• Nationwide Drug Take-Back Program - September 27, 2014
• Hydrocodone Products to Get More Severe, Schedule II Classification
• FDA Approves New "Abuse-Deterrent" Oxycodone
• Growth Hormone Use in Childhood Linked to Hemorrhagic Stroke in Adulthood
• Probiotics May Help Reduce Blood Pressure
• Even Moderate Alcohol Intake Is Associated with Atrial Fibrillation
• Comparison of Cardiovascular Risk-Factor Burden in Low-, Middle-, and
High-Income Countries
• Self-Measurement of Pulse Can Help Identify Atrial Fibrillation in Stroke Patients
• Should Patients with Hypertension Be Treated Based on Blood Pressure or
Overall Cardiovascular Risk?
• Low Serum Vitamin D Level Is Associated with Excess Cardiovascular-Related Mortality
MM: Over the past several years the Nationwide Drug Take-Back Program has succeeded in preventing thousands of tons of medication from entering our landfills and water supply thereby protecting our children, ourselves and future generations. This is one of those programs that is truly cost effective and worthwhile. If you or anyone you know has old medications, whether expired or something that is simply no longer needed, consider taking it to one of these sites for destruction. There is no cost other than your time, effort and and for our future health.
Nationwide Drug Take-Back Program - September 27, 2014
Twice each year the DEA coordinates with local law enforcement to accept expired or otherwise unwanted medications of all sorts including controlled substances. This prevents these products from entering the land fill or our water supply and helps to deter drug diversion nationwide.
The following link provides local locations, times and other useful information related to these Drug Take Back Days.
http://www.awarerx.org/get-informed/find-disposal-information/option-2-dea-nationwide-drug-take-back-sites
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MM: At this point, it's my guess that most people affected by this very stringent change in availability of hydrocodone products are already aware of these changes that will go into effect at the beginning of October 2014. The crucial aspect of the new regulations are that not more than a 0ne (1) month supply may be dispensed at a time, prescriptions may no longer be phoned or faxed to a pharmacy unless the patient is in hospice care and there will no longer be refills available on a single prescription. All subsequent fills must have a new ORIGINAL prescription.
Hydrocodone Products to Get More Severe, Schedule II Classification
By Amy Orciari Herman
Combination hydrocodone products, currently considered Schedule III drugs, will be reclassified as Schedule II because of their high risk for abuse. The new regulation from the Drug Enforcement Administration will take effect in 45 days.
"Schedule II drugs ... are defined as drugs with a high potential for abuse, less abuse potential than Schedule I drugs, with use potentially leading to severe psychological or physical dependence," according to the DEA's definition. "These drugs are also considered dangerous."
The move means the drugs will be subject to tighter government regulations, including more stringent prescribing practices. The most commonly prescribed combination product affected by the ruling is hydrocodone plus acetaminophen (marketed as Vicodin or Lortab).
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-19922.pdf
http://www.justice.gov/dea/druginfo/ds.shtml
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MM: This is another step in trying to prevent recreational drug overdoses and drug diversion. Unfortunately, it will have little impact on the "drug parties" and their dangers as this product only deters the use of the product as an injection or for nasal use.
FDA Approves New "Abuse-Deterrent" Oxycodone
By Kristin J. Kelley, Edited by William E. Chavey, MD, MS
The FDA has approved a new abuse-deterrent treatment for severe pain — oxycodone hydrochloride and naloxone hydrochloride extended-release tablets marketed as Targiniq ER.
Approval was based on data from a clinical trial of some 600 patients with chronic low back pain, in addition to in vitro and in vivo abuse liability studies. Postmarketing studies will be done to assess the risks for abuse, addiction, hyperalgesia, and overdose with long-term use (over 12 weeks). Nausea and vomiting are the most common side effects.
The opioid analgesic deters abuse via injection and snorting, but it doesn't completely prevent it. Naloxone, which is used to treat opioid overdose, blocks the euphoric qualities of Targiniq ER when crushed. The drug can still be abused when taken orally.
Due to Targiniq ER's abuse potential, the FDA says, "it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management."
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406407.htm
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MM:A lot of young people have electively chosen to use HGH as a performance enhancer. The dangers of this product have generally been downplayed to youthful users. The increased risk of stroke in users where it is not medically necessary should be emphasized as a form of consumer education and perhaps this fear will act as some increased deterrent to its elective use in young people.
