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Alpha-Blockers Urospecific ; Prior authorization is required for urospecific alpha-blockers Flomax, Uroxatral ; . Payment will be authorized only for members who: Have documentation of previous trials and therapy failure with a preferred alpha1-adrenergic blocker; or Have a history of postural hypotension or hypotension; or Use antihypertensive or other medication that may exacerbate hypotension.
The Institute of Medicine's widely publicized report on the FDA focused on the need for upgraded post-marketing surveillance-which we endorse. But the FDA and Congress have to recognize that rare safety issues can only be reliably detected post-approval. It was also ironically coincidental with Mark McClellan's announcement that he would be leaving his post as Medicare Czar to work for a 'Think Tank', which will be quite the contrast with working for this administration. McClellan's brief but promising 18 month tenure tenure as FDA Commissioner stands in stark contrast to the hapless circus that followed. His departure in March 2004 was a black day for pharmaceutical prospects in the US; the consequences have continued to reverberate, unabated.
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Currently available therapies in the united states include long-lasting oral alpha1-blockers, such as terazosin hytrin ; , doxazosin cardura ; , and alfuzosin uroxatral ; , and the alpha1a-blocker tamsulosin flomax.
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VASCULAR OVEREXPRESSION OF THE ENDOTHELIN A RECEPTOR IN TRANSGENIC RATS RESULTS IN MEDIA HYPERTROPHY AND BLOOD PRESSURE ELEVATION A. Saxena, F. Zollmann, S. Kliesch, M. Bader, M. Paul, H.-D. Orzechowski Inst. of Clinical Pharmacology & Toxicology, Charit, 12200 Berlin, Germany Pharmacological studies were not conclusive regarding a causative role of endothelin A receptor ETA ; in vascular hypertrophy because of concomitant blood-pressure effects. To directly assess a role of ETA in blood pressure regulation and vascular hypertrophy we have established a transgenic tg ; rat model expressing human ETA in vascular smooth muscle cells. Vascular expression of tg mRNA was demonstrated by RT-PCR. Tg expression was quantified using quantitative PCR. In the aorta, total ETA transcript level i.e., endogenous and transgenic ETA ; was increased to 200% of controls in L6351 p 0.01 ; and to 150% in L6878 ns ; . In contrast, ETA was significantly increased in mesenteric arteries in L6878 only 250% of controls, p 0.01 ; . Bood pressure was normal in L6351, but was significantly increased in L6878 compared to non-tg controls mean pressure: 108 + -5 mmHg vs 83 + -7 mmHg, p 0.01 ; . Normalized ratio of aortic media was significantly p 0.01 ; increased in L6351 0.21 + -0.02 ; and in L6878 0.20 + -0.01 ; compared to non-tg controls 0.17 + -0.01 ; . Our data are consistent with 1 ; blood-pressure independent vascular hypertrophy and 2 ; blood pressure elevation exerted by chronic ETA overexpression and fosamax.
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In BMRC trials, 6-month intermittent regimens have yielded 95% success rates despite resistance to INH 4 ; 5 ; . Injectable agents IA ; , such as streptomycin, were slightly more active than EMB in these trials. In cases of SM resistance, amikacin, kanamycin, or capreomycin may be employed. Fluoroquinolones FQNs ; were not employed in BMRC studies, but should strengthen the regimen for patients with more extensive disease. To provide a sufficient margin of safety, the oral agents in addition to RIF ; should be continued beyond the first 2 months with RIF and at least one additional active agent being given throughout the 6 months. INH should be stopped in cases of INH monoresistance see text for additional discussion ; . RIF and EMB for 12 months may be used. In such cases, extended treatment is needed to lessen the risk of relapse. In cases with extensive disease, the use of an additional agent "alternative agents" ; may be prudent to lessen the risk of failure and additional acquired drug resistance. Resectional surgery may be appropriate see text ; . Use the first-line agents to which there is susceptibility. Add two or more alternative agents in case of extensive disease. Surgery should be considered see text ; . A thrice-weekly regimen of INH, PZA, and SM was effective in a BMRC trial. However, extended use of an injectable agent may not be feasible. An all oral regimen for 12 months should be effective. But for more extensive disease and or to shorten duration, an injectable agent may be added in the initial two-months of therapy. INH and EMB can be given for 18 months with PZA included for the first two months, for instance, flomax capsule.
