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ACHIEVING OPTIMAL MANAGEMENT OF COPD MARK MILLARD MD BAYLOR MARTHA FOSTER LUNG CARE CENTER Take home points: • Improved office-based care of COPD means… – Spirometry for diagnosis and staging – Identification of active smokers for intervention – Identification of hypoxemic patients – Stage-driven inhaler therapy – Early treatment of exacerbations Take home points: • Improved survival in COPD happens with… – Smoking cessation – Continuous oxygen if saturation <88% – High dose ICS with LABA in patients with FEV1 <50% and frequent exacerbations – LVRS with specific anatomy (upper lobe disease) and poor exercise tolerance Case #1 JW is a 55 y/o male with a history of mildly elevated cholesterol, on medication, who comes in for a yearly check-up. As part of his preappointment questionnaire, he notes that he has smoked 1 pack of cigarettes per day for 35 years. In direct questioning, he notes a morning cough and slightly brown tinged sputum that he attributes to “allergies”, and denies shortness of breath with exertion, although he acknowledges that going up a flight of stairs causes temporary dyspnea, quickly relieved with rest. He denies any exertional chest pain or pressure. He has had no significant lower respiratory tract infections in the last several years, and denies any antibiotic use for as long as he can remember. He doesn’t wheeze. No significant family history other than a brother who uses an inhaler when he gets short of breath for possible asthma is obtained. Colonoscopy performed last year was normal. Review of systems is otherwise negative. His only medication is a low-dose statin. Case #1 On physical exam, he is overweight but looks healthy. BP is 140/90, pulse 65, oxygen saturation 95%, and he is afebrile. Weight 200 lbs., 5’10” HEENT- mildly red posterior oro-pharynx and uvula with slight edema Chest- clear breath sounds Heart- RRR, S1, S2, without gallops or murmurs Abdomen- benign without hepato-splenomegaly Neuro- non-focal No cyanosis, clubbing or edema Skin- no rashes Case #1 Audience Response Question What diagnosis cannot be assumed? 1) 2) 3) 4) 5) 6) Hypertension Dyslipidemia Obesity Tobacco abuse COPD Chronic bronchitis Case #1 Audience Response Question What is this patient’s greatest health risk? 1) 2) 3) 4) Hypertension Dyslipidemia Tobacco abuse Obesity Assessing Tobacco Use in the Office Practice Setting Case #1 Audience Response Question Would this patient justify an ECG (rest)? 1) Yes 2) No Case #1 Audience Response Question Would this patient justify a lipid panel and liver function tests? 1) Yes 2) No Case #1 Audience Response Question Would this patient justify a chest xray? 1) Yes 2) No Case #1 Audience Response Question Would this patient justify a spirometry? 1) Yes 2) No Case #1 Audience Response Question Can you perform spirometry in your office? 1) Yes 2) No Case #1 Data Lipid profile- normal Liver function testing- normal ECG- NSR, NAD, NAC Chest x-ray- normal inspiratory effort without cardiomegaly. Clear lung fields. SpirometryFVC 90% predicted, FEV1 65% predicted, FEV1/FVC 0.55. No response to inhaled bronchodilator on re-testing. WHY SPIROMETRY IN YOUR OFFICE ? • More objective and accurate than clinical assessment • Results direct work-up • Results direct therapy • You get paid for better quality care! http://www.nlhep.org/resources.html WHY IS SPIROMETRY A PROBLEM IN YOUR OFFICE ? • Requires pre-planning • Requires trained office staff • Unclear coding? – 94010 ($34.17) – 94060 ($58.83) – ICDM: 786.05, 496,493.90 WHO TO TEST WITH SPIROMETRY? • Every asthmatic • Every smoker with >10 pack year history • Patients with chief complaint of dyspnea, especially with exertion • Patients with chronic cough, phlegm, or wheeze NHLEP, GOLD, JRD Supplement 2000 OBJECTIVE MEASUREMENTS OF AIRFLOW The FEV1 is the volume exhaled in the first second. The forced vital capacity is the total exhaled volume in one breath. In COPD, the FEV1/FVC ratio is <0.7, and does not normalize with bronchodilators. SPIROMETRY IN COPD • Identifies smokers in need of intervention • FEV1 used by GOLD and ATS/ERS in assigning stage severity, and “gold standard” of FDA • Often mildly (+) to inhaled bronchodilators, but… • Bronchodilator response may affect lung volumes more than FEV1. • Changes in inspiratory capacity predict exercise improvements more than FEV1 Case #1 Audience Response Question Does this patient have COPD? 1) Yes 2) No Case #1 Audience Response Question If he has COPD, what Stage severity? 1) 2) 3) 4) 5) Stage 1 (mild) Stage 2 (moderate) Stage 3 (severe) Stage 4 (life-threatening) He doesn’t have COPD. Case #1 Audience Response Question Do his symptoms of cough and sputum, in addition to dyspnea with exertion reflect COPD alone or other processes? 1) Primarily COPD 2) Obesity, and deconditioning primarily 3) Probably both Case #1 Audience Response Question Would his symptoms of chronic bronchitis and shortness of breath justify treatment? 1) Yes 2) No Case #1 Audience Response Question What would be the optimal treatment regimen? 1) Albuterol MDI 2 puffs, as needed for shortness of breath 2) Tiotropium, one capsule inhaled daily with as needed albuterol 3) Fluticasone/salmeterol 250/50, one puff inhaled B.I.D. with back up albuterol 4) Albuterol/ipratropium combination MDI, 2 puffs, QID 5) Guaifenesin expectorant for chronic bronchitis Case #1 Diagnoses Impression: 1) COPD with chronic bronchitis, Class II, based on abnormal FEV1/FVC (<70), and an FEV1 between 50 and 80% predicted. 2) Mild hypertension 3) Mild hypercholesterolemia, on medication 4) Tobacco abuse 5) Obesity DEFINITION OF COPD: GOLD 2001 Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. COPD VS. ASTHMA: A COMPARISON IN THE UNITED STATES Condition COPD Asthma Annual mortality (N) Estimated annual cost 100,000 5000-6000 $25 billion $12 billion Martin RJ. American Academy of Allergy, Asthma, and Immunology 56th Annual Meeting; March 4, 2000; San Diego, Calif. WHY ARE PATIENTS WITH COPD SO SHORT OF BREATH? • Static and dynamic hyperinflation increases diaphragmatic work • Reduced FEV1 reduces maximal ventilation (FEV1 X 36) • Exercise-related hypoxemia • Deconditioning and intrinsic muscle weakness Vital Capacity (VC) Vital Capacity Functional Residual Capacity (FRC) Residual Volume (RV) Functional Residual Capacity Residual Volume Obstructive Pattern Normal Pattern HYPERINFLATION IN COPD • STATIC – Structural changes are irreversible – Loss of elastic recoil – Reduced tethering of small airways • DYNAMIC – Increased airway resistance – Increased cholinergic tone – Adrenergic responsive GOLD STAGES OF COPD Old 0: At Risk I: Mild New 0: At Risk I. Mild Characteristics • Chronic symptoms •Exposures to risk factors •Normal spirometry FEV1/FVC<70% •FEV1>80% •With or without symptoms • IIA II: Moderate II. Moderate FEV1/FVC<70% •50%>FEV1<80 % •With or without symptoms • IIB III. Severe FEV1/FVC<70% •30%>FEV1<50% •With or without symptoms • III: Severe IV. Very severe FEV1/FVC<70% •FEV1<30% or presence of chronic respiratory failure or right heart failure • Avoidance of risk factor(s); influenza vaccination Add short-acting bronchodilator when needed Add regular treatment with one or more long-acting bronchodilators Add rehabilitation Add inhaled