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The NEW ENGLA ND JOURNAL of MEDICINE Perspective march 24, 2011 Under Siege — The Individual Mandate for Health Ins...

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The

NEW ENGLA ND JOURNAL

of

MEDICINE

Perspective march 24, 2011

Under Siege — The Individual Mandate for Health Insurance and Its Alternatives Jonathan Oberlander, Ph.D.

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he battle over the Patient Protection and Affordable Care Act (ACA) rages on: in January, House Republicans passed legislation repealing the ACA, but the measure failed to clear the Democratic-

controlled Senate. Although Republicans’ best chance to overturn the law won’t come until 2013 — and then only if they win a majority in both Congressional houses and the presidency in 2012 — they may meanwhile pursue targeted repeal of controversial provisions. No provision is currently more beleaguered than the individual mandate to obtain health insurance or pay a penalty. Many analysts view this mandate as crucial to ensuring that healthier people join state-based insurance exchanges: since the law prohibits insurers from charging higher premiums to or turning away people with preexisting conditions, exchanges would other-

wise attract disproportionately sicker, costlier enrollees. That adverse selection would drive up premium costs and threaten exchanges’ stability. Reformers had hoped the mandate would also confer political advantages. Some Republicans, including former Massachusetts governor Mitt Romney, previously supported the policy. In a 2006 opinion piece, Romney defended Massachusetts’ decision to impose penalties on people who didn’t purchase insurance as a “personal responsibility principle. Some of my libertarian friends balk at what looks like an individual mandate,” he wrote. “But remember, someone has to pay for the health care that must, by

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law, be provided: either the individual pays or the taxpayers pay. A free ride on government is not libertarian.”1 The Massachusetts mandate has in fact encouraged healthy people to obtain coverage.2 But Massachusetts proved to be only an oasis of bipartisanship. Among Republicans in Washington, pro-mandate arguments about personal responsibility gave way to concerns over individual liberty and the political priority of handing the Obama administration a defeat. The mandate now confronts a legal and political backlash. Florida’s Roger Vinson recently became the second federal judge to deem it unconstitutional, and the issue appears headed for the Supreme Court. Some state legislatures are seeking to block the mandate’s implementation. A few Democratic senators, including Claire McCaskill (MO) and Ben Nelson (NE), 1085

The New England Journal of Medicine Downloaded from nejm.org at MEDIZINISCHE UNIVERSITAT WIEN on March 26, 2011. For personal use only. No other uses without permission. Copyright © 2011 Massachusetts Medical Society. All rights reserved.

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who are up for reelection in 2012, say they’d like to find alternatives to the mandate. And while conservatives rail against the mandate and politically vulnerable moderates run away from it, many liberals support it reluctantly because of concerns that insurance remains unaffordable and that the requirement is a gift to the insurance industry. Increasingly, Democrats may wonder whether the provision is an albatross that should be jettisoned to save reform. Inasmuch as the health care reform debate is defined by the mandate, Democrats have a problem. The policy is highly unpopular — 76% of Americans view it unfavorably3 — and makes reform seem punitive. Although Democrats can highlight other consumer-friendly provisions that target health insurers, in the mandate fight they are allied with the insurance industry. Furthermore, President Barack Obama could in 2012 be in the uncomfortable position of defending a mandate that he argued against in the 2008 Democratic primary. (The mandate’s prominence also complicates Romney’s potential bid for the Republican presidential nomination.) Still, it’s not clear how much Democrats would gain politically by dumping the mandate. Many Republicans also oppose the ACA’s requirements that employers offer coverage or pay a penalty, the Medicaid expansion, increased government regulatory authority over the insurance industry, reductions in projected Medicare savings, and the cost of the subsidies for the uninsured to purchase insurance. Opponents of health care reform are attacking the mandate because it’s the most politically vulnerable part of the 1086

