People have had difficulty obtaining these drugs on NHS prescription from as early as 1997 when donepezil became available in the UK, with people in some areas suffering from `postcode prescribing'. In 2001, the National Institute for Health and Clinical Excellence NICE ; in England and Wales recommended that the NHS fund treatment for Alzheimer's disease drugs and the Health Technology Board for Scotland HTBS ; issued similar recommendations. In late 2002, memantine was launched in the UK but, following a decision in early 2004 by the Scottish Medicines Consortium, it was not recommended for use in Scotland, although it was available in England until the recent decision. More recently, NICE conducted a costeffectiveness appraisal of all four drugs. After much opposition it announced in late 2006 that donepezil, galantamine and rivastigmine should in future only be made available on the NHS to treat those with moderate Alzheimer's disease. NICE also recommended that memantine should not be used to treat people with moderately severe to severe Alzheimer's disease except as part of a clinical trial. Although the NICE decision applies to England and Wales, the relevant body in Scotland, NHS Quality Improvement Scotland NHS QIS ; , has.
Make sure you tell your doctor if you have any other medical problems, especially: asthma or history of ; or blockage in the intestines or stomach, or heart problems, including slow heartbeat or hypotension low blood pressure ; , or stomach ulcer or history of ; or urinary tract blockage or difficult urination— rivastigmine may make these conditions worse epilepsy or history of seizures or diabetes, hormone, or thyroid problems that are poorly controlled— rivastigmine may cause seizures back to top proper use take this medicine only as directed by your doctor!
Rivastigmine was not genotoxic in three in vitro assays: the ames test , the unscheduled dna synthesis uds ; test in rat hepatocytes a test for induction of dna repair synthesis ; , and the hgprt test in v79 chinese hamster cells.
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Clinical professor of pharmacy practice, temple university school of pharmacy, philadelphia, pa; clinical consultant, episcopal hospital, philadelphia; and clinical advisor and trustee, institute for safe medication practices, huntingdon valley, pa 19006.
The injectable formulations of diazoxide and nitroprusside are primarily administered in an institution. Since they are not routinely dispensed in an outpatient pharmacy, these products were not included in this review and sertraline.
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Onto the weakly basic amino group at the C-7 position in 2a, a POM ester of CZX. AS-924, a bifunctional prodrug of CZX with an L-alanyl and POM moiety, showed a good log P value for absorption and the highest oral absorption among the prodrugs with other amino acids. The log P value was too low in compounds with glycyl and L-lysyl moieties 4g, 4l ; , and too high in compounds with L-leucyl and L-isoleucyl moieties 4j, 4k ; . In the CZX ester with a L-valyl moiety 4i ; , oral absorption was not increased despite an appropriate log P value and water-solubility. Therefore, factors other than lipophilicity and water-solubility appeared to influence its absorption. Prodrugs are required to be converted to their parent compounds at the appropriate place and time during and or after absorption. Compound 4i was resistant to hydrolysis in rabbit intestinal homogenate. The UR values of the bifunctional prodrugs, in which Lalanine was introduced to the various esters of CZX showed a parabolic correlation to log P. The log P value of AS-924 was closest to the calculated optimal values for absorption among the prodrugs examined. At all log P values, the UR values of bifunctional prodrugs were higher than those of the corresponding monofunctional prodrug, clearly indicating that introduction of an L-alanyl moiety improved the oral absorption by increasing the water-solubility Fig. 2 ; . In rabbits, AS-924 showed a higher UR value after oral administration than CFTM-PI and CTM-HE, both orally active cephalosporins used clinically. Drugs given orally as a form of tablets or capsules are absorbed via disintegration and dissolution. Thus, the water-solubility of the drug is an important factor in oral absorption when drugs are administered to patients as pharmaceutical dosage forms. Indeed, an improvement in oral absorption of the CZX ester by the Lalanyl moiety was more clearly demonstrated when administered using capsule in dogs Table 4 ; . In conclusion, a bifunctional prodrug method using an Lalanyl moiety was demonstrated to be applicable to parenteral cephalosporins bearing an aminothiazoleoxime moiety such as CZX. AS-924, a bifunctional prodrug of CZX with an L-alanyl and POM moiety showed a good balance of lipophilicity and water-solubility for oral absorption, and is expected to be efficiently and reliably absorbed when administered clinically as a pharmaceutical dosage form.
