Pharmacy and Therapeutics - January 2008 - (Page 11) NEW DRUGS NEW DRUG Nebivolol (Bystolic) For Hypertension The Food and Drug Administration (FDA) has approved a new beta blocker, nebivolol (Bystolic, Mylan Bertek and Forest), for patients with hypertension. The drug’s safety and efficacy were assessed in three randomized, doubleblind, multicenter, placebo-controlled trials that lasted for up to three months. A fourth placebo-controlled clinical trial demonstrated additional reductions of blood pressure when nebivolol was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. In total, more than 2,000 people received the drug during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers. (Source: FDA, December 17, 2007.) DRUG NEWS what they term the first use of a powerful technology called “two-dimensional electrophoresis” to study changes in different proteins present in two groups of patients with coronary artery disease, which is the underlying cause of most heart attacks. One group of patients was aspirin-sensitive, and the other had aspirin resistance. The researchers found increased levels of three proteins involved in the binding of vitamin D in the aspirin-resistant patients. They also described laboratory experiments in which those proteins could inhibit aspirin’s effects in preventing blood clots. The researchers concluded that the results might aid in developing more effective therapies for aspirin-resistant patients. (Source: J Proteome Res 2007;6[7]: 2481–2487.) hypertension when used alone or in combination with other antihypertensive agents. It is also indicated for the treatment of heart failure. (Source: Novartis, December 3, 2007.) Duloxetine (Cymbalta) For Maintenance Therapy Of Major Depressive Disorder Eli Lilly has announced the FDA’s approval of duloxetine HCl (Cymbalta) for the maintenance treatment of major depressive disorder (MDD) in adults 18 years of age and older. Treating the broad range of depression symptoms may minimize residual symptoms (e.g., anxiety, guilt) and delay relapse. The efficacy and safety of duloxetine for this indication were established in a double-blind, placebo-controlled clinical trial. Patients with major depression (n = 533) received 60 mg once daily. After 12 weeks, 278 patients entered the continuation phase and were randomly assigned to receive either duloxetine at the same dose or placebo for six months. The duloxetine patients experienced a longer time to relapse of depression than the placebo patients. A serotonin–norepinephrine reuptake inhibitor (SNRI), duloxetine, is also approved for the acute treatment of MDD, management of diabetic peripheral neuropathic pain, and treatment of generalized anxiety disorder, all in adults. (Sources: Eli Lilly, November 30, 2007; www.cymbalta.com.) NEW INDICATIONS Valsartan (Diovan) For Hypertension in Children Valsartan (Diovan, Novartis), an angiotensin-receptor blocker (ARB), has been approved by the FDA for the treatment of high blood pressure in children and adolescents six to 16 years of age. Hypertension has become a multigenerational health issue; 30% of adults in the U.S. are affected, and nearly 5% of children and adolescents may have this condition. Experts suggest that this increase among these younger age groups might be related to the growing pediatric obesity epidemic. The proportion of overweight children (6 to 11 years of age) increased from 13.8% to 16% between 1999 and 2004, and the proportion of overweight adolescents (12 to 19 years of age) rose from 14% to 18% during the same period. Valsar tan blocks a hormone that causes arteries to constrict. In adults, this drug is indicated for the treatment of Indomethacin (Indocin) Prevents Preterm Labor But May Harm Babies A drug commonly used to halt premature labor may be associated with brain damage and intestinal problems in premature babies. Sometimes, when a baby is not ready to breathe air on its own, the pregnant mother is given a tocolytic agent to stop labor and a steroid to help the baby’s lungs mature faster. After the steroid has been working for a couple of days, the tocolytic agent is stopped and the mother may give birth shortly afterward. A meta-analysis at the University of Rochester suggests an association between use of indomethacin (Indocin, Merck) and periventricular leukomalacia in the baby. The analysis also showed an association between indomethacin and necrotizing enterocolitis, especially for babies who were exposed to the drug within days of bir th. However, indo methacin before birth is not associated DRUG NEWS Better Treatments For Aspirin Resistance In a first-of-its-kind study, scientists from Madrid, Spain, have identified blood proteins that seem to be involved in aspirin resistance. People with aspirin resistance cannot reap the drug’s protection against heart disease and stroke. López-Farré and colleagues described Vol. 33 No. 1 • January 2008 • P&T® 11 http://www.cymbalta.com
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