The economic effect of switching from sildenafil to another phosphodiesterase type 5 inhibitor.Patients who could benefit from additional education about treatments for erectile dysfunction Erectile Dysfunction Definition Erectile dysfunction (ED), formerly known as impotence, is the inability to achieve or maintain an erection long enough to engage in sexual intercourse. (ED) may prematurely discontinue dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: or switch ED medications, resulting in unnecessary resource utilization. In a retrospective cohort study A cohort study is a form of longitudinal study used in medicine and social science. It is one type of study design. In medicine, it is usually undertaken to obtain evidence to try to refute the existence of a suspected association between cause and disease; failure to refute using a large, aggregated health claims database, the costs associated with switching from sildenafil sildenafil /sil·den·a·fil/ (sil-den´ah-fil?) a phosphodiesterase inhibitor that relaxes the smooth muscle of the penis, facilitating blood flow to the corpus cavernosum; used as the citrate salt to treat erectile dysfunction. to another phosphodiesterase phosphodiesterase /phos·pho·di·es·ter·ase/ (-di-es´ter-as) any of a group of enzymes that catalyze the hydrolytic cleavage of an ester linkage in a phosphoric acid compound containing two such ester linkages. type 5 (PDE-5) inhibitor were compared with those for patients refilling sildenafil. Of the 15,584 patients with an index sildenafil claim, 10,863 had a second PDE-5 inhibitor prescription (10,137 for sildenafil, 726 for vardenafil or tadalafil). Erectile dysfunction?attributable costs in the six-month preindex period were similar (P = .72), but postindex six-month ED costs were higher in patients who initially switched from sildenafil ($173.38) versus patients who refilled sildenafil ($131.51; P < .001). Regression analysis In statistics, a mathematical method of modeling the relationships among three or more variables. It is used to predict the value of one variable given the values of the others. For example, a model might estimate sales based on age and gender. estimated that corrected ED-attributable and overall costs were 41% (P < .001) and 43% (P < .001) higher for patients who switched versus those who refilled sildenafil, respectively. ********** Erectile dysfunction (ED) is a condition that affects 20 million to 30 million men in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. (1) and more than 150 million men worldwide, (2) and the prevalence is expected to increase with an aging population. (2) Sildenafil citrate Sildenafil Citrate Definition Sildenafil citrate (Viagra) is a medication used to treat erectile dysfunction (ED), or impotence, in men. was the first oral phosphodiesterase type 5 (PDE-5) inhibitor available in the United States for the treatment of ED. It has proven to be efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic and generally well tolerated. (3-8) The efficacy and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol of sildenafil, along with its preferable mode of delivery compared with intracavernosal injection, transurethral transurethral /trans·ure·thral/ (trans?u-re´thral) performed through the urethra. transurethral performed through the urethra. pellets, or penile implants Noun 1. penile implant - an implant that creates an artificial erection implant - a prosthesis placed permanently in tissue , were associated with a dramatic expansion in ED treatment. (9) In 2003, two additional oral PDE-5 inhibitors were approved by the Food and Drug Administration: (1) vardenafil (10) and (2) tadalafil. (11,12) Evidence suggests that ED is both underdiagnosed and undertreated. (13,14) This is notable, because the prevalence of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , hypertension, diabetes, dyslipidemia, and depression is increased in men with ED, (15,16) and because of the potential implications for the emotional well-being of men with ED (17,18) and their partners. (19,20) With regard to the former, a diagnosis of ED may lead to the discovery of serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . In addition, patients with ED may discontinue medications for comorbidities because of a perceived effect on erectile erectile /erec·tile/ (e-rek´til) capable of erection. e·rec·tile adj. 1. Of or relating to tissue capable of filling with blood and becoming rigid. 2. function. (21) Sildenafil can be highly efficacious in men with ED with varying cultural backgrounds, (4-8,22,23) comorbidities, (24-30) and ED etiology etiology /eti·ol·o·gy/ (e?te-ol´ah-je) 1. the science dealing with causes of disease. 2. the cause of a disease. . (31-33) Moreover, several studies have demonstrated that a substantial number of nonresponders (34,35) or patients who self-identify as poor responders to sildenafil can be successfully treated after reeducation Reeducation may refer to:
