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HEALTHLINE August 2005 INDICATIONS/WARNINGS Results Show Valsartan/Hydrochlorothiazide (Diovan HCT) Superior To Amlodipine (Norvasc) At Reducing Blood Pressure In Patients With Moderate To Severe Hypertension Patients with moderate to severe hypertension showed superior reductions in blood pressure when they received 160 mg/25 mg Diovan compared with Norvasc (dose), according to results from the VAST study. The double-blind, active-controlled, parallel group VAST study was designed to evaluate the efficacy of 160 mg/12.5 mg Diovan HCT, 160 mg/25 mg Diovan HCT and 10 mg Norvasc. A total of 1,088 patients with moderate to severe high blood pressure and additional cardiovascular risk factors were randomized to receive one of the three drug regimens for 24 weeks. At baseline, patients in all three treatment groups had similar average systolic blood pressure and diastolic blood pressure. Diovan HCT 160 mg/25 mg was superior to Norvasc at reducing systolic blood pressure, as evidenced by the average 27.1 mmHg, -29.7 mmHg and 27.6 mmHg changes in blood pressure observed in the 160 mg/12.5 mg Diovan HCT, 160 mg/25 mg Diovan HCT and Norvasc groups, respectively. However, the groups showed no statistically significant differences in diastolic blood pressure. Moreover, patients who received either dose of Diovan HCT had significantly lower rates of treatment-related adverse events than those treated with Norvasc. In a sub-study of VAST, a significantly greater proportion of 160 mg/25 mg Diovan HCT-treated patients achieved their blood pressure goal of 130/80 mmHg as compared with Norvasc-treated subjects (60.8 percent vs. 50.9 percent). Diovan is in a class of medications called angiotensin receptor blockers, known to be safe and effective in elderly individuals. Diovan is also approved for treating patients with heart failure and protects against the progression of kidney disease in persons with Type 2 diabetes. References Ruilope L, et al. Fixed-Dose Valsartan + Hydrochlorothiazide Combination Therapy Compared With Amlodipine Monotherapy In Hypertensive Patients With Additional Cardiovascular Risk Factors: The VAST Study. Clinical Therapeutics 2005 27:578-88. In addition, two new analyses of the VALUE trial demonstrated that Diovan may reduce the development of heart failure Julius S et al. VALUE Study: Outcomes In 7080 Patients Treated With Monotherapy. Presented June 19 at ESH 2005. and the onset of type II diabetes Kjedlsen SE, et al. Effects of Valsartan Preventing the Development of Type 2 Diabetes in High Risk Hypertensive Patients: Analysis from the VALUE Trial. Presented June 18 at ESH 2005. in high-risk patients with hypertension when compared with amlodipine. Top Ten Dangerous Drug Interactions In Long Term Care One of the important components of a medication review is the identification of dangerous drug interactions. To help improve medication use in long term care, the American Medical Directors Association (AMDA) and American Society of Consultant Pharmacist (ASCP) have joined in collaboration to identify the top 10 drug interactions involving long term care residents. Medications chosen for the Top Ten list were based on their frequency of use in older adults in long term care and the potential for adverse consequences if used together. However, due to individual variability, not all adults taking these medications together will experience an adverse affect. This list should be used to alert the health care team of potentially serious interactions and Copyright 2005 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 1 HEALTHLINE August 2005 enable the team to take steps to choose alternative therapy, adjust doses, put monitoring tools in place, or other corrective actions. Drug Interaction Impact Warfarin – NSAIDs/COX-2s Potential for serious GI Bleed Avoid concomitant use. Use Tylenol instead. Monitor INR weekly. Nursing monitor for S&S of active bleed. Warfarin – Sulfa Drugs Potential for serious bleed due to increased effects of warfarin Avoid concomitant use. If use is imperative, reduce warfarin dose 50% during antibiotic therapy and 1 week after. Monitor INR every 3 days until INR stable. Nursing monitor for S&S of active bleed. Warfarin – Macrolides Potential for serious bleed due to increase effects of warfarin Avoid concomitant use. If use is imperative, reduce warfarin dose 50% during antibiotic therapy and 1 week after. Monitor INR every 3 days until INR stable. Nursing monitor for S&S of active bleed. Warfarin – Quinolones1 Potential for serious bleed due to increased effects of warfarin Avoid concomitant use with Penetrex, Cipro, Noroxin,and Floxin. Focus on newer agents. Monitor INR every other day. Adjust warfarin dose as necessary. Nursing monitor for S&S of active