Oral almotriptan vs. oral sumatriptan in the abortive treatment of migraine: a double-blind, randomized, parallel-group, optimum-dose comparison.

BACKGROUND: Almotriptan malate is a novel, selective serotonin(1B/D) agonist, or triptan, developed for the abortive treatment of migraine. In double-blind, placebo-controlled studies, it has been shown to be effective, well tolerated, and safe. OBJECTIVE: To compare the efficacy, tolerability, and safety of almotriptan with that of the "standard triptan," sumatriptan succinate. The power calculation of the study was based on 24-hour headache recurrence, an efficacy measure in the abortive treatment of migraine, and on the occurrence of adverse events. SUBJECTS AND METHODS: Subjects, aged between18 and 65 years, with migraine with or without aura but otherwise healthy, were randomized to take orally either almotriptan malate, 12.5 mg, or sumatriptan succinate, 50 mg. The medications were provided in identical-looking capsules to ensure blinding and were taken for the treatment of moderate or severe headache. Efficacy was determined in terms of (1) headache relief-a decrease in pain intensity to mild or no pain; (2) headache freedom-a decrease to no pain; (3) use of rescue medications, allowed after 2 hours; and (4) headache recurrence-moderate or severe pain returning within 24 hours after headache relief at 2 hours. Adverse events were collected for 96 hours after treatment and for safety evaluation, vital signs, blood tests, and electrocardiograms were performed at the screening and exit visits. RESULTS: Seventy-five investigators enrolled 1255 subjects of whom 1173 were treated (591 with almotriptan and 582 with sumatriptan). At 2 hours, almotriptan treatment provided headache relief in 58.0% of the subjects and sumatriptan treatment in 57.3%; headache freedom was provided by the medications in 17.9% and 24.6%, respectively (P =.005). Rescue medications were taken by 36.7% of the subjects in the almotriptan-treated group and by 33.2% in the sumatriptan-treated group; headaches returned to moderate or severe intensity in 27.4% and 24.0%, respectively. Treatment-emergent adverse events occurred in 15.2% of the subjects in the almotriptan-treated group and in 19.4% in the sumatriptan-treated group (P =.06); treatment-related adverse events occurred in 9.1% and 15.5% of the subjects, respectively (P =.001), including chest pain, which occurred in 0.3% and 2.2%, respectively (P =.004). CONCLUSIONS: Almotriptan and sumatriptan are similarly effective in the abortive treatment of moderate or severe migraine headache; they are also similarly well tolerated and safe.

Treatment satisfaction, functional status, and health-related quality of life of migraine patients treated with almotriptan or sumatriptan.

BACKGROUND: Patient-reported outcomes, such as treatment satisfaction, functional status, and health-related quality of life (HRQOL) are essential components of migraine research. Almotriptan is a new selective serotonin 1B/1D agonist triptan migraine treatment. OBJECTIVE: The purpose of this double-blind, multicenter, randomized, parallel-group study was to compare treatment satisfaction, functional status, and HRQOL of patients treated with oral almotriptan versus sumatriptan, the leading triptan on the market. METHODS: Migraine patients, aged 18 to 71 years, took equivalent oral doses of 12.5 mg almotriptan or 50 mg sumatriptan for the abortive treatment of a migraine headache. Treatment satisfaction differences between study groups were assessed using a 6-item measure to determine patients' satisfaction with pain relief and satisfaction with side effects 48 hours after drug administration. Functional status was assessed by analyzing the change in patients' ability to perform normal activities during the course of the migraine. HRQOL was compared between treatment groups at 24 hours using the Migraine Quality of Life Questionnaire. End points were assessed using entries from patients' 48-hour diaries. RESULTS: A total of 1173 patients were treated with almotriptan or sumatriptan. There were no significant differences between the 2 treatment groups in terms of satisfaction with pain relief; however, patients in the almotriptan group were significantly more satisfied (less bothered) with side effects than those receiving sumatriptan (P = 0.016). Functional status and HRQOL outcomes were not significantly different between groups. CONCLUSIONS: In this study, migraine patients treated with almotriptan were significantly more satisfied with the side-effect profile of the drug than patients treated with sumatriptan. The results of this study may help inform practicing physicians and neurologists about the potential treatment satisfaction advantages of almotriptan.

Economic costs of anxiety disorders.

Anxiety disorders are estimated to affect 26.9 million individuals in the United States at some point during their lives. This study used the human capital approach to estimate the direct and indirect costs of these highly prevalent disorders. In 1990, costs associated with anxiety disorders were $46.6 billion, 31.5% of total expenditures for mental illness. Less than one-quarter of costs associated with anxiety disorders were for direct medical treatment; over three-quarters were attributable to lost or reduced productivity. Most of these indirect costs were associated with morbidity, as mortality accounted for just 2.7% of the total. Greater availability of effective, relatively low-cost outpatient treatment could substantially reduce the economic and social burden of these common and often crippling disorders.

Economic costs of obsessive-compulsive disorder.

