The effects of soy milk and isoflavone supplements on cognitive performance in healthy, postmenopausal women.

RATIONALE: The decline in estrogen concentrations in women after menopause can contribute to health related changes including impairments in cognition, especially memory. Because of the health concerns related to hormone replacement therapy (HRT), alternative approaches to treat menopausal symptoms, such as nutritional supplements and/or diet containing isoflavones, are of interest. OBJECTIVES: This study investigated whether soy isoflavones (soy milk and supplement) could improve cognitive functioning in healthy, postmenopausal women. PARTICIPANTS, INTERVENTION AND DESIGN: A total of 79 postmenopausal women, 48-65 years of age, completed a double-blind, placebo-controlled trial in which they were randomly assigned to one of three experimental groups: cow's milk and a placebo supplement (control); soy milk and placebo supplement (soy milk, 72 mg isoflavones/day); or cow's milk and isoflavone supplement (isoflavone supplement, 70 mg isoflavones/day). MEASUREMENTS: Cognitive functioning was assessed using various cognitive tasks before the intervention (baseline) and after the intervention (test). RESULTS: In contrast to predictions, soy isoflavones did not improve selective attention (Stroop task), visual long-term memory (pattern recognition), short-term visuospatial memory (Benton Visual Retention Test), or visuo-spatial working memory (color match task). Also, the soy milk group showed a decline in verbal working memory (Digit Ordering Task) compared to the soy supplement and control groups. CONCLUSION: Soy isoflavones consumed as a food or supplement over a 16-week period did not improve or appreciably affect cognitive functioning in healthy, postmenopausal women.

Utility of a transdermal delivery system for antihypertensive therapy. Part 1.

A retrospective evaluation of patient-level Medicaid claims data from two states was undertaken to discern the fiscal utility of transdermally delivered clonidine versus both the oral formulation of clonidine and oral formulations of eight other antihypertensive agents. In the first phase of our two-part study, we compared paid claims data (n = 1,135) from Florida for transdermal and oral clonidine. Multivariate regression analysis was used to evaluate the incremental impact of six variables on health-care expenditures in the first year after patients were given a diagnosis of hypertension. These variables were: age, gender, prior utilization of medical services, regimen complexity, and dosage formulation. Patients prescribed transdermal clonidine experienced a significant (p less than or equal to 0.001) increase in prescription expenditures and significant reductions in the use of physician (p less than or equal to 0.05), laboratory (p less than or equal to 0.10), and hospital (p less than or equal to 0.05) services. Moreover, savings were maximized (p less than or equal to 0.001) where multi-drug regimens incorporated the transdermal delivery system. In the second phase of our study we compared paid claims data (n = 8,894) from South Carolina for transdermal clonidine and for nine oral antihypertensive agents: atenolol, captopril, clonidine, diltiazem, enalapril, metoprolol, prazosin, terazosin, and verapamil-SR. Once again, regression analysis was used, this time to evaluate the incremental impact of five variables on health-care expenditures in the first year post diagnosis: age, gender, prior utilization of medical services, regimen complexity, and Medication Possession Ratio (MPR), an index of compliance. The data from part 2 of our study revealed that patients assigned a b.i.d. oral antihypertensive agent experienced a significant reduction (p less than or equal to 0.05) in MPR and a significant (p less than 0.05) increase in health-care expenditures when compared to patients prescribed the transdermal delivery system and to patients prescribed once-daily oral medications. These data confirm previous findings concerning the impact of complicated dosing regimens on compliance in hypertensive patients. In this two-part paper we report the data from both phases of our study.

Economic outcomes with antidepressant pharmacotherapy: a retrospective intent-to-treat analysis.