Growth Hormone Use in Childhood Linked to Hemorrhagic Stroke in Adulthood
By Christine Sadlowski Edited by Susan Sadoughi, MD
Use of growth hormone in childhood is associated with increased risk for stroke — particularly hemorrhagic stroke — later in life, a Neurology study shows.
Researchers analyzed stroke outcomes in almost 7000 adults in France who had received growth hormone as children between 1985 and 1996 for conditions associated with low morbidity and mortality, such as idiopathic isolated growth hormone deficiency and idiopathic short stature. During 2008-2010, strokes occurred significantly more often in the cohort (11 strokes total) than in healthy control groups in France (standardized incidence ratio, 2.2) and England (SIR, 5.3). Compared with both control groups combined, SIRs were 2.6 for hemorrhagic stroke and 4.6 for subarachnoid hemorrhage.
An editorialist concludes: "It may be prudent" for providers to consider this potential association "when determining 'net benefit' to the patient for [growth hormone] treatment. If the family and practitioner proceed with therapy, the family and patient should be counseled to be knowledgeable about signs and symptoms of, and the importance of seeking prompt treatment for, cerebrovascular disease."
http://www.neurology.org/content/early/2014/08/13/WNL.0000000000000737
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MM: Once again, we are what we eat and probiotics are certainly an edible. probiotics are safe, effective and reasonably priced but it is important to realize that their effects tend to be dose dependant. That is, to get benefits it is necessary to take a substantial dose. This may be assisted by also taking a prebiotic. Also known as "fast food for the friendly bacteria". Dr Kelly Karpa expounds on this synergistic approach in her wonderful book, Bacteria for Breakfast.
Probiotics May Help Reduce Blood Pressure
By Larry Husten, Edited by Jaye Elizabeth Hefner, MD
Consuming probiotics may modestly improve blood pressure, according to a meta-analysis in Hypertension.
Researchers analyzed data from nine randomized, controlled trials including some 540 participants. Overall, the probiotic arms had a 3.56-mm Hg reduction in systolic blood pressure and a 2.38-mm Hg reduction in diastolic BP, relative to controls. Larger reductions in blood pressure were observed in trials in which baseline blood pressure was at least 130/85 mm Hg, when treatment lasted at least 8 weeks, and when the daily dose of probiotics contained a larger number of colony-forming units.
The authors note that although the treatment effect was "modest ... even a small reduction of BP may have important public health benefits and cardiovascular consequences." They conclude that their findings "suggest that probiotics may be used as a potential supplement for future interventions to prevent hypertension or improve BP control."
http://hyper.ahajournals.org/content/early/2014/07/21/HYPERTENSIONAHA.114.03469
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MM: There seems to be great deal of controversy regarding Atrial Fibrillation, its risk factors, potential aggravants and likely outcomes. Limited or moderate alcohol consumption has been both demonized and lauded medically. Resveratrol contained in red wines has been proclaimed as one of the most beneficial and cost effective anti-oxidants available. In my opinion, it comes down once again to moderation. The studies that describe the increased risk of alcohol and A fib seem to be associated with greater consumption tends to lead to greater risk. For those with already diagnosed A fib, abstinence would appear to be the best recourse or the occasional single drink in a celebratory mode would likely be acceptable.
J Am Coll Cardiol 2014 Jul 22; 64:281.
Even Moderate Alcohol Intake Is Associated with Atrial Fibrillation
One to three drinks daily increased relative risk by roughly 10% to 20%.
Consuming large quantities of alcohol is linked to excess risk for atrial fibrillation (AF), but what about more moderate intake? To answer the question, Swedish researchers conducted a prospective cohort study and then performed a meta-analysis that included their study and six others.
In the Swedish study, relative risks for AF among participants whose weekly alcohol intakes were 1 to 6 drinks, 7 to 14 drinks, 15 to 21 drinks, and >21 drinks, were 1.01, 1.07, 1.14, and 1.39, respectively, compared with those who had <1 drink weekly. Results were similar even when binge drinkers (i.e., those who consumed ≥5 drinks on a single occasion) were excluded. In the meta-analysis of seven studies (>12,000 cases of AF), relative risks associated with daily alcohol intakes of 1, 2, 3, 4, and 5 drinks were 1.08, 1.17, 1.26, 1.36, and 1.47, respectively, compared with nondrinking.
