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Not examination of the one alternate therapy most likely to explain discontinuation rates of ACE inhibitors, the most logical therapeutic alternative to ACE inhibitors, the angiotensin II receptor blockers ARBs ; . For the other 2 drug classes studied, proton-pump inhibitors PPIs ; and statins, the results of implementation of 3-tier copay designs were inconsistent among the 2 employer groups and their matched comparisons. There was a higher rate of discontinuation of statins for employer 1 versus its comparison P 0.04 ; but not for employer 2 and its comparison P 0.45 ; . There was a higher rate of discontinuation of PPIs for employer 1 versus its comparison P 0.001 ; but not for employer 2 versus its comparison P 0.79 ; . Part of the reason for these apparently disparate findings may lie with the magnitude of the copays and the type of change. Beneficiaries of the employer 1 drug plan were converted from a single-tier copay $7 for generic or brand-name drug for community pharmacy ; to a 3-tier copay design community pharmacy copayments of $8 for generic, $15 for preferred brand drugs and $30 for nonpreferred brand drugs ; compared with a comparison group with an unchanged 2-tier plan of $8 copay for generic drugs and $15 copay for brand-name drugs. Beneficiaries in employer 2 were confronted with a smaller magnitude and extent of change, transitioned from a 2-tier plan of $6 copay for a generic drug and $12 for a brand-name drug to a 3-tier plan design with the same copays for tier-1 and tier-2 drugs and simply the addition of a third-tier copay of $24 for nonpreferred drugs. The comparison group for employer 2 had an unchanged 2-tier plan design of $6 and $12. Some consumer research suggests that copay differences of as much as $35 per prescription are necessary to influence consumer behavior in use of PPIs, 16 a dollar amount more than twice the tier-3 copayment "penalty" in the 3-tier drug benefit designs in this study of PPIs, ACE inhibitors, and statin drugs. So, there is much that remains to be answered about the effects of 3-tier drug benefit copay designs on clinical, service-humanistic, and cost outcomes. The important and useful answers will come from carefully designed studies, but even these results will require interpretation since drug formularies upon which 3-tier copay plans are based differ markedly in content from one managed care organization to another. For example, the inconsistent and even contradictory results in the recent study might be explained, in part, by characteristics unique to the study population. The formulary of the pharmacy benefit manager PBM ; contained only 2 statins in tier 3 throughout the study, fluvastatin and lovastatin, and the latter became available by generic name in the middle of the study period. Readers might be better able to judge the importance of this variable if the authors had disclosed the actual patient counts for each of the 3 statin drugs in tier-3, one of which Mevacoe ; became available by generic name in December 2000, the midpoint of the study period, and cerivastatin Baycol ; , which changed tier-copay status from nonformulary tier-3 copay ; to formulary status tier-2 copay ; in October 2000, also in the midpoint of the study period. Baycol was withdrawn from the market in August 2001, about 5 months prior to the completion of the and maxalt.
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Ommendations is included in the ncep atp III guidelines, which are accessible through the National Heart, Lung, and Blood Institute Web site: : nhlbi.nih.gov guidelines. Specific recommendations include reducing total fat to no more than 35% of the total daily caloric intake; reducing saturated fat intake to less than 7% of the total calories consumed daily; reducing dietary cholesterol to less than 200 mg day; increasing intake of plant sterols stanols and soluble fiber to enhance ldl reductions; weight reduction through reduced caloric intake; and, last but not least, exercise. For patients who experience elevated triglyceride and or cholesterol levels while receiving a protease inhibitor-based regimen, there has been a significant amount of research indicating that switches to regimens that do not contain protease inhibitors are beneficial. As was reviewed in an article focusing on the metabolic effects of switching antiretrovirals, published in the September 2001 issue of The prn Notebook, regimens employing nevirapine, efavirenz, or abacavir as their therapeutic backbone are useful switch options to consider. A switch to a nevirapine-containing regimen has been shown to reduce both triglycerides and total cholesterol and to raise hdl cholesterol; dropping a protease inhibitor in favor of efavirenz may result in additional triglyceride increases, but with increases in hdl cholesterol seen as well; and switching to an abacavir-based regimen has been shown to reduce both triglycerides and total cholesterol. Moving on to pharmacologic interventions, hmg CoA reductase inhibitors "statins" ; are recommended by the ias-usa for the management of hypercholesterolemia [see Table 2]. However, they should be prescribed with caution, given the documented likelihood of cyp 3A4 interactions with the protease inhibitors and the non-nucleoside reverse transcriptase inhibitors. Simvastatin Zocor ; and lovastatin Mevaacor ; are generally contraindicated in patients receiving protease inhibitors. Atorvastatin Lipitor ; is a possibility, though the starting dose should be reduced and then titrated, if necessary, to achieve the desired cholesterollowering effect. Conversely, standard doses of pravastatin Pravachol.
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These data demonstrate that a catalytic antibody raised to a transition-state analog of cocaine hydrolysis is able to increase the rate of cocaine degradation in vivo, protect against cocaine's lethal effects, and block its reinforcing effects. The potential usefulness of an effective anticocaine therapeutic can be inferred from two decades of experience with the pharmacologic treatment of heroin addiction. Heroin treatment programs that employ both counseling and methadone report abstinence rates between 60% and 80%, in contrast to 10% and 30% for programs that rely strictly on nonpharmacological approaches. In contrast to methadone, which is itself addictive, a catalytic antibody would not be expected to enter the brain and therefore would not be psychoactive. Whereas simple blockers of heroin such as naltrexone are useful for treating opiate overdose, they are not generally useful in treating addiction because the blocker requires daily administration, is easily discontinued, and rapidly clears. Thus, were an analogous blocker of cocaine developed, as a small molecule it would also likely be short-lived in vivo and, in the absence of a depot formulation, of limited utility for addiction. In contrast, natural antibodies have plasma half-lives of 3 weeks and a humanized mAb with a half-life sufficient for a dosing interval of several weeks would provide an appropriate treatment for a population prone to recidivism and relapse. The incidence of emergency room presentation for cocaine overdose in the United States is 80, 000 cases per year, and cocaine-related deaths exceed 3, 000 per year 1 ; . In contrast to the treatment of heroin overdose, the treatment of cocaine overdose is a more tenuous proposition due to cocaine's relatively short plasma half-life, 2040 min vs. 46 hr. Thus, cocaine's toxicity frequently manifests early and many patients expire before obtaining medical attention. Nevertheless, an anticocaine catalytic antibody could be a useful emergency room therapeutic for the subset who present with serious complications such as seizures and arrhythmias. Of note, we chose a simple overdose model based on pretreatment with antibody for this first demonstration of principle, and further assessment in a post-treatment model of cocaine overdose will be required. Since our original report on anticocaine catalytic antibodies 11 ; , others have described variations on the concept of.
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