Herein we describe a retrospective intent-to-treat evaluation designed to compare the natural course of antidepressant utilization and direct health service expenditures for the treatment of a single episode of major depression among patients enrolled in a multistate network-model health maintenance organization and initially prescribed either a tricyclic antidepressant (amitriptyline or nortriptyline) or the serotonin selective reuptake inhibitor (SSRI) fluoxetine. Patient-level paid-claims data for the period July 1, 1988, through December 31, 1991, were abstracted. During the above time frame, fluoxetine was the only SSRI available in the United States. Patients prescribed amitriptyline were more than three times as likely to require a change in antidepressant pharmacotherapy (OR = 3.27, 95% CI = 2.31 to 5.49), while patients prescribed nortriptyline were nearly four times more likely to change medication (OR = 3.82, 95% CI = 2.74 to 6.83) relative to patients initially prescribed fluoxetine. Consistent with our intent-to-treat design, all accrued health service expenditures were assigned to the pharmacotherapeutic option initially prescribed. Multivariate analyses revealed that initiation of antidepressant pharmacotherapy with amitriptyline resulted in a 25.7% increase in per capita depression-related health service expenditures per year, while initiation of antidepressant pharmacotherapy with nortriptyline resulted in a 28.1% increase in per capita depression-related health service expenditures per year relative to patients initially prescribed fluoxetine. A financial break-even point was achieved at the conclusion of Month 5, at which time all three intent-to-treat cohorts had comparable health service expenditures in total. From a financial perspective, results stemming from this inquiry suggest that the initiation of antidepressant pharmacotherapy with an SSRI is warranted.

Total parenteral nutrition: clinical considerations.

Nutritional support is recognized as an important therapeutic intervention to promote wound healing sustained traumatically, surgically, or caused by chronically debilitating illness, and as an adjunctive therapy in patients with life-threatening infectious diseases. The total parenteral nutrition (TPN) formulation should be carefully tailored to meet the needs of each individual patient. Factors important in determining the TPN formula include nutritional assessment; total volume; duration of therapy; solution compatibilities; and disease-specific clinical considerations. TPN should be employed for patients who are unable to or should not consume nutrients via the gastrointestinal tract and patients who cannot consume enough nutrients to sustain nutritional requirements. Patients need not be malnourished to qualify for TPN. The provision of nutritional support requires calculation of basic components of the normal diet, including water, carbohydrate, fat, protein, electrolytes, vitamins, and trace elements. The total daily expenditure of calories can be calculated as a multiple of the patient's basal energy expenditure. Disease-specific considerations may require alterations in the amount of protein provided and the percentage of dextrose and fat calories utilized.

Dosing considerations in the pediatric patient.

Pediatric patients experience unique differences from the adult population in pharmacokinetic parameters and, consequently, require individualized dosing. Medications useful in pediatric medicine often lack a therapeutic indication and dosing guideline for this population. In addition, the absence of an available pediatric dosage form for some medications increases the potential for dosing errors and may produce serious--sometimes fatal--complications in young patients. It is important to select an appropriate medication and dose based on individualized pharmacokinetic considerations: one must evaluate a patient's age, size, and level of organ maturity, and not simply administer a "small adult" dose. Thus specific dosing guidelines and useful dosage forms for pediatric patients need to be developed in order to optimize therapeutic efficacy and limit, or prevent, serious adverse side effects.

Medication-induced systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease affecting a variety of tissues and organs. The diagnosis of SLE can be made only after several related illnesses are considered and ruled out. The etiology of SLE is unclear, but hormonal factors, environmental toxins, infectious viruses, genetic predisposition, and certain medications have all been considered risk factors. Idiopathic SLE is seen predominantly in young women, with a female:male ratio of approximately 10:1. Each patient is unique and may suffer from a variety of signs and symptoms. The disease is highly unpredictable, and most patients experience flare-ups or fluctuations. The epidemiologic characteristics of medication-induced SLE (MI-SLE) are different from those of idiopathic SLE. Musculoskeletal symptoms predominate the clinical presentation of MI-SLE, while renal and central nervous system involvement is rare or absent. Moreover, a greater percentage of caucasian patients with no female predominance is evidenced in MI-SLE. Several medications can produce positive results on an antinuclear antibody test with or without evidence of clinical lupus. Hydralazine and procainamide are the most commonly recognized medications for inducing SLE. The onset of procainamide- and hydralazine-induced SLE occurs after 50 years of age, which is directly related to the age of the population using these medications. Estrogen-containing oral contraceptives and ibuprofen can exacerbate the symptoms of idiopathic SLE. Clinical judgment dictates the importance of careful patient monitoring and selection of therapy.

