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	<title>Elder Drugs &#187; New Drugs</title>
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		<title>FDA Approves First Sleep Agent for Early Awakening: Intermezzo</title>
		<link>http://elderdrugs.com/2011/11/fda-approves-first-sleep-agent-for-early-awakening-intermezzo/</link>
		<comments>http://elderdrugs.com/2011/11/fda-approves-first-sleep-agent-for-early-awakening-intermezzo/#comments</comments>
		<pubDate>Sun, 27 Nov 2011 23:19:09 +0000</pubDate>
		<dc:creator>Alan Lukazewski</dc:creator>
				<category><![CDATA[Conditions]]></category>
		<category><![CDATA[FDA Alerts]]></category>
		<category><![CDATA[Insomnia]]></category>
		<category><![CDATA[New Drugs]]></category>
		<category><![CDATA[drug]]></category>
		<category><![CDATA[early awakening]]></category>
		<category><![CDATA[hypnotic]]></category>
		<category><![CDATA[sleep]]></category>

		<guid isPermaLink="false">http://elderdrugs.com/?p=1151</guid>
		<description><![CDATA[FDA just approved a new drug for early awakenings, called Intermezzo, a low-dose form of zolpidem, the active ingredient in Ambien and Ambien CR. In addition to the lower doses, each different for men and women, it is a sublingual tablet, or to be used under the tongue. The drug is intended to be used in the middle of the night, with at least 4 hours of sleep remaining, in those who have difficulty in getting back to sleep after an early awakening. The drug is NOT intended for routine use, as is any other hypnotic. Routine use of hypnotics is associated with daytime drowsiness, increased risk for falls, cognitive impairment and forms of amnesia. The dose for men is 3.5mg and the dose for women is 1.75mg, lower because women apparently metabolize zolpidem slower than men. Using a higher dose than 1.75mg in women may make the drug unsafe. Commonly reported side-effects are: headache, nausea and fatigue. As stated above, routine use of hypnotics is not recommended in older adults. for more information on how you can improve your sleep, go to the AgePages brochure at: http://www.nia.nih.gov/NR/rdonlyres/98A1060C-2151-4F9A-A558-964E3D2D4EFA/17898/GoodNightsSleep.pdf]]></description>
			<content:encoded><![CDATA[<p>FDA just approved a new drug for early awakenings, called Intermezzo, a low-dose form of zolpidem, the active ingredient in Ambien and Ambien CR. In addition to the lower doses, each different for men and women, it is a sublingual tablet, or to be used under the tongue. The drug is intended to be used in the middle of the night, with at least 4 hours of sleep remaining, in those who have difficulty in getting back to sleep after an early awakening. The drug is NOT intended for routine use, as is any other hypnotic. Routine use of hypnotics is associated with daytime drowsiness, increased risk for falls, cognitive impairment and forms of amnesia.</p>
<p>The dose for men is 3.5mg and the dose for women is 1.75mg, lower because women apparently metabolize zolpidem slower than men. Using a higher dose than 1.75mg in women may make the drug unsafe. Commonly reported side-effects are: headache, nausea and fatigue.</p>
<p>As stated above, routine use of hypnotics is not recommended in older adults. for more information on how you can improve your sleep, go to the AgePages brochure at: <a href="http://www.nia.nih.gov/NR/rdonlyres/98A1060C-2151-4F9A-A558-964E3D2D4EFA/17898/GoodNightsSleep.pdf">http://www.nia.nih.gov/NR/rdonlyres/98A1060C-2151-4F9A-A558-964E3D2D4EFA/17898/GoodNightsSleep.pdf</a></p>
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		<title>Xarelto (rivaroxaban): Newer, novel anticoagulant</title>
		<link>http://elderdrugs.com/2011/11/xarelto-rivaroxaban-newer-novel-anticoagulant/</link>
		<comments>http://elderdrugs.com/2011/11/xarelto-rivaroxaban-newer-novel-anticoagulant/#comments</comments>
		<pubDate>Sun, 06 Nov 2011 15:49:16 +0000</pubDate>
		<dc:creator>Alan Lukazewski</dc:creator>
				<category><![CDATA[New Drugs]]></category>
		<category><![CDATA[atrial fibrillation]]></category>
		<category><![CDATA[coumadin]]></category>
		<category><![CDATA[deep vein thrombosis]]></category>
		<category><![CDATA[enoxaparin]]></category>
		<category><![CDATA[Lovenox]]></category>
		<category><![CDATA[Pradaxa]]></category>
		<category><![CDATA[pulmonary embolism]]></category>
		<category><![CDATA[rivaroxaban]]></category>
		<category><![CDATA[warfarin]]></category>
		<category><![CDATA[Xarelto]]></category>

		<guid isPermaLink="false">http://elderdrugs.com/?p=1097</guid>
