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Are the patients who consent to random to DSM-IV 296 order 400mg indinavir with mastercard. This assignment representative of the entire group of patients in restriction was intended to reduce the possibility of a selec- routine practice buy indinavir 400mg mastercard, or are they different in some important tion bias if the patients chosen to receive the newest medica- way? Relatively little attention has been paid to this issue tions were more refractory as a group than patients chosen in depression research discount 400 mg indinavir with amex, although in one study, the patients to receive more established medications. This possibility participating in a randomized trial of depression had signifi- may still have influenced the analysis because in subsequent cantly fewer comorbid diagnoses than did excluded patients studies, it was found that some patients with 'single-epi- and were more likely to have a single episode of depression sode' depression had had previous episodes that were (27). At present, only two prospective pharmacoeconomic The fourth study in Table 78. The initial report study, the time horizon (1995 through 1996) was 3 to 4 fromthe first study included data up to 6 months after years after the launch of sertraline and paroxetine. Patients were followed for 2 years after study found the three SSRIs to be equally cost-effective. Patients were enrolled fromparticipating pri- other newer non-SSRI antidepressants are similar to SSRIs mary care clinics in a large HMO in the United States. Patient out-of-pocket copayment prescription expenses The retrospective database method may be especially vul- were waived. Patient identification depended on primary nerable to publication bias. Because the retrospective studies care physician referral. Physicians were asked to refer pa- are inexpensive in comparison with prospective trials, and tients whomthey were starting on an antidepressant for because the number of potential study sites is large, the depression when both patient and physician were willing possibility is greater with retrospective studies that multiple to consider randomassignment. Of 621 patients referred, analyses are conducted but only a limited number pub- 579 (93%) were eligible, and 536 (93%) consented and lished. At baseline, 67% of randomized patients met DSM-III-R criteria for major depression; the remainder met criteria for either minor depression or dysthymia. The PROSPECTIVE COST-EFFECTIVENESS average score on the Hamilton Depression Scale at baseline TRIALS was below 14. Patients were randomly assigned to receive fluoxetine (N 173) or the commonly prescribed TCAs Prospective randomized cost-effectiveness experiments offer imipramine (N 182) or desipramine (N 181). After a potential 'gold standard' methodology for investigating randomization, the patients were free to switch antidepres- cost-effectiveness because of the internal validity arising sants. Evaluators but not patients or prescribing physicians fromthe randomization. In addition, they directly collect were blinded to the initial treatment assignment. The randomization per- ized patients were evaluated at baseline and at 1, 3, 6, 9, mits the investigator to ascribe any observed differences in 12, 18, and 24 months with measures of symptoms, quality cost-effectiveness among treatment groups to the treatment of life, and service utilization. The major difficulty with prospective randomized continuing on the original antidepressant was nearly 60% Chapter 78: Cost-effectiveness of the Newer Antidepressants 1133 for fluoxetine, less than 40% for imipramine, and approxi- the data provide no clear guidance in the initial selection of mately 30% for desipramine. At the 24-month follow-up, antidepressant medications and that patient and physician the proportion of patients continuing on the original antide- preference therefore provide an appropriate basis for treat- pressant was roughly 35% for fluoxetine and 10% to 15% ment selection. These data suggest a sub- Interestingly, this group conducted a retrospective data- stantial acceptability advantage for the SSRI over the TCAs, base analysis of patients during a similar period of time who at least when patients and prescribers are aware of the iden- did not participate in the randomized trial (47). However, the proportion of patients ingly, the cost-effectiveness results (Table 78. These data suggest that clusions may not apply to other practices. In particular, patients who find TCAs unacceptable generally agree to similar studies in psychiatric specialty practices are needed. Rates of symptoms The depression of patients in psychiatric specialty practices and quality of life showed similar improvement at all time is generally more severe, and the consequences of delay in points, although some evidence was found at or near the treatment response related to a need to switch medications trend level for the fluoxetine group to be slightly more im- and start over may be more worrisome. These data indicate The second randomized prospective antidepressant cost- that the clinical outcomes in actual practice are essentially effectiveness study was conducted in a primary care setting equivalent whether patients are initially assigned to an SSRI in France (2). If average improvement is slightly faster when major depression were randomized to sertraline (50 to 150 an SSRI is the initial choice, perhaps because fewer patients mg/d; N 122) or fluoxetine (20 to 60 mg/d; N 120) switch and start over, any difference is no longer apparent in double-blinded fashion for 6 months. The method of measurement with fluoxetine utilized more medical resources. Analyses of adverse effects is not described in detail. Differences in comparing groups in regard to work and productivity losses adverse events between the groups were not reflected in the were not significant. Cost comparisons (converted to dol- measures of quality of life. Outpatient costs and inpatient COSTS OF AVERTING SUICIDE medical and inpatient psychiatric costs were lower, although not significantly so, in the fluoxetine group ($1,750 vs. Suicide is fortunately a fairly rare event, even in depressed $2,008 for imipramine and $2,238 for desipramine during patients (48,49). As a result, many cost-effectiveness studies the first 6 months and $6,092 vs. We touch on and $6,381 for desipramine for the entire 24 months).