Outcome measures scoring ; , and assesses selected areas of cognitive impairment memory, language, orientation, reason and praxis ; . It was administered at screening, baseline and at weeks 4 and 12. The MMSE was undertaken at screening, baseline and weeks 4 and 12 by clinicians who had knowledge of the patients assigned medication Adverse events were assessed during clinic visits at weeks 4 and 12, and additionally at 2 and 6 for those receiving rivastigmine. In addition physicians performed telephone interviews with caregivers at weeks 6 donepezil ; and 8 rivastigmine ; for adverse events and compliance Satisfaction ease of use by Likert-type questionnaires at weeks 4 and 12 to physicians and caregivers. Questionnaire developed by Pfizer and Eisai in conjunction with an external consultant see below for scoring ; . Questions related to factors such as ease of use, satisfaction with dosing frequency, titration schedule and frequency of patient monitoring Length of follow-up: 12 weeks and sildenafil.
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Results Results of the analysis of workplace acetic acid using the passive SPME ; and active charcoal ORBO 32 ; methods are reported in Table 2. Using the Student's T-test for paired samples, there appears to be no significant difference between the two methods p 0.05 ; . Acetic acid levels in the air breathed by the workers ranged from 1.5 to 4.1 mg m3 mean 2.81.05 ; by the SPME method and 1.1 to 4.2 mg m3 mean 2.70.98 ; with the charcoal method. Of importance to the workers, all acetic acid values were well below the TLV-TWA of 25 mg m3 suggested by the ACGIH and simvastatin.
Tem to generate the prescription label and to bill third-party payers. The software also interfaces with Script-Pro 200, a robotic dispensing system that holds the clinic's 180 top-volume drugs. The decision to invest in the Script-Pro 2000 was also made to improve quality of care and financial performance. "Eliminating prescription filling errors and allowing our pharmacists to have more face-to-face contact with our patients was the driving force in moving to the robot, " says Brandenberg. "Nearly 75% of the medications that need to be counted and poured are now dispensed automatically, " Henriksen reports, noting that cough syrups and other liquid medications used for their large pediatric population can't be dispensed from the machine. The clinic pharmacy staff includes three technicians and 3.5.
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T HE -MOST effective diuretic agents which we have today, organic mercurial compounds, were introduced by German investigators in the early 1920's. These compounds are effective in promoting diuresis in over 90 per cent of edematous patients when given intravenously or intramuscularly. In recent years they have been found to promote satisfactory diuresis when given orally.2 The diuretic effect of mild mercurous chloride calomel ; has been recognized for many decades and used for this purpose in Addison's pill. Because its action was uncertain and because adequate dosage caused untoward effects such as diarrhea, stomatitis, albuminuria, and hematuria, the drug was not wholly satisfactory. The first clinically valuable organic mercurial compound, Novasurol, was introduced by Zeiler3 in 1917 for the treatment of syphilis. Linking mercury with an organic compound reduced the undesirable effects of mercury while preserving its antitreponemal action. In this form, it was found possible to give the drug parenterally. The strong diuretic action of the compound was soon observed, 4 but was unsuitable for general use because of its undesirable effect on the kidneys.5 In 1924, Bernheim6 introduced Salyrgan, a more powerful and sporanox.