Management of pain in the cancer patient.

Pain is the most common symptom experienced in patients with advanced cancer. This pain may be acute, chronic, or intermittent, and often has a definable origin, usually related to tumor recurrence and treatment. The goal of therapy is to provide patients with enough pain relief to enable them to tolerate diagnostic and therapeutic manipulations and allow them freedom of movement and choice, while limiting medication-induced adverse effects. Morphine is the medication of choice, and is available in a sustained-release oral formulation with convenient around-the-clock administration every 8 to 12 hours. Morphine can also be administered subcutaneously, intravenously, and rectally, which provides enhanced flexibility for dosing patients unable to take oral medications. The transdermal fentanyl patch may provide a convenient dosage-form alternative if oral morphine preparations are not tolerated. Some patients with advanced cancer may require other adjunctive medications such as nonsteroidal anti-inflammatory agents, tricyclic antidepressants, steroids, or benzodiazepines, as well as psychologic techniques, to assist in pain management.

Clinical presentation and treatment of migraine.

The pathogenesis of migraine is not completely understood but may involve vasodilation of cerebral blood vessels and/or the release of vasoactive neuropeptides (ie, norepinephrine) from the perivascular axons in the dura mater after activation of the trigeminovascular system. Many environmental factors and physiologic influences may provoke a migraine or increase its severity. The typical migraine headache without aura is unilateral, pulsating, of moderate-to-severe intensity, and aggravated by physical activity. Migraine prevention is best achieved by avoidance of known migraine triggers or enhancers and by reducing the amount of lifestyle stressors. Pharmacotherapeutic options in the treatment of migraine are discussed herein.

Current concepts in the treatment of Alzheimer's disease.

The etiology of Alzheimer's disease (AD) is still unknown, and a definitive diagnosis of the disease can be determined only at autopsy or by brain biopsy. AD can be characterized by various structural changes, including cerebral cortical atrophy, neuronal loss, neuritic plaques, and neurofibrillary tangles. The primary defect involves reduced activity of choline acetyltransferase. Neurotransmitters, such as norepinephrine, serotonin, dopamine, and somatostatin, are also compromised. Treatment of AD requires maintenance of a consistent lifestyle and environment for the patient, as well as counseling and support for the patient's family. Medications, which have been effective in some patients, are primarily used to improve cognitive function and modify behavior. Cognitive medications such as tacrine hydrochloride and physostigmine have proven beneficial in some patients, while behavioral medications have been effective in the treatment of depression, aggression, agitation, and anxiety associated with AD. However, the side effect profile of each medication and its probable overall benefit to the individual patient should be evaluated before beginning therapy. Continued research in patients with AD is required to identify medications that will consistently ameliorate the memory loss associated with the disease.

Trends in the rate of depressive illness and use of antidepressant pharmacotherapy by ethnicity/race: an assessment of office-based visits in the United States, 1992-1997.

