Statewide Pharmacy and Therapeutics 7 30 04 Formulary Class Review Angiotensin II Receptor Antagonists AIIRAs ; Candesartan Atacand, AstraZeneca ; Eprosartan Teveten, Biovail ; Irbesartan Avapro, BMS S-S ; Losartan Cozaar, Merck ; Olmesartan Benicar, Sankyo Pharma ; Telmisartan Micardis, Boehringer Ingelheim ; Valsartan Diovan, Novartis ; INTRODUCTION1 Hypertension affects approximately 50 million individuals in the United States and approximately 1 billion worldwide. As the population ages, the prevalence of hypertension will increase even further unless broad and effective preventive measures are implemented. For individuals 40-70 years of age, each increment of 20 mmHg in systolic BP or 10 mmHg in diastolic BP doubles the risk of CVD across the entire BP range from 115 75 to 185 115 mmHg. The benefits of lowering blood pressure have been proven in multiple clinical trials. Antihypertensive therapy has been associated with reductions in stroke incidence averaging 35-40 percent; myocardial infarction, 20-25 percent; and heart failure, more than 50 percent. The JNC 7 guidelines recommend a goal of blood pressure less than 140 90 mm Hg. However, for those with diabetes or renal disease, a lower BP goal of less than 130 80 mm Hg recommended. INDICATIONS1, 6 The AIIRAs are indicated for the treatment of hypertension, alone or in combination with other antihypertensive agents. Losartan Cozaar ; and irbesartan Avapro ; are indicated for neuropathy in type 2 diabetes, valsartan Diovan ; for the treatment of heart failure in patients who are intolerant of ACEIs, and losartan Cozaar ; is indicated for hypertension with left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients. The JNC 7 recommends the AIIRAs be used in heart failure, diabetes, and chronic kidney disease. In heart failure, for those with symptomatic ventricular dysfunction or end-stage heart disease, AIIRAs and aldosterone blockers are recommended along with a loop diuretic. In diabetic hypertension, ACEI or AIIRA-based treatments favorably affect the progression of diabetic neuropathy and reduce albuminuria, and the AIIRAs have been shown to reduce progression to microalbuminuria. In those with chronic kidney disease, ACEIs and AIIRAs have demonstrated favorable effects on the progression of diabetic and nondiabetic renal disease. PHARMACOLOGY1 These agents are angiotensin II receptor type AT1 ; antagonists. Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme ACE kininase II ; is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. Its effects are vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal re-absorption of sodium. AIIRAs block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues. There is also an AT2 receptor in many tissues, but is not known to be associated with cardiovascular homeostasis. AIIRAs do not inhibit ACE kininase II, the enzyme that converts angiotensin I to Angiotensin II and degrades bradykinin ; , nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. AIIRAs inhibit the pressor effect of angiotensin II as well as angiotensin I ; infusions. Removal of the negative feedback of angiotensin II causes a 2-3 fold increase in plasma rennin activity and a consequent rise in angiotensin II plasma concentration in hypertensive patients. The resulting increased plasma rennin activity and angiotensin II circulating levels are insufficient to alter the effects of AIIRAs on blood pressure. AIIRAs do not affect the response to bradykinin, whereas ACE inhibitors do increase the response. AIIRAs have very little effect on serum potassium.
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We would like to thank: D. de Vries, Pharma Bio-Research BV, Zuidlaren, The Netherlands; M.P. Bouche, J&J PRD, Beerse, Belgium; and M. El-Malt, Tibotec, Mechelen, Belgium.
EDITOR Jack J. Chen, PharmD, BCPS, CGP Associate Professor Neurology ; Movement Disorders Center Schools of Medicine Clinical ; and Pharmacy Loma Linda University Loma Linda, CA EDITORIAL BOARD Thomas Morrow, MD President, National Association of Managed Care Physicians Alpharetta, GA Lorraine Tarnove Executive Director American Medical Directors Association Columbia, MD and telmisartan.
