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NEW TREATMENT for HYPERTENSION Aliskiren (Tekturna), a New Antihypertensive and the First of a Class Called Renin Inhibitors, Ha

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NEW TREATMENT for HYPERTENSION Aliskiren (Tekturna), a New Antihypertensive and the First of a Class Called Renin Inhibitors, Ha Watch NEW TREATMENT FOR HYPERTENSION ing plasma volume, raise blood can occur when aliskiren is pressure by increasing peripheral administered to diabetic patients • Aliskiren, in a new class of anti- resistance and cardiac output. who are also taking an ACE hypertensive agents called renin Other classes of antihyperten- inhibitor (and rarely in other inhibitors, effectively treats mild- sives lower blood pressure by patients), and electrolytes and to-moderate hypertension. affecting the process of regula- renal function should be rou- • Once-daily dosing works alone or combined with other antihy- tion at later stages, but aliskiren tinely monitored in that popula- pertensives. directly inhibits the production tion. There have been rare • Aliskiren should not be used after of renin. The long-term effects of reports of angioedema of the the first trimester of pregnancy. reducing plasma levels of renin head and neck, including respi- are not yet known. ratory distress, in patients taking Treatment with other drugs aliskiren. This allergic reaction liskiren (Tekturna), a new that alter the renin–angiotensin– has been associated with other Aantihypertensive and the first aldosterone system is less effec- antihypertensive agents that of a class called renin inhibitors, tive in blacks than in whites and act on the renin–angiotensin– has been approved by the U.S. Asians, and the same is true for aldosterone system. Aliskerin’s Food and Drug Administration aliskiren. Like ACE inhibitors adverse gastrointestinal effects, (FDA) for the treatment of mild- and ARBs, aliskiren is in FDA such as diarrhea, are mostly mild to-moderate hypertension. pregnancy category D and and more common at higher In randomized, double-blind, should not be used in the second doses. Cough, comparable to placebo-controlled trials, aliskiren or third trimester because “drugs that induced by ACE inhibitors used alone once a day was effec- that act directly on the renin– but much less common, can tive within two weeks. Using it angiotensin system can cause fetal also occur in patients taking in combination with the diuretic and neonatal morbidity and aliskiren. hydrochlorothiazide was more death,” according to the FDA. U.S. Food and Drug Administration. FDA effective than using either drug Aliskiren is metabolized news: FDA approves new drug treatment for high blood pressure. 2007 Mar 6. http:// alone. When compared with through the cytochrome P-450 www.fda.gov/bbs/topics/NEWS/2007/ drugs in the antihypertensive class enzyme system, but it does not NEW01580.html; Novartis Pharmaceuticals of angiotensin-receptor blockers inhibit or induce any part of that Corp. Tekturna (aliskiren) tablets 150 mg and 300 mg. 2007 Feb. http://www.fda.gov/ (ARBs), aliskiren was at least as system. Some drugs alter the cder/foi/label/2007/021985lbl.pdf; Oh B-H, effective. But whether blood serum level of aliskiren: irbesar- et al. J Am Coll Cardiol 2007;49(11):1157- pressure can be further reduced tan (Avapro), one of the ARBs, 63; Gradman AH, et al. Circulation 2005; 111:1012-8. by using aliskiren in combination significantly reduces the peak with angiotensin-converting serum level of aliskiren, and enzyme (ACE) inhibitors or both atorvastatin (Lipitor), an TWO DRUGS OFF U.S. MARKET FOR β-blockers is not yet known. antilipidemic, and ketoconazole CARDIOVASCULAR RISKS While aliskiren does lower blood (Nizoral), an antifungal agent, sig- pressure, there is no evidence yet nificantly increase that level. In • Tegaserod maleate, used to that it lessens the morbidity or addition, aliskiren significantly treat irritable bowel syndrome, mortality associated with hyper- reduces the peak serum level of may increase the risk of myo- tension. the loop diuretic furosemide cardial infarction, stroke, and severe angina. Blood pressure is regulated by (Lasix). Changes in the dosage of • Pergolide, a dopamine agonist the renin–angiotensin–aldosterone aliskiren might be indicated in used to treat Parkinson disease, system. Renin, an enzyme pro- patients taking any of those drugs. increases the risk of damage to duced in the kidneys, sets in Aliskiren is usually well toler- heart valves. motion processes that, by increas- ated and hypotension is unlikely, ing vasoconstriction and circulat- although volume depletion result- ing from aggressive diuretic ther- n March, the U.S. Food and Diane S. Aschenbrenner is the course apy should be corrected before IDrug Administration (FDA) coordinator for undergraduate pharma- initiating therapy with aliskiren. If asked Novartis, the manufac- cology, Johns Hopkins University School hypotension does develop, an iv turer of tegaserod maleate of Nursing, Baltimore, MD. She also coordinates Drug Watch: dianea@son. infusion of normal saline solution (Zelnorm), to withdraw it from jhmi.edu. should be given. Hyperkalemia the U.S. market because it may 28 AJN M July 2007 M Vol. 107, No. 7 http://www.nursingcenter.com By Diane