A Pooled Analysis of Three Clinical Studies: DISCUSSION

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Pooled AnalysisTreatment with gabapentin tablet has been found to be effective in relieving pain caused by PHN, bringing about improved scores and specific domains of the SF-36. These results were well demonstrated in this pooled analysis, which reinforces the findings of the pivotal studies comparing gabapentin with placebo in PHN. Because the demographics of the pooled analysis were consistent with epidemiological data, these find ings may be extrapolated to the PHN population.

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A Pooled Analysis of Three Clinical Studies: RESULTS

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Demographic Data

Table 1 shows a comparison of the demographic data from the Rowbotham and Rice studies and for the pooled analysis.

Only patients who had at least 1,800 mg/day of gabapentin or placebo at baseline and at the end of study were included in the pooled analysis. The total number of patients from the three ITT populations was 334 + 229 + 40 = 603. A total of 603 ITT patients were analyzed. There were more women (54.5%, 329/603) than men (45.4%, 274/603). Most patients were 65 years of age or older (78.5%, 473/603), and almost 50% were older than 75 (46.8°%, 282/603). The median age was 74.

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A Pooled Analysis of Three Clinical Studies: METHODS

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The clinical studies used for the pooled analysis were of similar design. All were rigorous, multicenter, randomized, double-blind, parallel-design, placebo-controlled trials, and all of them used the same measurements to demonstrate the efficacy of gabapentin in the treatment of PHN. Patients were randomly assigned to receive either medication gabapentin or placebo. They then entered a period of titration to the maximum dose and were monitored for seven to eight weeks.

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A Pooled Analysis of Three Clinical Studies

Posted by James

Three Clinical StudiesINTRODUCTION

Pain is one of the most common reasons why patients seek health care. Estimates indicate that 20% of the elderly in the general population and 50% of community-dwelling older adults have some form of persistent pain. Approximately 20% of older people take analgesics several times a week for pain relief.

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Contemporary Issues Affecting P&T Committees: USE OF PHARMACOECONOMIC DATA

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USE OF PHARMACOECONOMIC DATA

The growing prominence of drug therapies in health care and their rapidly rising costs have led to a dramatic rise in the use of health outcomes data for therapeutics and formulary decisions. The expanded use of cost-effectiveness data, analyses of health outcomes, and various pharmacoeconomic (PE) models have become commonplace in today’s world of rising costs and increased utilization. For a medication to be considered effective—and at the same time to be less expensive to use than other drugs available in the therapeutic class—numerous cost comparisons are required along with health outcomes studies.

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Contemporary Issues Affecting P&T Committees: CHANGES

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CHANGES IN THE MAKEUP OF P&T COMMITTEES

Every day, decisions about which drugs to accept into a health plan or onto a hospital formulary, issues surrounding their coverage, and the level of co-pays, deductibles, and coinsurance affect physicians, pharmacists, and patients. The composition of P&T committees is changing to meet their increasing demands and responsibilities. These committees were originally composed primarily of physicians and pharmacists. Today’s committees utilize the assistance of numerous physician-specialists and experts and include input from various advisory subcommittees. Some organizations are also adding health care ethicists, economists, and geneticists to their P&T committees (Table 1).

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Contemporary Issues Affecting P&T Committees

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Contemporary Issues AffectingFORMULARIES AND COMMITTEE EVOLUTION THROUGH EMERGING MANAGED SYSTEMS OF CARE

Pharmaceutical care and the number of individuals who play a large role in its delivery have made rapid strides over the years. Part 1 of this series, published in the November 2004 issue of P&T, described how and when pharmacy and therapeutics (P&T) committees came into being and their specific roles over the years.

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