World of Drug Information

World of Drug Information - Volume 8, Issue 1 - March 1997

In This Issue ...
 Search Tip 
 Search Strategies--Current Clinical Issues 
 FDA Drug Approvals 
 Staff Profile 
 Exhibit Schedule 

SEARCH TIP: Efficient Use of Modification of Effect Descriptors

Many variables are capable of altering the pharmacokinetic and pharmacodynamic properties of drugs. This variation in response may occur between individual patients (interindividual variability) or in one individual with repeated exposure under changing conditions (intraindividual variability). In the IDIS database, factors that influence the effects of drugs are tagged with modification of effect descriptors. Prior to August 1995, descriptor 42 MODIFICATION OF EFFECT was the sole means of identifying these factors. In the August 1995 update, more specific descriptors were added to enhance the ability to differentiate these variables when searching the IDIS database. Since this change, hundreds of articles have been tagged with each of these descriptors. Strategies combining modification of effect descriptors with drug terms, disease terms, descriptors, and global searching may be used to efficiently retrieve specific articles.

150 PHARMACOGENETICS (609 Citations)

150 PHARMACOGENETICS is used to denote differences in drug response due to factors such as gender, race, ethnic background, weight (other than obesity), and cytochrome P450 status. Variations in drug metabolism like fast or slow acetylating rate are identified by this descriptor. Articles dealing with differences in drug pharmacokinetics due to genetic factors may be found by combining the desired valid drug term with the descriptors 150 PHARMACOGENETICS and 74 PKIN PHARMACOKINETICS. To locate citations dealing with changes in pharmacodynamics caused by genetic variability, the appropriate pharmacodynamic descriptor could be used in combination with 150 PHARMACOGENETICS and the associated valid drug term. In the case of DILTIAZEM 24120410, for example, 106 PDYN CARDIOVASCULAR may be paired with 150 PHARMACOGENETICS to find articles concerned with the cardiovascular effects of diltiazem due to genetic differences. Using the disease term V87. RACE in combination with this descriptor would identify citations in which the main point is differences in drug effects due to race. Searching the global or title fields using words such as GENDER or WEIGHT might also be used in conjunction with the above combinations to further limit a search to a specific genetic factor of interest.

151 MODIFICATION EF DISEASE (1,189 Citations)

Changes in drug response ascribed to a particular disease state are indexed with 151 MODIFICATION EF DISEASE. Searches may be limited to pharmacokinetic or pharmacodynamic effects as shown with the pharmacogenetics descriptor. The specific disease causing variation in drug response is indexed with this descriptor. For example, retrieval of articles discussing changes in the effects of vancomycin caused by renal failure may be accomplished by combining VANCOMYCIN 8122813, 586. FAILURE, RENAL, and 151 MODIFICATION EF DISEASE. Other instances of commonly encountered conditions with valid disease terms included in the IDIS database that may affect pharmacological response to drugs are: liver failure, pregnancy, obesity, and smoking.

152 MODIFICATION EF AGE (593 Citations)

Variations in pharmacokinetics or pharmacodynamics attributable to patient age are identified by this descriptor. To limit searches as described above, a valid drug term and 152 MODIFICATION EF AGE may be combined with 74 PKIN PHARMACOKINETICS or the appropriate pharmacodynamic descriptor. The age group of interest can be targeted by adding the associated age tag to the disease field. Age tags used in the IDIS database include:

For example, articles dealing with pharmacokinetic alterations in geriatric patients taking phenytoin can be located by combining PHENYTOIN 28120805, V86. GERIATRIC, 74 PKIN PHARMACOKINETICS, and 152 MODIFICATION EF AGE.

42 MODIFICATION OF EFFECT (31,000 Citations since 1985)

Before the August 1995 update, all of the factors described above were identified with this descriptor. Also included under 42 MODIFICATION OF EFFECT before August 1995, were cases of drug resistance and drug tolerance. These are also now covered under the specific descriptors 148 DRUG RESISTANCE and 149 DRUG TOLERANCE. Since August 1995, 42 MODIFICATION OF EFFECT has been used to tag articles dealing with factors affecting drug response that are not covered by the specific descriptors discussed above.