Comment: This large meta-analysis not only confirms the association between risk for AF and high alcohol consumption, it also suggests that even moderate alcohol intake is associated with significantly higher risk. Moreover, the strong dose-response relation observed in this study suggests causality, although not all of the mechanisms by which alcohol begets AF are known. The elevated risk for AF associated with small to moderate amounts of alcohol should be balanced against the lower risk for ischemic heart disease that also is associated with mild to moderate alcohol intake
Citation(s): Larsson SC et al. Alcohol consumption and risk of atrial fibrillation: A prospective study and dose-response meta-analysis. J Am Coll Cardiol 2014 Jul 22; 64:281.
(http://dx.doi.org/10.1016/j.jacc.2014.03.048)
http://www.ncbi.nlm.nih.gov/pubmed/25034065?access_num=
25034065&link_type=MED&dopt=Abstract
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MM: This is somewhat confounding information. We seem to accept that situations of higher stress accompany higher income situations but perhaps we are mis-defining stress and stressors and their relative effects on health. The bottom line is that countries with better healthcare and emergency facilities lead to a greater survival rate for those who experience a CV accident.
N Engl J Med 2014 Aug 28; 371:818
Comparison of Cardiovascular Risk-Factor Burden in Low-, Middle-, and High-Income Countries
Paradoxically, risk factors were lowest but the incidence of cardiovascular events was highest in low-income countries.
The incidence of cardiovascular disease is increasing rapidly in low- and middle-income countries, with these countries accounting for an estimated 80% of the global burden. To understand the cardiovascular risk-factor burden worldwide, the PURE investigators studied cardiovascular risk-factor burden (according to INTERHEART risk score), incident cardiovascular disease, and death in more than 150,000 adult residents of 17 high-, middle-, and low-income countries.
The mean cardiovascular risk-factor burden was highest in high-income countries and lowest in low-income countries. Compared with urban areas, rural areas had higher risk-factor burden in high-income countries but lower burden in middle-income and low-income countries. For primary prevention, the use of antiplatelet drugs was highest in high-income countries and lowest in low-income countries. A similar pattern was observed for beta-blockers, renin-angiotensin system blockers, and statins. Overall and cardiovascular death rates were highest in low-income countries and lowest in high-income countries. Nonmajor cardiovascular events, in contrast, were higher in high-income countries. Among individuals with a cardiovascular event, death rates were highest in low-income countries.
Comment: The main finding in this study is paradoxical: In low-income countries, the risk-factor burden was lowest but the incidence of cardiovascular events was highest. The rate of death after a cardiovascular event was also highest in low-income countries. These results suggest that improved healthcare delivery and access to high-quality care in low- and middle-income countries could save many lives.
Citation(s): Yusuf S et al. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med 2014 Aug 28; 371:818.
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MM: Don't be afraid to take these simple self tests. It may take some repetition and a little practice but it may make the difference between a stroke and a high quality of life.
Self-Measurement of Pulse Can Help Identify Atrial Fibrillation in Stroke Patients
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Measurement of the peripheral pulse by stroke patients or their relatives can help distinguish paroxysmal atrial fibrillation (AF) from normal heart rhythm, according to a feasibility study in Neurology.
Over 200 patients hospitalized with acute cerebral ischemia, as well as some of their relatives, were instructed in pulse measurement and in differentiating between normal pulse sensation and suspected AF. Then, patients, relatives, and clinicians took pulse measurements while ECG (with the screen turned off) was performed as the gold standard for comparison.
Pulse measurements by clinicians had a sensitivity of 97% and specificity of 94% for detecting AF. Those performed by relatives were 77% sensitive and 93% specific, and those by competent patients were 54% sensitive and 96% specific. In all measurement scenarios, false-positive rates were low.
http://www.neurology.org/content/83/7/598
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MM: It makes a lot of sense to treat the patient rather than simply chasing the numbers. When we focus on the individual rather than looking at generalities, then it will inevitably lead to better health and care, not just healthcare!
Lancet 2014 Aug 16; 384:591
Should Patients with Hypertension Be Treated Based on Blood Pressure or Overall Cardiovascular Risk?
A meta-analysis of hypertension trials shows that overall CV risk is most important.