The Individual Mandate and Its Alternatives

law. Were it to fall, they would not endorse the ACA, but move on to attack other controversial provisions. If the mandate cannot be sustained, alternatives exist. The country could adopt single-payer, tax-financed national health insurance as a universal entitlement. There would be no need for penalties and no worries about adverse selection, since the government would operate one risk pool. Enrollment would be much easier to administer and universal coverage would be ensured. Yet single payer would require compulsory participation, new taxes, and the political transformation necessary to displace private insurance. It remains infeasible. Staying within the reform’s existing boundaries, one alternative is to limit enrollment in the exchanges to a fixed period each year and impose premium penalties for eligible people who choose to wait and buy coverage later — and to make the penalty apply not just the first time they purchase insurance, but across their lifetimes.4 This model is employed by the Medicare Part D program for prescription-drug coverage, which the Bush administration and many Congressional Republicans supported. However, to induce healthy uninsured people to sign up, the late penalty might have to be substantial, in which case this arrangement would be operating similarly to the mandate. As the health care economist Len Nichols points out, if we don’t have the political will to impose a strong penalty in conjunction with an individual mandate, we probably wouldn’t have the will to impose one as part of a fixed enrollment system. Furthermore, it’s not clear how a lifetime late penalty would work

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when people’s insurance coverage could shift over time among private plans in the exchange, private plans outside the exchange, Medicaid, employer-based coverage, and eventually, Medicare. Another alternative would be to automatically enroll people in health insurance plans, permitting them to opt out. Auto-enrollment would occur primarily at the workplace but could also happen at state offices such as the Division of Motor Vehicles. This model could have bipartisan appeal: a 2009 health care reform bill cosponsored by Republican Senators Richard Burr (NC) and Tom Coburn (OK) and Republican Congressmen Paul Ryan (WI) and Devin Nunes (CA) relied on autoenrollment.5 Auto-enrollment can be combined with a premium penalty for people who opt out but later decide to purchase coverage. Medicare Part B, which pays for physicians’ services, works this way. Once again, though, the lateenrollment penalty might have to be substantial for auto-enrollment to effectively induce healthier people to pay for insurance coverage. Inertia alone may not be a sufficiently strong force to get younger, healthier workers to stay insured, given high and rising insurance premiums. Auto-enrollment may also not work as well outside the workplace or for workers’ dependents.4 Substituting either of these alternatives for the mandate would, as economist Jonathan Gruber argues, attenuate the ACA’s benefits, resulting in an increased number of uninsured Americans and higher premiums in the nongroup insurance market (as healthier people decline coverage).4 Implementing the rest of the ACA without any substitute

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policy would similarly reduce coverage gains and destabilize insurance pools. The substantive case for the mandate is still strong, even if its political and legal foundations are shaken. It’s also unclear whether past Republican support for alternative policies would be sustained or, as with the individual mandate, evaporate in the heat of the political spotlight. Insofar as Republicans continue to support alternatives, they will be interested in them as part of a broader conservative health care reform package, not a means of bolstering the ACA. Republicans’ good chances of winning control of the Senate in 2012 further reduce their incentives to cooperate now on an alternative plan. What reformers may need even more than a policy alternative to the mandate is an alter-

The Individual Mandate and Its Alternatives

native rationale, especially since any provision meant to ensure broad participation in insurance pools must include financial penalties. The mandate’s defenders could again invoke the rhetoric of personal responsibility. Or they could emphasize that the mandate makes possible the insurance reforms that guarantee the availability of coverage to sick people.3 Alternatively, reformers could appeal to the mandate’s communitarian foundations, arguing that there are some public programs — such as Social Security and Medicare — that produce invaluable social benefits and that succeed because everyone participates in them. Ultimately, the furor over the mandate underscores the reality that solidarity remains elusive in U.S. health policy.

Disclosure forms provided by the author are available with the full text of this article at NEJM.org. From the University of North Carolina, Chapel Hill. This article (10.1056/NEJMp1101240) was published on February 16, 2011, at NEJM.org. 1. Romney M. Health care for everyone? We’ve found a way. Wall Street Journal. April 11, 2006. 2. Chandra A, Gruber J, McKnight R. The importance of the individual mandate — evidence from Massachusetts. N Engl J Med 2011;364:293-5. 3. Kaiser Family Foundation/Harvard School of Public Health. The public’s health care agenda for the 112th Congress. January 2011. (http://www.kff.org/kaiserpolls/upload/ 8134-F.pdf.) 4. Gruber J. Health care reform without the individual mandate. Washington, DC: Center for American Progress, February 9, 2011. (http://www.americanprogress.org/issues/ 2011/02/gruber_mandate.html.) 5. Coburn T. Individual auto-enrollment: an alternative to an individual mandate. (http:// coburn.senate.gov/public/index.cfm?a=Files .Serve&File_id=e87f06bf-d429-4eac-8e7eade046b8b882.) Copyright © 2011 Massachusetts Medical Society.

