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4/1/2013 PHARMACOTHERAPY UPDATE Benjamin Gross, Pharm D, BCPS, BCACP, BC‐ADM, CDE Associate Professor Director of Residency Programs Lipscomb University College of Pharmacy and Health Sciences 1 4/1/2013 DISCLOSURE • I DO NOT HAVE ANY DISCLOSURES TO REPORT 2 4/1/2013 Contact • Email: – [email protected] – [email protected] • Office – One University Park Drive – Nashville, TN 37204 – Phone: 615.966.7195 3 4/1/2013 Objectives • Discuss common medication issues in the elderly • Discuss adverse effects of medications and their impact on treatment plans • Discuss new medications and their impact on the elderly • Discuss new medications, adverse effects, or restrictions for the general population 4 4/1/2013 5 4/1/2013 Drug Therapy in the Elderly • Among people ≥ 65 years of age – 90% use at least one medication per week – 40% use at least 5 different medications per week – 12% use ≥ 10 different medications per week • Women take more medications • Medication use greatest among frail elderly, hospitalized patients, and nursing home residents • Nursing home resident – 7 to 8 different drugs 6 4/1/2013 Drug Therapy in the Elderly • Elderly Patients – Use more drugs than any other age group – More likely to have chronic disorders – Physiologic reserves are reduced – Aging alters pharmacodynamics and pharmacokinetics – Less able to obtain or afford drugs 7 4/1/2013 Pharmacokinetics in the Elderly • • • • Absorption Distribution Metabolism Excretion 8 4/1/2013 Pharmacokinetics in the Elderly Class or Category Decreased Hepatic Metabolism Analgesics and anti‐inflammatory drugs Naproxen Ibuprofen Morphine Meperidine Antibiotics Cardiovascular Drugs Decreased Renal Elimination Amikacin Ciprofloxacin Gentamicin Nitrofurantoin Streptomycin Tobramycin Amlodipine Diltiazem Lidocaine Nifedipine Propranolol Quinidine Theophylline Verapamil Captopril Digoxin Enalapril Lisinopril Procainamide Quinapril 9 4/1/2013 Pharmacokinetics in the Elderly Class or Category Decreased Hepatic Metabolism Diuretics Decreased Renal Elimination Amiloride Furosemide Hydrochlorothiazide Triamterene Psychoactive Drugs Alprazolam Chlordiazepoxide Desipramine Diazepam Imipramine Nortriptyline Trazadone Triazolam Risperidone Others Levodopa Amantadine Chlorpropramide Cimetidine Glyburide Lithium Metoclopramide Ranitidine 10 4/1/2013 Pharmacodynamics in the Elderly • What the drug does to the body or the response of the body to the drug – Effects of similar drug concentrations at the site of action may be greater or smaller in the elderly compared to younger patients – Particularly sensitive to anticholinergic drug effects • Those with dementia: prone to CNS adverse effects of anticholinergic drugs – Anticholinergic drugs » Commonly cause: constipation, urinary retention, blurrred vision, orthostatic hypotension, and dry mouth 11 4/1/2013 Effect of Aging on Drug Response Class Drug Action Effect of Aging Analgesics Morphine Acute analgesic effect Anticoagulants Warfrain PT Bronchodilators Albuterol Bronchodilation Cardiovascular Angiotensin II receptor blockers Decreased BP Diltiazem, Enalapril, Felodipine, Verapamil Acute antihypertensive effect Diazepam Sedation Diphenhydramine Psychomotor function Haloperidol Acute Sedation Levodopa Adverse effects Psychoactive Others 12 4/1/2013 Drug‐Related Problems in the Elderly • • • • • • • Inappropriate medications Overdosage Underprescribing Drug/Disease Interactions Inadequate monitoring Poor communication Lack of adherence 13 4/1/2013 Beers Criteria • Avoid – Indomethacin – First generation antihistamines – Alpha blockers • Treatment hypertension – Antiarrhythmic drugs (Class Ia, Ic, III) – Benzodiazepines • Treatment for insomnia, agitation, or delirium – Digoxin > 0.125 mg/day – Tertiary TCAs – Glyburide • Complete list: – http://www.americangeriatrics.org/files/documents/beers/PrintableB eersPocketCard.pdf J AM Geriatr Soc 2012. doi:10.1111/j.1532‐5414.2012.03923.x 14 4/1/2013 Drug Categories of Concern in Elderly • Analgesics – NSAIDs • May be prone to adverse effects of these drugs • Anticoagulant – Increase sensitivity to the anticoagulant effect of warfarin • Antidepressants – Fluoxetine: long elimination half‐life – Paroxetine: more sedating, more drug interactions, anticholinergic effects – Sertraline: diarrhea most common adverse effect 15 4/1/2013 Aspirin and Macular Degeneration • Aspirin: Increased risk of age‐related macular degeneration (AMD) Liew, G. et al. JAMA intern Med. 2013; 258‐264 16 4/1/2013 Liew, G. et al. JAMA intern Med. 2013; 258‐264 Klein, et al. JAMA 2012; 2469‐2478 17 4/1/2013 Aspirin and Macular Degeneration • Prospective observational study – 5000 patients over period 20 years – Age: 43‐86 – 99% white – 56% women – Regular aspirin use • At least twice weekly use for more than three months – Mean duration of follow‐up almost 15 years Klein, et al. JAMA 2012; 2469‐2478 18 4/1/2013 Aspirin and Macular Degeneration • Results – Regular aspirin use ten years prior was associated with an increase risk of AMD – Incidence of AMD in aspirin users was 1.76% compared to 1.03% in nonusers – Increased risk with neovascular or “wet” AMD Klein, et al. JAMA 2012; 2469‐2478 19 4/1/2013 Aspirin and Macular Degeneration • Prospective observational study – 2389 patients – 15 years of follow‐up – Mean age: 65 years – Regular Aspirin Use • At least once weekly use for the past year Klein, et al. JAMA 2012; 2469‐2478 20 4/1/2013 Aspirin and Macular Degeneration Liew, G. et al. JAMA intern Med. 2013; 258‐264 21 4/1/2013 Aspirin and Macular Degeneration Christen, W.G., et al. Ophthalmology 2009: 2386‐92. 22 4/1/2013 Azithromycin and Risk of Potentially Fatal Heart Rhythms • FDA MedWatch Safety Alert • Azithromycin – Abnormal changes in the electrical activity of the heart – Fatal irregular heart rhythm • At risk – – – – Patients QT interval prolongation Low blood levels of potassium and magnesium Slower than normal heart rate Medications used for arrhythmias http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343 350.htm 23 4/1/2013 Ray, W.A. et al. NEJM 2012; 366:1881‐90. 24 4/1/2013 Ray, W.A. et al. NEJM 2012; 366:1881‐90. 25 4/1/2013 Ray, W.A. et al. NEJM 2012; 366:1881‐90. 26 4/1/2013 Zolpidem‐Containing Products • FDA recommends lower doses – New data show that blood levels high enough the next morning to impair activities that require alertness – Ambien, Ambien CR, Edluar, and ZolpiMist – Highest risk • With extended‐release forms • Women – Intermezzo (Zolpidem tartrate): no change 27 4/1/2013 Zolpidem‐Containing Products Dosing recommendation in FDA’s proposed new current drug label for dosing recommendations zolpidem for zolpidem Ambien, Edluar, ZolpiMist Men and Women: 10 mg once daily, immediately before bedtime Women: 5 mg once daily, immediately before bedtime Men: 5 or 10 mg once daily, immediately before bedtime Ambien CR Men and Women: 12.5 mg Women: 6.25 mg once daily, immediately before once daily, immediately bedtime before bedtime Men: 6.25 or 12.5 mg once daily, immediately before bedtime 28 4/1/2013 Vitamin D and Calcium Supplementation • U.S. Preventive Services Task Force (USPSTF) recommendation statements – Recommends against daily supplementation with 400 IU or less of Vitamin D3 and 1000 mg or less of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women (Recommendation D) – Insufficient data to assess balance of the benefits and harms of daily supplementation greater than 400 IU of vitamin D3 and greater than 1000 mg of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women http://www.uspreventiveservicestaskforce.org/uspstf/uspsvitd.htm 29 4/1/2013 http://www.uspreventiveservicestaskforce.org/uspstf/uspsvitd.htm 30 4/1/2013 Vitamin D and Calcium Supplementation http://www.uspreventiveservicestaskforce.org/uspstf/uspsvitd.htm 31 4/1/2013 Vitamin D and Calcium Supplementation National Osteoporosis Foundation. 