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Форум » Информационный центр » FAQ » WarcraftTFT v 1.22;1.21;1.20 (Как поменять версию)
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The acquisition of relevant data to elucidate the benefit–risk ratio in the target population requires more than merely balancing the absolute numbers of patients. Depending on the drug's profile and the target population, investigators will face a learning curve with regard to acquiring data and modulating risk for patients who might be more susceptible to adverse outcomes, such as frail patients or those taking multiple medications. In designing a strategic plan for drug development, it will be important to engage in a dialogue with regulators to ensure that the needs and requirements of older patients are considered. Investigation of population pharmacokinetics or a specific pharmacokinetic study including the very elderly should be performed and will help inform prescribing. Modeling and simulation can offer powerful tools for quantitatively evaluating differences in pharmacokinetics and pharmacodynamics, recommending dosing regimens, and identifying patients at risk. Some of the lessons learned from the experience in pediatric clinical trials can be applied to the older population; heterogeneity can, in some measure, be allowed and analyzed in clinical-trial design both before and after market authorization.
In France, a centralized body makes reimbursement decisions after assessing the safety and effectiveness of individual devices. Reimbursement decisions in Italy are devolved to the various regions, and Britain and Germany conduct broader assessments of device types or procedures, rather than of individual devices. Typically, innovative devices not covered under an existing diagnosis-related group (DRG) require review under the lengthier Health Technology Assessment process, which assesses safety, clinical benefit, and cost-effectiveness. Government-provided information on time to reimbursement varies by country. Estimated time frames are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in Britain.
The use of data extrapolation for the approval of Budeprion XL 300 mg should be considered in historical context. When applications for generic versions of Wellbutrin XL 300 mg began to come under FDA review in 2005, more than 11 million prescriptions for the brand-name product were being written each year. Programs to develop generic bupropion products, and the requisite bioequivalence studies, were important for addressing the widespread need for the treatment of major depressive disorder. At the same time, the FDA and sponsors recognized that bupropion conferred a dose-related risk of seizures, which the agency believed warranted a conservative approach to bioequivalence testing of bupropion in healthy volunteers. Bioequivalence studies that used only the lower strength (150 mg) reflected this conservative approach.
To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see tableComparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.
Each year in the United States, nearly 500,000 infants — 1 in every 8 — are born prematurely, before 37 weeks of gestation. Despite substantial advances in their care, premature infants face a daunting array of challenges; they are at high risk for death in infancy and face severe and lifelong health problems if they survive.1 The National Institutes of Health (NIH) has a legal and moral responsibility to do research in partnership with scientists and families to optimize the care of these highly vulnerable infants. In recent weeks, a major public debate has arisen regarding a study designed to do just that. And the ramifications go well beyond this one study: the outcome of this debate could affect how we conduct and communicate about critical research on interventions that are within the standard of care for all diseases and conditions.
In a 2012 observational study involving Tennessee Medicaid patients, Ray et al.1 quantified the risk of death from cardiovascular causes associated with azithromycin as compared with other antibacterial drugs or nonuse. The study showed that the risks of death, both from any cause and from cardiovascular causes, associated with azithromycin were greater than those associated with amoxicillin. For every 21,000 outpatient prescriptions written for azithromycin, one cardiovascular death occurred in excess of those observed with the same number of amoxicillin prescriptions. The excess risk over amoxicillin varied considerably according to cardiovascular risk factors; the researchers estimated that there was one excess cardiovascular death per 4100 prescriptions among patients at high cardiovascular risk but less than one per 100,000 among patients with lower cardiovascular risk.
The risks and benefits of antibacterial therapy should be considered in prescribing decisions. Pharmacologic and epidemiologic data point to lethal arrhythmias as a potential consequence of QT-interval prolongation with use of azithromycin, other macrolides, and fluoroquinolones. This possibility should give clinicians pause when they're considering prescribing antibacterial drugs, especially for patients with preexisting cardiovascular risk factors or clinical conditions in which antibacterial drug therapy has limited benefits.