A few of the more common examples include:

Modification of drug effects in athletes is also indexed under this descriptor. These articles may be located by adding V88. ATHLETE to the disease field. The large number of citations for this descriptor necessitates combining it with global searching, title searching and specific years, to focus on areas of interest like those listed above. This is especially true of articles indexed before August 1995. For example, when searching for articles indexed prior to August 1995 discussing changes in phenytoin effects in geriatric patients, the best strategy would be to combine 42 MODIFICATION OF EFFECT, PHENYTOIN 28120805, and V86. GERIATRIC.

When searching for articles dealing with modification of drug effects, consult the descriptor definitions in the thesaurus, and then choose appropriate combinations of search terms to target the specific area of interest. It is also important to note that before August 1995, the specific modification of effect descriptors did not exist. Articles discussing factors affecting drug response indexed before August 1995 will all be identified by 42 MODIFICATION OF EFFECT.

Lori Huynh, R.Ph., Pharm.D.


CURRENT CLINICAL ISSUES -- SEARCH STRATEGIES

EVIDENCE-BASED MEDICINE

Evidence-Based Medicine is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients" (Sackett). The practice of evidence- based medicine requires the integration of individual clinical expertise and judgment with the best available external evidence from systematic research. The goal of this philosophy of practice is to improve the care of patients by making better use of available evidence. This goal is consistent with the goals of the Iowa Drug Information Service database since its inception in 1965 which include; "to promote better patient care through rational drug therapy by the improved availability of drug information". Following a brief summary of issues surrounding evidence-based medicine, this article will describe strategies for the use of the IDIS system for support of activities in this type of practice.

The practice of evidence-based medicine has gained increased attention due to the growing recognition of opportunities to improve the quality and efficiency of the health care process. Decision making in health care is often performed with incomplete information, either due to an incomplete research database, or due to incomplete awareness of the available evidence by the persons making decisions. In order to incorporate the best evidence into practice for drug therapy decisions, the results of research must be: found, critically appraised, a synthesis created, and conclusions reached on which subsets of patients would be expected to experience more benefit than harm from a given therapy. We have all felt overwhelmed at one time or another by the task of trying to keep up with developments in the medical literature.

Evidence generated by medical research is not currently being incorporated into clinical practice in a timely and dependable manner. Studies have shown that some well documented beneficial therapies are utilized in one-third or less of eligible patients (Soumerai), examples include: influenza vaccination, aspirin and beta-blockers after myocardial infarction, angiotensin converting enzyme inhibitors for reduced ventricular function or diabetic nephropathy. Other therapies that have been proven ineffective or harmful continue to be utilized. Several studies conducted by researchers at Dartmouth, the Rand Corporation, and others have demonstrated significant variations in the provision of selected healthcare services (Blumenthal). The variations were not associated with improvements in outcomes, and could not be explained by different baseline risks or severity of illness in the populations involved. In addition, recent studies have documented the problems and costs associated with drug misadventuring and adverse drug events (Johnson, Bates).

The documentation of suboptimal care and the wide variations in provision of care casts doubt on the knowledge base or decision making process or both. Those that subscribe to the philosophy of the evidence-based practice of medicine believe that access to properly formatted, systematically collected and synthesized evidence, will improve the decision making process, reduce unnecessary variability in the provision of care and improve the overall quality and outcomes of care.

To learn more about evidence-based medicine the following text and web sites would be helpful: Sackett DL et al. Evidence-based medicine, how to practice & teach EBM. New York: Churchill Livingstone, 1997, and http://cebm.jr2.ox.ac.uk/ or http://hiru.mcmaster.ca/. To monitor or participate in lively discussions about practicing and teaching evidence-based medicine you may also wish to join the evidence-based medicine list server by sending the message "join evidence-based-health yourname" to mailbase@mailbase.ac.uk.

USING THE IDIS DATABASE TO SUPPORT EBM

SYSTEMIC REVIEWS

Several tools have been developed which are useful in the practice of evidence-based medicine, one such tool is the systematic review article. The key features that distinguish a systematic review article are: 1) it is based on a focused clinical question, 2) it uses explicit search strategy to be comprehensive in locating original studies, 3) the selection of studies to be included in the review is criteria based, 4) individual studies are critically appraised, 5) a quantitative summary is included, 6) the conclusions are evidence-based (Cook 1997). A systematic review that includes specific methodological and statistical techniques for combining quantitative data is a meta-analysis.