OBJECTIVE: This study was undertaken to determine ethnicity/race-specific (white, black, and Hispanic) population-adjusted rates of US office-based physician visits in which a diagnosis of a depressive disorder was recorded or in which a diagnosis of a depressive disorder was recorded and antidepressant pharmacotherapy was prescribed. METHODS: Data from the National Ambulatory Medical Care Survey for 1992 through 1997 were partitioned into three 2-year periods: 1992-1993, 1994-1995, and 1996-1997. For each 2-year period, data from office-based physician visits for patients aged 20 to 79 years were extracted to assess, by ethnicity/race, (1) the number of visits in which a diagnosis of a depressive illness was recorded (International Classification of Diseases, Ninth Revision, Clinical Modification codes 296.2-296.36, 300.4, or 311) and (2) the number of visits in which a diagnosis of a depressive illness was recorded and antidepressant pharmacotherapy was prescribed. We calculated ethnicity/race-specific rates (per 100 US population aged 20 to 79 years) of office-based visits in which a diagnosis of a depressive disorder was recorded and in which a diagnosis of a depressive disorder was recorded and antidepressant pharmacotherapy was prescribed. The specialty of the reporting physician and the proportion of patients receiving a selective serotonin reuptake inhibitor (SSRI) were also discerned. RESULTS: From 1992-1993 to 1996-1997, the rate of office-based visits (per 100 US population aged 20 to 79 years) in which a diagnosis of a depressive disorder was recorded increased 3.7% for whites (from 10.9 to 11.3; P = 0.001), 31.0% for blacks (from 4.2 to 5.5; P = 0.001), and 72.9% for Hispanics (from 4.8 to 8.3; P = 0.001). The rate of office-based visits in which a diagnosis of a depressive disorder was recorded and antidepressant pharmacotherapy was prescribed increased 18.5% for whites (from 6.5 to 7.7 per 100; P = 0.001), 38.5% for blacks (from 2.6 to 3.6 per 100; P = 0.001). and 106.7% for Hispanics (from 3.0 to 6.2 per 100; P = 0.001). Between 1992-1993 and 1996-1997, use of an SSRI increased among whites and blacks (from 50.0% to 65.8% and from 40.5% to 58.2%, respectively), but declined among Hispanics (from 51.4% to 48.6%; all comparisons P = 0.001). CONCLUSION: By 1996-1997, the population-adjusted rates for Hispanics were within a quartile of those observed for whites, whereas the rates for blacks remained at less than half those observed in whites. The observed divergence in population-adjusted rates by ethnicity/race may reflect the nature of the patient-physician relationship, sensitivity and specificity of diagnostic techniques and instruments, and the wider social context in which an office-based visit occurs, including access to and type of health insurance and coverage for mental health services.

Effect of pharmaceutical formulation for diltiazem on health care expenditures for hypertension.

A 1-year retrospective analysis was undertaken to discern the economic utility of providing prescription coverage for the sustained-release (SR) formulation of diltiazem, a calcium-channel antagonist, under the state of South Carolina's Medicaid program. Data for this analysis were derived from the state of South Carolina's Medicaid computer archive. The study population consisted of 347 ambulatory beneficiaries diagnosed with hypertension for whom either the SR or immediate-release (IR) formulation of diltiazem was prescribed. Multivariate regression analysis was used to discern the incremental influence of selected demographic characteristics, use of medical services prior to diagnosis for hypertension, and prescribed formulation of diltiazem on health care expenditures 1-year postdiagnosis. Patients for whom the SR formulation of diltiazem was prescribed achieved a significant (P < or = 0.05) increase in the medication possession ratio, an index of compliance (SR, 0.63 +/- 0.17) relative to patients for whom the IR formulation was prescribed (IR, 0.44 +/- 0.13). Results indicate that receipt of diltiazem in an SR formulation was associated with a significant decrease in aggregate health care expenditures over the 1-year study period ($258.80, P < or = 0.05). Receipt of the SR formulation was associated with an increase in expenditures for antihypertensive therapy ($109.26, P < or = 0.05), and a decrease in financial commitments for physician ($128.70, P < or = 0.05), hospital ($211.84, P < or = 0.05), and laboratory ($27.52, NS) services. At the managerial and policy levels, these data argue for an increased use of therapeutic alternatives that facilitate a reduction in the patient's daily dosing schedule for antihypertensive therapy.

Ipratropium bromide in the management of chronic obstructive pulmonary disease: effect on health service expenditures.

Chronic obstructive pulmonary disease (COPD), which is estimated to affect 32 million Americans, is the fifth leading cause of death in the United States. This retrospective study was designed to discern the economic utility of initial pharmacotherapy with various individual drugs in the management of COPD, as well as subsequent costs incurred as disease progression necessitated combination therapy. Data for this analysis were derived from the computer archive of a network-model health maintenance organization. During the first 6 months post-diagnosis for COPD, results indicated a significant (P < or = 0.05) increase in expenditures for physicians, hospital care, and total health service utilization for patients prescribed theophylline, a corticosteroid (triamcinolone or beclomethasone) delivered via a metered-dose inhaler, or albuterol delivered via a metered-dose inhaler as initial monotherapy compared with patients prescribed ipratropium bromide (IB) delivered via a metered-dose inhaler. Patients receiving initial pharmacotherapy with ipratropium bromide and subsequently adding albuterol used significantly less health care services (P < or = 0.05) during the first 15 months post-diagnosis for COPD than did patients prescribed all other combination therapies we evaluated.