		<description><![CDATA[Xarelto (rivaroxaban) was recently approved for the prevention of blood clots (DVT and PE) after hip and knee replacement surgery. It is a useful alternative to Coumadin (warfarin) and other anticoagulants such as Lovenox (enoxaparin), Fragmin (daltaperin) or heparin. It works differently than Pradaxa (dabigatran), the most recently approved oral anticoagulant alternative to Coumadin (warfarin), and is taken only once a day. Similar to Pradaxa, no lab monitoring needs to be done in most circumstances. FDA recently added the approved indication for prevention of stroke in those with atrial fibrillation, an abnormal heart rhythm known to be a significant risk factor for stroke from blood clots. In one clinical trial, Xarelto was shown to be more effective at preventing clots than Lovenox (one less clot for every 62 people treated), yet had the same incidence of bleeding events, and at a much lower cost. The drug is more expensive than warfarin, even when you consider lab tests for warfarin monitoring, but far less expensive than Lovenox and others. However, in light of the new competition with Xarelto, the manufacturers of Lovenox reduced the wholesale acquisition cost (WAC) of Lovenox by 33%. We&#8217;ll soon see how the market settles out and how pricing changes drive market share. There are concerns with Xarelto, such as drug interactions (refer to product labeling), and need to use with caution, if at all, in people with significant renal (kidney) impairment, which means renal function tests must be performed. The drug should not be used in those with an estimated kidney function, as measured by creatinine clearance, (CrCl), of &#60;30ml/min, and should be used cautiously in those with CrCl between 30 and 49ml/min. Question: Can anyone define how to use the drug &#8220;cautiously&#8221;? How would I use the drug differently if renal function is somewhat impaired? I guess I&#8217;d want to look for the slightest signs of bleeding and perhaps monitor hemoglobin, an indicator that there is internal bleeding. However, with use in those with knee replacement being only 12 days of therapy, that&#8217;s probably not needed nor practical. However, in those who are using the drug post-hip replacement then hemoglobin may be appropriate, especially in those with a history of bleeding or the &#8220;old-old&#8221; (&#62;84y/o). That leads to another major concern: Since this drug is not innocuous we must use it with caution, and the use of Xarelto in those taking other drugs that can increase the risk for bleeding should be contraindicated (not used), such as NSAIDs, aspirin, Plavix (clopidogrel), and other drugs or drug regimens that suggest the older adult is at risk for bleeding. BE CAREFUL: What is shown in controlled, pre-market studies is far different than what is seen in the post-marketing, medically complex, frail elder population.  A wise older physician shed light on that subject when Pradaxa was first approved, in that he approached the drug with caution citing the vascular frailty experienced by older adults and their tendency to bleed much easier. He took a &#8220;wait and see&#8221; attitude, and I tend to agree. If the drug is not a block-buster, game-changing drug that will greatly impact on survival then there isn&#8217;t any reason to rush into its use in a population that is at high risk for harm. Note: This is NOT a complete review of Xarelto but only a brief review. Please consult your physician or submit a question to Ask A Pharmacist for more specific information. Here is a link to the product labeling guide: http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100]]></description>
			<content:encoded><![CDATA[<p>Xarelto (rivaroxaban) was recently approved for the prevention of blood clots (DVT and PE) after hip and knee replacement surgery. It is a useful alternative to Coumadin (warfarin) and other anticoagulants such as Lovenox (enoxaparin), Fragmin (daltaperin) or heparin. It works differently than Pradaxa (dabigatran), the most recently approved oral anticoagulant alternative to Coumadin (warfarin), and is taken only once a day. Similar to Pradaxa, no lab monitoring needs to be done in most circumstances. FDA recently added the approved indication for prevention of stroke in those with atrial fibrillation, an abnormal heart rhythm known to be a significant risk factor for stroke from blood clots.</p>
<p>In one clinical trial, Xarelto was shown to be more effective at preventing clots than Lovenox (one less clot for every 62 people treated), yet had the same incidence of bleeding events, and at a much lower cost. The drug is more expensive than warfarin, even when you consider lab tests for warfarin monitoring, but far less expensive than Lovenox and others. However, in light of the new competition with Xarelto, the manufacturers of Lovenox reduced the wholesale acquisition cost (WAC) of Lovenox by 33%. We&#8217;ll soon see how the market settles out and how pricing changes drive market share.</p>