glucocorticosteroids if repeated exacerbations NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. April 2001 (Updated 2003). Add LTOT Consider surgical Rx BRONCHODILATORS: SITE OF ACTION Anticholinergic M1 M2 M3 Contraction -agonist Relaxation cAMP AMP Theophylline Smooth Muscle Cell Spector SL. In: Anticholinergic Agents in the Upper and Lower Airways. New York, NY: Marcel Dekker; 1999. INHALED BETA2 AGONISTS SHORT-ACTING • Albuterol MDI @ 90 mcg/puff vs. 2500 mcg / nebulizer tx. • Improve PFTs and exercise tolerance. • Use may reflect patient activity. LONG-ACTING • Salmeterol or formoterol-different onset of activity • DPI: multi-dose vs. unit dose • Improved PFTs, ?QOL ANTI-CHOLINERGICS IPRATROPIUM • Equal, but slower bronchodilatation • QID dosing • Improves PFTs and exercise tolerance. • MDI or nebulized with/without albuterol TIOTROPIUM • Equal bronchodilatation • QD dosing • Improved PFTs, QOL, and exercise tolerance • DPI DURATION OF ACTION 1.00 Salbutamol Ipratropium Placebo 0.95 Mean FEV1 (L) 0.90 0.85 0.80 0 1 2 3 4 5 6 Time (hours) Matera MG et al. Pulmonary Pharmacol. 1995;8:267-271. 8 10 12 DOES ADDING INHALERS IMPROVE LUNG FUNCTION? 100 Albuterol Ipratropium + Albuterol Ipratropium % Responding 90 80 70 60 50 40 0 15 30 45 60 75 90 105 Minutes post-drug administration Dorinsky PM, et al. Chest. 1999;115:966–971. 120 DURATION OF ACTION 1.00 Salmeterol Salbutamol Ipratropium Placebo 0.95 Mean FEV1 (L) 0.90 0.85 0.80 0 1 2 3 4 5 6 Time (hours) Matera MG et al. Pulmonary Pharmacol. 1995;8:267-271. 8 10 12 IMPACT OF LONG-ACTING ANTICHOLINERGIC ON PREDOSE FEV1 1.35 1.30 1.25 Day 1 Day 92 Tiotropium FEV1 (L) 1.20 1.15 1.10 1.05 Placebo 1.00 0.95 0.90 0.85 -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Hours after drug administration Casaburi R, et al. Chest. 2000;118:1294-1302. FEV1 RESPONSE: TIOTROPIUM, SALMETEROL AND PLACEBO • Mean FEV1 with tiotropium was statistically better than salmeterol. • The difference was ~50 ml. ADDING LONG ACTING BRONCHODILATORS: TIOTROPIUM & FORMOTEROL FEV1 IMPROVEMENT POST DOSE: FSC 250/50 VS. FP250, SALMETEROL, AND PLACEBO FEV1 (ml) Placebo Salmeterol FP250 FSC 250/50 350 350 300 300 250 250 200 200 150 150 100 100 50 50 0 0 -50 -50 20 0 2 4 *P0.003 vs FP 6 8 12 Time (weeks) Adapted from Hanania etal Chest 124: 834-843, 2003 16 * (27%) (19%) (14%) (6%) 24 Endpoint TIOTROPIUM & LUNG FUNCTION IN COPD FSC 250/50 REDUCES HYPERINFLATION (Adjusted Mean Change From Baseline at Week 8*) FSC 250/50 Placebo Salmeterol (n=62) (n=64) (n=59) Primary Endpoint Postdose FRC, mL –392 + 95* –40 + 92 –303 + 96* Postdose RV, mL –410 + 101* –57 + 98 –359 + 103* 213 + 43* 18 + 44 165 + 46* 181 + 28‡ 15 + 27 91 + 28* Postdose Exercise IC,† mL Predose FEV1, mL Data are adjusted mean + SEM. *P≤0.03 vs placebo. †At isotime (defined as last common timepoint across exercise challenges). ‡P≤0.012 vs salmeterol; except mean change from Baseline at Endpoint. Some patients had emphysema without chronic bronchitis Data on File, GlaxoSmithKline (SCO40030). Case #1 Treatment This patient was begun on Tiotropium, one capsule inhaled daily, as well as being given a prescription of albuterol MDI, 2 puffs as needed for shortness of breath not relieved within 3-5 minutes of rest. He was asked to return in one month for a follow-up spirometry and clinical assessment. If he was still symptomatic, then substitution of FSC 250/50, one puff twice daily would be recommended with another follow-up visit in one month to assess for improvement. STAGE 2006 OPTIONS FOR TREATMENT IN COPD Albuterol p.r.n. I + II + Tiotropium q.d. FSC 250/50 b.i.d. (+ LABA) III IV Tiotropium q.d. + Fluticasone 440 b.i.d. FSC 500/50 b.i.d. Tiotropium q.d. + FSC 500/50 b.i.d. Tiotropium q.d. + FSC 500/50 b.i.d. ?theophylline Case #1 Audience Response Question What is the most pressing additional issue to be addressed in health status of this patient? 