon-sored, multi-center, randomized, double-blind clinical trial designed to compare the effect of ticlopidine and aspirin in the prevention of recurrent stroke, myocardial infarction, and vascular death in AAs with recent, noncardioembolic ischemic stroke. Eligibility criteria for the study have been reviewed previously in the AAASPS clinical trial design paper. All enrollees identified themselves as being African American. In brief, these were African American non-car-dioembolic ischemic stroke patients entered from seven to ninety days of the onset stroke. At baseline, age, sex and income level were ascertained. In addition, past medical history of the following risk factors was ascertained: htn, diabetes mellitus, hypercholesterolemia, myocardial infarction, angina pectoris, congestive heart failure, atrial fibrillation, valvular heart disease, leg claudication, cardiac surgery, carotid endarterectomy, peripheral arterial vascular surgery and thoracic or abdominal aortic surgery.
Hypertension was defined as the history of hypertension requiring treatment by diet and/or medications, or either systolic or diastolic blood pressure elevated to > 139/89 mmHg. It was defined as a random (non-fasting) plasma glucose > 200 mg/dl (> 11.1 mmol/1), fasting venous or capillary whole blood glucose > 119 mg/dl (> 6.7 mmol/1), venous plasma glucose > 139 mg/dl (> 7.8 mmol/1) or a history of diabetes mellitus requiring treatment with diet, oral hypoglycemic or insulin. Hypercholesterolemia was defined as the history of hypercholesterolemia requiring treatment with diet and/or medication or fasting plasma cholesterol > 200 mg/dl.