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Chapter 4: Drug Literature Evaluation I: Controlled Clinical Trial Evaluation

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The STOPAH trial was a multicenter, double-blind, randomized controlled clinical trial that assessed the effectiveness of prednisolone versus pentoxifylline in reducing short-term (28-day) mortality in subjects with alcoholic hepatitis and severe disease. Subjects who met inclusion criteria were randomized in a 2:2 fashion to one of four treatment groups: pentoxifylline placebo and prednisolone placebo, prednisolone and pentoxifylline placebo, pentoxifylline and prednisolone placebo, or prednisolone plus pentoxifylline. Secondary endpoints were 90-day mortality and liver transplantation at 90 and 365 days. Study investigators determined that 1,026 subjects were needed for the total study sample in order to detect 30% and 21% reduction in 28-day mortality between subjects receiving each active therapy or placebo, respectively. Results from all subjects were included in the final analyses and a p-value less than 0.05 was considered significant.

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After randomization, data from 1,053 subjects were available for the primary endpoint analysis. Subjects were distributed evenly across all treatment groups based upon predefined characteristics. Incidence of 28-day mortality occurred in 14% (73/526) of subjects receiving prednisolone-based therapy, 18% (95/527) of those not receiving prednisolone, 16% (85/518) of those receiving pentoxifylline, and 16% of those not receiving pentoxifylline (32/535). The resulting ratio for 28-day mortality in individuals receiving pentoxifylline versus no pentoxifylline was 1.07 (95% CI, 0.77 to 1.49; p = 0.69) and with prednisolone versus no prednisolone was 0.72 (95% CI, 0.52 to 1.01; p = 0.06). There was no difference in primary outcome occurrence between prednisolone and pentoxifylline at 28 days as significant overlap between the CI ranges for the individual therapies was present (p = 0.41). Nor was difference between therapies present at prespecified 90-day and 365-day checkpoints. Incidence of serious infections was more common in individuals receiving prednisolone (13%) versus those who did not receive prednisolone (7%) (p = 0.002).

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What type of blinding was used in this study?

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a. No blinding

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b. Single-blinding

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c. Open-label

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d. Double-blinding

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e. Triple-blinding

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d. Double-blinding

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The STOPAH trial was a multicenter, double-blind, randomized controlled clinical trial that assessed the effectiveness of prednisolone versus pentoxifylline in reducing short-term (28-day) mortality in subjects with alcoholic hepatitis and severe disease. Subjects who met inclusion criteria were randomized in a 2:2 fashion to one of four treatment groups: pentoxifylline placebo and prednisolone placebo, prednisolone and pentoxifylline placebo, pentoxifylline and prednisolone placebo, or prednisolone plus pentoxifylline. Secondary endpoints were 90-day mortality and liver transplantation at 90 and 365 days. Study investigators determined that 1,026 subjects were needed for the total study sample in order to detect 30% and 21% reduction in 28-day mortality between subjects receiving each ...

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