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Microsoft word - this just in july 11 revised.doc

Forecast for analgesia in the elderly: Cloudy with a chance of pain? Are PPIs gaining a reputation of being bad to the bone? Dabigatran Update: Move over warfarin… at least a bit. Findings from 2011Pharmacy Student family medicine projects ARE NSAIDs ACTUALLY SAFER THAN OPIOIDS IN THE ELDERLY? The use of NSAIDs in the elderly carries much concern due to negative effects on various systems, namely GI, renal, and cardiovascular. In the face of pain and immobility due to conditions such as arthritis, avoiding the use of these agents for safety reasons may lead to prescription of opioid analgesics. Are opioids in fact a safer option for the elderly population? This question is the focus of a recent study of elderly Medicare beneficiaries with arthritis.1 What did we know prior to this study? 2-6 o GI bleed incidence = ~2.5%/year (age >65 o Risk of acute renal failure in first 30 days on NSAID ~2X greater if age >65 yrs; GFR ↓ 10-12mL/min if age 60-80 yrs o HTN, aggravation of heart failure and edema o Most will slightly ↑ CV event risk (except Opioids o ↓ pain by 3 points on a scale of o Most common side effects include nausea, o NNH for any side effects = 12 over 4 weeks; NNH for discontinuation due to side effects = • No comparative safety RCTs exist for NSAIDs vs. opioids Cohort of Medicare beneficiaries with a diagnosis of osteoarthritis (~90%) or rheumatoid arthritis (~10%) with new use of an NSAID, coxib, or opioid (combination products with acetaminophen were included) Many baseline characteristics were documented for the 3 propensity score-matched groups and most were very similar * With sensitivity analysis, rofecoxib and valdecoxib (removed from the market) were not included, resulting in no difference between coxibs (i.e. celecoxib) and NSAIDs ‡ When high-dimensional scoring was used (includes 500 empirically derived covariates to reduce confounding), opioids were found to have a lower risk of GI bleeding than NSAIDs. Hazard ratios for all other previously significant outcomes were slightly lower, but remained statistically significantly higher vs. NSAIDs What implications might this have for practice?7 • Interpretation of observational studies always requires extra caution. Were those that received opioids sicker than those getting other analgesics? Seemingly similar baseline characteristics and further high-dimensional scoring do not indicate that this explains the entire difference. Over-the-counter acetaminophen or NSAIDs would not appear in the drug database. • There is uncertainty over the mechanism of CV risk increase and whether this means that baseline CV disease is an extra risk factor to be concerned with when prescribing opioids. Further study of this outcome is warranted. • However, this study should heighten our concern for an overall higher risk of harm with the use of opioids vs. other analgesics in the elderly. Although not addressed specifically in this study, continuing to heed individual patient factors (e.g. risk of GI bleed, renal impairment (NSAIDs) and presence of osteoporosis and fall risk (opioids)) should remain an important part of analgesic prescribing. • Make sure we ask ourselves (and the patient) the appropriate questions: Is it the right opioid dose? Too much, too little? • Could other analgesic formulations be tried such as topical NSAIDs (RCT evidence showing superiority to placebo and equivalence to oral NSAIDs for OA)? Solomon DH, Rassen JA, Glynn RJ, et al. The Comparative Safety of Analgesics in Older Adults with Arthritis. Arch Intern Med 2010;170(22):1968-78. El-Srrag HB, et al. Arch Intern Med 2002;162:2105-10. BMJ Trelle S, Reichenbach S, Wandel S, et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ 2011;342c:c7086. Friedewald, VE, Bennett JS, Christo J, et al. Am J Cardiol 2010;106:873– 84. Nüesch E, Rutjes AWS, Husni E,Welch V, Jüni P. Oral or transdermal opioids for osteoarthritis of the knee or hip. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD003115. DOI: 10.1002/14651858.CD003115.pub3. 