[Effects of modified inclusion criteria and negative reporting about PSA screening on the number of potentially recruitable patients for the PREFERE study]. / Auswirkungen geänderter Einschlusskriterien und negativer Berichterstattung zum PSA-Screening auf die Zahl potentiell für die PREFERE-Studie rekrutierbarer Patienten.

BACKGROUND: The PREFERE study is currently below expectations. The objective of this study was to investigate the effect of the modification of the inclusion criteria in 2015 on the number of recruitable patients with localized prostate cancer. Furthermore we analyzed whether fewer cases of low-risk prostate cancer were detected in 2014 than in 2010. PATIENTS AND METHODS: Prostate biopsies of 2136 patients (9 hospitals) of the years 2010 and 2014 were retrospectively reviewed, regarding the eligibility for participation in the PREFERE study. RESULTS: According to PREFERE criteria version 3.2, 16.8 % (in 2010) and 16.7 % (in 2014) of the patients fulfilled the inclusion criteria for the study, whereas 41.9 % (in 2010) and 30.1 % (in 2014) of the patients met the criteria in version 5.0. CONCLUSIONS: Our results indicate that the modified inclusion criteria result in an increase in the number of recruitable patients for the PREFERE study. Furthermore, there were 11.8 % fewer cases of potentially recruitable patients in 2014 than in 2010 by use of version 5.0. This is a possible indication for an altered use of prostate biopsy.

Relation of the first hypertension-associated event with medication, compliance and persistence in naïve hypertensive patients after initiating monotherapy.

OBJECTIVE: To analyze the relation of medication, compliance and persistence with the risk of the first hypertension associated event in naïve hypertensive patients after initiating monotherapy with any of the first-line antihypertensive drug classes. METHODS: A retrospective cohort study in the IMS Disease Analyzer database was performed. The study cohort comprised all previously untreated hypertensive patients who were free from hypertension-associated comorbidities, in whom new monotherapy with angiotensin II receptor blockers (ARBs), ACE-inhibitors (ACEIs), beta-blockers (BBs), calcium channel blockers (CCBs) or diuretics was initiated. Compliance and persistence were determined within 2 years. The relation between medication, compliance, persistence and risk of the first hypertension-associated event was analyzed using a Cox regression model. Outcomes in the ARB cohort were compared with outcomes in each other drug class cohort separately and with outcomes in the group of non-ARBs (pooled data). RESULTS: 7,661 patients were identified with a follow-up of at least 2 years (totaling 45,585 patient-years of follow-up). ARBs were associated with more favorable measures (all p < 0.05) of compliance (0.86 vs. 0.82 and 0.74, respectively) and persistence (509 days vs. 459 and 324 days) compared with the group of non-ARBs and diuretics, respectively. The risk of the first hypertension-associated event was higher (all p < 0.05) with diuretics (adjusted hazard ratio (aHR) 0.68), BBs (0.79), CCBs (0.78), and the group of non-ARBs (0.81) and was similar with ACEIs (aHR 0.93, p = 0.37) compared to ARBs. Overall, high compliance was associated with a reduced risk of the first event (p < 0.05). CONCLUSION: Our real-world data suggest that initiating a treatment with ARB monotherapy shows significant benefits in most outcomes including hypertension-related complications compared to other antihypertensive drug monotherapies. The documented impact of compliance on the risk of the first event should have clinical and policy implications.