Recent guidelines for lipid management have urged that patients be treated based on overall cardiovascular (CV) risk rather than on lipid concentrations (NEJM JW Gen Med Nov 12 2013), largely because a 2012 meta-analysis of lipid trials showed that baseline CV risk was the major determinant of the absolute benefit of statin therapy (NEJM JW Gen Med Jun 12 2012). However, guidelines for managing hypertension continue to focus largely on achieving target blood pressures.
Researchers applied the methods of the 2012 meta-analysis to >50,000 patients in 11 hypertension trials in which major adverse CV events were reported; trials were either placebo controlled or comparisons between intensive and less-intensive regimens. Based on known risk factors and event rates in the placebo groups, participants were stratified into four risk groups with baseline 5-year CV risks of <11%, 11% to 15%, 15% to 21%, and >21%. During a median 4-year follow-up, relative risks for adverse CV events were about 15% lower in the intervention groups in all four risk strata. Consequently, absolute risk reduction was greater in the groups at higher baseline risk: The number needed to treat for 5 years to prevent 1 adverse CV event declined from 71 in the lowest-risk group to 51, 41, and 26 in successively higher-risk groups.
Comment: This study suggests that, to prevent the greatest number of CV events and maximize cost-effectiveness, antihypertensive treatment should be targeting patients at highest overall CV risk, not simply patients with the highest blood pressures. Antihypertensive treatment guidelines might need to be revised to place greater emphasis on overall CV risk assessment.
Citation(s): The Blood Pressure Lowering Treatment Trialists' Collaboration.Blood pressure-lowering treatment based on cardiovascular risk: A meta-analysis of individual patient data. Lancet 2014 Aug 16; 384:591.
(http://dx.doi.org/10.1016/S0140-6736(14)61212-5)
http://www.ncbi.nlm.nih.gov/pubmed/25131978?access_num=
25131978&link_type=MED&dopt=Abstract
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MM: Vitamin D3 has a beneficial effect on cell aging and especially on cells within the immune system, our bodies' policeman. This protective mechanism is especially effective on the heart and other CV tissue. For those adults with CV disease, I recommend 5000-10,000IU daily in an oral form with a blood target level of 60-80ng/ml. Especially in the form available at mark Drugs where Vitamin D3 is mixed into a probiotic matrix to enhance absorption and overall bio-availability. However, taking a supplement is simply not enough when it comes to D3. It is important to have your levels checked by a doctor or other healthcare professional.
BMJ 2014 Jun 17; 348:g3656
Low Serum Vitamin D Level Is Associated with Excess Cardiovascular-Related Mortality
Vitamin D levels were associated with cancer-related mortality only in patients with histories of cancer.
Evidence suggests an inverse relation exists between serum 25-hydroxyvitamin D (25[OH]D) level and mortality. In this meta-analysis of individual participant data from eight prospective European and U.S. studies, investigators determined whether 25(OH)D levels were associated with cardiovascular (CV)-related, cancer-related, and all-cause mortality in 26,000 older adults (age range, 50–79).During median follow-up ranging from 4 to 16 years, 6700 deaths occurred. All-cause mortality was 1.6-fold higher among participants in the lowest quintile of serum vitamin D levels than among those in the highest quintile. Results were similar for CV-related mortality in patients with and without known CV disease (risk ratios, 1.7 and 1.4, respectively) and for cancer-related mortality in patients with histories of cancer (RR, 1.7) but not in those without prior cancer. Analyses in which data were stratified by risk factors for vitamin D deficiency yielded similar results.
Comment: In this meta-analysis, low serum 25(OH)D levels were associated with excess all-cause and cardiovascular-related mortality, and with excess cancer-related mortality in patients with histories of cancer. However, given the study's design, reverse causality is possible (i.e., low serum vitamin D might be a marker for, rather than a cause of, poor health). Nonetheless, recent evidence suggests that vitamin D3 supplementation might prevent early mortality (NEJM JW Gen Med May 1 2014); randomized trials to explore this possibility are under way
Citation(s): Schottker B et al. Vitamin D and mortality: Meta-analysis of individual participant data from a large consortium of cohort studies from Europe and the United States. BMJ 2014 Jun 17; 348:g3656.
(http://dx.doi.org/10.1136/bmj.g3656)
http://www.bmj.com/content/348/bmj.g3656?ijkey=4664468bf7f1eb53fec
92426f0d4c0b43b2ddb02&keytype2=tf_ipsecsha
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