Search Strategy: Review Articles

To find a review article in the IDIS database: Use drug and/or disease terms in the field search template to define the topic area of interest and type "review" in the descriptor field. This will include all review articles on that topic including systematic reviews and traditional narrative reviews. If the retrieval is too large with this strategy, you may wish to include the word "systematic" or "academic" in the global field of the search template to restrict the retrieval to articles that include one of these words in the title or abstract. Since this terminology is very recent and not standardized in the literature, the results may vary.

Search Strategy: 145 Meta Analysis

To find a meta-analysis use drug and/or disease terms in the field search template and number 145 in the descriptor field. Since the term meta-analysis is more consistently used in the literature, and the IDIS database uses the defined descriptor for this article classification, the retrieval with this strategy will be more consistent than the strategy available for systematic reviews.

CLINICAL PRACTICE GUIDELINES

Clinical practice guidelines have also been created by professional associations and other groups for the purpose of supporting evidence-based decision making in health care. A wide variety of terms have been used in the literature to describe this type of document including: clinical algorithm, practice parameters, critical path, care map, protocol, consensus guideline, care guideline and others.

Search Strategy: Clinical Practice Guidelines/Clinical Algorithm

To find a clinical practice guideline or clinical algorithm in the IDIS database input drug and/or disease terms in the field search template to define the topic area, and then you may use one of the following options a) V84. in the disease field for specifying a clinical algorithm, b) type "guideline*" in the global field or the title field, or c) type any of the other terms mentioned above that have been used in the literature as full words or with truncation (like the guideline* example) in the global or title field.

RANDOMIZED CONTROLLED TRIALS

According to the rules of evidence, randomized controlled trials are the strongest design for producing valid evidence and are clearly the gold standard for questions about the efficacy of drug therapy (Cook 1995).

Search Strategy: Randomized Controlled Trials

To restrict your retrieval of articles in the IDIS database to randomized controlled trials input drug and/or disease terms in the field search template, and combine this with one of the following numbers in the descriptor field: 135, 136, or 137, for RCT's in adults, pediatrics, or geriatrics respectively. If you are not interested in limiting your search to one of the three age groups, type in the word "randomize" in the descriptor field to retrieve articles indexed with any one of these three descriptors.

PHARMACOECONOMIC ANALYSIS

Another relatively recent type of study in the literature which is useful for the practice of evidence-based medicine is a pharmacoeconomic analysis.

Search Strategy: Pharmacoeconomic Studies

The IDIS database utilizes five different descriptors for indexing pharmaco-economic studies. These include 129 for drug economics ( a general term, the more specific terms are usually preferred), 130 for cost benefit analysis, 131 for cost effectiveness, 132 for cost minimization, 133 for cost of illness studies, and 134 for cost utility analysis. To restrict your search results to studies of one of the specific pharmacoeconomic designs you may use one of these descriptor numbers in the descriptor field of the field search template, or you may type "econ" in the descriptor field to retrieve articles with any one of these descriptors.

CURRENT AWARENESS/CONTINUING EDUCATION

Another area of emphasis in teaching evidence-based medicine is that health care professionals should practice self directed life-long learning. In order to do this the practitioner must have regular and convenient access to primary literature particularly of the type described above. The IDIS database provides that access. The practitioner should have a plan to update their knowledge on a frequent basis. The IDIS database can be used as a current awareness tool, and to identify continuing education articles.

Search Strategy: Current Awareness

The save search feature of the IDIS database may be used to facilitate current awareness. Once a search statement has been defined on the search template, the criteria can be saved to a file on your computer's hard drive. This file can then be retrieved and executed at any time. For example, if you want to focus on keeping up to date with a certain drug, drug class or a certain disease, you can use the CD-ROM system to define the search with drug, disease, and descriptor terms until you get the type of articles that you want. You may then save that strategy to be run each time you receive your monthly update. To save a search strategy first type your search terms in the field search template, then press <F7> to activate the search files menu, select Save Search, press <enter>, type in a file name for the search, and then press <enter>. The next time you get your IDIS update, press <F7> while you are in the field search template, then select Retrieve Search from the menu and press <enter>, use the up or down arrow keys to highlight the file name of the saved search and press <enter>, press <enter> again and the search will be run. If you wish to restrict the search to just the most current year, you may type the year in the appropriate field at the bottom of the field search template before you press <enter> the second time. The most current articles will be at the top of the result list of your search.