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TABLE 1. Age, sex, clinical status, extended disability status scale score, and current medications for MS patients in this study and
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But all the evaluations were in; it seemed more like patriotism. It doesn't matter what Tufts did to us, or does to others, it's our Big Day. Another activist from an article called "Singin' the Med School Blues": It often seems to me that medical students are not well exposed to regular life; most of them have basically only gone to school, and that with a single-minded goal - to beat out twenty other people at the med school of one's choice. But this lack of experience makes students quite uncritical of the process they are undergoing. I have a fantasy of the entire freshman class chanting in unison 'everything is for the best, in this best of all possible worlds.'[199] "Always hold firmly to the thought that each one of us can do something to bring some portion of misery to an end." [200] But I won. Two months after I sent those first letters, the administration capitulated, citing as delay changing department chairs. Departmental policy will evidently soon include a stipulation that doctors should ask permission from patients - what a concept - to have students practice pelvic exams on them while they're under. It feels like such a hollow victory; they shouldn't have been doing it in the first place. And will the dean keep her word? Will the doctors care? I did involve some of the preclinical students, though. At least if one of them complains, she or he may at least be able to point to a piece of paper. It is not because things are difficult that we do not dare; is because we do not dare that things are difficult. - Seneca Not to pass on a 10, 000 person audience opportunity, I decide to make some other sign for graduation - if nothing else than for tradition's sake. In high school I picketed Reagan; at Cornell's graduation I hoisted "47, 000 Kids Under the Age of 5 Were Killed in the Persian Gulf War." I reminded of a parable Irene shared with me: There is a person on a street corner holding a sign with some social justice-type message on it. The person is approached by someone who asks, "Why are you holding that sign? Do you think you're going to change the world by holding some sign?" "No, " the gentle sign holder replies. "With this sign I'm not trying to change the world; I'm trying to keep the world from changing me." Sentient beings are numberless, and I vow to save them - Buddhist saying So in our stray wonder-hamster Golda's honor, I chose antivivisection, carrying a placard stating "TUFTS TORTURES. Stop Klaus Miczek's Cruel Animal Experiments." I hand out explanatory pamphlets I xeroxed on the school's copier. The commencement speaker warns everyone, "Don't shave and meloxicam.
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There may be no single formulation, which is ideal for paediatric patients of all ages such that a range of dosage forms in the portfolio will be preferred. The following will be important considerations: Minimal dosage frequency One dosage form fits all or a full range Minimal impact on life style Minimum, non-toxic excipients Convenient, easy, reliable administration Easily produced, elegant, stable Cost and commercial viability and
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Relapse. When planning for the success of the renewed recovery, the physician should inquire about and document the patient's use of support groups or 12-step programs, and ask if the patient's spouse, friends, and significant others are supportive of recovery or are themselves using alcohol or drugs. Prescribing and General Care Guidelines At every visit, the physician should review all of the medications, including nonprescription drugs and herbal supplements, that the patient is currently taking. Patients with chronic illnesses should be reminded that maintaining sobriety helps with the successful treatment of other medical and psychologic conditions.13 The relapsing patient is likely to be noncompliant, 14 whereas patients in recovery are more likely to adhere to medical advice.13 If the recovering patient does not comply with medical advice for medical problems, this may signal a relapse. Recovering patients may be reluctant to use medications, fearing that they will precipitate relapse. If appropriate, physicians should recommend nonpharmacologic treatment e.g., lifestyle changes ; , as initial therapy.
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Disposal Hospital Individual doses of controlled drugs, which are prepared but not administered, shall be destroyed on the ward in the presence of a second healthcare professional. Destruction of all other controlled drugs shall be witnessed by a pharmacist. In both cases, an entry shall be made in the ward Controlled Drug Register, including the names of those involved in the destruction. Community Patient's own home. These are the property of the patient. The patient or their representative should be encouraged to return them to their community pharmacist if no longer required or they may destroy any controlled drug left over in their possession once medical treatment has ceased. Alternatively, these drugs may be accepted by doctors, dentists or pharmacists for destruction. Although there is no legal requirement to make any record of their destruction or to have the destruction supervised by an authorised person, it is good practice to record the returned item, and date of its return, in a separate part of the Practice Controlled Drugs Register or a separate record book kept for this purpose and have this witnessed. Controlled drugs returned by patients or their representatives should be destroyed and not retained as stock for future use.