v. To determine the concentration of a solution by titration or perform the operation of titration. ti to 100 mg after one unsatisfactory attempt with a 50-mg dose. Patients spent an average of 12 minutes with the physician, and 94% of patients maintained responsiveness to sildenafil 26 months later. Jiann and colleagues (36) were able to treat 58.5% of 41 nonresponders after reviewing proper usage instructions and recommending that patients make four attempts at sexual activity with the 100-mg dose. Despite these findings, recent evidence suggests that dose titration is underutilized. (37) Thus, some patients may prematurely discontinue sildenafil or switch to another oral PDE-5 inhibitor, even though no studies have shown other medications to be more effective than sildenafil. (4,10,11) To date, no properly designed, head-to-head efficacy studies that show one PDE-5 inhibitor is superior to another have been conducted. A limited number of head-to-head preference studies have been performed, but these are deeply flawed flaw 1 n. 1. An imperfection, often concealed, that impairs soundness: a flaw in the crystal that caused it to shatter. See Synonyms at blemish. 2. . (38) At the time of the current study, no data on costs of switching among oral PDE-5 inhibitors were published. Thus, the cost associated with switching from sildenafil to another oral PDE-5 inhibitor was evaluated by comparing ED-attributable and overall resource utilization for patients who refilled sildenafil versus patients who switched their PDE-5 inhibitor medication. METHODS A retrospective cohort study was conducted using Atlanta-based NDCHealth's Intelligent Health Repository (IHR IHR Institute for Historical Review (Orange Country, California) IHR International Health Regulations IHR Institute for Health Research (Lancaster University, UK) IHR Inside Home Recording ) database to compare the health care costs of patients who switched ED medications with those who refilled sildenafil after receiving their first sildenafil prescription. The IHR database contains pharmacy and medical claims linked by anonymous patient identification numbers. Transaction data from approximately 40,000 U.S. pharmacies representing all 50 states are included in the database, accounting for approximately 40% of all U.S. retail pharmacy transactions. A small percentage (1%-2%) of claims is from mail-order pharmacy. However, no indicator on the IHR claims identify them as such. The IHR database also includes approximately 160 million physician claims per year (approximately 25% of all physician claims) and 72 million hospital claims (20% of all hospital claims). Men at least 18 years of age with an initial prescription claim for sildenafil between November 2003 and March 2004 were identified from the IHR database. The date of the initial sildenafil claim was defined as the index date. Patients with prescription or medical claims activity (for any reason) in the IHR database at least six months before and at least six months after their index date were eligible for the study. Patients with zero total charges in the preindex period were excluded, and patients were required to have at least one medical claim during either the six-month preindex or postindex period. Prescription activity during the six-month postindex period was used to categorize cat·e·go·rize tr.v. cat·e·go·rized, cat·e·go·riz·ing, cat·e·go·riz·es To put into a category or categories; classify. cat patients according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. whether their second prescription second prescription, n the homeopathic remedy given after the initial remedy. See also remedy, following; repetition of dose; response to prescription; single dose; and homeopathy, unicist. was for sildenafil (i.e., refilled) or another oral PDE-5 inhibitor (i.e., switched). Overall costs and those attributable to ED were evaluated in the six-month preindex and postindex sildenafil periods. Costs were defined as all medical and pharmacy expenses incurred by patients that were covered by payers and all patient out-of-pocket expenses out-of-pocket expenses n. moneys paid directly for necessary items by a contractor, trustee, executor, administrator or any person responsible to cover expenses not detailed by agreement. , including copays and charges for items and services not covered not covered Health care adjective Referring to a procedure, test or other health service to which a policy holder or insurance beneficiary is not entitled under the terms of the policy or payment system–eg, Medicare. Cf Covered. by insurance providers. Costs attributed to ED were based on claims for International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM ICD-9-CM International Classification of Disease, 9th edition, Clinical Modification A standardized classification of disease, injuries, and