Early Accelerated Approval for Highly Targeted Cancer Drugs Bruce A. Chabner, M.D.

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he striking results of recent phase 1 trials of targeted cancer drugs have provoked serious discussion about shortening the road to drug approval. A typical cancer drug takes 7 years from entry into human trials to approval by the Food and Drug Administration (FDA), which requires proof of efficacy in “well-controlled clinical trials.” In these randomized phase 3 trials, a new treatment alone or added to a drug combination is compared with a “standard” drug or combination. The most convincing end point for such trials is improved survival, although the FDA has accepted surrogates such as tumor progression, response rate,

or rarely, symptomatic relief. These trials are invaluable for establishing the benefits of new drugs in instances where reasonable alternative therapies exist. But phase 3 trials are expensive and time-consuming, usually taking at least 2 to 3 years to reach survival end points. The news of a highly successful new compound in phase 1 or 2 rapidly reaches physicians and patients, creating demand for early access. For drugs aimed at diseases with limited effective treatments, delaying access during phase 2 and 3 trials creates difficult ethical issues for regulatory agencies and pharmaceutical sponsors and agonizing decisions

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for physicians and patients. As Miller and Joffe recently emphasized, the concept of equipoise (uncertainty as to which treatment carries greater benefit), underlies the ethical basis for randomization.1 Strong early results in phase 1 or 2 may tip the balance and argue against delaying access by performing phase 3 trials, but Miller and Joffe contend that such trials may nonetheless be justified by the need to establish new drugs’ long-term efficacy. New understanding of the molecular and genetic lesions that cause cancer has sharpened the discussion, however, by enabling rapid development of drugs that 1087


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Accelerated Approval for Targeted Cancer Drugs

Mutations in NRAS

Activation of PDGFR-β and IGF-1 receptor

Dimerization of BRAF and CRAF PLX4032 inhibits BRAF

Increased expression of the P13K–AKT signaling pathway

BRAF V600E — protein from mutated BRAF

Increase in CRAF

MEK Increased expression of COT ERK Mechanism of Action of PLX4032 in Melanoma. BRAF dimerizes with its partner CRAF and acts as a relay point for signals for normal cell growth and survival. The BRAF V600E mutation, found in 60% of melanomas, signals constitutively and drives the malignant behavior of the tumor. PLX4032, an inhibitor of BRAF, kills BRAF-dependent tumors and has proved to be highly effective in phase 1 trials.1 Further mutations in BRAF or activating mutations in NRAS, changes in expression of mitogen-activated protein kinase kinase kinase 8 (MAP3K8, or COT) or elements of the PI3 kinase pathway, or activation of alternative signaling pathways such as platelet-derived growth factor receptor β (PDGFR-β) have led to resistance to BRAF inhibition in experimental settings (labels in red) and in clinical settings (labels in green) and form the basis for new therapeutic strategies. IGF-1 denotes insulin-like growth factor 1. The image of CRAF was produced with the use of the Chimera software and is based on the 3omv crystal in the Protein Data Bank (www.wwpdb.org).

specifically target tumors bearing aberrant signaling pathways.2 Inhibitors of the BCR-ABL kinase in chronic myelogenous leukemia (CML) and inhibitors of the epidermal growth factor receptor (EGFR) in EGFR-mutated non– small-cell lung cancer (NSCLC)3 have replaced cytotoxic chemotherapy for these indications. Two new drugs have produced excellent results in phase 1 trials against cancers that responded poorly to standard treatments: PLX4032 yielded an 81% response rate in 38 patients with BRAF mutated melanoma (see diagram),4 and crizotinib had a 57% response rate in 82 patients with the EML4-ALK fusion in NSCLC.5 Rates of disease control (response 1088

or stable disease for at least 8 weeks) exceeded 90% in both trials, with minimal toxicity. Because only a fraction of patients with NSCLC and melanoma have tumors harboring the aberrant pathways, a biomarker test for the mutations was required to select appropriate trial subjects. Drugs such as PLX4032 and crizotinib normally undergo a second phase 2 trial (involving 30 to 100 patients) to confirm their activity as second- or third-line therapy. Because of their early promise, both of these drugs entered phase 3 trials directly after phase 1. Patients with newly diagnosed BRAF-mutation–positive melanoma were randomly assigned to PLX4032 or dacarba-

