Percentage rise in PSA: The median percentage change in PSA for patients in the Pomi-T group was a rise of 14.7% (95% CI 3.4%-36.7%), compared to a rise of 78.5% (95% confidence interval 48.1% -115.5%) for patients in the placebo group. The median PSA increased at a significantly slower rate in the Pomi-T group compared to men taking placebo (difference of 63.8% ANCOVA, p=0.0008)
Percentage of men having a stable or a lower PSA at the end of the study: At trial completion, the number of men with a stable PSA or a lower PSA was 61 (46%) in the Pomi-T group, compared to 9 (14%) in the placebo group. This difference was statistically significant (Chi-squared value with 1 degree of freedom = 19.58, p=0.000010).
Percentage of men in whom Pomi-T prevented a change in management: One hundred and fourteen (92.6%) men in the Pomi-T group continued surveillance or WW at the end of their involvement in the study, as opposed to 38 (74%) in the placebo group. This difference of 18.6% was statistically significant (p=0.01).
Subgroup analysis: There was no significant difference in the median change in PSA from baseline to 6 months in the Pomi-T or placebo group between any of the pre-determined subgroups (BMI, Gleason grade, age or treatment category). There were no significant differences at the beginning or the end of the study between the subgroups for measures of cholesterol, blood pressure, serum glucose or C-reactive protein.
Side effects, safety and drug interaction: Pomi-T was well tolerated with no repored central nervous system symptoms, such as agitation, insomnia or tremors. None of the men on warfarin reported any unexpected changes in the INR or blood pressure whilst on ramipril. 12% of men in the Pomi-T group and 4.6% men in the placebo reported positive effects; 24% men in the Pomi-T group and 34% men in the placebo group reported adverse events; gastrointestinal events, considered separately, were reported by 15.5% men in the Pomi-T group as opposed to 7.5% men in the placebo group. None of these differences were statistically significant.