causes of death, by etiology and anatomic localization and codified into a 6-digit number, which allows ) codes (302.70, 302.71, 302.72, 302.9, V41.7, and 607.84) as well as NDC NDC National Drug Code NDC NATO Defense College NDC National Documentation Centre (National Hellenic Research Foundation, Athens, Greece) NDC National Dairy Council NDC National Democratic Congress codes for sildenafil, tadalafil, and vardenafil (Appendix). Overall costs included ED-attributable and non-ED-attributable ("all other") costs. Preindex and postindex costs of patients who initially switched to a different oral PDE-5 inhibitor were compared with the respective costs of patients who refilled sildenafil. Analysis of the ICD-9-CM codes identified comorbidities of interest, including hypertension (401.xx), dyslipidemia (272.xx), depression (296.22, 296.3, 311.xx), and diabetes (250.xx), in addition to medications associated with these comorbidities using NDC codes (Appendix). Statistical Analysis. Differences in demographic characteristics and costs between patients who switched to an alternative oral PDE-5 inhibitor and those who refilled their sildenafil prescription were evaluated using t tests and chi-square tests chi-square test: see statistics. . Differences in ED-attributable and overall costs were further evaluated using ordinary linear regression Linear regression A statistical technique for fitting a straight line to a set of data points. , for which costs were log transformed. The following covariates were included in the model: patient age, presence of other chronic conditions, index sildenafil cost, and preindex costs. Statistical analyses were performed using SAS/STAT Version 8.2 (SAS Institute SAS Institute Inc., headquartered in Cary, North Carolina, USA, has been a major producer of software since it was founded in 1976 by Anthony Barr, James Goodnight, John Sall and Jane Helwig. , Cary, NC). RESULTS A total of 15,584 patients had their first claim for sildenafil during the study period, of which 10,863 had a second prescription for a PDE-5 inhibitor (10,137 sildenafil, 726 vardenafil or tadalafil). Patient characteristics for those who initially refilled sildenafil and those who immediately switched to another PDE-5 inhibitor are presented in Table I. Although preindex costs attributable to ED were similar between those who initially refilled ($19.32) and those who switched ($20.81) from sildenafil (P = .72), postindex ED costs were significantly higher (P < .001) in patients who switched ($173.38) relative to patients who refilled their sildenafil prescription ($131.51) (Figure 1). Pharmacy ($116.43 vs. $146.73, P < .0001) and medical ($15.08 vs. $26.65, P = .016) costs were lower for those who did not switch their PDE-5 inhibitor. Overall costs during the postindex period were not significantly higher among patients who initially switched ED medications than among those who refilled ($757.31 vs. $648.40, respectively, P = .087), which was consistent with differences in preindex costs ($794.91 vs. $636.48, respectively, P = .061) (Figure 2). Controlling for differences in age, comorbidities, preindex costs, and index sildenafil cost, ordinary linear regression revealed the ED-attributable costs incurred during the postindex period by patients who switched medications were approximately 41% greater than the ED-attributable costs incurred by patients who refilled their prescription for sildenafil (P < .001; Table II). In addition to medication switching, the regression analysis revealed that index sildenafil cost, preindex costs (P < .001, all comparisons), and patient age (P = .002) were significantly associated with higher ED-attributable costs during the postindex period. The presence of diabetes and depression (P < .001, all comparisons) was significantly associated with lower ED-attributable costs (Table II). Medication switching, index sildenafil cost, presence of dyslipidemia, presence of hypertension, preindex costs (P < .001, all comparisons), age (P = .007), presence of diabetes (P = .0057), and presence of depression (P < .001) were associated with significantly higher overall health care costs during the postindex period (Table II). DISCUSSION Oral PDE-5 inhibitors are currently the first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy. for ED, owing to owing to prep. Because of; on account of: I couldn't attend, owing to illness. owing to prep → debido a, por causa de their efficacy, tolerability, and ease of use. (39) However, one of the major challenges of successful ED treatment in clinical practice is the lack of patient education and appropriate dosage dosage /dos·age/ (do´saj) the determination and regulation of the size, frequency, and number of doses. dos·age n. 1. Administration of a therapeutic agent in prescribed amounts. titration. (40) These difficulties may result in patients prematurely switching medications and