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NON-PREFERRED tier 3 ; Drugs generic chemical ; name. common brand trade ; name amlodipine-benazepril. LOTREL L ; candesartan-HCTZ. ATACAND HCT L ; enalapril-felodipine. LEXXEL L ; eprosartan-HCTZ. TEVETEN HCT L ; losartan-HCTZ. HYZAAR L ; nadolol-bendroflumethiazide. CORZIDE L ; quinapril-HCTZ. ACCURETIC L ; telmisartan-HCTZ. MICARDIS HCT L ; trandolapril-verapamil. TARKA L ; valsartan-HCTZ. DIOVAN-HCTZ L and
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What will the landmark trial ONTARGETTM mean for patients? The ONTARGET TM trial programme is set up to investigate the potential benefits of the combination of the angiotensin-II receptor blocker telmisartan ed: MICARDIS ; and the ACE inhibitor ramipril in reducing myocardial infarction, stroke, heart failure and cardiovascular death. We also have a parallel study called TRANSCEND where people who can't take ramipril receive either telmisartan or placebo. So between these two trials we will learn whether telmisartan is at least as good as ramipril, and whether the combination is more effective. This is important because ramipril has some side effects and a significant proportion of people can't tolerate it. If telmisartan is as good as ramipril, but is tolerated better, that is a positive finding for patients. The second possibility is that telmisartan when added to ramipril will have more benefit than either drug alone. That would be the most exciting finding if confirmed.
Combined net sales grew by 34% in 2006 to EUR 967 million, making micardis our second biggest prescription medicine and securing it blockbuster status. The most important factor for a successful treatment of acute myocardial infarction is time to treatment. Thrombolytic therapy is established as one of the most successful modern AMI treatment options.
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Drugs are covered for labeled indications or Drug Utilization Review DUR ; Board approved indications only. Specific classes of drugs are excluded by OBRA 91 statue. 1 ; Cosmetic preparations 2 ; Minerals 3 ; Patches 4 ; Vitamins, except prenatal 5 ; W eight gain or loss, for example, micardis alcohol.
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From the CERAMM Centre d'Exploration et de Radaptation des Anomalies Mtaboliques et Musculaires ; E.R. ; , University Hospital Lapeyronie; and the Department of Clinical Biochemistry, Faculty of Pharmacy, Montpellier, France. Address correspondence to Dr. Eric Raynaud, PhD, CERAMM, University Hospital Lapeyronie, F-34295 Montpellier cedex 5, France.
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Synopsis Progenics Pharmaceuticals today announced positive results from a phase 2 clinical trial of its investigational drug, methylnaltrexone MNTX ; for the management of post-operative bowel dysfunction. Patients who received MNTX following major abdominal surgery exhibited an acceleration of gastrointestinal recovery by at least one day on average compared to placebo. Significant improvements were seen in clinically important measures of gastrointestinal recovery: time to first bowel movement and discharge eligibility from the hospital. MNTX was generally well tolerated in this study, with no reports of serious adverse events related to the drug. Biospace reports that there is currently no approved therapy for post-operative bowel dysfunction, a gastrointestinal impairment following abdominal or other major surgeries and a cause of prolonged patient hospital stays and increased healthcare costs.