By the DPC, now include memantine, which will be treated in the same way as donepezil, rivastigmine and galantamine, with the memory clinic prescribing for the first 3-4 months and continuing the mental state monitoring. 9. Accurate current prescribed information for consultants: Brian had been copied into an email from Lymington Hospital suggesting that it would be helpful for referring GPs to attach an up to date drug list for the patient to the referral letter. Task Group members reported that this was already common practice. 10. Support pharmacists in surgeries Trinity ; : Attention was drawn by Sally Aldridge to this company's activities. Specifically, the figures quoted by the company for practice savings were on occasions very inaccurate. Many Trinity products m r nsaids and twice daily nifedipine ; are not ones we wish to use anyway. It would be preferable to review such patients. Troinity's calcium supplement was unpalatable and many patients at Fordingbridge had had to be changed back. The Group again stated that it was not appropriate to give people from the industry access to practice computer systems. Where a company had a plan to assist practices it was preferable for them to provide financial support and for the practice or the Medicines Management team to arrange for the work to be carried out. Ivax has agreed this for practices wishing to switch to CFC-free beclometasone pressurised inhalers. GSK has a fairly aggressive approach to engaging practices in respiratory reviews which is not always helpful. 11. Draft NICE guideline for management of hypertension thiazide beta blocker combination. This was drawn to the Group's attention. It conflicts a little with current BHS guidelines for hypertension in that the combination of a thiazide and beta blocker is not recommended because of concerns over precipitating diabetes. The consultation continues for a week or so and the Group will be kept informed of the final guideline issued by NICE. 12. Date of next meeting: 22nd April at the Fenwick 13. AOB: There was none.
TREATMENT HISTORY OF PATIENT 17. 565 ; Which of the following prescription medications for Alzheimer's disease have you heard of? Read list. Select all that apply. [RANDOMIZE] Aricept donepezil. Exelon rivastigmine . Razadyne Reminyl galantamine . xx-1 -2 -3 and starlix.
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All teens should be encouraged to use a method for pregnancy prevention as well as condoms for protection against HIV STDs. Dual methods are recommended for all teens and are especially important for those adolescents who engage in high risk behaviors, such as having partner s ; with unknown HIV STD status, multiple partners and anal intercourse. In addition to teens sometimes failing to use their chosen contraceptive method, teens also experience forced sex. For teenage women in either of these circumstances, post-coital contraceptive methods have gained acceptance among adolescent health care providers. These methods include the use of combined oral contraceptive pills as emergency contraception EC ; or immediate IUD insertion. In 1996, the Food and Drug Administration concluded that some types of oral contraceptives can be safely and effectively used post-coitally. When used within 72 hours of unprotected intercourse, emergency contraception can reduce the risk of pregnancy by up to percent and thus prevents abortions and unintended births. 7. Include counseling in family planning services, especially with pregnancy testing. Research shows that teenagers can benefit from directive contraceptive education and counseling both before they become sexually active and after pregnancy. Nathanson, Becker, 1985 ; Although many providers usually offer the necessary information and encourage clients to make their own decisions regarding contraceptive choice, research shows directive or guided counseling to be highly helpful to teens, especially in choosing an appropriate method, anticipating complications, and addressing problems. Special medical history forms are helpful for directive counseling. Such forms address mental health concerns, relationships, violence, sexual abuse, substance use, and academic achievement. For example, the "TeenSMART Reproductive Health Questionnaire, " developed under the auspices of the California Office of Family Planning, which assesses medical, psychosocial, educational, and family-related concerns is one example Appendix E ; . Another example is the "Reproductive Health History" form from the National Adolescent Reproductive Health Partnership Appendix F ; . The Clinician's Guide to the Adolescent Reproductive Health History Form will assist the clinician in assessing the completed health history form to obtain a complete sexual history of the client Appendix G ; . The TeenSMART program uses enhanced counseling to strengthen clinical services for teens. The TeenSMART program helps teens make--and stick to--smart decisions about their sexual behavior. The program includes an STD pregnancy risk assessment using a self-administered questionnaire, an expanded counseling session, intervention planning, and a facilitated referral process. Counselors receive special training to deal with each specific area of concern, and clinics are compensated for spending additional time with each teen client. Approximately 50 family planning agencies throughout California have implemented the program which is currently undergoing evaluation. The TeenSMART Program cites the following as important elements for enhanced counseling services. Counselors should: involve teens as collaborators in identifying problem issues and in setting counseling priorities; identify and praise the teen's strengths and successes, rather than focus on behaviors which place him or her at reproductive health risk; actively assist teens to access appropriate community resources; and.
17 Ford AR, Bassett K, Batt S et al. 2004, Jan 22 ; . Complaint letter to Minister of Health regarding Pfizer "toe-tag" ad. whp-apsf en documents pfizerCampaign and sumatriptan.