Both types of isotopes can be used to label ligands for human brain: (a) morphology [computed tomography (CT) specific receptor 400 mg indinavir otc, transporter indinavir 400mg with visa, or enzymatic systems to be and magnetic resonance imaging (MRI)];(b) electrical and used with PET or SPECT to quantify these parameters in living human brains buy 400mg indinavir with mastercard. In addition, PET tracers such as [18F] magnetic signals [electroencephalography (EEG) and mag- or [11C]-labeled deoxyglucose (FDG, CDG) and [15O]-la- netoencephalography (MEG)];(c) neurotransmission [posi- tron emission tomography (PET) and single photon emis- beled water can be used to measure regional brain glucose sion computed tomography (SPECT)];(d) tissue metabolism and cerebral blood flow (CBF), and SPECT tracers such as 99mTc hexamethylpropyleneamineoxime composition [magnetic resonance spectroscopy (MRS)]; and (e) blood flow and metabolism [functional MRI (HMPAO) can be used to measure CBF. This information can be used to obtain images that reflect This chapter focuses mainly on the application of PET, brain structure, brain function, or chemical composition. SPECT, and MRI for the investigation of the effects of Information on structure in the brain can be obtained on drugs of abuse in the human brain and their relationship the basis of differences in chemical composition between with their reinforcing, addictive, and toxic effects. For structural brain imaging, this is description of these imaging techniques follows. Information on detect and measure the spatial distribution and movement brain function is derived from the differences in magnetic of radioisotopes in tissues of living subjects. PET measures properties of oxygenated versus deoxygenated hemoglobin compounds labeled with positron emitting radioisotopes (blood oxygenation-dependent or BOLD contrast). During and SPECT with single photon emitting radioisotopes. An activation of a brain region, an excess of arterial blood is advantage of the positron emitters is that some of these are delivered into the area, with concomitant changes in the isotopes for the natural elements of life (11C, 15O, 13N), and ratio of deoxyhemoglobin to oxyhemoglobin. Concentra- this feature enables labeling of compounds without affecting tion on a wide variety of compounds that reflect metabolic their pharmacologic properties. Although labeling an or- state of the tissue and cell integrity can be obtained with ganic compound with a single photon emitter such as 123I MRS. MRS can also be used to measure the concentration and metabolism of compounds such as 13C-glucose. The positron emitters used for which can be done using imaging modalities that measure imaging have shorter half-lives than the single photon emit- electrical activity, CBF, or brain metabolism. Of the modali- ties used for functional imaging, fMRI has the highest spa- tial resolution. Conversely, MEG and EEG are the imaging technologies with the highest temporal resolution, which Nora D. Volkow: Medical Department, Brookhaven National Labora- enables the examiner to assess the temporal displacement tory, Upton, New York. Fowler: Chemistry Department, Brookhaven National Labora- of activation signals as they propagate in brain on the order tory, Upton, New York. IMAGING MODALITIES USED TO INVESTIGATE THE LIVING HUMAN BRAINa Parameter Temporal Spatial Measured Resolution Resolution Sensitivity MEG Function 1 ms 5 mm EEG 1 ms 10–15 mm CT Structure ms MRI Structure ms 1. Research instruments have been developed that have better performance. CT, computed axial tomography; EEG, electoencephalography; MEG, magnetoencephalography; MRI, magnetic resonance imaging; PET, positron emission tomography; SPECT, single photon emission computed tomography. The effect of drugs of abuse on neurotransmission has thus can provide information on potential organ toxicity. PET and SPECT have the highest sensi- has been evaluated with PET. Co- PHARMACOLOGIC PROPERTIES OF DRUGS caine and MP were found to have a large brain uptake (7% OF ABUSE IN THE HUMAN BRAIN to 10% injected dose) and to have an almost identical pat- tern of distribution in the human brain, where they bound The investigation of the pharmacologic properties of drugs entails studies of their pharmacokinetics (primarily using PET and the [11C]-labeled drug) as well as their pharmaco- TABLE 103. DRUGS WITH ABUSE LIABILITY THAT dynamics (using PET or SPECT and a radiotracer with HAVE BEEN LABELED WITH A POSITRON EMITTER specificity for a particular molecular or biochemical target (CARBON-11) or using PET, SPECT, and fMRI to assess brain function). Drug Class Specific Drug Reference or Review Because these studies are done in awake human subjects, one can investigate the relationship between the behavioral Psychostimulants Cocaine 5,6 effects of drugs and their effects on brain function and neu- Methylphenidate 113 Metamphetamine 114 rochemistry. Opiates Morphine 115 Heroin 115 Codeine 115 Pharmacokinetics Buprenorphine 116 Methadone 117 PET can be used to measure the absolute uptake, their re- Cannabinoids THC 118 11 Nicotine Nicotine 119–120 gional distribution, and the kinetics of [ C]-labeled drugs Caffeine Caffeine 112 in the human brain. Moreover, the labeled drug can also LSD LSD 121 be used to determine the target organs for the drug and Chapter 103: Application of Imaging Technologies in Drug Addiction 1477 rate of drug clearance is relevant in their reinforcing effects. In the case of cocaine, the fast rate of clearance enables repeated, frequent administration that is characteristic of cocaine bingeing (cocaine is taken every 15 to 30 minutes), whereas for MP, its relatively slow clearance from brain is likely to produce accumulation and toxicity that thus pre- vents frequent repeated administration. Pharmacodynamics Multiple parameters pertaining to the mechanisms of action of the drug of abuse can be investigated with imaging. These include measurement of the efficacy of the drug of abuse at the molecular target that is associated with the reinforcing effects of the drug of abuse (i. These parameters can be assessed both in nonaddicted control subjects and in ad- FIGURE 103. Left: Images at the level of the striatum obtained dicted patients to determine whether there are differences with [11C]cocaine and with [11C]methylphenidate at different in the responses between them. Right: Time activity curves for radiotracer concentration in striatum and temporal course for the 'high' expressed as a percentage from peak after pharmacologic doses of intravenous cocaine (upper panel) and of intravenous methylphenidate (lower panel).
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