Trends in the prescribing of antidepressant pharmacotherapy: office-based visits, 1990-1995.

Data from the National Ambulatory Medical Care Survey for the period 1990 through 1995 were used to discern the population-adjusted rate of office-based physician-patient encounters at which the prescribing or continuation of antidepressant pharmacotherapy (tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitors [SSRIs], or others), a diagnosis of depression (International Classification of Diseases, 9th Revision, Clinical Modification codes 296.2 through 296.36, 300.4, or 311), or both were documented. National estimates of the number of office-based visits resulting in a prescription for or continuation of antidepressant pharmacotherapy for any purpose escalated from 16,534,268 in 1990 to 28,664,796 in 1995, a 73.4% increase. Although the number of office-based visits at which a diagnosis of depression was documented increased 23.2% during this period, the proportion of patients with a diagnosis of depression who were prescribed or continued antidepressant pharmacotherapy increased only 14.9%, from 52.1% in 1990 to 67.0% in 1995. Among patients with a diagnosis of depression, use of a TCA declined from 42.1% in 1990 to 24.9% in 1995. In contrast, use of an SSRI for the treatment of depression increased from 37.1% in 1990 to 64.6% in 1995. The rate of office-based visits at which the use of antidepressant pharmacotherapy for any purpose was documented increased from 6.7 per 100 US population in 1990 to 10.9 in 1995, a 62.7% increase; documentation of a diagnosis of depression increased from 6.1 per 100 US population in 1990 to 7.1 in 1995, a 16.4% increase; and the recording of a diagnosis of depression in concert with the prescribing or continuation of antidepressant pharmacotherapy increased from 3.2 per 100 US population in 1990 to 4.8 in 1995, a 50.0% increase. Further research is required to elucidate the effect of observed trends on clinical and financial outcomes.

Antidepressant pharmacotherapy: economic outcomes in a health maintenance organization.

Recent pharmacotherapeutic advances in the treatment of depression have included the development of selective serotonin re-uptake inhibitors (SSRIs). The present study was designed to contrast direct health service expenditures for the treatment of depression among patients enrolled in a health maintenance organization (HMO) and prescribed either the SSRI fluoxetine or one of three tricyclic antidepressants (TCAs) (amitriptyline, nortriptyline, or desipramine). Information regarding health service utilization was derived from the computer archive of a network-model HMO system serving 400,000 beneficiaries. A total of 701 HMO beneficiaries were found to satisfy the study selection criteria. Multivariate regression analysis was used to discern the incremental influence of selected demographic, clinical, financial, and provider characteristics on 1 year post-period expenditures (PPE) for health care. Analysis-of-variance procedures with Duncan's multiple-range test, or chi-square analyses, revealed no significant difference across antidepressant pharmacotherapy for age, sex, 6-month prior-period expenditures for physician visits, psychiatric visits, laboratory tests, hospitalizations, or psychiatric hospital services related to the treatment of depression, or number of prescribed therapeutic agents for disease state processes other than depression. Receipt of fluoxetine was associated with a significantly (P < or = 0.05) higher rate of initial prescribing by psychiatrists, an increase in the number of prescriptions for antidepressant pharmacotherapy obtained (30-day supplies), and a reduction in the number of monthly intervals during which time antidepressant pharmacotherapy was not procured. Receipt of fluoxetine as antidepressant pharmacotherapy was associated with a significantly (P < or = 0.05) higher mean medication possession ratio (MPR) relative to amitriptyline, nortriptyline, or desipramine. Multivariate findings for patient-level data reflecting a definitive diagnosis of depression (n = 555) indicate that receipt of a TCA resulted in a significant (P < or = 0.05) increase in the use of physician visits ($36.07), psychiatric visits ($41.38), laboratory tests ($1.71), hospitalizations ($208.77), and psychiatric hospital services ($187.27), and a significant (P < or = 0.05) reduction in expenditures for antidepressant pharmacotherapy (-$162.21), for a total increase in health service utilization of $312.99 (P < or = 0.05) 1 year post-initiation of antidepressant pharmacotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of pharmaceutical formulation for antihypertensive therapy on health service utilization.