S. Aschenbrenner, MS, APRN,BC increase the risk of myocardial drawn from the market and NEW WARNINGS ABOUT TWO DRUG infarction, stroke, and unstable should help patients transition to CLASSES angina. Tegaserod is used for another therapy. short-term treatment of irritable The FDA also requested that • The labeling of all sedative– bowel syndrome with constipa- manufacturers of pergolide hypnotic drugs must now tion in women and for treatment (Permax), a dopamine agonist warn about possible anaphylaxis, of chronic idiopathic constipa- used along with levodopa and angioedema, and complex sleep-related behaviors. tion in patients younger than age carbidopa to manage Parkinson • The labeling of all erythropoiesis- 65. Prior to tegaserod’s approval disease, withdraw it from the stimulating agents, used to treat in 2002, clinical trials had U.S. market. Permax is made by anemia, must warn about revealed a slight and not statisti- Valeant Pharmaceuticals, and increased risks of cardiovascular cally significant increase in the Par and Teva manufacture events and tumor progression. incidence of angina in patients generic versions. The FDA’s taking it. However, in February, request came after new studies he U.S. Food and Drug Novartis submitted to the FDA a associated pergolide with a TAdministration (FDA) has metaanalysis of 29 clinical trials higher risk of regurgitation at requested that changes be made that showed a slightly but statis- the mitral, tricuspid, and aortic to warnings on the labels of tically significant higher risk, in valves of the heart, the symp- drugs in two classes. comparison with placebo, of car- toms of which include shortness First, as the result of case diovascular effects associated of breath, fatigue, and heart pal- reports submitted to the FDA’s with its use. Thirteen patients pitations. In 2006 a black box MedWatch program, the packag- (0.1% of those receiving warning was added to the prod- ing of all sedative–hypnotic tegaserod) experienced serious uct labeling for pergolide to alert drugs now must warn about the and life-threatening events: four clinicians and patients to the possibility of anaphylaxis and had a heart attack (one fatal), mounting evidence of valve dam- angioedema occurring as early as six had severe angina, and three age with its use, and recently with the first dose. The labeling had a stroke. In the placebo published studies confirm the must also warn that patients may group, only one patient had association. engage in activities while asleep, symptoms indicative of a stroke, Pergolide therapy should not such as driving, preparing and but they resolved spontaneously. be discontinued abruptly. Instead, eating food, and making tele- Novartis noted in its official the dosage should be tapered. phone calls, and then not recall statement that the 13 patients Patients who still require treat- the activity upon awakening. The who experienced cardiovascular ment with a dopamine agonist FDA has also directed the manu- events had existing cardiovascu- should be switched—using a pub- facturers to develop a patient lar disease or risk factors and lished transition regimen—to one medication guide that will be dis- that the incidence of cardiovas- of the several others available pensed with each prescription to cular events associated with that do not damage valves. The advise consumers of the drugs’ tegaserod “corresponds approxi- FDA, working with the manufac- possible adverse effects. The mately” with the incidence in turers, may institute a program to drugs involved include Ambien the general population. The allow patients who have not been and Ambien CR (zolpidem), FDA plans to meet to review able to successfully change to Butisol (butabarbital), Carbrital tegaserod’s risks and benefits and another drug therapy to continue (pentobarbital and carbromal), also has offered to work with taking pergolide. Dalmane (flurazepam), Doral Novartis to create a program that U.S. Food and Drug Administration. FDA (quazepam), Halcion (triazolam), will allow patients who have no public health advisory: tegaserod maleate Lunesta (eszopiclone), Placidyl other treatment options to con- (marketed as Zelnorm). 2007 Mar 30. http:// (ethchlorvynol), ProSom (estazo- www.fda.gov/cder/drug/advisory/tegaserod. tinue using the drug if it is deter- htm; Novartis. Media release: Novartis sus- lam), Restoril (temazepam), mined that the benefits would be pends US marketing and sales of Zelnorm in Rozerem (ramelteon), Seconal greater than the risks. However, response to request from FDA. 2007 Mar 30. (secobarbital), and Sonata (zale- http://cws.huginonline.com/N/134323/PR/ any plan for a limited reintroduc- 200703/1116336_5_2.html; U.S. Food and plon). The FDA does not state tion of tegaserod to the market Drug Administration. FDA news: FDA whether case reports involving announces voluntary withdrawal of pergolide would first be discussed at a products. 2007 Mar 29. http://www.fda.gov/ each of the drugs were received. “public advisory committee meet- bbs/topics/news/2007/new01596.html; U.S. The labeling of the erythro- ing.” Nurses caring for patients Food and Drug Administration. FDA public poietic agents epoetin alfa health advisory: pergolide (marketed as who take tegaserod should be Permax).
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