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By John W. Mucenski, BS, PharmD, Director, Pharmacy Operations, UMPC Cancer Centers A review of recent clinical trials in the field of oncology. Included are the methods, results, conclusions, and managed care implications of each trial reviewed.
Cardiovascular Disease CVD ; is the foremost cause of mortality and morbidity in the Western World. The World Health Organization estimates one-third of all global deaths 16.6 million ; are attributable to CVD. The lipid-lowering prescription market represents a substantial component for the treatment of CVD. Datamonitor estimates that there are nearly 307 million people in the seven major markets with total cholesterol greater or equal to 200 mg dL. In the US, of the 140 million people with dyslipidemia only 66 million have been diagnosed. As a possible market entrant, Forbes is developing a cholesterol absorption inhibitor called FM-VP4. This drug is an amphipathic water and lipid-soluble ; analogue of phytostanols looking to be a market participant in the world's top selling medicinal category. The growth of lipid lowering pharmaceuticals has been fueled by the tremendous success of statins, with the leading compound, Lipitor expected to be the first "$10 billion pill" and Zodor estimated to peak at sales of over $6 billion. The evolution of this market has seen large drug manufacturers maneuver to protect their statin franchises from patent expirations and increasing competition. The development of statin combination pills is emerging as a key life-cycle management strategy for statin manufacturers, the market for which is estimated to grow to $4.7 billion over the next 5-7 years. Datamonitor, Dec 2003 ; The safety and effectiveness of Forbes' cholesterol absorption inhibitor has recently been investigated in a European Phase II human trial at the Academic Medical Center AMC ; in Amsterdam. The trial's primary efficacy endpoint of significantly lowering low-density lipoprotein LDL ; cholesterol was met. The reduction in LDL cholesterol, as compared to placebo, was 11%, with 33% of subjects at 400 mg per day achieving a greater than 15% reduction. Additionally, FM-VP4 continued to demonstrate an excellent safety profile with no difference between dosing and placebo groups. The trial provided Forbes with insight into design parameters for its US Phase II trial including; number of participants, trial duration, and dosage range. Forbes remains committed to the development of FM-VP4 and the US Phase II trial planned for next year under a FDA Investigational New Drug IND ; application. To protect the Company's intellectual property surrounding its drug development pipeline, patent applications have been filed for the compounds, formulations, and indications of FM-VP4 and the FM-VPx library of compounds with both the US patent office and other international jurisdictions and zyrtec.
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Delayed non-match to sample: Food-restricted male Long-Evans rats were trained in Coulbourn Allentown, PA ; operant chambers. Two retractable levers extended on either side of the food hopper nosepoke apparatus. The hopper nosepoke apparatus contained photocells that monitored pellet delivery and receipt. Rats were initially trained on an FR1 schedule where the animal would initiate a trial with a nosepoke in the hopper, which produced extension of one lever. Lever extension varied from left to right throughout the entire session during this initial training period, where the animal learned to initiate a trial with a nosepoke and to receive a reward by pressing the extended lever. During the second phase of training, trial initiation again produced only one lever; this now served as the "study" phase of the trial. After variable delays of 0.5, 1 or 2 seconds, both levers would extend, and the animal would be required to choose the lever alternate to that presented during the study phase. Rats continued in this phase of training until they reached an 80% criterion with 100 obtained reinforcements. Training then proceeded with variable delays of 1, 2, 4, and 20 seconds, until rats achieved a 70% accuracy criterion regardless of delay. Delays were presented in a random order, using a list without replicate scheme. Rats were then assigned to treatment groups based upon their accuracy at the 20 sec delay. Indiplon was administered by oral gavage 30 minutes prior to testing at a dose low enough to allow at least 70% of vehicle responding 2 mg kg ; . During testing, rats were and accolate.
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See, for example, evidence reviews by Illingworth and Tobert [12] and Wood [13]. Recall that Pharmac had patients treated for a WADC of $1.05. Using Wood's assessment of the relative lipid-lowering effects of the various statins, Lescol 20 mg ; , for example, was subsidised at a daily rate of $0.97 and produced, on average, a 16.9% reduction in total cholesterol levels, while the 40 mg version of Lescol cost the RHAs $1.13 daily for a 19.7% reduction. Zocor, however, received a daily subsidy of $0.78 for both its 10 mg and 20 mg tablets, but the former achieved a 22 reduction in total cholesterol while the latter achieved a 26.8% reduction. Recently, Thomas et. al. [14] evaluated the impact of RP on patients switching from simvastatin to fluvastatin by examining the fasting lipid profiles of 262 patients treated via the Dunedin Hospital Pharmacy. The authors reported a significant increase in total cholesterol, LDL cholesterol, and tryglycerides across these patients, although lipid elevations were somewhat lower for higher doses of fluvastatin. They concluded p. 293 ; that it "was inappropriate to base New Zealand's first attempt at referencebased pricing on the premise that all statins are equipotent", that it "was inappropriate then to compel patients to change their established prescriptions based on this flawed premise", and that subtherapeutic dosing of high risk patients "may prove more costly in the long run than all apparent savings expected to be gleaned from reference-based pricing". Subsequently, Thomas and Mann [15] reported an increase in lipid concentrations in 94% of 126 patients with established atherosclerosis, along with a tripling in thrombotic vascular events over a six month period following their being switched from simvastatin to fluvastatin Cf., Miriyana Alexander, Drug policy threat to patients, say doctors, Sunday StarTimes, April 19, 1998 See the modified criteria as per the Pharmaceutical Schedule monthly update for August 1997, p. 33. 17.