A significant factor in the management of hypertension is the extent to which patients comply with the treatment regimen. A retrospective analysis was undertaken to determine the relationship between antihypertensive formulation, regimen compliance, and the utilization of health care services. Data for this analysis were derived from the state of South Carolina's Medicaid computer archive. The study population consisted of 1000 randomly selected patients initially prescribed one of the following antihypertensive regimens as monotherapy: atenolol once daily, captopril BID, oral clonidine BID, transdermal clonidine once weekly, diltiazem BID, enalapril BID, metoprolol BID, prazosin BID, terazosin once daily, and sustained-release verapamil once daily. Multivariate regression analysis was used to determine the incremental influence of selected demographic characteristics, use of medical services before diagnosis of hypertension, initial antihypertensive medication, medication possession ratio for antihypertensive therapy, and number of maintenance medications for diseases other than hypertension on post-period health care expenditures. The results indicated that patients initially prescribed antihypertensive medication requiring once-daily or once-weekly administration experienced an increased utilization of antihypertensive medication, needed fewer changes in their therapeutic regimen, and far less need for concomitant therapy for blood pressure control compared with those prescribed a BID regimen. Patients in the once-daily or once-weekly groups also used significantly fewer physician, hospital, and laboratory services (P < or = 0.05).

Effect of health education in promoting prescription refill compliance among patients with hypertension.

A multifactorial health-education program designed to enhance compliance with a once-daily regimen of atenolol was evaluated among 453 patients enrolled in health maintenance organizations (HMOs). The initiation of the 180-day study period was used to classify patients as either new or existing cases of hypertension. In turn, patients in these two categories were randomly assigned to a control or an experimental group. Patients assigned to the experimental groups received an enrollment kit upon exercising their initial prescription (new patients) or their first refill request (existing patients). The kit contained: a 30-day supply of atenolol; an educational newsletter about hypertension; information on nutrition and life-style changes; and an explanation of the intent and content of the program. Before the next scheduled prescription-refill date, each patient was contacted by telephone to inquire about his or her experience with the therapy and to stress the importance of adherence to the regimen. Each month thereafter, the newsletter and an enclosed prescription-refill reminder were mailed to each patient. The medication possession ratio, defined as the number of days' supply of atenolol obtained by a patient during the 180-day study period, was significantly (P less than or equal to 0.001) enhanced for the new and existing experimental groups relative to the control groups. Multiple regression analyses revealed that enrollment in the health-education program increased the number of days' supply of atenolol obtained by existing patients by 27 (P less than or equal to 0.001), and by new patients by 40 (P less than or equal to 0.001).

Effectiveness of the C Cap in promoting prescription refill compliance among patients with glaucoma.

In an attempt to increase patient compliance with a dosing regimen, prescriptions for topical solutions of glaucoma medication were refilled using the C Cap, a memory aid designed to help patients to remember to instill the medication as prescribed. A comparison of the number of prescription refills requested by 121 patients with glaucoma showed that patients who received the C Cap requested significantly more refills in the six months after receiving the C Cap than before and requested significantly more refills than did patients who did not receive the C Cap.

Effect of value-added utilities on prescription refill compliance and health care expenditures for hypertension.