incurring additional costs. The current study demonstrates that ED-attributable costs in patients receiving an initial prescription for sildenafil are significantly lower among patients who refill refill noun A second allotment of a prescription agent obtained from a pharmacy, which is allowed by the original prescription verb Pharmacology To obtain more of a particular drug, after the initially prescribed amount of the agent has been used or their sildenafil prescription compared with patients who switch to another PDE-5 inhibitor agent. Specifically, patients who refilled their sildenafil prescription incurred an average of $131.51 in health care costs attributable to ED during the six-month postindex period, compared with an average of $173.38 among patients who switched ED medications. The difference in ED costs was primarily attributed to an additional $30 in pharmacy costs, which was accompanied by an additional $12 in medical costs for patients who switched. No significant differences were noted in the prevalence of comorbidities, and preindex overall costs were not significantly higher in the switch cohort. Patients who switched were slightly older and had a higher index sildenafil cost. Thus, regression was used to correct for differences in age, comorbidities, preindex costs, and index sildenafil cost. The regression analysis revealed that ED-attributable health care costs were approximately 41% lower among those who refilled their sildenafil prescription compared with those who switched. The regression analysis for overall costs was consistent with this finding, indicating 43% higher costs in patients who switched medications. However, this was not a surprise because preindex costs were also numerically higher for the switch cohort. Index sildenafil cost, patient age, and preindex costs were significantly associated with higher ED-attributable and overall costs in the regression models. As expected, depression and diabetes were associated with higher overall costs; however, these comorbidities were also connected to lower ED-attributable costs. This may be related to a potential negative effect of depression and diabetes on ED treatment success, resulting in discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance of PDE-5 medications and subsequently lower ED-attributable costs. Although the presence of dyslipidemia and hypertension was not significantly associated with ED-attributable costs, overall costs were significantly higher for patients with these comorbidities. Limitations. The results of this study should be interpreted in the context of its limitations. First, costs were only examined in patients whose initial prescription claim was for sildenafil. Furthermore, the IHR does not contain indicators for prescriptions from mail-order pharmacy. It is possible that for socially sensitive medical conditions, such as ED, mail-order services may be used more often than for other types of medical conditions. Although this may have an effect on pharmacy costs, mail-order pharmacy accounts for only 1% to 2% of prescriptions in the IHR. There is no reason to assume that the distribution of mail-order prescriptions differed across the study comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. groups, which were derived from a cohort of patients who filled their first PDE-5 inhibitor prescription for sildenafil. Although a retrospective study retrospective study, a study in which a search is made for a relationship between one phenomenon or condition and another that occurred in the past (e.g. using a claims database has the advantage of reflecting real-world patient experience, it lacks the control of a properly conducted clinical trial. Moreover, such data may be subject to miscoding or undercoding and cannot account for the distribution of medication samples by physicians, a practice that could influence a patient's propensity to switch their medications. Another important limitation of this analysis is that the data were culled from patients who received their index prescription for sildenafil between November 2003 and March 2004. Both vardenafil and tadalafil were approved in 2003 and thus were relatively new to the market at the beginning of the study period. This may have contributed to the minimal switching observed in this study and subsequent underestimation of the costs of switching. CONCLUSIONS The present study suggests that patients who switch to another PDE-5 inhibitor agent after receiving an initial prescription for sildenafil incur greater ED-attributable and overall costs than patients who refill their sildenafil prescription. Although the influence of physician communication about ED was not evaluated in this study, perhaps additional discussion with patients about appropriate use and expectations for ED treatment, including potential need for dose titration, may prevent switching and associated additional costs.
