The effectiveness of antidepressants in elderly depressed outpatients: a prospective case series study.

BACKGROUND: This study examined the effectiveness of antidepressants in a group of elderly depressed outpatients by assessing depression prevalence and recording adverse events over time. METHOD: A prospective practice-based observational study (1991-1994) included consecutive outpatients at least 65 years of age with a DSM-III-R diagnosis of major affective disorder and who were prescribed antidepressant medications. Depressive symptoms were examined over time (stage 1 = 0 to 2 months; stage 2 = 2 to 6 months; stage 3 = 6 months to 2 years) with the Montgomery-Asberg Depression Rating Scale (MADRS). The cutoff scores of MADRS <18 and MADRS > or =18 were used in survival statistics. Adverse events were recorded systematically. RESULTS: A total of 213 patients were seen over 2677 visits (mean +/- SD age = 75.5+/-6.1 years). MADRS scores for 85.8% of patients declined to below 18 within the first 2 months of antidepressant treatment. MADRS scores were above 18 for 37.3% of patients after 6 months and for 37.1% after 2 years. The mean time to decline in MADRS scores to below 18 in stage 1 was 36.1 days, and there was a significant difference between the antidepressant classes (log rank = 8.3, df = 3, p = .04), with tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs)/reversible inhibitors of monoamine oxidase A (RIMAs) having shorter times to response. The mean time to reach scores above cutoff during stage 2 was 144.3 days (log rank = 5.7, df = 3, p = .13) and during stage 3, 538.6 days (log rank = 9.8, df = 3, p = .02). Patients receiving TCAs and MAOIs/RIMAs had longer durations of MADRS scores below cutoff during stage 3 than those taking atypical antidepressants and selective serotonin reuptake inhibitors. All antidepressant classes reported similar adverse event profiles. CONCLUSION: This study systematically examined antidepressant effectiveness in a prospective design. TCAs and MAOIs/RIMAs were shown to be superior in effectiveness during 2 of the 3 treatment stages.

Cohort maintenance and comparability in a pharmacoepidemiologic study using a commercial consumer panel to recruit comparators.

The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study of users of ROGAINE (REGAINE in international markets) Topical Solution 2% (N=11,122) and a Comparator cohort (N=11,173) which was selected and group matched by stratified random sampling from among members of a commercial consumer panel. Study endpoints were confirmed cause-specific deaths and hospitalizations within 12 months of study entry. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. At least 94% of both cohorts completed 12 months of follow-up, with the completion rate highest in the Comparator cohort (96.8%). Although successful matching was achieved on the demographic variables used to select the Comparators, members of the two cohorts differed significantly in the presence of baseline chronic medical conditions and other risk factors for study endpoints. A commercial consumer panel is valuable for rapid selection of demographically-matched comparators for targeted cohorts which continue in the study through long-term follow-up. Multi-stage sampling may need to be employed when more specific characteristics must be identified.

Use of a commercial consumer panel to recruit a comparator cohort for a pharmacoepidemiologic study.

The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study designed to comply with the US FDA's request that 10,000 users of ROGAINE (REGAINE in international markets) Topical Solution 2% (2% minoxidil solution) be systematically studied in the first year following the product's approval. Members of the Drug cohort were recruited at the time they filled prescriptions for 2% minoxidil solution at cooperating retail pharmacies in the United States. To meet the need for rapid identification of a cooperative comparison group, the Comparator cohort was selected by stratified random sampling from members of a commercial consumer panel. Group matching of Comparators to the Drug cohort on four variables--age, sex, race, and geography of residence--was accomplished prior to recruitment on the basis of information available from the consumer panel records; education was obtained via consent procedures and was also used as a group matching variable. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. Interviewing costs averaged 18.88 US dollars/completed interview. A commercial consumer panel offers a pool of rapidly identifiable subjects with known demographic characteristics and established willingness to participate in research for efficient cohort recruitment.

Experience in the development of a postmarketing surveillance network: the pharmacy medication monitoring program.

OBJECTIVE: To describe the pilot and early implementation phase of a system for assembling and recruiting cohorts of patients taking selected prescription medications and prospectively monitoring them for new health events. DESIGN: Prospective observational study, based on telephone interviews, of 1475 patients filling prescriptions for a nonsteroidal antiinflammatory drug (NSAID). Patients were interviewed by telephone using trained interviewers at a central site. Hospitalizations and deaths were followed up and reviewed by an independently physician. SETTING: Community setting in a region of Hamilton, Ontario, Canada. PARTICIPANTS: All consenting patients filling new or repeat prescriptions for NSAIDs at participating pharmacies. MAIN OUTCOME MEASURES: The authors report on the development and assessment of systems for: (1) ongoing recruitment of patients through community pharmacies; (2) data transfer from pharmacies to the coordinating center; (3) surveying patients; (4) classifying, coding, and evaluating new health events; and (5) following up on new serious adverse events. RESULTS: Fifty-one percent of patients approached were recruited, and 83% of these provided completed interviews. For patients picking up their own medications, pharmacy workload varied from 4 to 10 minutes per patient approached. Nineteen percent of patients reported having a new health problem or unusual symptom at the initial telephone interview. Reported health-related events were similar to those described in other studies of NSAIDs. CONCLUSIONS: Most aspects of the monitoring system performed well. One limitation was the low recruitment rate for patients who did not directly drop off or pick up their own prescriptions. Even so, this method of patient accrual may complement alternative monitoring programs.

A methodologic study of post-marketing drug evaluation using a pharmacy-based approach.

There has been an increasing interest in monitoring medications in their customary use after they are marketed. A variety of approaches have been discussed. This study was undertaken to test the feasibility of assembling a cohort of patients receiving target medications through the pharmacist and following the patients for their health course over a period of one month. The class of drugs chosen with oral antibacterials. The logic and strategy of this approach as a model is presented along with the methods and the results.

Post-marketing surveillance: drug epidemiology.

A description of the need for and appropriateness of a multi-component application of epidemiological methods to the post-marketing evaluation of drugs is presented. There is a need for the development of the art and science of Drug Epidemiology. The large number of drugs introduced over the last 40 years and the number of interventions constitute an issue of public health interest. It is appropriate that scientifically sound information be collected about medications. There has been considerable discussion about the methods to be used in any such systematic approach. The choice of method is obviously dependent upon the questions to be addressed and the functions to be satisfied. The proposal is presented for the appropriate content functions of post-marketing drug evaluation, and a description of some and currently employed approaches show how they differentially satisfy the functions. It is concluded that there is a need for the development and application of multiple complementary methods to satisfy the requirements of a meaningful system for post-marketing drug evaluation.