1) 2) 3) 4) Hypertension Obesity Tobacco abuse Dyslipidemia Case #1 Audience Response Question What would likely happen to his spirometry if this patient quits smoking? 1)It will normalize 2)It will continue to decline as previously from normal because he has COPD which is “progressive” 3)It may slightly improve, but will decline now at the rate of a non-smoker 4)I don’t know FEV1 (% of value at age 25 y) Quit before its too late! Never smoked or not susceptible to smoke Stopped at 45 y Stopped at 65 y Smoked regularly and susceptible to its effects 100 75 Dyspnea on exertion 50 Disability 25 Death 0 25 50 Age (y) Adapted with permission from Fletcher C, Peto R. BMJ. 1977;1:1645-1648. 75 Options for Smoking Cessation • U.S. Public Health Service Guidelines for quit attempts: – Offer effective pharmacotherapy – At least 3 minutes of behavioral counseling • • • • Behavioral approaches/Patient education Nicotine replacement therapy (NRT) Buproprion SR Varenicline NICOTINE REPLACEMENT From: Urso, in The 2003 Sourcebook for Advanced Practice Nurses. pp 11-21; Lippincott Williams & Wilkins Abstinence Rates for Weeks 9-52: Varenicline vs. Bupropion or Placebo Any questions? Case #2 SA is a 70 year old female who presents with shortness of breath and cough. She has recently moved from another city to be near to her children and comes in somewhat upset about her diagnosis. She had been hospitalized in the past for congestive heart failure and told by her doctor elsewhere that she had a weak heart predisposing her to recurrent episodes of pneumonia that required hospitalization. She receives antibiotics and “cortisone” for treatment several times per year. However, a cardiologist recently told her that her heart was just “fine”. She smoked 2 packs per day for 30 years, stopping when she turned 50, at which time she had no symptoms except for chronic bronchitis. Currently, she is short of breath walking one block, and has to stop and rest after vacuuming one room in her daughter’s house where she now lives. She has a night-time tickle in her throat and in the morning produces about 2 tbs. of yellowish sputum. Case #2 Other significant history is high cholesterol, hypertension (both treated), and degenerative arthritis in her hip. She has had bilateral cataract extractions in the past. Medications include: statin, ACE-inhibitor, diuretic, and cox-2 inhibitor. Physical exam: a mildly anxious senior female, accompanied by her daughter. BP 135/85 P70, oxygen saturation 88% at rest while sitting. HEENT: small pupils, white nasal discharge, dentures Chest: increased AP diameter, mild kyphosis, diminished breath sounds with a few high pitched expiratory wheezes Heart: PMI indistinct, S1, S2, without gallops, murmurs Abdomen: benign No cyanosis, clubbing, trace edema Neuro: non focal Skin: no rash Case # 2 Audience Response Question Which tests would be reasonable to order before initiating treatment? 1) 2) 3) 4) 5) Chest x-ray Spirometry ECG None of the above All of the above Case #2 Chest xray: large lung volumes, with increased markings bilaterally. Pulmonary arteries appear enlarged centrally. Flattening of diaphragm. Spirometry: FVC 70% predicted, FEV1 40% predicted, FEV1/FVC 0.45. Bronchodilator response of 220 ml (13%) was noted. ECG: sinus rhythm with PACs. NAD, NSSTW changes noted Audience Response Question What is the most likely pulmonary diagnosis? 