APPENDIX: ICD-9-CM AND NATIONAL DRUG CODES
Medical
Codes Pharmaceuticals
ED 302.70, 302.71, Viagra, Cialis, Levitra
302.72, 302.9,
V41.7, 607.84
Hypertension 401.xx Accupril, Accuretic, acebutolol,
Aceon, Adalat CC, Afeditab CR,
Altace, Atacand, Atacand HCT,
atenolol, atenolol/chlorthalidone,
Avalide, Avapro, benazepril, benaze-
pril HCTZ, Benicar, Benicar HCT,
Betachron, Betapace, Betapace AF,
betaxolol, bisoprolol fumarate,
bisoprolol fumarate/HCTZ, Blocadren,
Calan, Calan SR, Capoten, Capozide,
captopril, captopril/HCTZ, Cardene,
Cardene SR, Cardizem, Cardizem CD,
Cardizem LA, Cardizem SR, Cardura,
Cartia XT, Cartrol, Catapres,
Catapres-TTS 1, Catapres-TTS 2,
Catapres-TTS 3, clonidine, Clorpres,
Coreg, Corgard, Corzide, Covera-HS,
Cozaar, Dilacor XR, Dilt-XR, Diltia
XT, diltiazem, diltiazem XR, Diovan,
Diovan HCT, Diutensen-R, doxazosin
mesylate, Dynacirc, Dynacirc CR,
enalapril maleate, enalapril maleate/
HCTZ, Enduronyl, Enduronyl Forte,
fosinopril sodium, guanabenz acetate,
guanfacine, HCTZ/reserpine/
hydralazine, Hydra-Zide, hydralazine,
Hytrin, Hyzaar, Inderal, Inderal LA,
Inderide-40/25, Innopran XL, Isoptin
SR, Kerlone, Labetalol, Levatol,
Lexxel, Lisinopril, Lisinopril/HCTZ,
Loniten, Lopressor, Lopressor HCT,
Lotensin, Lotensin HCT, Lotrel, Mavik,
methyldopa, methyldopa/HCTZ,
metoprolol tartrate, Micardis,
Micardis HCT, Minipress, Minizide 1,
minoxidil, moexipril, Monopril,
Monopril HCT, nadolol, nicardipine,
Nifediac CC, Nifedical XL,
nifedipine, nifedipine ER, Nimotop,
Normodyne, Norvasc, pindolol,
Plendil, prazosin, Prinivil, Prinzide,
Procardia, Procardia XL, propranolol,
propranolol w/HCTZ, Quinaretic,
reserpine, Sectral, Sorine, sotalol,
sotalol AF, sotalol, Sular, Tarka,
Taztia XT, Tenex, Tenoretic 100,
Tenoretic 50, Tenormin, terazosin,
Teveten, Teveten HCT, Tiazac,
Timolide, timolol maleate, Toprol XL,
Trandate, Uniretic, Univasc, Vascor,
Vaseretic, Vasotec, verapamil,
Verelan, Verelan PM, Visken, Wytensin,
Zebeta, Zestoretic, Zestril, Ziac
Dyslipidemia 272.xx Advicor, Altocor, Altoprev, Caduet,
cholestyramine, cholestyramine light,
Colestid, Crestor, fenofibrate,
gemfibrozil, Lescol, Lescol XL,
Lipitor, Locholest, Lofibra, Lopid,
lovastatin, Mevacor, Niaspan,
Pravachol, Pravigard PAC, Prevalite,
Questran, Questran Light, Tricor,
Welchol, Zetia, Zocor
Depression 296.22, 296.3, Amitriptyline, amoxapine, Anafranil,
311.xx Aventyl, Budeprion SR, bupropion,
Celexa, clomipramine, desipramine,
Desyrel, Effexor, Effexor XR, Elavil,
Emitrip, fluoxetine, fluvoxamine
maleate, imipramine, Lexapro,
Ludiomil, Luvox, maprotiline,
mirtazapine, nefazodone, Norpramin,
nortriptyline, Pamelor, paroxetine,
Paxil, Paxil CR, Pexeva, Prozac,
Prozac Weekly, Remeron, Serzone,
Surmontil, Tofranil, Tofranil-PM,
Trazodone, Vivactil, Wellbutrin,
Wellbutrin SR, Wellbutrin XL, Zoloft
Diabetes 250.xx Actos, Amaryl, Avandamet, Avandia,
chlorpropamide, Diabeta, Diabinese,
Fortamet, Glipizide, Glipizide ER,
Glipizide XL,Glucophage, Glucophage
XR, Glucotrol, Glucotrol XL,
Glucovance, glyburide, glyburide
micronized, glyburide-metformin,
Glynase, Glyset, Humalog, Humalog Mix
75/25, Humulin 50/50, Humulin 70/30,
Humulin L, Humulin N, Humulin R,
Humulin U, Iletin II Lente Pork,
Iletin II NPH Pork, Iletin II Regular
Pork, Iletin NPH, Lantus, Metaglip,
metformin, metformin ER, Micronase,
Novolin 70/30, Novolin L, Novolin N,
Novolin R, Novolog, Novolog Mix
70/30, Prandin, Precose, Riomet,
Starlix, tolazamide, tolbutamide,
Tolinase, Velosulin Human BR
ED = Erectile dysfunction; ICD-9-CM = International Classification of