1-136 Cognitive Enhancer Benefits TIPS Question: Is Aricept used to treat behaviour issues associated with dementia or just to maintain memory? If no significant changes have been made, should it be discontinued? Response: This is a most interesting question as it lets us go back to the Psychotropic Template. Looking at Aricept which is a cholenergic drug ; it was developed as a cognitive enhancer, i.e. improvement of memory. There is, however, research being conducted to examine other benefits. For example, cholenergic drugs have been found to have some benefit in people with apathy and attention difficulties. Still other research is looking at the benefit of the cholenergic drugs being used for behaviour. The actual possible benefit from a cognitive enhancer therefore has to be evaluated on multiple parameters. Often our Partners-in-Care i.e. friends and family who know the person better than we do, may be able to pick up more subtle improvements that care providers may miss. I have also had the experience of only knowing there was a positive effect this time on behaviour ; when the medication was decreased and behavioural problems emerged! There may be incidents when Aricept may actually precipitate increased confusion as an adverse side effect. Current research looking at cognitive enhancers is investigating other alternate uses including the use in Lewy Bodies Dementia to help relieve the distress caused by this illness. References: McKeith, I., Grace, J.B. , Walker, Z, Byrne, E.J., Wilkenson, D., Stevens, T. & Perry, E.K. rivastigmine in the treatment of dementia with Lewy bodies: preliminary findings from an open trial. Int. Journal of Ger. Psych. 15, 387-392 2000 ; . Also, visit: : mentalhealth fr30.
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Reviewed that assessed the efficacy of EGb 761, the patients with Alzheimer's disease had a mean improvement in ADAS-cog score of -0.6 points after daily doses of 120 mg EGb 761 for 26 weeks. The drug-placebo difference of 1.7 points in this study was in the lower range relative to that reported for high doses of rivastigmine 1.6 points ; and for 5 mg donepezil 1.5 points ; . It was concluded that the rate of cognitive decline in placebo-treated patients is not related to the therapeutic power of the tested drug, but rather to the characteristics of the study sample and the therapeutic environment. Thus, "direct numerical comparison of drugplacebo differences between studies is not a suitable tool for assessing the relative potencies of anti-dementia drugs." Furthermore, the data do not allow a "firm conclusion" to be made as to whether EGb 761 is more or less efficacious than are ChE inhibitors in the treatment of Alzheimer's disease. The best available evidence comes from comparisons that take into account the characteristics of the respective study samples, especially the rates of the decline of the patients receiving placebo. For example, Wettstein compared the efficacies of ChE inhibitors and EGb 761 by relating the drug-placebo differences to the rates of decline on placebo reported. "The times of delay of symptom progression so calculated were remarkably similar for all substances."1 --Brenda Milot, ELS.
Beth yw donepezil, rivastigmine a galantamine? and temovate and rivastigmine.
The drug may produce mild improvements in symptoms of thinking for a short period of time, but rivastigmine does not cure or stop progression of underlying diseases.
The rapid increase in plasma ACTH levels after iv cocaine administration was significantly correlated with plasma cocaine levels P 0.0001 ; . Pharmacokinetic analysis revealed that the tmax of plasma ACTH and cocaine levels after iv injection of 0.2 mg kg cocaine occurred at 7.3 1.2 and 6.0 1.4 min, respectively. Significant cocaine effects for induction of euphoria were observed 5 min after iv cocaine adminis and terbinafine.
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Alzheimer's disease AD ; . The S ; -enantiomer has a 10-fold affinity for brain G1 AChE and better The nitrogen in the trimethylamine moiety of rivastigmine was Nevertheless, the nitrogen in the assumed to be protonated in the physiological pH range.
Rivastigmine dose unclear ?612 mg ; , versus placebo.