1. Stage III COPD with recurrent exacerbations 2. Adult onset asthma 3. Congestive heart failure 4. You can’t tell; further testing is necessary FEV1 (% of value at age 25 y) Why quit when you’re 50? Never smoked or not susceptible to smoke Stopped at 45 y Stopped at 65 y Smoked regularly and susceptible to its effects 100 75 Dyspnea on exertion 50 Disability 25 Death 0 25 50 Age (y) Adapted with permission from Fletcher C, Peto R. BMJ. 1977;1:1645-1648. 75 Audience Response Question What would be the appropriate inhaler therapy, based on evidence-based medicine? 1. Albuterol MDI, 2 puffs as needed for shortness of breath only 2. Tiotropium, one capsule inhaled daily 3. Fluticasone-Salmeterol 250/50, inhaled twice daily 4. Fluticasone-Salmeterol 500/50, inhaled twice daily WHY WORRY ABOUT EXACERBATIONS IN COPD? • Raise “misery index” of COPD • Increase health care utilization and cost – Drugs – PCP VISIT/ED/HOS • Prolonged time to recover in some; permanent worsening of lung function in others: <50% FEV1 at risk population Chest. 121(3):688-696, March 2002 COPD EXACERBATIONS: TIOTROPIUM, SALMETEROL AND PLACEBO • The proportion of each patient group with exacerbations was no different within treatment groups, ~1/3. • The number of patients requiring steroids was no different. FSC 500/50 REDUCES EXACERBATION RATE DO ICS/LABA IMPACT MORTALITY IN COPD? • • • Observational study: COPD, >65 y/o, post-discharge ICS Rx reduced rate of rehospitalization & mortality Sin & Tu. AJRCCM 164:580-584, 2001 • TORCH 2006 • Randomized to detect mortality difference with FSC 500/50 • 17% improved mortality at 3 yrs. • P=.052 • March 2006, GSK Treating COPD Exacerbations • Exacerbations defined: – Increased cough and dyspnea and – Change in color or quantity of sputum • Early antibiotics reduce complications – Tm-Smx; macrolide; amox/clav – Quinolone if at high risk • Prednisone improves symptoms and function – 40-60mg per day for 10-14 day course Audience Response Question Should she be prescribed oxygen? 1. 2. 3. 4. Yes, continuously for 16-18 hours per day Yes, but only as she feels like she needs it Yes, but only with exertion No Oxygen Therapy Trial 100 90 80 COT 70 Cumulative Survival (%) 60 50 MRC O2 NOT 40 30 MRC controls 20 10 0 0 10 20 30 40 50 60 70 COT = continuous oxygen therapy; NOT = nocturnal oxygen therapy; MRC controls = no oxygen therapy; MRC = domiciliary oxygen therapy. Flenley DC. Chest. 1985;87:99-103. Case #2 Treatment The patient was begun on fluticasone/salmeterol combination 500/50, to reduce recurrent episodes of bronchitis, an off-label use, although well documented in the peer-reviewed literature. Additional bronchodilatation with a long-acting anticholinergic (tiotropium) may be tried after the initial use of FSC, if symptom relief is not optimal, as the combination of both anti-cholinergic and beta agonists has been shown to improve FEV1 more than with either agent alone. Tiotropium has also been associated with a reduction in number of bronchitic exacerbations. She should also be prescribed supplemental oxygen for use at least 16-18 hours per day and referred to a pulmonary rehabilitation program. Questions? Take home points: • Improved office-based care of COPD – Spirometry for diagnosis and staging – Identification of active smokers for intervention – Identification of hypoxemic patients – Stage-driven inhaler therapy – Early treatment of exacerbations Take home points: • Improved survival in COPD – Smoking cessation – Continuous oxygen if saturation <88% – High dose ICS with LABA in patients with FEV1 <50% and frequent exacerbations – LVRS with specific anatomy (upper lobe disease) and poor exercise tolerance