Diseases, 9th Edition, Clinical Modification; HCTZ =
hydrochlorothiazide.
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Lowentritt BH, Sklar GN: The effect of erectile dysfunction on patient medication compliance (abstract). J Urol 2004;171:231. (22.) Benchekroun A, Faik M, Benjelloun S, et al: A baseline-controlled, open-label, flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction. Int J Impot Res 2003;15(suppl 1):19-24. (23.) Becher E, Tejada Noriega A, Gomez R, et al: Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. : A double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation es·ca·late v. es·ca·lat·ed, es·ca·lat·ing, es·ca·lates v.tr. To increase, enlarge, or intensify: escalated the hostilities in the Persian Gulf. v.intr. study. Int J Impot Res 2002;14(suppl 2):33-41. (24.) Seidman SN, Roose SP, Menza MA, et al: Treatment of erectile dysfunction in men with depressive de·pres·sive adj. 1. Tending to depress or lower. 2. Depressing; gloomy. 3. Of or relating to psychological depression. n. A person suffering from psychological depression. symptoms: Results of a placebo-controlled trial with sildenafil citrate. Am J Psychiatry 2001;158:1623-1630. (25.) Rendell MS, Rajfer J, Wicker PA, et al, for the Sildenafil Diabetes Study Group: Sildenafil for treatment of erectile dysfunction in men with diabetes. JAMA 1999; 281:421-426. (26.) Katz SD, Parker JD, Glasser DB, et al: Efficacy and safety of sildenafil citrate in men with erectile dysfunction and chronic heart failure. Am J Cardiol 2005;95:36-42. (27.) Conti Conti (kôNtē`), cadet branch of the French royal house of Bourbon. Although the title of prince of Conti was created in the 16th cent. CR, Pepine CJ, Sweeney M: Efficacy and safety of sildenafil citrate in the treatment of erectile dysfunction in patients with ischemic heart disease Ischemic heart disease Insufficient blood supply to the heart muscle (myocardium). Mentioned in: Myocarditis ischemic heart disease . Am J Cardiol 1999;83(suppl 5A):29C-34C. (28.) Olsson AM, Persson CA: Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in men with cardiovascular disease. Int J Clin Pract 2001; 55:171-176. (29.) Pickering TG, Shepherd AM, Puddey IB, et al: Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this. an·ti·hy·per·ten·sive adj. Reducing high blood pressure. n. agents: A randomized controlled trial. Am J Hypertens 2004;17(12 pt 1):1135-1142. (30.) Chen J, Mabjeesh NJ, Greenstein A, et al: Clinical efficacy of sildenafil in patients on chronic dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. . J Urol 2001;165:819-821. (31.) Giuliano F, Hultling C, El Masry WS, et al: Randomized trial of sildenafil for the treatment of erectile dysfunction in spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. . Ann Neurol 1999;46:15-21. (32.) Lowentritt BH, Scardino PT, Miles BJ, et al: Sildenafil citrate after radical retropubic prostatectomy Radical retropubic prostatectomy is a surgical procedure in which the prostate gland is removed through an incision in the abdomen. It is most often used to treat individuals who have early prostate cancer. . J Urol 1999;162:1614-1617. (33.) Olsson AM, Speakman MJ, Dinsmore WW, et al: Sildenafil citrate (Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic psychogenic /psy·cho·gen·ic/ (-jen´ik) having an emotional or psychologic origin. psychogenic (sī´kojen´ik), adj or mixed aetiology aetiology see etiology. . Int J Clin Pract 2000;54:561-566. (34.) McCullough