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Numbers refer to their masses in kDa ; , have been characterized by a number of investigators for a review, see Ref. 31 ; . Until the present report, only FKBPl2 had any relevance to the immunosuppressive effects of FK-506 because the other FKBPs do not complex with CaN in thepresence of drug 32h3This has been confirmed in transfection experiments where FKBPl2 is the only FKBP whose overexpression in Jurkatcells results in increased sensitivity to FK-506 32 ; . Of the cyclophilins, at least four, CyPA, CyPB, CyPC, and CyP-40, have been reported t o bind CaN in thepresence of CsA 21, 33, 34 ; , and two, CyPA and CyPB, when overexpressed in Jurkat cells cause the cells to exhibit increased sensitivity to CsA 32 ; . Therefore, in contrast t o the FKBPs, several of the cyclophilins have potential relevance to either the immunosuppressive or toxic effects of CsA. While screening tissues brain and kidney ; pertinent to the toxicity of FK-506 for the presence and abundance of known FKBP and CaNisoforms, a novel12.6-kDa FKBP, named FKBP12.6, was identified. We report upon its purification and characterization. FKBP12.6 becomesthe second FKBP identified that, in the presence of FK-506, binds and inhibits CaN. Its amino acid sequence and biochemical characteristics demonstrate that FKBP12.6, of all theFKBP family members, is most closely related to FKBP12 and sertraline.
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Rivastigmine Exelon ; Anticonvulsants carbamazepine Carbatrol, Equetro, Tegretol XR ; divalproex sodium Depakote, Depakote ER ; ethosuximide gabapentin lamotrigine Lamictal ; levetiracetam Keppra ; oxcarbazepine Trileptal ; phenytoin Dilantin ; pregabalin Lyrica ; primidone tiagabine Gabitril ; topiramate Topamax ; valproic acid zonisamide Antidepressants Aminoketones bupropion IR & SR buproprion Wellbutrin XL ; MAOIs none phenelzine Nardil ; selegeline Emsam Patch ; tranylcypromine Parnate ; SNRIs venlafaxine venlafaxine XR Effexor XR ; SSRIs citalopram fluoxetine paroxetine sertraline TCAs amitriptylline desipramine doxepin imipramine nortriptyline Tetracyclics mirtazapine tabs & soltabs ; Triazolopyride trazodone Antipsychotics Atypicals clozapine olanzapine Zyprexa ; olanzapine Zyprexa Zydis ; olanzapine fluoxetine Symbyax ; risperidone Risperdal ; ziprasidone Geodon ; First Generation Antipsychotics & Misc. chlorpromazine molindone Moban ; aripiprazole Abilify ; quetiapine Seroquel ; risperidone Risperdal M-Tabs ; imipramine pamoate Tofranil ; protriptyline Vivactil ; trimipramine Surmontil ; escitalopram Lexapro ; fluoxetine Sarafem ; paroxetine Paxil & Paxil CR ; paroxetine mesylate Pexeva ; duloxetine Cymbalta ; carbamazepine Tegretol ; NTI rules apply- see Pharm. Manual Section 31.11 ethotoin Peganone ; felbamate Felbatol ; methsuximide Celontin.
From his January 3, 1999 visit to North Oaks Medical Center and acknowledged he had complaints of neck pain, back pain, and rib pain following the automobile accident on January 2, 1999. However, although the records also reflected that he.
2.1. Water for injection H2O redist. ; . Use of deionised water can disturb the test procedure. 2.2. Adjustable micropipettes. 2.3. Clean glass or plastic containers for dilution of Wash Buffer and specimen. 2.4. Suitable device for microplate washing e.g. multistepper or ELISA washer ; . 2.5. Incubator for 37 C.
The next line shows the location of the document within the hierarchy. This is known as a 'breadcrumb trail'. Home Martindale: The Complete Drug Reference Contents Preparations By Country Each entry in the breadcrumb trail acts as a link to a more general document, sub-section, or contents list. Tip: The Next link is also available at the bottom of the screen. Tip: Once you choose Hide highlighting, both that link and the Return to search link will disappear. If you then wish to check the results of your last search, use the Back button on your browser to return to the search results list. Selecting a document will highlight the search terms as usual.