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Test product, dose and mode of administration, batch number: Alfuzosin Geomatrix UroxatralTM ; : 10 mg tablet, One tablet daily for 5 days period taken orally immediately following a meal, 03B0399. Matching placebo: 1 tablet daily for 5 days period taken orally immediately following a meal, 03B0398. Duration of treatment: The duration of the study was approximately 45 days 10 days screening; 5 days of dosing period and 10-14 days washout period following periods 1 and 2 ; . Reference therapy, dose and mode of administration, batch number: Tamsulosin Flmoax ; : 0.4 mg capsule, two capsules daily 5 days period, taken orally immediately following a meal, 03B0260 Matching placebo: 2 capsules daily, 5 days period, taken orally immediately following a meal, 03B0263. Criteria for evaluation: The primary efficacy variables were 1 ; the change from baseline in the ejaculate volume on Day 5 and 2 ; the change from baseline in the sperm concentration in post-ejaculate urine on Day 5. As secondary endpoints, each primary endpoint was transformed dichotomized ; into a binary outcome measure i.e., subjects with 20% decrease in the ejaculate volume on Day 5 compared to baseline, and subjects with 20% increase in sperm concentration observed in urine of postejaculate urinalysis on Day 5, respectively ; . Secondary efficacy variables also included the change from baseline on Day 5 in 1 ; semen fructose and semen viscosity; 2 ; semen sperm concentration, total sperm count, sperm motility, forward sperm progression, and sperm morphology; 3 ; urine fructose; and 4 ; MES and DANPSS-sex. Safety was evaluated by monitoring treatment-emergent adverse events AEs ; , serious adverse events SAEs ; , discontinuations due to AEs, and any clinically significant changes in routine laboratory tests, cardiovascular safety vital signs and ECGs ; , and physical examinations and glyburide.
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Healthcare accounts: Abbott: Abbott Diabetes Care, Meridia, Zemplar IV Oral; American Express: health savings accounts; BioMarin: Naglazyme, Sapropterin; Boehringer-Ingelheim: Flomax; Boehringer-Ingelheim Pfizer: Spiriva; Bristol-Myers Squibb: Ipilimumab, Ixabepilone, Muraglitazar; Centocor: CNTO 1275, NC-503; Cyberonics: VNS Therapy for TRD treatmentresistant depression Encysive: Thelin; Endo Pharmaceuticals: DepoDur, Frova, Opana, Percocet; Gilead Bristol-Myers Squibb: new HIV product; GlaxoSmithKline: Altabax, Augmentin XR, Lamictal, vaccines division, Valtrex, Wellbutrin XL; Johnson & Johnson: Aveeno; KOS Pharmaceuticals: Icatibant; Eli Lilly: Cialis global MedImmune: FluMist, Synagis; Merck: Cozaar, Fosamax, Propecia, Zocor, professional media AOR; Merck EMD: Sarizotan; Reliant: Omacor; Roche: Actemra, CERA; Serono: Saizen; Trane: Clean Air System; Tibotec Therapeutics: Yondelis. Accounts gained 13 ; : American Express: health savings accounts; Bristol-Myers Squibb: Ipilimumab; BioMarin: Naglazyme, Sapropterin; Centocor: CNTO 1275, NC-503; Endo Pharmaceuticals: Opana; GlaxoSmithKline: Altabax; KOS Pharmaceuticals: Icatibant; Merck EMD: Sarizotan; Roche: Actemra; Trane: Clean Air System; Tibotec Therapeutics: Yondelis. Accounts lost 2 ; : Astellas: Vesicare; Novartis: Exjade. Services: ProHealth: professional education; TPM: patient education; CSM: customer segment marketing; Emerging Markets: specialty and ethnic markets; Strategic Planning: ensure strategic and creative relevance; Closed Loop Sales Promotion: certified gold content provider from ProScape; Rated Rx: art buying, creative production. New hires: SVP group management directors: Robert Karcewski, Terrie Blalock. FEATURED WORK Product: Omacor Client: Reliant Pharmaceuticals Creative account team: Creative Account team: Mary Dickson, SVP associate creative director, art; Bebe Barbour, SVP creative director, copy; Nicole Geraghty, copywriter; Tony Rubey, group art supervisor; Jeff Giermek, senior art director; Joe Peterson and hydrocodone.