Search Strategy: 147 CE Credit Pharmacy

Articles that are approved for continuing education credit by the American Council on Pharmaceutical Education (ACPE) are indexed with descriptor number 147 (added September 1994). To identify a CE article, input drug and/or disease terms in the field search template and type 147 in the descriptor field. There are 258 records for CE articles in the current IDIS database.

CONCLUSION

In conclusion, evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The IDIS database is a useful tool to support evidence-based practice in the provision of drug therapy.

Kevin G. Moores, R.Ph., Pharm.D.

REFERENCES:

Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997;277:307-311

Blumenthal D. The variation phenomenon in 1994 [editorial]. N Engl J Med 1994;331:1017-1018

Cook DJ, Guyatt GH, Laupacis A, et al. Clinical recommendations using levels of evidence for antithrombotic agents. Chest 1995;108(Suppl):227S-230S

Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376-380

Johnson JA, Bootman JL. Drug-related morbidity and mortality: a cost of illness model. Arch Intern Med. 1995;155:1949-1956

Sackett DL, Rosenberg WMC, Gray JAM, et al. Evidence-based medicine: What it is and what it isn't. BMJ 1996;312:71-71

Soumerai SB, McLaughlin TJ, Spiegelman D, et al. Adverse outcomes of underuse of beta-blockers in elderly survivors of acute myocardial infarction. JAMA 1997;277:115-121. (IDIS Article Number 378090)


FDA DRUG APPROVALS

1996 FDA APPROVALS SET NEW RECORDS

The Food and Drug Administration approved 139 new drugs and biological products in 1996. This was a record increase of 63 percent over such products approved in 1995. The highlight of the year was the approval of 131 new drugs, a 60 percent increase over the 82 new drugs approved in 1995, in the median time of 15.4 months, 7 percent faster than the 16.5 months the year before.

Fifty-three of these medications, 89 percent more then the 28 such drugs in 1995, were new molecular entities, products containing an active substance that had never before been marketed in the United States. These drugs were approved in the median approval time of 14.3 months, 10 percent faster than the 15.9 months in 1995. Nine of the drugs, including three HIV therapies and two cancer drugs, were approved in six months or less.

New cancer drugs approved last year were notable for their effectiveness against a wide variety of cancer: topotecan for metastatic carcinoma of the ovary; irinotecan for colorectal cancer; docetaxel for advanced breast cancer; gemcitabine for cancer of the pancreas; and nilutamide for cancer of the prostate. Three new HIV therapies included indinavir, nevirapine, and ritonavir. New drug approvals also included azfirlikast, the first of a new class of drugs for asthma, donepezil the second treatment for Alzheimer's disease; and glatiramer indicated for the treatment of relapsing-remitting multiple sclerosis.

Major biological products approved last year included RespigamTM, the first medication to protect infants against serious respiratory syncytial virus disease, AvonexTM, the second interferon product for multiple sclerosis, and VerlumaTM, a new diagnostic imaging agent that can determine the extent of small cell lung cancer in different parts of the body at one time.

Ruth Calloway, M.S., R.Ph.


NEW DRUG SELECTED BIBLIOGRAPHY

This new drug selected bibliography provides a selection of key clinical studies of new drugs approved by the FDA during November and December. IDIS SYSTEM/CD-ROM was searched to retrieve randomized controlled trials relevant to the new drugs and their approved uses. The bibliography also includes some of the supportive studies used to gain market approval as well as some comprehensive drug reviews

Amlexanox
Greer RO, Lindenmuth JE, Juarez T et al. A double-blind study of topically applied 5% amlexanox in the treatment of aphthous ulcers. J Oral Maxillofac Surg 1993;51:242-8. (IDIS Article Number 310933)

Atorvastatin
Bakker-Arkema RG, Davidson MH, Goldstein RJ et al. Efficacy and safety of a new hmg-coa reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA 1996;275:128-33. (IDIS Article Number 357912)

Heinonein TM, Stein E, Weiss SR et al. The lipid-lowering effects of atorvastatin, a new hmg-coa reductase inhibitor; results of a randomized, double-masked study. Clin Ther 1996:18:853-63. (IDIS Article Number 376629)