In the Federal District Court in Boston a few days later, GSK pleaded guilty to two criminal counts for sales of misbranded Paxil (paroxetine) and Wellbutrin (bupropion). These drugs are considered misbranded when they are promoted for indications for which they have not been approved by the Food and Drug Administration — the practice commonly known as off-label promotion. Providers cannot be reimbursed for misbranded drugs under federal and state rules. GSK also pleaded guilty to a third crime, failing to report safety data related to Avandia (rosiglitazone). Failing to report safety data violates the Food, Drug, and Cosmetic Act and leads to serious questions about whether clinicians are basing their decisions on the best evidence. GSK also settled related civil liabilities for these and other drugs.
Even when inclusion and exclusion criteria are set adequately, clinicians and ethics review boards often act as gatekeepers in the recruitment process, creating a selection bias by allowing enrollment of only some of the eligible patients. They are particularly likely to exclude the “older old” and patients with coexisting conditions. Again, every effort should be made to gather evidence in these patients during the premarketing period of drug development. Regulatory guidance for these patients is often lacking, and more work is needed to strengthen the guidance on expectations concerning such patients when guidelines are drafted or revised.
The other major difference observed between Budeprion XL 300 mg and Wellbutrin XL 300 mg was in the time to peak drug concentration in the blood (Tmax) (see graph). Although FDA guidance does not include Tmax as a criterion for bioequivalence of bupropion hydrochloride products, the Tmax for Budeprion XL (4 hours) is shorter than that for Wellbutrin XL (5 hours). A similar difference in Tmax values was also observed in the bioequivalence study of the 150-mg products that was originally used for extrapolation of data for Budeprion XL 300 mg. But because the comparative area-under-the-curve and Cmax values for the 150-mg products fell within FDA parameters and were supported by data on the performance of the product in vitro, Budeprion XL 300 mg was approved.
One must, of course, weigh any observed drug-associated risk against clinical benefits, so it's appropriate to consider the possibility that certain offsetting benefits of azithromycin may not have been reflected in the risk data analyzed by Ray et al. For example, other studies have suggested that macrolides have an advantage over other antibacterial agents in terms of overall survival from community-acquired pneumonia. In a recent Canadian observational study, researchers followed 2973 outpatients with community-acquired pneumonia and found significantly lower 30-day mortality among patients receiving macrolides than among those receiving fluoroquinolones (adjusted odds ratio, 0.28; 95% CI, 0.09 to 0.86).2 A recent meta-analysis of observational studies showed a statistically significant 25% difference in mortality among hospitalized patients with community-acquired pneumonia favoring macrolides over nonmacrolide antibacterials.3 Such findings, which must be considered with due regard for the limits of observational studies, do not necessarily contradict the results of Ray et al. Past the 5-day period of risk of azithromycin-associated cardiovascular death, the drug might reduce the longer-term (e.g., more-than-30-day) rate of death due to pneumonia. Pneumonia was an uncommon indication among the Tennessee Medicaid patients treated with azithromycin.
Regulators must ensure that the development and evaluation of drugs take into account global demographic changes, so that safe and effective drugs reach the patients who ultimately use them.
The NIH is committed to ensuring that prospective research participants — and the people who speak for and love them — are given clear, complete, and accurate information about the risks and benefits of participating in research. We are strongly committed to supporting critical research studies like SUPPORT, which inform clinical care by providing rigorous evidence for use in daily practice. This controversy has alarmed some of the parents of infants who were in the study, confused the biomedical research community, and befuddled IRBs. Several other studies seeking new insights to improve care for these vulnerable infants have been put on hold as the field tries to understand the OHRP findings.
It's important to provide adequate information to patients and prescribers. That's impossible if there are no good data, but sometimes data included in a drug-development dossier are not adequately reflected in the approval documents. There must be greater focus on the package insert, the regulatory document most widely referred to by the public, which must do a better job of explaining how to take the medication, whether dosage adjustments are advised for older patients, and what is known about use with concomitant medications.
Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets (see figureComparison of Time to Market in Premarket Approval and Reimbursement Processes.). The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.
But controversies such as this are also an opportunity to advance shared understanding, provide clarification, and encourage progress. The public debate surrounding the SUPPORT study has set the stage for a substantive national dialogue with the research, advocacy, and ethics communities on how best to respect and protect participants in research studies conducted within the standard of care and how to define “reasonably foreseeable risks” in this setting. The timing is critical — the clinical research community, bioethicists, regulators, IRBs, and prospective research participants are paying close attention now. The NIH is happy to work with all stakeholders to advance this important dialogue and its translation into clear guidance, in accordance with the plan just announced by the DHHS (www.hhs.gov/ohrp/). In addition, a new letter to the University of Alabama at Birmingham from the OHRP, stating its intention to put all compliance actions on hold until the process of producing appropriate guidance is completed, is available now on the OHRP website (www.hhs.gov/ohrp/detrm_letrs/YR13/jun13a.pdf).
A new study by Svanström and colleagues (pages 1704–1712), using Danish national health care data, found no difference between azithromycin and penicillin V in the 5-day risk of cardiovascular death (relative risk, 0.93; 95% confidence interval <CI>, 0.56 to 1.55). However, the upper bound of the 95% confidence interval does not exclude an increased risk of as much as 55%. As Svanström et al. point out, the population they studied differed from that studied by Ray et al. with respect to the baseline risk of death and cardiovascular risk factors. Overall, the Danish patients had better cardiovascular health than the Tennessee Medicaid patients. In a subgroup analysis of patients with a history of cardiovascular disease, the risk ratio for azithromycin versus penicillin V was greater than 1, though the difference was not statistically significant (relative risk, 1.35; 95% CI, 0.69 to 2.64). Svanström et al. conclude that their results do not conflict with those of Ray et al. Rather, the effect on cardiovascular mortality may be limited to patients with cardiovascular disease.
Depending on patients' frailty and disability status, the desirable outcome and treatment choices might vary: different patients place different values on benefits and risks. Certain adverse events, such as dizziness leading to falls, may be of greater importance in the geriatric population. The design of a clinical trial should consider age-appropriate end points; for older people, functional outcomes may be most important, and an emphasis on such outcomes could lead to reduced costs for health care systems.
Kefauver initially stuck to his guns on issues of compulsory licensing and patents, but his persistence ultimately cost him control of his own bill. In June of 1962, officials from the Kennedy administration and the pharmaceutical industry presented the subcommittee with an alternate bill — with no regulatory language about patents included. Kefauver cried foul, the Kennedy administration eased off its support, and S.1552 seemed to all observers to be a dead letter. It was only by chance timing that the summer of 1962 also produced a highly visible tragedy (thalidomide), a hero (Frances Kelsey), and enough ensuing public outcry to persuade Kefauver and Kennedy to embrace the gutted bill.
Clinicians must consider the arrhythmogenic potential not only of azithromycin but also of potential alternative antibacterial drugs. An earlier study showed an association between the use of erythromycin and sudden cardiac death, augmented by concomitant use of inhibitors of the cytochrome P-450 3A isozymes that metabolize erythromycin.4 Labels for erythromycin and clarithromycin include warnings regarding QT-interval prolongation and arrhythmias. All labels for fluoroquinolone products similarly have warnings regarding QT-interval prolongation, and grepafloxacin was withdrawn from the market because of that risk. A recent observational study of elderly residents of Quebec, Canada, showed an association between outpatient fluoroquinolone use and serious arrhythmias (as defined by hospital discharge diagnoses of ventricular arrhythmia or sudden or unattended death).5 And although Ray et al. found the risk of cardiovascular death to be greater with azithromycin than with ciprofloxacin, they found the risk with levofloxacin similar to that with azithromycin. The authors interpreted this similarity as evidence that levofloxacin may be proarrhythmic; however, levofloxacin was not implicated as proarrhythmic in the Canadian study.

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