Syndrome which may terminate in sudden death." Shulack defines the syndrome in six parts: 1 ; Sustained motor and mental excitement with continual activity for 2 days to 2 weeks, 2 ; Rapid thready pulse, 3 ; Rapid loss in body weight, 4 ; Profuse clammy perspiration, 5 ; Fall in blood pressure and pulse pressure, 6 ; Hyperpyrexia from 100 to 104F if death does not occur. Around 1953 chlorpromazine was introduced for the treatment of acute mania and schizophrenia. It became a widely used `miracle drug' for psychoses across the board. It goes to the credit of the great `drug watcher', Frank Ayd who in 1956 reported the first case of a lethal hyperpyrexia: Fatal Hyperpyrexia during Chlorpromazine Therapy. Journal of Clinical and Experimental Psychopathology, Vol XVII, #2, June 1956 ; . He describes the case as follows: A 41 year old man was given increasing doses of chlorpromazine to 2.5 gm day. On the 21st day his temperature went to 108, he had several seizures and died. Although the name of the syndrome was not established at that time, Ayd concluded that "Chlorpromazine may cause sudden elevation of temperature.
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APPG The All-Party Pharmacy Group has sent its response to the Office of Fair Trading report on control of entry to ministers at the Department of Health and the Department of Trade and Industry following its meeting last month PJ, 15 February, p215 ; . The APPG report says that the group is not convinced that outright deregulation of the controls over pharmacy contracts would achieve the OFT's stated aims of improving access, choice, competition and quality. The APPG recommends a collaborative approach to achieving these aims and, as part of this process, suggests that ways of modifying the current control of entry arrangements are found. Such changes should take place alongside the introduction of a new contract for community pharmacy, it says, and a firm date for this should be set. Ministers are urged to make a decision on control of entry as soon as possible. London Pharmacies in the areas covered by six local pharmaceutical committees North East London; Hertfordshire; Lambeth, Southwark and Lewisham; Kensington, Chelsea and Westminster; Merton, Sutton and Wandsworth; and Croydon ; have been sent 270, 000 postcards to be signed by customers opposing the OFT recommendation. The postcards will be sent back to pharmacies for forwarding to ministers and Members of Parliament. North east London North East London Local Pharmaceutical Committee is holding a dinner at the House of Commons on 28 March, hosted by Tony Banks Lab, West Ham ; . The 15 MPs in its area, including the Leader of the Opposition Iain DuncanSmith ; , and primary care trust chief executives have been invited to hear about plans for improving health through pharmacies. Numark Pharmacist members of Numark have been using geodemographic profiles of their areas to explain their cases in meetings with MPs. The profiles show localities in their area which have high numbers of older people, those on low incomes or who do not have access to a car. The maps also show current distributions of pharmacies and supermarkets. Scotland The Scottish Parliament discussed its response to the OFT report on 20 February. First Minister Jack McConnell said that the Scottish Executive would aim to protect the community pharmacy network on behalf of the National Health Service in Scotland. He noted the health advisory role of pharmacists and the need to maintain access to pharmacies, particularly in rural areas. The Royal Pharmaceutical Society has sent a briefing note on the OFT report to all MSPs.
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