Cabergoline
Ciccarelli E, Giusti M, Miola C et al. Effectiveness and tolerability of long term treatment with cabergoline, a new long-lasting ergoline derivative, in hyperprolactinemic patients. J Clin Endocrinol Metab 1989;69:725-8. (IDIS Article Number 309351)

Ferrari C, Mattei A, Melis GB et al. Cabergoline: long-acting oral treatment of hyperprolactinemic disorders. J Clin Endocrinol Metab 1989;68:1201-6. (IDIS Article Number 254918)

Melis GB, Gambacciani M, Paoletti AM. Dose-related prolactin inhibitory effect of the new long-acting dopamine receptor agonist cabergoline in normal cycling, puerperal, and hyperprolactinemic women. J Clin Endocrinol Metab 1987;65:541-5. (IDIS Article Number 317944)

Webster J, Piscitelli G, Polli A et al. A comparison of cabergoline and bromocriptine in the treatment of hyperprolactinemic amenorrhea. N Engl J Med 1994;331:904-9. (IDIS Article Number 337191)

Danaparoid
Gent M, Hirsh J, Ginsberg JS et al. Low-molecular-weight heparinoid orgaran is more effective than aspirin in the prevention of venous thromboembolism after surgery for hip fracture. Circulation 1996;93:80-4. (IDIS Article Number 360282)

Fosfomycin
Crocchiolo P, Balocco G, Bonifati C et al. Single-dose fosfomycin trometamol versus multiple-dose cotrimoxazole in the treatment of lower urinary tract infections in general practice. Chemotherapy 1990;36 (Suppl 1):37-40. (IDIS Article Number 297404)

Elhanan G, Tabenkin H, Yahalom R et al. Single-dose fosfomycin trometamol versus 5-day cephalexin regimen for treatment of uncomplicated lower urinary tract infections in women. Antimicrob Agts Chemother 1994;38:2612-4. (IDIS Article Number 337800)

Ferraro G, Ambrosi G, Bucci L et al. Fosfomycin trometamol versus norfloxacin in the treatment of uncomplicated lower urinary tract infections of the elderly. Chemotherapy 1990;36 (Suppl 1):46-9. (IDIS Article Number 297406)

Neu HC. Fosfomycin trometamol versus amoxycillin--single-dose multicenter study of urinary tract infections. Chemotherapy 1990;36 (Suppl 1):19-23. (IDIS Article Number 297400)

Principi N, Corda R, Bassetti D et al. Fosfomycin trometamol versus netilmicin in children's lower urinary tract infections. Chemotherapy 1990;36 (Suppl 1):41-5. (IDIS Article Number 297405)

Van Pienbroek E, Hermans J, Kaptein AA et al. Fosfomycin trometamol in a single dose versus seven days nitrofurantoin in the treatment of acute uncomplicated urinary tract infections in women. Pharm World Sci 1993;15:257-62. (IDIS Article Number 322973)

Glatiramer
Bornstein MB, Miller A, Slagle S et al. A placebo-controlled, double-blind, randomized, two-center, pilot trial of cop 1 in chronic progressive multiple sclerosis. Neurology 1991;41:533-9. (IDIS Article Number 377366)

Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase iii multicenter double-blind, placebo-controlled trial. Neurology 1995;45:1268-76. (IDIS Article Number 350103)

Ivermectin
Awadzi K, Addy ET, Opoku NO et al. The chemotherapy of onchocerciasis xx: ivermectin in combination with albendazole. Trop Med Parasitol 1995;46:213-20. (IDIS Article Number 361301)

Datry A, Hilmarsdottir I, Mayorga-Sagastume R et al. Treatment of strongyloides stercoralis infection with ivermectin compared with albendazole: results of an open study of 60 cases. Trans R Soc Trop Med Hyg 1994;88:344-5. (IDIS Article Number 334866)

Gann PH, Neva FA, Gam AA. A randomized trial of single- and two-dose ivermectin versus thiabendazole for treatment of strongyloidiasis. J Infect Dis 1994;169:1076-9. (IDIS Article Number 329296)

Greene BM, Dukuly ZD, Munoz B et al. A comparison of 6-, 12-, and 24-monthly dosing with ivermectin for treatment of onchocerciasis. J Infect Dis 1991;163:376-80. (IDIS Article Number 276837)