Caused by excipients led to a shift in the melting peak towards lower temperature. Hence, DSC was not a useful method for polymorph identification in CLP tablets. Therefore, XRPD and FTIR were used for identification of the solid-state form in tablets. XRPD. Powder obtained from the tablets was first analyzed using XRPD. Excipient peaks complicated the XRD patterns of all three tablets, but identification of CLP peaks was possible in all cases Fig. 7 ; . All three dosage forms were found to contain form II. The unique peaks related to form II were unambiguously identified and no peak due to form I was observed. The position of crystalline reflections 2q ; remained the same within experimental error, regardless of the shift from the baseline. This shift from the baseline was due to the presence of excipients in tablets. In all cases comparison revealed that peak positions were in accord with the USP limit. The USP general chapter on X-ray diffraction states that identity is established if the scattering angles of the ten strongest reflections obtained for an analyte agree within 0.20 degrees with that of reference material 19 ; . In all formulations, relative intensities of the peaks decreased. Intensity of the diffraction peaks can be affected by dilution due to excipients in the dosage form and or preferred orientation. Grinding the tablets could have minimized the preferred orientation, which, however, was avoided to prevent phase transitions. The shift from the baseline and the change in intensity of peaks due the presence of excipients precludes the use of XRPD for quantification. Accurate quantification using XRPD relies profoundly on the absence of orientation effects and the particle size uniformity. The difference in the particle size distribution of API and excipients is a matter of great concern. Moreover, differences in mass absorption coefficients between the drug and excipients may result in severe deviations from linearity during quantification 20 ; . Sophisticated methods of pattern subtraction, pattern-fitting by the Rietveld method and quantitative phase analysis may help in quantification of API in dosage forms using XRPD 21 ; . FTIR. CLP tablets contain a large mass fraction of excipients; hence, the FTIR spectra exhibited a number of bands associated with excipients. However, it was possible to identify the bands of CLP. For identification of polymorphs, the bands chosen were 841.
Consumers and doctors are inundated with messages about which drug to use. Ubiquitous advertising is not necessarily bad; doctors need to learn the new treatments available, and consumers can be inspired to see their doctors for necessary treatment, as well as empowered to be active participants in their health care. But when drug marketers give false and misleading information about their products to doctors, patients are placed at risk. On purely medical criteria, the decision to prescribe a certain drug for a certain person is very complex; each drug's effects are different, and each patient has unique issues that must be considered, including their age, gender, disease state, other medications they are taking, and other medical conditions they have. Moreover, non-medical factors also can influence prescribing decisions. Research reveals patient demand, driven by direct-to-consumer advertising, affects prescribing, 1 as does contact between doctors and sales representatives, 2 advice from other doctors, 3 gifts to doctors, 4 the availability of free samples, 5 and the insurance coverage the patient has.6 Nonetheless, our society has so far maintained bedrock faith in one idea: doctors can sort through all the issues and pressures and consistently make appropriate prescribing decisions. A 2003 survey showed broad trust in doctors' prescribing decisions, but also the corrosive effect of drug marketing.7 Roughly two-thirds of the respondents "trust[ed] [their physician] to choose the drug that is best, " while 23 percent worried their doctors' judgment might be impaired by drug marketing and another ten percent were undecided. The public's trust in their doctors' prescribing decisions might plummet if the public understood just how often drug marketers conceal risks from doctors, urge doctors to prescribe drugs for uses that have not been shown to be safe or effective, and make misleading claims to doctors about the drugs they promote. Deceptive Advertising Distorts the Crucial Risk Benefit Analysis The Food and Drug Administration FDA ; approves drugs for very particular uses, based on the data showing safety and efficacy and the balance between them. After negotiation with the drug's maker, the FDA codifies its risk-benefit judgment as the drug's indication in the drug's label. As Dr. Henry I. Miller, former head of the FDA's Office of Biotechnology recently explained in the Wall Street Journal: Journal The `safety' of a drug is a relative thing. Safety and efficacy, the two criteria required for marketing approval of a drug, are inextricably linked. The judgments of regulators and practicing physicians ; require a global and often difficult calculation of risk and benefit, including consideration of what alternative therapies are available. For a given drug, we are willing to tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than a new drug that treats heartburn. When FDA grants marketing approval, the drug is deemed safe and effected to be used for the conditions on the label.8 Thus, for the uses the FDA has said a drug maker can market a drug--and only for those uses--the public should have confidence a drug is effective enough to be worth the risk. FDA's critics, however, argue such confidence is misplaced.9 If the critics are right, some drugs approved uses, however limited, are already broader than justifiable. The delicate risk-benefit analysis that underlies prescription drug approvals is what makes ensuring doctors have full and accurate information about a drug so important. The marketing regulations are intended to ensure that is what doctors get. Doctors are free to prescribe "off-label, " meaning.
| Micardis prescription cardVolume 25, issue 10-11 , pages 1648 - 1651 special issue: paper symposium capillary electrophoresis in clinical and forensic analysis.
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