bleed. Warfarin – Phenytoin Increased effects of warfarin and/or phenytoin Obtain baseline INR and serum phenytoin concentration. Monitor INR and phenytoin concentrations. Nursing monitor for S&S of active bleed. ACE Inhibitors – Potassium Supplements Elevated serum potassium Draw K+ level prior to initiation of ACE-I. Adjust K+ supplementation if concentrations increase. ACE Inhibitors – Spironolactone Elevated serum potassium Draw K+ concentration prior to initiation of spironolactone. Monitor K+ concentrations, and renal function. Avoid K+ supplements. Digoxin – Amiodarone Digoxin toxicity Draw digoxin concentration prior to initiation of amiodarone. Decrease dose of digoxin 50%, then monitor Q week for several weeks. Maintain digoxin concentration ≤1ng/mL to avoid digoxin toxicity. Nursing monitor for S&S of toxicity. Digoxin – Verapamil Digoxin toxicity Monitor heart rate and EKG-PR interval. Evaluate selection of this combination. Monitor HR & EKG-PR interval. Monitor for S&S of digoxin toxicity. Theophylline – Quinolones1 Theophylline toxicity Obtain baseline theophylline concentration before initiation of Quinolones1 (especially Cipro and Penetrex). Monitor theophylline concentrations. Maintain concentration between 515 mcg/mL. Monitor for S&S of theophylline Copyright 2005 All Rights Reserved Prevention Published by Omnicare, Inc. distributed by PBM Plus, Inc. Management Page - 2 HEALTHLINE August 2005 toxicity. 1 Quinolones that interact include in descending order of greatest impact: enoxacin >ciprofloxacin>norfloxacin=ofloxacin. Where S&S means signs and symptoms, K+ means potassium, HR means heart rate, INR means Internationalized Ratio To review the complete report and its details go to http://www.scoup.net/M3Project/topten PATIENT CARE Treatment of Parkinson’s Disease The prevalence of this disease is estimated to be between 6-8% of nursing home residents with another 10-15% presenting with other movement disorders, primarily essential tremor. As with many of the co-morbidities facing our elderly residents, this disease is also often misdiagnosed and not optimally treated. Parkinson’s is defined by having two of four specific symptoms: resting tremor, muscular rigidity, gait instability and bradykinesia. Parkinson’s Disease is caused by a deficiency of the neurotransmitter dopamine and therefore the administration of dopamine (in the form of levodopa) was thought to provide appropriate therapy. As this medication had limited effect, and also induced nausea and vomiting, pairing it with carbidopa (Sinemet) and assuring that residents receive at least 70 mg of carbidopa daily became the gold standard for treating Parkinson’s patients. As the disease progresses, so does the need to increase the dose of carbidopa/levodopa or adding other therapies: - Eldepryl (selegiline) was initially expected to exhibit neuroprotective effects, but now is used as an adjunct to treatment that may allow the reduction of the dose or intervals of levodopa/carbidopa - The anticholinergic medications such as Artane and Cogentin are also used as adjunctive therapy but due to their side effect profiles are not well tolerated by the elderly. - Dopamine agonists such as Parlodel, Permax and Requip are occasionally added initially or used adjunctively. - The drug Comtan can be added to carbidopa/levodopa when there is a wearing off effect of this drug. A new drug named Stalevo is a combination of carbidopa/levodopa and Comtan. Nearly all residents will face side effects from carbidopa/levodopa including drug induced psychosis and hallucinations. It is typically not possible to lower the dose to reduce these symptoms and psychoactive therapy often is necessary. The two classes of psychoactive drugs shown to have the most benefit in these patients are the atypical antipsychotics, clozapine and Seroquel in particular, as usually they do not worsen Parkinson’s symptoms like conventional antipsychotics and the cholinesterase inhibitors (e.g. Aricept, etc.) because they help restore the relative balance between acetylcholine and dopamine in the central nervous system. Please contact your Consultant Pharmacist for more information on medication management in residents with Parkinson’s Disease. Copyright 2005 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 3 HEALTHLINE August 2005 Resources: Geriatric Pharmaceutical Care Guidelines, 2004 Clinical Pharmacology, 2005 Annals of Long Term Care Editorial Board Karen Burton, R. Ph., GCP, FASCP Mark Coggins, Pharm. D., GCP, FASCP Kelly Hollenack, Pharm. D. CGP Philip King, Pharm. D., GCP, FASCP Susan Kleim, B.S., Pharm., GCP, FASCP Terry O’Shea, Pharm. D., GCP, FASCP Elmer Schmidt, Pharm. D., GCP, FASCP Barbara J. Zarowitz, Pharm. D., GCP, FASCP Copyright 2005 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 4