<p>There are concerns with Xarelto, such as drug interactions (refer to product labeling), and need to use with caution, if at all, in people with significant renal (kidney) impairment, which means renal function tests must be performed. The drug should not be used in those with an estimated kidney function, as measured by creatinine clearance, (CrCl), of &lt;30ml/min, and should be used cautiously in those with CrCl between 30 and 49ml/min. Question: Can anyone define how to use the drug &#8220;cautiously&#8221;? How would I use the drug differently if renal function is somewhat impaired? I guess I&#8217;d want to look for the slightest signs of bleeding and perhaps monitor hemoglobin, an indicator that there is internal bleeding. However, with use in those with knee replacement being only 12 days of therapy, that&#8217;s probably not needed nor practical. However, in those who are using the drug post-hip replacement then hemoglobin may be appropriate, especially in those with a history of bleeding or the &#8220;old-old&#8221; (&gt;84y/o). That leads to another major concern: Since this drug is not innocuous we must use it with caution, and the use of Xarelto in those taking other drugs that can increase the risk for bleeding should be contraindicated (not used), such as NSAIDs, aspirin, Plavix (clopidogrel), and other drugs or drug regimens that suggest the older adult is at risk for bleeding. BE CAREFUL: What is shown in controlled, pre-market studies is far different than what is seen in the post-marketing, medically complex, frail elder population.  A wise older physician shed light on that subject when Pradaxa was first approved, in that he approached the drug with caution citing the vascular frailty experienced by older adults and their tendency to bleed much easier. He took a &#8220;wait and see&#8221; attitude, and I tend to agree. If the drug is not a block-buster, game-changing drug that will greatly impact on survival then there isn&#8217;t any reason to rush into its use in a population that is at high risk for harm.</p>
<p>Note: This is NOT a complete review of Xarelto but only a brief review. Please consult your physician or submit a question to Ask A Pharmacist for more specific information. Here is a link to the product labeling guide: <a href="http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100">http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100</a></p>
]]></content:encoded>
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		<title>Prolia (denosumab): Another Option For Those At High Risk For Fracture</title>
		<link>http://elderdrugs.com/2011/10/prolia-denosumab-another-option-for-those-at-high-risk-for-fracture/</link>
		<comments>http://elderdrugs.com/2011/10/prolia-denosumab-another-option-for-those-at-high-risk-for-fracture/#comments</comments>
		<pubDate>Tue, 11 Oct 2011 01:10:29 +0000</pubDate>
		<dc:creator>Alan Lukazewski</dc:creator>
				<category><![CDATA[Adverse Drug Events]]></category>
		<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Falls]]></category>
		<category><![CDATA[New Drugs]]></category>
		<category><![CDATA[Osteoporosis]]></category>
		<category><![CDATA[Syndromes]]></category>
		<category><![CDATA[bone health drugs]]></category>
		<category><![CDATA[denosumab]]></category>
		<category><![CDATA[Prolia]]></category>

		<guid isPermaLink="false">http://elderdrugs.com/?p=1005</guid>
		<description><![CDATA[So far in the arsenal of bone health drugs used to treat osteoporosis we have, Evista (raloxifene); bisphosphonates such as Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), and Reclast (zoledronic acid); Forteo (teripartatide); and Miacalcin (calcitonin). All have their established efficacy and their associated adverse effects. Evista is not that effective and causes hot flashes and has the risk for thromboembolism. Forteo is effective at increasing bone density and reducing fracture risk, but use is limited to two years. The bisphosphonates carry the largest amount of controversy with them, those being: osteonecrosis of the jaw; renal failure with IV administration of Reclast; and atypical fractures of the femur. There are also concerns with use beyond 5 years, not knowing if the drugs are safe and still yet effective. Miacalcin (calcitonin) is not as effective as the bisphosphonates but has minimal side-effects and can be useful as an adjunct in those with back pain from vertebral crush fractures. Now I will be the first one