7. Allan MG, Turner R. ACFP Tools for Practice ( NIACIN TRIAL STOPPED FOR LACK OF EFFECT & CONCERN FOR HARM Niacin has had a small place in the armamentarium of lipid management medications as a result of its ability to effectively lower triglycerides (TG) and elevate HDL. With the exception of the common adverse effect of flushing, niacin has generally been well tolerated. As is always the case with alteration of surrogate markers (e.g. lipids), the question arises as to whether altering these surrogate markers results in a reduction of harder outcomes such as cardiovascular events. The AIM-HIGH trial, designed to address this question, was recently stopped, 18 months prior to the planned completion date. What did we know prior to this study?1-4 Multiple meta-analyses showing CVD reduction with the use of niacin include mostly small studies (n < 200) and are highly driven by the CDP study (n=3,908) published in 1975, decades before current highly effective therapies were standards of care. • Fibrates are also effective at increasing HDL and decreasing TG. How have they Diabetes: FIELD (fenofibrate) and ACCORD Lipid (fenofibrate + statin) both indicate a reduction in CVD events vs. no fibrate (NNT=20-24 over ~5 yrs), but only in subgroups with high TG (≥ 2.3mmol/L) + low HDL (<1.0mmol/L) at baseline. General primary and secondary prevention (meta-analysis): ↓ in non-fatal MI by 1.4% (NNT=74 over ~4 yrs) and ↑ withdrawals due to adverse events by 1.7% (NNH=59) vs. placebo; no difference in all-cause mortality What is the AIM-HIGH trial and why was it stopped?5-7 • RCT of n=3414 patients with vascular disease (CAD, symptomatic PAD, cerebrovascular or carotid disease) and dyslipidemia (high TG and low HDL) Simvastatin dosed to target LDL ≤ 2 mmol/L (ezetimibe added if needed to reach target), plus extended release niacin 1500-2000mg/day OR placebo • Results (at 32 months follow-up (18 months earlier than planned)): Triglyceride levels ↓ 25% and HDL levels ↑ 20% in niacin-statin group vs. statin alone Composite end point (CHD death, nonfatal MI, ischemic stroke, hospitalization for NSTEMI, or symptom-driven coronary or cerebral revascularization): no difference (5.8% niacin vs. 5.6% placebo) Strokes: 1.6% (niacin + statin) vs. 0.7% (statin alone) (statistical significance not reported) What implications might this have for practice? • Presentation of preliminary outcomes of AIM-HIGH are not expected until fall 2011. In the mean time, considering the lack of positive hard outcome results, unless one only looks at surrogate markers, use of niacin with statins doesn’t make sense. • Should niacin be stopped in those currently on it? What was the reason for starting it in the first place? Although the increase in stroke occurrence may be considered insignificant and due to chance, it is difficult to justify ongoing use based on current efficacy data. • What about niacin monotherapy for patients not tolerating multiple statin o We don’t have good data to suggest overall benefit or harm. • The ongoing HPS-2-THRIVE trial (target n=~25,000) is an RCT of niacin/laropiprant (reduces flushing) 2g daily in addition to simvastatin (+/- ezetimibe) in patients with CVD. The primary outcome is a composite of CV events (i.e. a similar but much larger trial than AIM-HIGH). It is planned to be completed in 2013 and may be the last chance for niacin to be revived.5 Scott R, O’Brien R, Fulcher G, et al. Effects of Fenofibrate Treatment on Cardiovascular Disease Risk in 9,795 Individuals With Type 2 Diabetes and Various Components of the Metabolic Syndrome Diabetes Care 2009;32:493–498. The ACCORD Study Group. Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus. N Engl J Med 2010;362:1563-74. Abourbih S, Filion KB, Joseph L, et al. Effect of Fibrates on Lipid Profiles and Cardiovascular Outcomes: A Systematic Review. Am J Med 2009;122,962.e1-962.e8. Wise J. Trial of niacin alongside statin is stopped early. BMJ 2011;342:d3400 NHLBI Communications Office. NIH stops clinical trial on combination cholesterol treatment. NIH News; May 26, 2011. PPIs AND FRACTURE RISK: HOW STRONG IS THE ASSOCIATION? Proton pump inhibitors (PPIs) have been near the top of medication sales in the US and Canada for several years. With wide-scale population use, any sign of potential harm can have important implications and begins to receive the attention of researchers. Concerns regarding negative effects of PPIs on bone health began to surface around 2005. Four meta-analyses on this topic have been published this year with similar