Green BM, Taylor HR, Cupp EW et al. Comparison of ivermectin and diethylcarbamazine in the treatment of onchocerciasis. N Engl J Med 1985;313:133-8. (IDIS Article Number 201907)

Mabey D, Whitworth JA, Eckstein M et al. The effects of multiple doses of ivermectin on ocular onchocerciasis: a six-year follow-up. Ophthalmology 1996;103:1001-8. (IDIS Article Number 371405)

Marti H, Haji HJ, Savioli L et al. A comparative trial of a single-dose ivermectin versus three days of albendazole for treatment of strongyloides stercoralis and other soil-transmitted helminth infections in children. Am J Trop Med Hyg 1996;55:477-81. (IDIS Article Number 377446)

Pacque M, Munoz B, Greene BM et al. Community-based treatment of onchocerciasis with ivermectin: safety, efficacy, and acceptability of yearly treatment. J Infect Dis 1991;163:381-5. (IDIS Article Number 276838)

Whitworth JAG, Maude GH, Downham MD. Clinical and parasitological responsess after up to 6.5 years of ivermectin treatment for onchocerciasis. Trop Med Int Health 1996;1:786-93. (IDIS Article Number 378582)

Miglitol
Escobar-Jimenez F, Barajas C, De Leiva A et al. Efficacy and tolerability of miglitol in the treatment of patients with non-insulin-dependent diabetes mellitus. Curr Ther Res 1995;56:258-68. (IDIS Article number 344480)

Johnston PS, Coniff RF, Hoogwerf BJ et al. Effects of the carbohydrase inhibitor miglitol in sulfonylurea-treated NIDDM patients. Diabetes Care 1994;20-9. (IDIS Article Number 324303)

Omar MAK, Seedat MA, Hillebrand I. The clinical efficacy of a second-generation alpha-glucosidase inhibitor in non-insulin-dependent diabetic patients. S Afr Med J 1987;71:422-3. (IDIS Article Number 231508)

Schnack C, Roggla G, Luger A et al. Effects of the alpha-glucosidase inhibitor 1 desoxynojirimycin (bay m 1099) on postprandial blood glucose, serum insulin and c-peptide levels in type ii diabetic patients. Eur J Clin Pharmacol 1986;417-9. (IDIS Article Number 219145)

Sparfloxacin
Allegra L, Konietzko N, Leophonte P et al. Comparative safety and efficacy of sparfloxacin in the treatment of acute exacerbations of chronic obstructive pulmonary disease: a double-blind, randomised, parallel, multicentre study. J Antimicrob Chemother 1996;37 (Suppl A):93-104. (IDIS Article Number 369609)

Gehanno P, Berche P, Danon et al. Sparfloxacin versus cefuroxime axetil in the treatment of acute purulent sinusitis. J Antimicrob Chemother 1996;37 (Suppl A):105-14. (IDIS Article Number 369610)

Ortqvist A, Valtonen M, Cars O et al. Oral empiric treatment of community-acquired pneumonia: a multicenter, double-blind, randomized study comparing sparfloxacin with roxithromycin. Chest 1996;1499-1506. (IDIS Article Number 378577)

Portier H, May T, Proust A et al. Comparative efficacy of sparfloxacin in comparison with amoxycillin plus ofloxacin in the treatment of community-acquired pneumonia. J Antimicrob Chemother 1996;37 (Suppl A):83-91. (IDIS Article Number 369608)

Rubinstein E. Safety profile of sparfloxacin in the treatment of respiratory tract infections. J Antimicrob Chemother 1996;37 (Suppl A):145-60. (IDIS Article Number 369614)

Tizanidine
Compston A et al. A double-blind, placebo-controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis: the united kingdom tizanidine trial group. Neurology 1994;44 (Suppl 9):S70-8. (IDIS Article Number 339526)

Nance PW, Bugaresti J, Shellenberger K et al. Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. Neurology 1994;44 (Suppl 9):S44-S52. (IDIS Article Number 339523)

Smith C, Birnbaum G, Carter JL et al. Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. Epilepsia 1994;44 (Suppl 9):S34-S43. (IDIS Article Number 339522)

Wallace JD. Summary of combined clinical analysis of controlled clinical trials with tizanidine. Neurology 1994;44 (Suppl 9):S60-9. Review. (IDIS Article Number 339525)