14. Reed SD, Anstrom KJ, Bakhai A, Briggs AH, Califf RM, Cohen DJ, Drummond MF, Glick HA, Gnanasakthy A, Hlatky MA, O'Brien BJ, Torti FM, Tsiatis AA, Willan AR, Mark DB, Schulman KA. Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus. American Heart Journal 2005; 149 3 ; : 434-443. 15. Willan AR, Goeree, R, Pinto EM, McBurney C, Blackhouse G. Economic Evaluation of Rivastigmine in Patients with Parkinson's Disease Dementia. Pharmacoeconomics 2006; 24: 93-106. Palencia R, Gafni A, Hannah ME. Ross S, Willan AR et al. The costs of planned caesarean versus planned vaginal birth in the Term Breech Trial. CMAJ 2006; 174: 1109-1113. Willan AR, Briggs AH. The Statistical Analysis of Cost-effectiveness Data. Chichester UK: Wiley 2006. 18. Sofronas M, Ichord RN, Fullerton HJ, Lynch JK, Massicotte MP, Willan AR, deVeber G. Pediatric stroke initiatives and preliminary studies: what is known and what is needed? Pediatric Neurology 2006; 34: 439-445. Willan AR. Statistical analysis of cost-effectiveness data from randomized clinical trials. Expert Rev. Phamacoeconomics Outcomes Res. 2006; 6: 337-346. Manca A, Willan AR. Lost in translation": accounting for between country differences in the analysis of multinational cost effectiveness data. Pharmacoeconomics 2006; 24: 1101-1119. Eckermann S, Willan AR. Expected value of information and decision making in HTA. Health Economics 2007; 16: 195-209. Pullenayegum EM, Willan AR. Semi-parametric regression models for costeffectiveness analysis: improving the efficiency of estimation from censored data. Statistics in Medicine 2007; 26: 3274-3299. Willan AR. Clinical decision making and the expected value of information. Clinical Trials 2007; 4: 279-285. Hossain A, Willan AR. Approximate MLEs of the parameters of location-scale models under type II censoring. Statistics accepted for publication ; 25. Eckermann S, Willan AR. Time and EVSI wait for no patient. Value in Health. accepted for publication ; . 26. Boutis K, Willan AR, Babyn P, Narayanan UG, Alman B, Schuh S. A randomized, controlled trial of a removable brace versus casting in children with low-risk ankle fractures. Pediatrics 2007; 119 6 ; : e1256-e1263. 27. Willan AR, Kowgier ME. Cost-effectiveness Analysis of a Multinational RCT with a Binary Measure of Effectiveness and an Interacting Covariate. Health Economics accepted for publication.
Table B-1 Cont'd ; . Citation Wilcock et al., 2003 Wilkinson et al., 2002 Mossello et al., 2004 Areosa Sastre et al., 2004 Type of Study Double-blind RCT Rater-blinded, randomized open-label study Observational study Meta-analysis of 9 doubleblind RCTs, analyzed separately by dose & duration Meta-analysis of 2 doubleblind RCTs Meta-analysis of 12 doubleblind RCTs Intervention vs. Comparison Group Donepezil 5 or 10 mg day ; vs. galantamine 8 or 12 mg day ; Donepezil 10 mg day ; vs. rivastigmine up to 12 mg day ; Donepezil 5-10 mg day ; vs. rivastigmine 6 - 12 mg day ; Memantine 10, 20, 30 mg day ; vs. placebo Memantine 10 or 20 mg day ; vs. placebo Tacrine varied dosages ; vs. placebo Length of Study ies ; 52 weeks Population Studied Mild moderate dementia due to AD Mild moderate dementia due to AD Mild moderate dementia due to AD Mild moderate or severe dementia due to AD & or vascular disease Moderate severe AD Probable AD no severity info provided ; Location UK.
Alzheimer's drugs, nice proposes to withdraw from nhs the drugs donepezil aricept ; , rivastigmine exelon ; , galantamine remynil ; , and memantine ebixa ; should no longer be prescribed on the national health service nhs ; to treat alzheimer's disease according a new draft guidance from the national institute for clinical excellence nice.