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zine, a standard agent with a response rate of 15%; crossover from the control group to the experimental group at the time of disease progression was not allowed, to preserve the integrity of the survival end point. (The trial has now completed enrollment and reached its survival end point and is being amended to allow crossover.) In its phase 3 trial for newly diagnosed NSCLC, crizotinib is being compared with standard chemotherapy, which has a 30 to 40% response rate, a limited survival benefit, and substantial toxicity. Patients in the control group who have disease progression may receive crizotinib by entering a phase 2 trial. Because we can now define

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patient subgroups with high response rates in phase 1 trials, performance of phase 3 trials for these drugs raises important issues. If patients with incurable disease who have the right biomarker for response are informed of these impressive early results, they will want and perhaps deserve access to the new drug and may not accept random assignment to a modestly effective and toxic standard agent. The phase 3 trial may lack equipoise in the eyes of both physicians and patients. There are alternatives for expediting access to new drugs for patients who are not eligible for or accepted into phase 3 trials. A phase 2 trial may be opened simultaneously for patients with progressive disease after initial therapy. Such trials are open for both PLX4032 and crizotinib, but they accrue limited numbers of patients and are conducted in only a few centers. In addition, compassionate-use protocols allow sponsors to distribute experimental drugs on a case-by-case basis. This mechanism was widely used to provide early access to experimental AIDS drugs, with few reports of unexpected adverse drug reactions. But sponsors often view compassionate use as competing with trial accrual and relieving pressure on the FDA for marketing approval. Neither crizotinib nor PLX4032 was available through an expanded-access protocol when its phase 3 trial opened, though such protocols are now available in a limited number of centers. A mechanism for early FDA approval, “accelerated approval,” was introduced in 1992. Reserved for serious or life-threatening illness not effectively treated by approved medications, this mechanism allows drugs to be registered

Accelerated Approval for Targeted Cancer Drugs

on the basis of surrogate end points in phase 2 — most commonly, a clearly demonstrable tumor response rate (often 20 to 30%). Accelerated approval is awarded with the stipulation that definitive trials, with a survival end point, must be conducted after approval. Of the 23 oncologic drugs given accelerated approval between 1993 and 2008, two were ultimately withdrawn from the U.S. market — gemtuzumab because of toxicity and gefitinib because of lack of ef ficacy. A 2008 study of accelerated approvals, from the Government Accountability Office, concluded that the FDA hasn’t effectively enforced requirements for postapproval trials. However, my review of accelerated approvals reveals that most such agents are integral to standard cancer treatment. Indeed, the more cogent question is whether accelerated approval can take place after phase 1. Given trialists’ ability to define patient subgroups with responsive tumors in phase 1 trials, I propose that for diseases lacking therapies that meaningfully extend survival, the FDA should set flexible standards permitting accelerated approval of new drugs after phase 1. These standards could be satisfied by the results of expanded and targeted phase 1 drug testing, as in the case of PLX4032. This strategy requires the early evaluation and validation of a companion biomarker for patient selection. Conceivably, non-targeted agents could also satisfy criteria for approval after phase 1. High response rates (>50%), high disease-control rates (>75%), and an acceptable toxicity profile in a biomarker-defined population of 75 to 100 subjects should be sufficient for acceler-

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ated approval if there’s a clear unmet need. Randomized comparisons with minimally effective treatments or placebo should not be required. Specific end points for early approval should be maximally flexible and adjusted according to the targeted disease and the effectiveness and toxicity of alternative therapies. More extensive study would be required for less effective or more toxic experimental agents. The post–phase-1 approval of new agents meeting these goals is highly unlikely to have significant negative consequences such as ineffective treatment or unforeseen, overwhelming toxic effects. Early approval would allow rapid general access to treatment, while further evaluation focused on defining optimal doses, schedules, and drug combinations; long-term benefits; toxic effects; and resistance mechanisms. When striking clinical results have been demonstrated in a sizable, readily identifiable patient population in phase 1, the journey to drug approval should not be prolonged. Disclosure forms provided by the author are available with the full text of this article at NEJM.org. From the Massachusetts General Hospital Cancer Center, Boston. 1. Miller FG, Joffe S. Equipose and the dilemma of randomized clinical trials. N Engl J Med 2011;364:476-80. 2. McClellan M, Benner J, Schilsky R, et al. An accelerated pathway for targeted cancer therapies. Nat Rev Drug Discov 2011;10:7980. 3. Sequist LV, Martins RG, Spigel D, et al. First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 2008;26: 2442-9. [Erratum, J Clin Oncol 2008;26:3472.] 4. Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010;363:809-19. 5. Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non–small-cell lung cancer. N Engl J Med 2010;363:1693-703. [Erratum, N Engl J Med 2011;364:588.] Copyright © 2011 Massachusetts Medical Society.