to state that we rely too heavily upon the use of drugs to reduce the risk of a fracture, and the most effective fracture risk-reduction strategy, especially in the old-old population, is fall risk-reduction (fall prevention). The approach needs to be multi-factorial, looking at a comprehensive assessment for fall risk factors, and engaging the person to address those risk factors, whether they be poor balance, medications, home safety issues, leg weakness, etc. But for those with high-fracture risk due to low bone density, where drug treatment is justified, along with the multi-factorial approach to reducing fall risk, there is now Prolia. Prolia (denosumab) is a monoclonal antibody which is very effective at increasing bone density, at least as effective as bisphosphonates and Forteo. It is easily administered by a subcutaneous injection (fatty tissue under the skin) twice a year. Many of the side-effects seen with bisphosphonates are not there, and the complexity of taking an orally administered bisphosphonate clearly disappears with an injection. The drug-drug interaction between proton pump inhibitors, e.g. Prilosec and others, is non-existent, which otherwise render bisphosphonates ineffective. It also doesn&#8217;t have the risk for renal failure, as is seen with Reclast injection. There are some data that suggest eczema and serious skin infections may occur, and more needs to be known about that. However, Prolia has been on the market, for other uses and other names for about 8 years. So the safety data are quite well established. For those that have very low bone density, and are at high fall and fracture risk, Prolia just might be a very reasonable alternative, to combine with an effective fall prevention strategy.]]></description>
			<content:encoded><![CDATA[<p>So far in the arsenal of bone health drugs used to treat osteoporosis we have, Evista (raloxifene); bisphosphonates such as Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), and Reclast (zoledronic acid); Forteo (teripartatide); and Miacalcin (calcitonin). All have their established efficacy and their associated adverse effects. Evista is not that effective and causes hot flashes and has the risk for thromboembolism. Forteo is effective at increasing bone density and reducing fracture risk, but use is limited to two years. The bisphosphonates carry the largest amount of controversy with them, those being: osteonecrosis of the jaw; renal failure with IV administration of Reclast; and atypical fractures of the femur. There are also concerns with use beyond 5 years, not knowing if the drugs are safe and still yet effective. Miacalcin (calcitonin) is not as effective as the bisphosphonates but has minimal side-effects and can be useful as an adjunct in those with back pain from vertebral crush fractures. Now I will be the first one to state that we rely too heavily upon the use of drugs to reduce the risk of a fracture, and the most effective fracture risk-reduction strategy, especially in the old-old population, is fall risk-reduction (fall prevention). The approach needs to be multi-factorial, looking at a comprehensive assessment for fall risk factors, and engaging the person to address those risk factors, whether they be poor balance, medications, home safety issues, leg weakness, etc. But for those with high-fracture risk due to low bone density, where drug treatment is justified, along with the multi-factorial approach to reducing fall risk, there is now Prolia.</p>
<p>Prolia (denosumab) is a monoclonal antibody which is very effective at increasing bone density, at least as effective as bisphosphonates and Forteo. It is easily administered by a subcutaneous injection (fatty tissue under the skin) twice a year. Many of the side-effects seen with bisphosphonates are not there, and the complexity of taking an orally administered bisphosphonate clearly disappears with an injection. The drug-drug interaction between proton pump inhibitors, e.g. Prilosec and others, is non-existent, which otherwise render bisphosphonates ineffective. It also doesn&#8217;t have the risk for renal failure, as is seen with Reclast injection. There are some data that suggest eczema and serious skin infections may occur, and more needs to be known about that. However, Prolia has been on the market, for other uses and other names for about 8 years. So the safety data are quite well established. For those that have very low bone density, and are at high fall and fracture risk, Prolia just might be a very reasonable alternative, to combine with an effective fall prevention strategy.</p>
]]></content:encoded>
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