Topiramate
Ben-Menachem E, Henriksen O, Dam M et al. Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia 1996;37:539-43. (IDIS Article Number 368333)

Faught E, Wilder BJ, Ramsay RE et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology 1996;46:1684-90. (IDIS Article Number 368533)

Privitera M, Fincham R, Penry J et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000 mg daily dosages. Neurology 1996;46:1678-83. (IDIS Article Number 368532)

Tassinari CA, Michelucci R, Chauvel P et al. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Neurology 1996;37:763-8. (IDIS Article Number 372665)

Valsartan
Oparil S, Dyke S, Harris F et al. The efficacy and safety of valsartan compared with placebo in the treatment of patients with essential hypertension. Clin Ther 1996;18:797-810. (IDIS Article Number 376624)

Zileuton
Israel E, Cohn J, Dube L et al. Effect of treatment with zileuton, a 5-lipoxygenase inhibitor, in patients with asthma. JAMA 1996;275:931-6. (IDIS Article Number 362020)

Israel E, Rubin P, Kemp JP et al. The effect of inhibition of 5-lipoxygenase by zileuton in mild-to-moderate asthma. Ann Intern Med 1993;119:1059-66. (IDIS Article Number 322559)

Larsen JS, Jackson SK. Antileukotriene therapy for asthma. Am J Health-Syst Pharm 1996;53:2821-30. Review (IDIS Article Number 377124)

Meltzer SS, Hasday JD, Cohn J et al. Inhibition of exercise-induced bronchospasm by zileuton: a 5-lipoxygenase inhibitor. Am J Resp Crit Care Med 1996;153:931-5. (IDIS Article Number 361063)

Wenzel SE, Kamada AK. Zileuton: the first 5-lipoxygenase inhibitor for the treatment of asthma. Ann Pharmacotherapy 1996;30:858-64. Review (IDIS Article Number 369046)

Wenzel SE, Trudeau JB, Kaminsky DA et al. Effect of 5-lipoxygenase inhibition on bronchoconstriction and airway inflammation in nocturnal asthma. Am J Resp Crit Care Med 1995;152:897-905. (IDIS Article Number 356177)

NOVEMBER & DECEMBER 1996
FDA APPROVALS

Generic Name (FDA Therapeutic Classification)

Trade Name

Sponsor

(Approval Date)

Valid IDIS Drug Term

Drug Number

(IDIS Citations)*

Indication/Use

Valid IDIS Disease Term

Modified ICD-9-CM Number

Amlexanox (1P)**

Aphthasol

Block Drug Co., Inc.

(Dec. 17)

AMLEXANOX

92000230

(4 citations)

Treatment of oral aphthous ulcers Aphthae, Oral
528.2
Atorvastatin Calcium (1P)

Lipitor

Warner-Lambert & Pfizer

(Dec. 17)

ATORVASTATIN

24060202

(16 citations)

Treatment of primary hypercholesterolemia and mixed dyslipidemia Hypercholesterolemia, Pure
272.0

Cabergoline (1S)***

Dostinex

Pharmacia & Upjohn Co.

(Dec. 23)

CABERGOLINE

28280017

(39 citations)

Treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas Disorder, Pituit Gland NEC
253.

Neop, BGN-Pituitary Gland
227.3

Danaparoid Sodium (1S)

Orgaran

Organon Inc.

(Dec. 24)

DANAPAROID

20120419

(52 citations)

For prophylaxis of post-operative deep vein thrombosis which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery Embolism, Pulmonary
415.1

Embolism/Thrombosis, VN NEC
453.

Prophylaxis NEC
V07.

Donepezil HCL (1P)

Aricept

Eisai America Inc.

(Nov. 25)

DONEPEZIL

28200039

(4 citations)

Treatment of mild to moderate dementia of the Alzheimer's Type Dementia, Presenile
290.1

Alzheimer's Disease
331.0

Ferumoxsil (1S)

GastroMark

Advanced Magnetics Inc.