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Tapping the Unmet Potential of Health IT

Tapping the Unmet Potential of Health Information Technology Ann S. O’Malley, M.D., M.P.H.

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ealth information technology (HIT) holds promise for facilitating vast improvements in care and, ultimately, in the health of Americans,1,2 but achieving that potential remains a daunting task. A recent article in the Los Angeles Times described the new phenomenon of hiring computer-savvy undergraduate “scribes” to take notes for physicians during patient encounters and enter the information into electronic health records (EHRs) — a practice that suggests how far we must go to develop EHRs that clinicians will embrace. Of course, the most highly trained professional in the room need not be the one to enter data into the computer, especially during an emergency, but the perceived need for scribes and providers’ experiences using EHRs3 raise important questions about both the efficiency of care processes and the usability of current EHRs. Although EHRs laudably provide immediate access to patient data and electronic messaging functions, clinicians have been frustrated by the difficulty of using them to support care delivery and coordination.3 Transforming EHRs into effective clinical tools rather than a means of capturing information primarily for documentation and billing purposes will require progress on multiple fronts. Clinical processes must evolve so as to improve care and be more responsive to patients’ needs, and HIT’s capabilities must evolve along with them. HIT has particular potential in such areas as coordination of care, workflow efficiency and use of teams, clinical decision support, and population health management — all 1090

areas offering glimpses of both the potential and the challenges associated with improved HIT use. Few providers today, for example, can truly coordinate care — integrating care, in consultation with patients and their relatives and caregivers, across all of a patient’s conditions, needs, clinicians, and health care settings.2-4 Outpatient practices and inpatient facilities lack well-developed processes for exchanging information, both within their own walls and during care transitions. Poor care coordination negatively affects patients — particularly those with multiple chronic conditions who account for an overwhelming proportion of U.S. health care expenditures. HIT, especially if widely implemented, can facilitate coordination by making information electronically available at the point of care. As clinical care processes become more effective and efficient, they can inform new HIT capabilities that will better support coordination. For example, providers need to develop consistent notification processes to ensure timely communication about care transitions. Medical and nursing professional societies could work with HIT vendors to develop standardized notification procedures, which could be implemented through refined criteria for the “meaningful use” of HIT.5 HIT can also better support care coordination through the development of referral-tracking systems, improved approaches to reconciling patients’ medications, and expansion of “problem list” capabilities — to avoid cluttering of lists with redundant information, for example, and permit n engl j med 364;12

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sorting and searching of lists and linking of listed problems to relevant portions of progress notes, assessments, and treatment plans.3 In addition, improving care coordination and health outcomes requires teamwork. Taking into account each team member’s training, skill set, and expertise when delegating tasks and defining roles is critical to improving efficiency, for both primary care teams within a practice and interspecialty teams sharing patients’ care. HIT can support team-based care with tools enabling team members to identify patient care goals and document and monitor progress using a shared care plan. In outpatient practices, providers report that electronic messaging and notification of staff about patient care tasks facilitate communication about delegation and task completion. Electronic messaging can also enable real-time communication with specialists — if they’re on the same system — to determine whether a consultation is necessary.2,3 Coordinating care for patients with complex health conditions who see multiple physicians can also be supported by better HIT interoperability.3 The primary care team may be in the best position to coordinate a patient’s care, but it will often need information from other providers.4 Most current EHRs don’t adequately support data exchange across providers and settings, so practices communicate with outsiders primarily on paper.3 To support information exchange, EHRs must present data in standard ways, and separate organizations providing services for the same patient need to share information securely.