Obsessive-compulsive disorder (OCD), classified as a severe mental illness by the National Advisory Mental Health Council, affects 2.1% of the population annually, as shown by the Epidemiological Catchment Area surveys. This study, using the human capital approach, estimated the direct and indirect costs of OCD. The total costs of OCD were estimated to be $8.4 billion in 1990, 5.7% of the estimated $147.8 billion cost of all mental illness, and 18.0% of the costs of all anxiety disorders, estimated to be $46.6 billion. The indirect costs of OCD, reflecting lost productivity of individuals suffering from or dying from the disorder, were estimated at $6.2 billion.

Prescription drug advertising trends: a study of oral hypoglycemics.

A content analysis of oral hypoglycemic drug advertisements was performed in selected medical journals published in the United States from 1963 to 1986. The 665 advertisements subsequently examined were studied for certain predetermined parameters in order to indicate trends. The trend results may be summarized as follows. As an extension of prescription drug advertising trends in general, oral hypoglycemic drug advertising showed an increasing length along with a subsequent decrease in the amount of space devoted to the copy portion of the advertisement. They also showed a decrease in the use of statistical information and rarely made references to competitors. Nongender specific, colored advertisements with product and use related appeals have become more common with the passage of time. Although the rationale and purpose behind advertising is unchanged, the format has changed considerably. These changes are primarily due to the enhancement of print technology and to some extent, the changing social environment.

Clinical pharmacy services in family practice: cost-benefit analysis. II. Referrals, appointment compliance, and costs.

The benefits, decreased referral rate and increased kept-appointment rate, and the costs that a family practice clinic could expect to incur by including a clinical pharmacist in the clinic are discussed. By using a clinical pharmacist as a consulting partner, the physician would have a decreased need to refer patients to specialists not affiliated with the medical practice. The benefit to the practice is the revenue from office and hospital visits that would not have been received had these patients been referred elsewhere. Involvement of a clinical pharmacist in providing drug therapy management for patients with selected chronic diseases results in an increase in office appointment compliance rates. The benefit to the practice is the revenue generated by the increased number of office visits per year. Costs that would be incurred by the practice include: physician time spent due to the increased number of office visits generated by the decreased referral rate and increased appointment compliance; increased operating expenses, including the clinical pharmacist's salary and fringe benefits; and the developmental expense of establishing a reference library for the clinical pharmacist.

Clinical pharmacy services in family practice: cost-benefit analysis. I. Physician time and quality of care.

The objectives of this study was to identify benefits and costs that a family practice clinic could expect to incur by including a clinical pharmacist in that clinic, to derive equations to estimate the magnitude of each benefit and cost, to discuss the rationale for each equation, and to demonstrate the application of these equations through the use of sample calculations. The benefits, freed physician time and improved quality of care, are discussed. The physician's time is freed since the clinical pharmacist can provide many services that were provided previously by a physician. Quantification is based on a determination of the amount of time spent by physicians in providing specific services and the proportion of those services that could be assumed by a clinical pharmacist. Literature sources document an improvement in quality of care due to clinical pharmacy services. The principle used to quantify this improvement in the quality of care involves determining a monetary value for this care before the addition of a clinical pharmacist. This baseline quality of care value is then multiplied by the projected fractional increase in the overall quality of care that would result from the inclusion of a clinical pharmacist.

Model for cost-benefit analysis of clinical pharmacy in family practice.

A cost-benefit analysis (CBA) model that can be used to estimate the economic consequences expected from the inclusion of clinical pharmacy services in a family practice clinic was developed; use of the model was demonstrated by applying it to a hypothetical solo-physician practice. The effects that clinical pharmacy services would have on the medical practice were evaluated and classified as either costs or benefits. Equations were derived to quantify all direct effects. Semi-structured, open-ended interviews of 15 family practice physicians and five family practice clinical pharmacists were conducted to generate data describing a hypothetical solo-physician practice. Responses from these interviews were averaged to provide the numerical values called for by the equations in the CBA model. The difference between total costs and total benefits was the net benefit that could be expected by the hypothetical solo-physician practice for the first year after including a clinical pharmacist in that practice. The net benefit determined by these calculations was $2744 assuming a 5% increase in overall quality of care, or $25,658 assuming a 20% increase in overall quality of care. The net-benefit figure obtained by applying the CBA model to the hypothetical case should not be generalized to other practices. Rather, by applying the CBA model, practitioners and administrators can calculate the expected net benefit specific for their particular medical practice.

Cost-benefit and cost-effectiveness: methodologies for evaluating innovative pharmaceutical services.

Cost-benefit and cost-effectiveness analysis techniques which can be of assistance in the evaluation of innovative pharmaceutical services are reviewed. Process and outcome measures are considered, and suggested steps in a cost-benefit study are presented. Samples of pharmacy studies using these techniques are appraised. Possible measures for benefits and costs along with literature references for evaluations of innovative pharmaceutical services are presented. Areas of pharmaceutical service discussed are ambulatory patient consultation, unit dose drug distribution, drug information services, monitoring drug therapy in acute care and long-term care, parenteral admixture services, patient and therapy responsibilities, patient discharge interviews, patient drug histories and profiles, and personnel substitutions. Although there have been several encouraging reports on the cost-benefit of pharmaceutical services, more evaluative research is needed to develop programs which maximize the benefit-to-cost ratio to society.