Cholesterol medications lipitor lescol mevacor pravachol crestor zocor pfizer wins lipitor patent case in ireland 09 july 2007 pfizer inc won a patent case in ireland that will prevent ranbaxy from launching its own version of pfizer's cholesterol-lowering drug lipitor and actonel and zocor.
TABLE 23 Prevalences in entire sample of kneehip pain, kneehip OA need ; and kneehip OA treatment ; in men: percentages all relate to entire sample of men in the given age range Age range years ; 3544 4554 5564 + All men KH, kneehip. Sample number 3, 413 2, Percentage with KH pain 13.7 17.8 25.5 Percentage with KH + OA 1.2 2.7 6.7 Percentage both with KH OA and using prescribed analgesia 0.4 1.4 3.9.
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The effect on the overall efficiency of the process is shown from the table below comparing the old and new processes.
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Lipitor, 10 mg. cholesterol ; Celebrex, 200 mg. 80.63~81.03 pain ; Zoloft, 50 mg. 74.59~74.97 depression ; Norvasc, 5 mg. 43.82~44.22 blood pressure ; Zocor, 10 mg. 59.37~59.77 Cholesterol ; Vioxx, 25 mg. 77.86~78.26 pain ; Celexa , 20 mg. 73.03~73.43 depression ; Nexium, 20 mg. 106.65~107.05 heartburn ; Zyrtec, 10 mg 57.60~58.00 allegies ; Prilosec, 20 mg. 90.15~90.55 ulcers ; * Comparable quantities not available * For 28 capsules instead of 30 and zoloft.
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To have positive effects on physician-patient interactions related to medical communication without negative effects on other areas, such as time available for patient concerns or communication about psychosocial issues.
2004 Rank by # of Claims Drug Name 1 2 3 Prices Strength mg mg mg mg mg mg mg mg mg mg mg mg mg mg % mg mg mg mg mg meq mg mg mg mg mg mg mg mg mg mg mg mg mg mg meq mg mg mg mg mcg mg mg mcg mg % mg mg mg iu Ac Dose Form tab tab tab tab tab cap tab cap tab cap DR tab tab tab tab sol tab tab tab tab tab tab ER tab tab aerosol tab ER cap tab tab tab tab tab tab tab tab tab ER tab ER tab tab cap tab tab tab tab tab tab sol tab tab tab spray FSS 1, 316.88 498.84 RFSS Big 4 887.16 NC Low 1, 295.76 779.16 Medicare Discount Card Prices Retail Mail Order High 1, 520.28 903.72 Low 1, 230.36 730.56 High 1, 440.60 814.32 Plavix 75 Lipitor 10 Fosamax 70 Norvasc 5 Protonix 40 Celebrex 200 Zzocor 20 Nexium 40 Lipitor 20 Prevacid 30 Norvasc 10 Toprol XL 50 furosemide 40 Actonel 35 Xalatan 0.005 Zoclr 40 metoprolol tartrate 50 Aricept 10 Zoloft 50 Toprol XL 100 Klor-Con M 20 Evista 60 Digitek 0.125 Combivent 1 isosorbide mononitrate 30 Detrol LA 4 Zetia 10 atenolol 50 Diovan 80 hydrochlorothiazide 25 Cozaar 50 Lipitor 40 Lexapro 10 Toprol XL 25 isosorbide mononitrate 60 Klor-Con M 10 Pravachol 40 atenolol 25 Flomax 0.4 Diovan 160 Synthroid 50 Zovor 10 Singulair 10 Synthroid 100 furosemide 20 Alphagan P 0.15 Aciphex 20 warfarin sodium 5 Ambien 10 Miacalcin 200.