results. Why might this happen?1-5 • Several theories exist, but none are well-founded or without controversy or Most common opinion: ↓ gastric acid secretion by PPIs by up to 98% → hypo/achlorhydria → ↓ pH-dependant intestinal calcium absorption Even more controversial: inhibition of osteoclast-based proton pump activity → ↓ bone resorption → ? less maintenance remodeling and resultant cortical stiffness ? (this inhibition could also ↑ BMD) Conflicting evidence, but if this occurs the decrease is modest at most Each contains 10 - 12 observational studies (mostly the same studies used in each meta-analysis) Studies involved patients using PPIs or H2-receptor blockers Hip fracture (PPI use): OR = 1.23 – 1.31 (est. NNH = 2672) Vertebral fracture (PPI use): OR = 1.5 – 1.56 (est. NNH = 337) No ↑ fracture risk with H2-receptor blockers • Individual study findings within the meta-analyses: Is the effect dose-related? – not likely The meta-analyses are inconsistent on this issue Several individual studies show ↑ fracture risk if > 3 - 7 yrs of use Does high vs. low baseline risk of osteoporosis make a difference? In 2 studies, there was no significant association of PPI use and ↑ fracture risk for patients with no other risk factors for fracture • PPIs remain very effective agents for prevention and treatment of GI ulcers and GERD. Considering the very high NNH and the observational nature of the studies, this evidence should not prevent use of these agents when indicated. However, … Important to question the need for ongoing PPI use Limited evidence exists to support a clinically relevant rebound acid hypersecretion post-PPI discontinuation When appropriate (e.g. no history of erosive esophagitis), has “on Is an H2-receptor blocker appropriate as step-down? Consider the patient’s other risk factors for osteoporosis • “All medications have adverse effects. The issue is being certain that the benefits of any medication exceed the risks and that we have identified all those opportunities where "less is more."” - Katz MH. Arch Intern Med 2011;171(11):1004-1005 Eom CS, Park SM, Myung SK, et al. Use of Acid-Suppressive Drugs and Risk of Fracture: A Meta-analysis of Observational Studies. Ann Fam Med 2011;9:257-267. Yu EW, Bauer SR, Bain PA, et al. Proton Pump Inhibitors and Risk of Fractures: A Meta-Analysis of 11 International Studies. Am J Med 2011;124:519-526. Ngamruengphong S, Grigorios IL, Radhi S, et al. Proton Pump Inhibitors and Risk of Fracture: A Systematic Review and Meta-Analysis of Observational Studies. Am J Gastroenterol 12 April 2011;doi:10.1038/ajg.2011.113 Kwok CS, Yeong JK, Loke YK, et al. Meta-analysis: Risk of fractures with acid-suppressing medication. Bone 2011;48:768–776. Targownik LE, Leslie WD. The relationship among proton pump inhibitors, bone disease and fracture. Expert Opin. Drug Saf. [Early Online] CADTH RELEASES DABIGATRAN RECOMMENDATION On June 22, CADTH’s Common Drug Review released its recommendations for the use of dabigatran for the prevention of stroke in the setting of atrial fibrillation. These recommendations have been sent to provincial drug plans who will now decide on the action to take for provincial coverage. The recommendations are as follows: “The Canadian Expert Drug Advisory Committee (CEDAC) recommends that dabigatran be listed for the prevention of stroke and systemic embolism in patients with atrial fibrillation meeting one of the following criteria: • Patients in who warfarin is indicated but who fail to achieve adequate INR control, despite monitored warfarin treatment, such as with: regular INR testing, dosage adjustment according to a validated nomogram, and patient education. Patients who fail to achieve adequate INR control should be referred to an anticoagulation management service, if available. • Patients who have a history of a serious hypersensitivity reaction to warfarin.” For more information on dabigatran and the trial used to support this decision (RE-LY), see the December 2010 and April 2011 issues of This Just In… FINDINGS FROM 2011 PHARMACY STUDENT PROJECTS As a result of multiple elective rotations by 4th year Pharmacy Students each year, we have the opportunity to gain an “outside” perspective of how we are doing inside of our family medicine teaching sites at FMC and KMC. The following is a brief summary of two