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

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.

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).

What type of blinding was used in this study?

a. No blinding

b. Single-blinding

c. Open-label

d. Double-blinding

e. Triple-blinding

d. Double-blinding

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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