A randomised trial was undertaken to discern the effect of pharmacy-based value-added utilities on prescription refill compliance with antihypertensive therapy and subsequent health care expenditures. The subjects were 304 Medicaid beneficiaries from the state of Florida, previously untreated for mild to moderate hypertension, prescribed 240 mg of calcium channel antagonist verapamil once daily and monitored regarding prescription refill compliance and health service utilisation for one year. Subjects provided informed consent and were randomly assigned to one of four experimental groups: (1) the control cohort received standard pharmaceutical care with each dispensing of antihypertensive therapy, (2) the second cohort received standard pharmaceutical care and was mailed a medication-refill reminder ten days prior to each sequential refill date, (3) the third cohort received standard pharmaceutical care and was provided unit-of-use packaging with each prescription-refill request and (4) the fourth cohort received standard pharmaceutical care, mailed medication-refill reminders and unit-of-use packaging. Analysis of variance (ANOVA) procedures revealed that patients receiving mailed prescription-refill reminders, unit-of-use packaging or a combination of both interventions achieved a significant (P < or = 0.05) increase in the Medication Possession Ratio (MPR) for antihypertensive therapy relative to controls. Receipt of both interventions resulted in a significant (P < or = 0.05) improvement in the MPR for antihypertensive therapy relative to all other groups no significant difference was discerned between groups receiving either mailed prescription-refill reminders or unit-of-use packaging.(ABSTRACT TRUNCATED AT 250 WORDS)

Utility of a sustained-release formulation for antihypertensive therapy.

Recent pharmacotherapeutic advances in the treatment of hypertension have included the development of sustained-release (SR) dosage formulations, providing patients with the convenience of once daily administration. A one year retrospective analysis was undertaken to determine the economic utility of providing prescription coverage for the SR formulation of verapamil, a calcium channel antagonist, under the state of Florida's Medicaid programme. Data for this analysis were derived from the state of Florida's Medicaid computer archive. The study population consisted of 274 ambulatory beneficiaries diagnosed with hypertension and prescribed either the SR or immediate-release (IR) formulation of verapamil. Multivariate regression analysis was used to discern the incremental influence of selected demographic characteristics, utilisation of medical services prior to diagnosis for hypertension and prescribed formulation of verapamil on health care expenditures one year post-diagnosis. Patients prescribed the SR formulation of verapamil achieved a significant (P < or = 0.05) increase in the Medication Possession Ratio (MPR), an index of compliance, (0.87 +/- 0.13) relative to patients prescribed the IR formulation (0.56 +/- 0.10). Results indicate that receipt of verapamil in an SR formulation was associated with a significant (P < or = 0.05) decrease in aggregate health care expenditures of $110.14 over the one year study period. Receipt of the SR formulation was associated with an increase in expenditures for antihypertensive therapy ($117.83, p < or = 0.05) and a decrease in financial commitments for physician ($50.42, p < or = 0.05), hospital ($153.61, p < or = 0.05) and laboratory ($23.94, p < or = 0.05) services.(ABSTRACT TRUNCATED AT 250 WORDS)

The need for an iterative process for assessing economic outcomes associated with SSRIs.

Pharmacotherapeutic advances in the treatment of depression have included the development of the selective serotonin reuptake inhibitors (SSRIs), thereby providing alternatives to tricyclic antidepressants. Concurrent with these events have been significant structural (e.g. pharmaceutical formularies) and regulatory (e.g. required pharmacoeconomic evaluations) changes in the delivery, financing, and oversight of healthcare programmes throughout the world. International cost-containment initiatives are increasingly mandating a demonstration of value for money, defined in terms of a measurable health and/or financial outcome, and, in the case of medicines, attributable to a given expenditure, for a given pharmacotherapeutic option. We examine the inherent strengths and weaknesses of 5 study designs used to discern and contrast financial outcomes stemming from the use of antidepressant pharmacotherapy for the treatment of depressive illness [randomised controlled trials (RCTs); meta-analyses; decision-analytical models (DAMs); retrospective database investigations; randomised naturalistic inquiry]. We argue that the economic appraisal of pharmacotherapy requires an iterative process extending from the developmental (RCTs; meta-analyses; DAMs) through to the postmarketing phase (database reviews; naturalistic inquiry), thereby resulting in a portfolio of evidence as to the safety, efficacy and effectiveness of a given pharmacotherapeutic category (e.g. SSRIs) and/or a specific medication. Database reviews, while nonrandomised, and prospective naturalistic inquiry afford greater insight into the patterns of use and financial merits of prescribing specific pharmacotherapeutic options for the treatment of depression within the context of clinical practice as compared with RCTs, meta-analyses and DAMs. The portfolio of evidence to date indicates that the first-line use of SSRIs in the treatment of depression is clinically warranted, and represents value for money.