projects that were presented earlier this year… 1) Nurse-led Anticoagulation Monitoring in a Family Medicine Setting Project authors: Crystal Gennick, Kathleen Vincent Site: Family Medical Centre; Feb, 2011 Canadian literature reports that the typical time in therapeutic range (TTR) for individuals on warfarin is 60-70% At FMC, nurses follow a practice guideline and clinic protocol, providing evidenced-based information to facilitate INR management The average time spent in therapeutic range (TTR) for each individual How these findings compare to the values found in the literature Retrospective chart audit performed over a 12-month time period (January-December, 2010) On warfarin continuously throughout the study period Using warfarin for other reasons (DVT/PE, valve replacement, previous Not taking warfarin continuously during study period 19 out of 28 (68%) patients had a TTR > 60% 22 out of 28 (79%) patients had a TTR > 50% The current method at FMC provides TTR results similar to national estimates It may be beneficial to calculate an individual’s TTR if it is suspected that they have poor control • Assumptions must be made to estimate INR results on those days when INR is • Values just outside the therapeutic range (e.g. 3.02 or 1.98) flagged as out of range, even though a change in warfarin dose would be unlikely. This could have contributed to a lower average TTR The current nurse-led protocol used at FMC is an effective method of monitoring patients’ anticoagulation therapy It would be a useful model for other health care professionals (e.g. pharmacists) to use when setting up monitoring programs Completing an audit of anticoagulation management could act as a useful tool to identify individual patients with a lower percentage 2) Ongoing Proton Pump Inhibitor Use in the Management of GERD Project authors: Ignacio Ayala, Bryan Neufeld Site: Kildonan Medical Centre; Feb, 2011 Antisecretory drugs are effective in treating patients with GERD syndromes (healing esophagitis and symptomatic relief) with PPI > H2RB > placebo (Grade A: American Gastroenterological Association 2008 Position Statement) Long-term therapy should be titrated down to the lowest effective dose based on symptom control (grade A) (no drug is innocuous: consider potential effects on bone health discussed above as well as links to C. difficile infections) As needed therapy is appropriate for patients with no esophagitis, whose main objective is symptom control (grade B) The frequency of reassessment of PPI use in patients with GERD The reasons for stopping PPIs and if they were restarted Retrospective chart audit performed over a 5-year period IPNs were searched for the initial diagnosis date Severity of symptoms, investigations done, therapy selected, response to therapy, side effects to therapy, trials off of medication and whether the medication was restarted in these cases were noted 18/50 patients (36%) had tried moving from daily therapy to either “on demand” dosing or stopping their PPI/H2 blocker • 10/18 restarted their therapy and the other 8 are either still using prn doses 7 were due to prescriptions running out 6 were done by patients on their own, or they suggested the idea 5 were due to a physician’s advice (i.e. 5/50 overall = 10%) PPI use reassessment is being attempted (and documented) in a small number of patients with GERD by physicians. A number of patients spontaneously stopped on their own • The time from symptom resolution to drug discontinuation/dose change was not collected as definitive documentation was difficult to find • Lack of documentation in the chart doesn’t mean it wasn’t discussed • Patients may discontinue or restart the medication on their own and not notify the physician, particularly with non-prescription therapy There is a small amount of reassessment of PPI therapy occurring. Likely due to a low side effect profile, few patients are being asked if they would like to consider a trial off their PPI therapy or being advised about trying “on demand” dosing. It is advisable to at least have the conversation with patients about stopping PPIs or reducing doses at some point once they achieve symptom resolution, assuming they are endoscopically negative (or uninvestigated) Nor’West Co-op Community Health Centre


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