Bystolic: New Hypertension Drug

"Recent studies show that about 65 percent of patients are falling to reduce their blood pressure to the acceptable range." 16 Hypertension or arterial hypertension refers to high blood pressure (HTN) in the arteries. 3 In the United States 72 million adults are affected by hypertension. 6 Arteries are vessels that carry blood from the heart to all tissues and organs of the body. Blood pressure reads systolic (arterial pressure of the heart during contraction of the left ventricle (lower two chambers of the heart 1) and diastolic pressure (Arterial pressure when the heart relaxes between beats. 2). When blood pressure is taken, the top number (high number) refers to systolic pressure and the bottom (lower number) number refers to diastolic pressure. 2 When systolic pressure is above 140 mmHG (milibar millimeter of mercury) and diastolic pressure is greater than 90 mmHg hypertension is present. Hypertension is either an essential (primary) referring to no specific medical cause or secondary as result of a medical condition, such as kidney disease or certain tumors. Hypertension increases the risk developing stroke, heart attack, heart, failure arterial aneurysm ("The bulge in a blood vessel can burst and lead to death at any time" 4) and chronic renal failure (Kidneys fail to function). 3

Symptoms common for high blood pressure include: Difficulty breathing, irregular heartbeat, severe headache, fatigue or confusion, vision problems, chest pain and blood in the urine. Approximately one-third of those who have high blood pressure have no symptoms or signs of hypertension. 5 Dr. Douglas C. Throckmorton Food and Drug Administration (FDA) deputy director of the Center for Drug Evaluation and Research said: "High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body." 7 People more likely to develop hypertension: Overweight or obese, lack of daily activity, smoking, African - Americans, women who take birth control pills, women who are pregnant, drinking excessive alcohol, eating to much fatty foods or food with too much salt. 5

Well, known types of medications that lower blood pressure are Beta blockers: Work by blocking the effects of the hormone epinephrine (adrenaline). "As a result, the heart beats more slowly with less force, thereby reducing blood pressure. Beta blockers also help blood vessels relax and open up to improve blood flow". Patients taking Beta blockers may experience (side effect): Fatigue, dizziness, cold hands, and weakness. Less known side effects include: Trouble sleeping, shortness of breath, loss of sex drive and slow heartbeat. 8

In December 2007, the FDA approved Mylan Incorporated, a new Beta blocker drug nebivolol (proposed brand name Bystolic). However, the approval was contingent upon improvements made in the manufacturing facility in Belgium, deficiencies were found. 9 In January 2008, Forest Laboratories plans to introduce Bystolic to the U.S market. In January 2006, Forest Laboratories licensed nebivolol from Mylan, and has responsibility for all sales, marketing, and future development programs. "In 2001, Nebivolol is already registered and successfully marketed in more than 50 other countries outside of North America for the treatment of hypertension." 9

The FDA approval for Bystolic based upon findings from four studies: More than 2,000 people recieved the medication.10 Clinical trial program examine the effects of Bystolic indicated a significant reduction in diastolic and systolic blood pressure. Also, Bystolic trial studies found low incidence of traditional Beta blocker side effects. Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine said: "These features will be attractive to both physicians and patients." 11 Bystolic medication is taken once daily. 15

Recommend patients taking Bystolic advised discontinuation of the beta blocker gradually over a period of one to two weeks, otherwise abrupt discontinuation may cause heart problems including severe exacerbation of angina (chest pain or discomfort occurs when the heart doesn't get a sufficient amount of blood and oxygen 12), occurrence of mycardial infarction (Myocardial Infarction or heart attack, occurs when the blood flow to the heart muscles stops or is reduced sufficiently for long enough to cause cell death." 13) and ventricular arrhythmias (Originating in the lower chamber of the heart or the ventricles an abnormal rapid heart rhythms or arrhythmias. 14). Also, drug maker of Bystolic recommends against combining the medication with other Beta blockers. 6

In 2013, Cowen & Company analyst Ian Sanderson expects Bystolic sales will range $650 million to $700 million with Mylan Incorporated getting 25 percent to 30 percent of royalty on sales. Also Mr. Sanderson cautious regarding initial sales of Bystolic, because hypertension drugs often get a slow start, as doctors are careful changing patients to new prescribed drugs.17

Additional information regarding Bystolic is available or prescribing information available by visiting website www. Bystolic.com or calling 1-800-678-1605. 6

References:

1.) Definition of Ventricle - http://www.medterms.com/script/main/art.asp?articlekey=5984

2.) Systolic and diastolic blood pressure - http://www.webmd.com/hw/health_guide_atoz/sts15325.asp

3) Hypertension - http://en.wikipedia.org/wiki/Hypertension

4.) Aneurysm - http://en.wikipedia.org/wiki/Aneurysm

5.) Hypertension: Blood Pressure Basics - http://www.webmd.com/hypertension-high-blood-pressure/guide/blood-pressure-basics

6.) Bystolic (TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension - http://money.cnn.com/news/newsfeeds/articles/prnewswire/NYTU03118122007-1.htm

7.) Bystolic Approved for High Blood Pressure - http://www.medicinenet.com/script/main/art.asp?articlekey=85921

8.) Beta blockers - http://www.mayoclinic.com/health/beta-blockers/HI00059

9.) Bystolic - http://www.drugs.com/nda/bystolic_071203.html

10.) Bystolic Approved for High Blood Pressure - http://www.medicinenet.com/script/main/art.asp?articlekey=85921

11.) Approved by the FDA for the Treatment of Hypertension - http://money.cnn.com/news/newsfeeds/articles/prnewswire/NYTU03118122007-1.htm

12.) What is Angina? - http://www.americanheart.org/presenter.jhtml?identifier=3007460

13.) Myocardial Infarction - http://www.reproline.jhu.edu/English/6read/6issues/6progress/prog46_b.htm