AR, Barada JH, Fawzy A, et al: Achieving treatment optimization with sildenafil citrate (Viagra) in patients with erectile dysfunction. Urology 2002;60(suppl 2B): 28-38. (35.) Atiemo H, Szostak M, Sklar G: Salvage of sildenafil failures referred from primary care physicians. J Urol 2003;170(6 pt 1): 2356-2358. (36.) Jiann BP, Yu CC, Su CC, et al: Rechallenge prior sildenafil nonresponders. Int J Impot Res 2004;16:64-68. (37.) Mulhall JP, McLaughlin TP, Harnett JP, et al: Medication utilization behavior Utilization behavior is a frontal lobe disorder in which the patient has difficulty resisting their impulse to "utilize" objects which are in their visual field and within reach. in patients receiving phosphodiesterase type 5 inhibitors for erectile dysfunction. J Sex Med 2005;2: 848-855. (38.) Mulhall JP, Montorsi F: Evaluating preference trials of oral phosphodiesterase 5 inhibitors for erectile dysfunction. Eur Urol 2006; 49(1):30-37. (39.) Montorsi F, Salonia A, Deho F, et al: Pharmacological Pharmacological Referring to therapy that relies on drugs. Mentioned in: Pain Management pharmacological, pharmacologic pertaining to pharmacology. management of erectile dysfunction. BJU Int 2003;91:446-454. (40.) Jiann BP, Yu CC, Tsai JY, et al: What to learn about sildenafil in the treatment of erectile dysfunction from 3-year clinical experience. Int J Impot Res 2003;15:412-417. DISCLOSURE Dr. Harnett and Dr. Russell disclosed they are employees of Pfizer Inc. Dr. Mulhall acknowledged that he received grant/research support from and was on the speaker's bureau for Pfizer, and was a consultant/advisory board member for Pfizer, Eli Lilly Eli Lilly can refer to:
Address for correspondence: James P. Harnett, PharmD, MS, U.S. Outcomes Research, Pfizer Inc, 235 East 42nd Street, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , New York 10017. E-mail: james. harnett@pfizer.com. To obtain reprints, please contact Kevin Chamberlain at (914) 337-7878, ext. 202 or visit our website at www.medicomint.com. Copyright 2006 by Medicom International. All rights reserved. Dr. Harnett is Director of Outcomes Research and Dr. Russell is Senior Director, Regional Medical & Research Specialist, U.S. Outcomes Research, Pfizer Inc, New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . Dr. McLaughlin is Director, Clinical Analytics and Outcomes, Quality Improvement and Patient Safety, Stanford University Medical Center Stanford University Medical Center (Stanford Hospital & Clinics) is one of four hospitals affiliated with Stanford University and Stanford University School of Medicine, along with the Lucile Packard Children's Hospital, the Veteran's Administration Hospital in Palo Alto, and Santa , Stanford, California Stanford is a census-designated place (CDP) in Santa Clara County, California, United States. The population was 13,315 at the 2000 census. Stanford is an unincorporated area of Santa Clara County and is adjacent to the city of Palo Alto. . Mr. McLean is Programmer, Statistician, NDCHealth, Phoenix. Dr. Mulhall is Associate Professor of Medicine, Department of Urology, Weill Medical College of Cornell University Cornell University, mainly at Ithaca, N.Y.; with land-grant, state, and private support; coeducational; chartered 1865, opened 1868. It was named for Ezra Cornell, who donated $500,000 and a tract of land. With the help of state senator Andrew D. , New York Presbyterian Hospital Presbyterian Hospital can refer to several places:
This research was supported by Pfizer Inc.