(Dec. 6)

FERUMOXSIL

36680047

(1 citation)

Indicated in adult patients for oral use with MRI to enhance the delineation of the bowel to distinguish it from organs and tissues that are adjacent to the upper regions of the GI tract Magnetic Resonance Imaging
88.9

Fosfomycin Tromethamine (1S)

Monurol

Forest/Zambon

(Dec. 19)

FOSFOMYCIN

8122848

(185 citations)

Single-dose therapy in the treatment of uncomplicated urinary tract infection Infection, Urinary Tract
599.0
Glatiramer Acetate (1S)

Copaxone

Teva Pharmaceuticals USA

(Dec. 20)

GLATIRAMER

14000028

(29 citations)

Reduction of frequency of relapses in patients with relapsing-remitting multiple sclerosis Sclerosis, Multiple
340.
Ivermectin (1P)

Stromectol

Merck

(Nov. 22)

IVERMECTIN

8080016

(152 citations)

For treatment of strongyloidiasis and onchocerciasis Strongyloidiasis
127.2

Filariasis and Dracontiasis
125.

Miglitol (1S)

Glyset

Bayer Corp.

(Dec. 18)

MIGLITOL

68200006

(17 citations)

Adjunct to diet or diet plus sulfonylurea therapy to improve glycemic control in patients with non-insulin-dependent diabetes mellitus Diabetes Mellitus
250.

Sparfloxacin (1S)

Zagam

Rhone-Poulenc Rorer

(Dec. 19)

SPARFLOXACIN

8122017

(116 citations)

Treatment of community-acquired pneumonia; acute bacterial exacerbations of chronic bronchitis, and acute maxillary sinusitis Pneumonia, Bacterial NEC
482.

Bronchitis, Chronic NEC
491.

Sinusitis, Acute
461.

Tizanidine HCL (1S)

Zanaflex

Athena Neurosciences Inc.

(Nov. 27)

TIZANIDINE

12200017

(25 citations)

For the acute and intermittent management of increased muscle tone associated with spasticity Involuntary Movement, ABN
781.0
Topiramate (1S)

Topamax

Johnson & Johnson

(Dec. 24)

TOPIRAMATE

28122035

(28 citations)

Adjunctive treatment for partial onset seizures in adults Epilepsy, Part No Impair Consc
345.5

Epilepsy, Part W Impair Consc
345.4

Valsartan (1S)

Diovan

Ciba Giegy

(Dec. 23)

VALSARTAN

24080042

(4 citations)

Treatment of hypertension (Angiotensin II receptor blocker) Hypertension
401.
Zileuton (1S)

Zyflo

Abbott

(Dec. 9)

ZILEUTON

86000042

(38 citations)

Prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older Asthma NEC
493.

*Through February 1997 Update. Complete bibliographic citations will be provided upon request.
**(1P) New Molecular Entity given a priority review.
***(1S) New Molecular Entity given standard review by FDA.


IDIS STAFF PROFILE

Julie Tomash
Julie Tomash

Julie Tomash joined IDIS as the Division Secretary in October of 1996. Julie's primary duties are to answer the phone, route inquiries, generate customer correspondence and process travel and exhibit arrangements. Julie is currently working on converting this newsletter to new software. A 15-year employee of the University, she has worked in customer service areas most of this time.

Much of Julie's spare time is devoted to her family. She spends her time at her children's school and social activities. She and her husband follow Iowa Hawkeye football and wrestling. The few hours left are spent with her 12-year old quarter horse gelding "Joe" or nose-deep in a good book.


1997 IDIS EXHIBIT SCHEDULE

Academy of Managed Care Pharmacy (AMCP)
Annual Meeting
New Orleans, Louisiana
May 8-11, 1997

American Society of Hospital Pharmacists (ASHP)
Home Care '97
Reno, Nevada
August 16-18, 1997

Federation Internationale Pharmaceutique (FIP)
World Congress of Pharmacy and Pharmaceutical Sciences
Vancouver, Canada
August 31-September 5, 1997

American Society of Hospital Pharmacists (ASHP)
Midyear Clinical Meeting (MCM)
Atlanta, Georgia
December 7-11, 1997


World of Drug Information is published quarterly
(March, June, September, December)
by the Division of Drug Information Service.

Editor: Donna Brus
Production/Design: Julie Tomash
Photographer: David Luck


Iowa Drug Information Service
The University of Iowa, 100 Oakdale Campus, N330 OH
Iowa City, IA 52242-5000 U.S.A.

Telephone: 319-335-4800 U.S. Toll-Free: 800-525-IDIS Fax: 319-335-4077
E-Mail: IDIS@uiowa.edu Home Page: http://www.uiowa.edu/~idis


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