2013. Clinician’s guide to prevention and treatment of osteoporosis 32 4/1/2013 Vitamin D and Calcium Supplementation Warensjo, E., et al. BMJ: 2011; 343:d1473 33 4/1/2013 Vitamin D and Calcium Supplementation Michaelsson, K., et al. BMJ: 2013;346:f228 34 4/1/2013 Glucagonlike peptide 1‐based therapies Singh, S., et al. JAMA Intern Med. 2013 doi:10.1001/jamainternmed.2013.2720 35 4/1/2013 Glucagonlike peptide 1‐based therapies • Population‐based case‐control study • Seven Blue Cross Blue Shield Plans – 1,269 cases • • • • Mean age: 52 years Male: 57% Sitagliptin and Exenatide Increased odds of hospitalizations for acute pancreatitis 36 4/1/2013 Glucagonlike peptide 1‐based therapies 37 4/1/2013 Statins and Acute Kidney Injury Dormuth, C.R., et al. BMJ 2013;346:f880 38 4/1/2013 NEW DRUG/INDICATION/DOSE APPROVALS • • • • • • • • • • • • • Exelon (rivastigmine transdermal system) Abilify Maintena Nesina, Oseni, Kazano Eliquis (apixaban) Xarelto (rivaroxaban) Fycompa (perampanel) Prolia (denosumab) Lucentis (ranibizumab) Nucynta (tapentadol) Qsymia (phentermine/topiramate) Horizant (gabapentin enacarbil) Belviq (lorcaserin) Dymista (azelastine and fluticasone) 39 4/1/2013 New Medication • Alogliptin (Nesina®) – Dipeptidyl peptidase‐4 (DPP‐4) inhibitor – Type 2 diabetes – Dose • 25 mg once daily • CrCL 30‐60 ml/min: 12.5 mg • CrCl < 30 ml/min or hemodialysis: 6.25 mg 40 4/1/2013 New Medication • Alogliptin – Adverse effect • • • • Nasopharyngitis Headache Upper respiratory tract infection Pancreatitis (0.2%) – Drug interactions • No significant drug‐drug interactions 41 4/1/2013 New Medication • Alogliptin and Pioglitazone (Oseni®) – How supplied • 12.5/15, 12.5/30,12.5/45 • 25/15, 25/30, 25/45 – Dosage • Congestive Heart Failure (Class I or II) – 25mg/15mg • CrCl 30‐60 ml/min – 12.5 mg/15 mg, 12.5 mg/30 mg, 12.5 mg/45 mg • Severe renal impairment – Not recommended but can use 6.25 mg dose – Adverse effects • Nasopharyngitis • Back pain • Upper respiratory tract infection 42 4/1/2013 New Medication • Alogliptin and Metformin (Kazano®) – 12.5 mg/500 mg – 12.5 mg/1000 mg – Adverse Effects • • • • • • • Upper respiratory tract infections Nasopharyngitis Diarrhea Hypertension Headache Back pain Urinary Tract Infections 43 4/1/2013 New Medicaiton • Phentermine and Topiramate extended‐ release (Qsymia®) – BMI >30 or BMI >27 plus hypertension or diabetes or dyslipidemia – Dosage • 7.5 mg/46 mg • After 12 weeks escalate dose or discontinue – Higher dose: 15mg/92mg – Take one dose every other day for at least one week to discontinue 44 4/1/2013 Qsymia® Davidson, MH, et al. Am J Cardiol 2013 45 4/1/2013 New Indication • Denosumab (Prolia®) – Treatment of increased bone mass in men with osteoporosis at high risk of fracture – ADAMO study • 12 months • Significant increase in BMD at all skeletal sites – RANK Ligand inhibitor • 60 mg subcutaneous injection every 6 months Orwol, E., et al. J Clin Endocrin Metab. 2012 46 4/1/2013 New Indication • Denosumab – Adverse effects • GI: – Diarrhea (20%), nausea (8.6‐31%), vomiting (15%) • Musculoskeletal – Arthralgia, backache, limb pain • • • • Fatigue Nasopharyngitis Upper respiratory infection Dyspnea 47 4/1/2013 New Dose • Rivastigmine transdermal system (Exelon® Patch) – Alzheimer's disease treatment – New Dose: 13.3 mg/24 h – OPTIMA study • Higher dose reduced deterioration compared to lower dose • Well tolerated Dement Geriatr Cogn Disord. 2012;33(5):341‐53. doi: 10.1159/000340056. Epub 2012 Jul 11. 48 4/1/2013 Questions 49