TABLE I: DEMOGRAPHIC CHARACTERISTICS
Refilled
Characteristic (N = 10,137)
Mean Age (yr) * 56.4 [+ or -] 11.1
Comorbidities of Interest ([dagger]) (N)
Dyslipidemia 4,920 (49%)
Hypertension 6,048 (60%)
Diabetes 2,015 (20%)
Depression 2,804 (28%)
Mean Index Sildenafil Cost * $24.80 [+ or -] $37.38
Switched
Characteristic (N = 726)
Mean Age (yr) * 58.5 [+ or -] 10.8
Comorbidities of Interest ([dagger]) (N)
Dyslipidemia 354 (49%)
Hypertension 425 (59%)
Diabetes 157 (22%)
Depression 207 (29%)
Mean Index Sildenafil Cost * $29.47 [+ or -] $43.21
Characteristic P Value
Mean Age (yr) * < .001
Comorbidities of Interest ([dagger]) (N)
Dyslipidemia .907
Hypertension .552
Diabetes .621
Depression .255
Mean Index Sildenafil Cost * .005
* Mean [+ or -] standard deviation.
([dagger]) See Appendix for ICD-9-CM codes.
N = Number; ICD-9-CM = International Classification of Diseases,
9th Edition, Clinical Modification.
TABLE II: REGRESSION ANALYSES OF POSTINDEX COSTS
Costs Attributable to ED
Variable Coefficient * P Value
Medication Switching 0.4076 < .001
Index Sildenafil Cost 0.0149 < .001
Age 0.0052 .002
Dyslipidemia 0.0595 .113
Hypertension -0.0540 .162
Depression -0.3115 < .001
Diabetes -0.1958 < .001
Preindex Cost 0.0958 < .001
Overall Costs
Variable Coefficient P Value
Medication Switching 0.4294 < .001
Index Sildenafil Cost 0.0081 < .001
Age 0.0043 .007
Dyslipidemia 0.2614 < .001
Hypertension 0.2536 < .001
Depression 0.1335 < .001
Diabetes 0.1179 .006
Preindex Cost 0.2222 < .001
* The coefficient, or partial regression coefficient, represents
the importance of the covariant to the costs.
ED = Erectile dysfunction.
Figure 1. Preindex and postindex costs contributable to
erectile dysfunction for patients who refilled their sildenafil
prescription compared with those who switched to another
phosphodiesterase type 5 (PDE-5) inhibitor. * P < .001.
Refill sildenafil Switch to another PDE-5
inhibitor
Preindex $19.32 $20.81
Postindex $131.51 $173.38
Note: Table made from bar graph.
Figure 2. Preindex and postindex overall health care costs for
patients who refilled their sildenafil prescription compared with
those who switched to another phosphodiesterase type 5 (PDE-5)
inhibitor.
Refill sildenafil Switch to another PDE-5
inhibitor
Preindex $636.48 $794.91
Postindex $648.40 $757.31
Note: Table made from bar graph.
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