Drug Topics - November 5, 2007 - (Page 10)

10 DRUG TOPICS NOVEMBER 5, 2007 www.drugtopics.com Rx Care Another antihypertensive combo approved Kelly Dowhower Karpa, Ph.D., R.Ph. early 65% of hypertensive patients are uncontrolled on their current blood pressure medication, and most patients will require two or more drugs to reach their blood pressure goal. Consistent with the necessity of a polypharmacy approach to treatment of hypertension, a report released earlier this year by the market research firm Decision Resources found that more than half of physicians prefer two drugs combined in a single pill when prescribing medication for treatment of cardiovascular diseases. N demonstrated statistically significant mean reductions in blood pressure when compared with monotherapy. Maximal antihypertensive effects can be anticipated within two weeks of initiating Azor or increasing Azor doses. Azor is approved for use alone or as an add-on therapy for patients not adequately controlled on other antihypertensive agents, but it is not intended to be used as initial therapy. Tablets are available in four strengths (amlodipine/olmesartan medoxomil): 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg. Combination approach To meet the demand for the combination approach, Azor (amlodipine/olmesartan medoxomil, Daiichi Sankyo) was recently approved by the Food & Drug Administration as a once-daily oral tablet containing both a calciumchannel blocker and an angiotensin receptor blocker. As a calcium-channel blocker, amlodipine reduces total peripheral vascular resistance by preventing calcium entry into blood vessel walls. Olmesartan medoxomil keeps angiotensin II, a potent endogenous vasoconstrictor, from binding to its receptor. Together, the two medications relax blood vessels to lower blood pressure. In clinical trials, Azor 10/40 mg reduced systolic blood pressure an average of 30.1 mm Hg and diastolic pressure by an average of 19.0 mm Hg. In comparison with amlodipine 10 mg monotherapy, Azor 10/40 mg provided a 53% greater reduction in mean change of systolic blood pressure. Previous clinical trials using similar combination products (amlodipine/valsartan; Exforge; Novartis) have also Clinical studies During clinical studies only edema occurred in >3% of patients treated with Azor and more frequently than placebo (22.1% versus 12.3%); edema is a known dosedependent side effect of amlodipine. Significantly, African Americans (a population more likely to develop hypertension than any other racial or ethnic group) comprised 25% of the studied population, and the magnitude of blood pressure reduction was similar in both African Americans and non-African Americans. As with other drugs that contain angiotensin receptor blockers, Azor should be avoided during pregnancy due to the risk of injury and death to the developing fetus. Increases in serum creatinine or blood urea nitrogen can be anticipated in individuals with renal artery stenosis. In general, calcium-channel blockers should be used cautiously in patients with heart failure. Due to the risk of symptomatic hypotension, close medical supervision is suggested when initiating Azor in volume-depleted or sodium-depleted patients. Overall, no differences in safety or efficacy were observed between subjects ≥ 65 years of age and younger subjects. When asked how Azor will likely fit into current clinical practice, Amy Seybert, Pharm.D., assistant professor of pharmacy and therapeutics at University of Pittsburgh School of Pharmacy and clinical cardiology pharmacist, commented, “It depends on the physician and patient comfort level…. Start with samples and reevaluate the drug therapy at a later point in time.” She believes that the difficulty in attaining blood pressure goals is due to several things. “Patient unawareness, insurance coverage, and a disease that does not show any symptoms are all factors in treatment failure.” THE AUTHOR TIPS TO REMEMBER Azor Azor combines the calcium-channel blocker amlodipine with the angiotensin receptor blocker olmesartan medoxomil. Azor should not be used as initial therapy for treating hypertension. Tablets are available in four strengths (amlodipine/ olmesartan medoxomil): 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg. is a clinical writer based in the Philadelphia area. http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - November 5, 2007

Drug Topics - November 5, 2007 Contents Latebreakers Latebreakers in Depth Letters Rx Care Community Practice 150 Years of American Pharmacy Hospital Practice Pharmacists at Risk Government and Law High-Density Lipoprotein New Products Advertisers Index Classified Viewpoint

Drug Topics - November 5, 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.