Abstract 1360 THE ASSOCIATION BETWEEN COGNITIVE FUNCTIONING AND THE RELIABILITY IN REPORTING PHYSICAL HEALTH RELATED QUALITY OF LIFE IN MULTIPLE SCLEROSIS PATIENTS D. M. Miller, W. R. Lenderking, E. Tafesse, J. I. Greenstein, J. T. Phillips, Mellen Center, Cleveland Clinic Foundation, Cleveland, OH Purpose: To determine the association between levels of perceived cognitive functioning PCF ; in MS patients and reliability and validity of self-reported physical functioning. MS produces mild to moderate cognitive deficits in about 50%, severe and global dysfunction in 5-10%. Monitoring health related quality of life HRQoL ; for patients affected by diseases characterized by cognitive impairment requires understanding how these deficits may affect the psychometric properties of HRQoL instruments. Subjects and methods: Generic and disease specific scores including PCF were collected from 2777 patients enrolled in the MSTRAC registry supported by Biogen. Physical wellbeing PWB ; was assessed using the SF-36 Physical Functioning PF ; & Role Physical RP ; scores. Patients in the highest and lowest quartiles of the Cognition sub-scale of the Modified Fatigue Impact Scale were characterized as high and low PCF. Internal consistency coefficients for the PF and RP were calculated separately in the two groups to assess reliability. Predictors of PF and RP were examined in the two groups in regression models examining disease severity, psychological well being and pain. Results: Patients with lower PCF reported both PF and RP with significantly less reliability, although only the RP coefficient was less than expected for the general population. Strikingly, considerably less variance in both PF and RP was predicted in the worse PCF group. Conclusion: As expected, the psychometric properties were affected by PCF with patients with lower levels of cognitive functioning showing less reliability and predicting less of the variance in aspects of physical functioning. This preliminary evidence suggests that cognitive impairment levels may need to be controlled for in examination of HRQoL in some patient groups. Future research using objective measures of cognitive functioning should be performed to confirm these findings.
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There are many incidents where the content of IPS Pharmacy advertisements appearing on websites and or being mailed to customers or potential customers in the United States are contrary to the Code of Ethics. All IPS Pharmacies are encouraged to review their advertisements and bring them into compliance with the provision for advertising described in the Code of Ethics. Certainly, non-IPS Pharmacies are also reminded to review the content of their advertisement. The following point must be kept in mind when advertising: There cannot be price comparisons to other pharmacies whether they are located in Canada or other countries. This would include claims of "discount" or lower prices identified by a "%". If the price of prescription drugs is being advertised, it should be limited to: a ; The brand name of the drug, or the generic name and the name of the manufacturer's product being quoted. b ; The dosage form and strength of the drug. c ; The total price charged for a specific quantity of medication and a full description if the price differs for certain payers or forms of payment. d ; The statement "Only available by Prescription" There cannot be claims of superiority or offering exclusive services. This would include not using words like "best quality", "top-notch service", "fast filling service", "premier service", etc. There cannot be claims that products are "FDA" approved, if they are not. All products dispensed in Manitoba must be "Health Canada approved". All homepage websites must indicate the pharmacy is licensed by the Manitoba Pharmaceutical Association and include the pharmacy license number and the pharmacy address. IPS Pharmacies cannot be affiliated with businesses and or websites that advertise in a manner that would represent to the public that the intermediary business is a pharmacy in Manitoba and or Canada if it is not. Any advertised pharmacy service that is required to be provided by all pharmacies, such as patient counselling, must include the statement "Required by law in all Manitoba pharmacies.
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On 18 November, FDA announced the issuance of a final rule on current good tissue practice GTP ; , the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls used to manufacture these products. The new approach will be fully implemented on 25 May 2005. The new rule, entitled "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Establishments; Inspection and Enforcement, " requires manufacturers to recover, process, store, label, package and distribute human cells, tissues and cellular and tissue-based products HCT Ps ; in a way that prevents the introduction, transmission, or spread of communicable diseases. The rule also includes a requirement for manufacturers to report certain adverse reactions and HCT P deviations, to have labeling that contains accurate and complete information, and to allow FDA inspections to ensure compliance with regulations. Two related rules have already been finalized by FDA. The first rule, "Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products" became effective on 21 January 2004, and requires tissue facilities to register with the FDA and list their products. The second rule, "Suitability Determination for Donors of Human Cellular and Tissue-Based Products, " was finalized on 25 May 2004, and focuses on donor screening and testing measures to prevent the unintentional use of contaminated tissues with potential to transmit infectious diseases. It will become effective on 25 May 2005. Once all three new regulations are effective next year, they will apply to cellular and tissue-based products recovered on or after 25 May 2005. FDA's current rules will remain in effect for products.
Competition may appear, and is likely to appear when and if GelStatTM Migraine, or any product of the Company, achieves commercial success. Competition would most likely arise from a company that is larger and better funded than GelStat, such as a pharmaceutical company. Such competition might be difficult to fend off, and the Company might fail in any attempt to do so. Alternately, would-be competition might elect to attempt an acquisition of the Company. Historically, pharmaceutical companies have expanded their product lines, especially in the OTC arena, through acquisition. Early acquisition might limit the potential growth in any investment by failing to allow sufficient time for the Company's full potential to be realized.
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Return to the table of contents acknowledgments return to the table of contents supported by a grant from bristol-meyers squibb, princeton, nj, and the university of texas anderson cancer center core grant no ca-16672 national cancer institute, national institutes of health, bethesda, md.
Total medical expense trend impact generally varies between 2% and + 2.
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