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The Health Information Technology for Economic and Clinical Health (HITECH) Act envisions the secure exchange of data across providers and settings occurring through the Nationwide Health Information Network, which will provide a common platform and protocols.5 Some states and communities are developing regional health information exchanges, but most are still in their infancy. It is hoped that these local and national efforts might eventually be linked. Some have raised concerns, however, about the sustainability of these exchanges absent a stronger business case to support them. Clearly, HIT alone cannot transform our health care system: financial incentives must be realigned to reward patient-centered care. Current fee-for-service reimbursement encourages EHR use for documentation of billable events rather than for tasks important to the quality of care, such as coordination. Payment innovations such as bundled payments and accountable care organizations aim to encourage providers to share accountability for outcomes. Such payment reform would offer clinicians incentives to demand HIT capabilities that better support the clinical tasks required to improve patients’ health and would make these activities important to the success of health care organizations. Fee-for-service reimbursement also makes it difficult for clinicians to take the time to listen to patients’ concerns. Unfortunately, adding an EHR to the clinical encounter can further distract clinicians from patients (which is one of the reasons that some emergency departments use scribes). To counter this tendency,

Tapping the Unmet Potential of Health IT

payment reform could be accompanied by training for clinicians, residents, and medical students in effective communication with patients in the presence of an EHR. HIT can also provide tools to help inform decision making with regard to diagnosis (with clinical prediction rules), prevention (reminders), disease management (registries), and treatment (electronic prescribing tools).2 The use of computerized medication orders, generated with the help of decision-support tools, is associated with reductions in adverse drug events.2 But most current commercial EHRs don’t provide or link to decision-support systems, particularly for managing chronic care or selecting preference-sensitive treatments. To permit the development of adequate decision-support tools, the evidence base must be expanded and actively maintained. Finally, primary care practices increasingly must focus not just on individual patients but on whole populations, as they strive to function as medical homes.2 A new orientation and effective methods for shifting practices from reactive and acute-symptom care to approaches including proactive, planned care for both healthy and chronically ill populations will be needed. Without HIT, it’s difficult to provide effective population-based care and report quality metrics, but most commercial EHRs currently cannot help identify which patients in a population may need particular services. Registries are another critical tool for population health management and an area where HIT applications could be better developed and integrated with EHRs. Regardless of HIT’s potential advantages, clinicians in the coun-

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try’s many small primary care practices can be overwhelmed by it and will need to be convinced that EHRs are affordable, enhance efficiency, and improve care. Then, they will need extensive, ongoing support. Under HITECH, HIT Regional Extension Centers will provide technical assistance, guidance, and information on EHR adoption and meaningful use, particularly to such practices.5 These centers could also compile clinicians’ feedback for policymakers and vendors, providing an infrastructure for shared learning. Unfortunately, the United States currently lacks an adequately trained workforce to support practices in these areas. Continued research on clinical care processes, the design and use of HIT, and payment reform, as well as ongoing support for clinicians, will be key to the effective and meaningful use of HIT. Today’s EHRs do not sufficiently support aspects of care delivery that are vital to improving care and controlling costs. Disclosure forms provided by the author are available with the full text of this article at NEJM.org. From the Center for Studying Health System Change, Washington, DC. 1. Goldzweig CL, Towfigh A, Maglione M, Shekelle PG. Costs and benefits of health information technology: new trends from the literature. Health Aff (Millwood) 2009;28: w282-w293. 2. Bates DW, Bitton A. The future of health information technology in the patient-centered medical home. Health Aff (Millwood) 2010;29:614-21. 3. O’Malley AS, Grossman JM, Cohen GR, Kemper NM, Pham HH. Are electronic medical records helpful for care coordination? Experiences of physician practices. J Gen Intern Med 2010;25:177-85. 4. Stille CJ, Jerant A, Bell D, Meltzer D, Elmore JG. Coordinating care across diseases, settings, and clinicians: a key role for the generalist in practice. Ann Intern Med 2005;142: 700-8. 5. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med 2010;363:501-4. Copyright © 2011 Massachusetts Medical Society.

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Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD Claus Vogelmeier, M.D., Bettina Hederer, M.D., Thomas Glaab, M.D., Hendrik Schmidt, Ph.D., Maureen P.M.H. Rutten-van Mölken, Ph.D., Kai M. Beeh, M.D., Klaus F. Rabe, M.D., and Leonardo M. Fabbri, M.D., for the POET-COPD Investigators*

A BS T R AC T BACKGROUND

Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-tovery-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β2-agonist salmeterol in preventing exacerbations of COPD. METHODS

In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 µg of tiotropium once daily with that of 50 µg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year. RESULTS

A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P

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