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PPIs may do more harm than good

Healthy volunteers taking a proton pump inhibitor (PPI) experienced heartburn, acid reflux, and indigestion-the very conditions PPIs are intended to treat. These study findings challenge the common practice of prescribing PPIs without a clear indication for using them. Doing so may cause rebound acid hypersecretion (RAHS) and create a genuine need for PPI therapy where none existed before.


In this study, 120 volunteers without gastrointestinal (GI) problems were randomly chosen to take 12 weeks of a placebo or 8 weeks of the PPI esomeprazole at 40 mg/day followed by 4 weeks of a placebo. Forty-four percent of those who took esomeprazole developed acid-related symptoms after stopping the drug, compared with 15% in the placebo group. The fact that symptoms developed after patients had stopped taking the drug indicates "unrecognized aspects of PPI withdrawal and supports the hypothesis that RAHS has clinical implications," researchers conclude. They didn't examine the response of patients taking a PPI as indicated for dyspepsia.


Source: Reimer C, Sondergaard B, Hilsted L, Bytzer P. Proton-pump inhibitor therapy induces acid-related symptoms in healthy volunteers after withdrawal of therapy. Gastroenterology. 2009;137(1):80-87.



One injection builds bones for two years

The FDA has approved a single dose of zoledronic acid 5 mg injection (Reclast) to prevent osteoporosis in postmenopausal women for 2 years. The approval was based on results of a study involving 581 postmenopausal women over age 45 with osteopenia (low bone mass), who were divided into three groups:


* One group received one dose of zoledronic acid at the beginning of the study and again at 1 year.


* A second group received the drug at the start of the study and a placebo at 1 year.


* The third group received a placebo at the start of the study and again at 1 year.



Researchers evaluated lumbar spine bone mineral densities 2 years after the start of the study. Women receiving just one injection of zoledronic acid at the beginning of the study benefited the most: Bone mineral density in the lumbar spine increased by 6.3% in women who were in the first 5 years of menopause and by 5.4% in women who'd entered menopause 5 or more years earlier.


The most common adverse reactions to the drug were transient postdose signs and symptoms, including fever and muscle pain. Most adverse reactions occurred within the first 3 days after a dose and resolved in 3 days. For more information, visit the FDA's Web site at http://www.fda.gov.



Keeping kids calm

Anxiety and emergence delirium-thrashing and other acute behavioral changes associated with emergence from anesthesia-are common in pediatric surgical patients. Giving adults oral melatonin before surgery can greatly reduce anxiety, but would it have the same benefit for children? To find out, researchers studied 148 children between ages 2 and 8 who were undergoing outpatient surgery under general anesthesia. Children were randomly selected to receive before surgery either melatonin (a nocturnal neurohormone secreted by the pineal gland, retina, and GI tract), or midazolam, a sedative used to relieve preoperative anxiety.


Researchers found that midazolam was better than melatonin at reducing anxiety at anesthesia induction, but melatonin was more effective at preventing emergence delirium.


Source: Kain ZN, MacLaren JE, Herrmann L, et al. Pre-operative melatonin and its effects on induction and emergence in children undergoing anesthesia and surgery. Anesthesiology. 2009;111(1):44-49.



Unique drug for atrial fibrillation approved

Described as a multichannel blocker, dronedarone (Multaq) affects calcium, potassium, and sodium channels and has antiadrenergic properties. Recently approved by the FDA, dronedarone is an antiarrhythmic drug indicated to treat patients with persistent or paroxysmal atrial fibrillation (AF) or atrial flutter who've had a recent episode of AF or atrial flutter and associated cardiovascular risk factors and who are in sinus rhythm or will be cardioverted. In a trial involving more than 4,600 patients, the drug reduced hospitalization for cardiovascular conditions or death from any cause by 24% when compared with placebo. Most of the benefit was attributed to reduced hospitalizations for atrial fibrillation.


Dronedarone is supplied as 400-mg oral tablets. The most common adverse reactions include diarrhea, nausea, abdominal pain, vomiting, and asthenia. It's contraindicated in patients with New York Heart Association (NYHA) Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. For more information, visit the FDA's Web site at http://www.fda.gov.