In August 2007, FDA's Division of Drug Marketing, Advertising, and Communications 1 DDMAC ; posted one warning letter and one untitled letter on its website. The letters addressed the issues below. This summary describes only DDMAC's allegations. It does not reflect the recipients' responses or analysis by Covington & Burling. Overstatement of Efficacy A professional file card for Exelon rivastigmine tartrate ; Capsules and Oral Solution was misleading because it suggested that Exelon is more effective than has been proven by substantial evidence or substantial clinical experience. Specifically, the file card made claims related to the efficacy of Exelon based on the Progressive Deterioration Scale PDS ; , but these claims were misleading because no method of analysis was specified for this measure in the protocol. Furthermore, the PDS was used as a secondary efficacy measure in several major studies of Exelon other than the referenced study ; with inconsistent results. The file card also contained misleading claims pertaining to the effect of Exelon on behavior. In particular, a graph presented the percentage of patients Exelon vs. placebo ; with symptoms at baseline improving on the individual components of the Effect on Behavioral Pathology in Alzheimer's Disease BEHAVE-AD ; scale. Other claims in the file card suggested that Exelon can help manage some behavioral aspects of Alzheimer's Disease, which has not been demonstrated by substantial evidence or substantial clinical experience. These claims were misleading for several reasons: First, highlighting a non-significant finding is inherently misleading as the observation may be no more than a chance observation. Second, the BEHAVE-AD scale was not a designated primary or secondary efficacy measure in any of the three pooled studies cited in the piece. Finally, the referenced retrospective pooled analysis was a subset analysis, which was subject to bias and is non-credible. The disclaimer that statistical significance was not shown is not sufficient to correct the misleading impression made by the claim. Novartis Pharmaceuticals Corporation, August 8, 2007 ; Omission of Risk Information A professional journal advertisement for Geodon ziprasidone mesylate ; for Injection discussed the boxed warning in the package insert for increased mortality in elderly patients with dementia-related psychosis, the warning for QT prolongation, and a list of the most commonly observed adverse events, but it failed to communicate other serious warnings and precautions associated with the use of the product. Specifically, the journal advertisement failed to include the warnings in the package insert for neuroleptic malignant syndrome, tardive dyskinesia, and hyperglycemia and diabetes mellitus. It did mention "movement disorders" and "low EPS, " but these presentations were insufficient to communicate the risk concepts associated with, and the seriousness of, tardive dyskinesia. The journal advertisement also failed to include important precautions.
Donepezil, Galantamine, Rivastigmine review ; and Memantine for the Treatment of Alzheimer's disease NICE Appraisal Consultation Document, January 2006 Response from the Royal College of Psychiatrists 13 February 2006 The College has previously made clear its support for all antidementia drugs to be made available though the NHS for their licensed indications and, as such, we clearly welcome the partial reversal of initial Appraisal Committee decision not to allow any of these drugs to be prescribed. However, we express severe misgivings regarding the targeting of cholinesterase inhibitors to only those with moderate disease and the stringent MMSE cut-offs on which these disease stages are defined. We also disagree that use of memantine, the only licensed and clinically effective treatment for severe dementia, should not be supported. We continue to feel that the Appraisal Committee is using as a base for its decisions a cost effectiveness model and QALY measure that is both inappropriate and totally inconsistent with the previous 2001 ; Appraisal. We also feel that our previous points made in consultation have not been adequately considered. For example, in responding to several of our comments made on the technical report No 2 with the addendum, the Institute's response is either stated as "noted" or stated as being "outwith the specification for the extra work". The central issue of using utility scores obtained with an instrument designed for use in children, and never validated for proxy use for people with dementia, undermines the whole basis of the NICE model which the Appraisal Committee uses for its decisions. The continued failure to include benefits for carers, including reduced time up to 1.5 hours a day ; spent supervising people with dementia, also represents a fundamental flaw in the model. The lack of any detailed response or rebuttal to this and the many valid points we and others have previously made highlights the extent to which this appraisal has taken insufficient account of the stro ng and overwhelming view of all commentators, consultees and patient and professional experts. Comments from the Faculty of Old Age Psychiatry The basis for the exclusion of patients with mild Alzheimer's disease from treatment appears to be based solely on post hoc analysis of trial data suggesting greater magnitude of cognitive response o n ADAS-Cog and MMSE in those with moderate dementia arbitrarily defined as MMSE 1020 ; . In our view this is a flawed and illogical argument which would pose severe ethical and other difficulties in clinical practice. Neither the MMSE nor ADAS-Cog are linear scales. Not only do they have obvious floor and ceiling effects, but in regard to the MMSE, in most instances the diagnosis of dementia equates to an MMSE score of under 24 while recognising that there are cases, particularly associated with high education and high occupational attainment, where dementia is diagnosed at higher MMSE scores ; . As such, although the MMSE itself is a scale which has a score range from 0 to 30, in patients with dementia it actually operates over a.
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