Luca Cindolo1, Luisella Pirozzi2, Caterina Fanizza2, Marilena Romero2, Andrea Tubaro3, Riccardo Autorino4, Cosimo De Nunzio3, Luigi Schips5. 1. Department of Urology, S. Pio da Pietrelcina Hospital, Vasto, Italy. Electronic address: lucacindolo@virgilio.it. 2. Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Santa Maria Imbaro, Italy. 3. Department of Urology, Ospedale Sant'Andrea, University La Sapienza, Rome, Italy. 4. University Hospitals, Urology Institute, Cleveland, OH, USA. 5. Department of Urology, S. Pio da Pietrelcina Hospital, Vasto, Italy.
Abstract
BACKGROUND: Little is known about drug adherence in men treated for lower urinary tract symptoms (LUTS). Benign prostatic hyperplasia (BPH) is one of the causes of LUTS. OBJECTIVE: To examine adherence to pharmacological therapy and its clinical value in men with LUTS. DESIGN, SETTING, AND PARTICIPANTS: Population-based cohort study using an administrative prescription database and hospital discharge codes for 1.5 million men aged ≥40 yr treated with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) alone or in combination (CT). INTERVENTIONS: Therapy with ABs and/or 5ARIs. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The 1-yr and long-term adherence; hospitalization rates for BPH and BPH surgery. Multivariate Cox proportional hazards regression model, propensity score matching, and sensitivity analyses. RESULTS AND LIMITATIONS: The 1-yr adherence was 29% in patients exposed to at least 6-mo therapy. Patients on CT had a higher discontinuation rate in the first 2 yr compared to those on monotherapy (p<0.0001). Overall hospitalization rates for BPH and BPH surgery were 9.04 and 12.6 per 1000 patient-years, respectively. A lower risk of hospitalization was observed for 5ARI compared to AB therapy (hazard ratio [HR] 0.46 and 0.23; p<0.0001). CT was associated with a reduced risk of hospitalization for BPH surgery (HR 0.94; p<0.0001) compared to AB. Discontinuation of drug treatment was an independent risk factor for hospitalization for BPH and BPH surgery (HR 1.65 and 2.80; p<0.0001) regardless of therapeutic group. Limitations include the paucity of clinical measures and the absence of patient-reported outcomes. CONCLUSIONS: Adherence to pharmacological therapy for BPH is low and could affect clinical outcomes. Long-term 5ARI and CT use was associated with an independent reduced risk of hospitalization for BPH surgery. Our findings suggest the need for new strategies to increase patient adherence to prescribed treatment and more appropriate prescribing by physicians. PATIENT SUMMARY: Our research shows that adherence to prescribed pharmacological therapy is crucial in the management of patients suffering from lower urinary tract symptoms. Moreover, pharmacological therapy can prevent disease progression.
BACKGROUND: Little is known about drug adherence in men treated for lower urinary tract symptoms (LUTS). Benign prostatic hyperplasia (BPH) is one of the causes of LUTS. OBJECTIVE: To examine adherence to pharmacological therapy and its clinical value in men with LUTS. DESIGN, SETTING, AND PARTICIPANTS: Population-based cohort study using an administrative prescription database and hospital discharge codes for 1.5 million men aged ≥40 yr treated with alpha blockers (ABs) and 5-alpha reductase inhibitors (5ARIs) alone or in combination (CT). INTERVENTIONS: Therapy with ABs and/or 5ARIs. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The 1-yr and long-term adherence; hospitalization rates for BPH and BPH surgery. Multivariate Cox proportional hazards regression model, propensity score matching, and sensitivity analyses. RESULTS AND LIMITATIONS: The 1-yr adherence was 29% in patients exposed to at least 6-mo therapy. Patients on CT had a higher discontinuation rate in the first 2 yr compared to those on monotherapy (p<0.0001). Overall hospitalization rates for BPH and BPH surgery were 9.04 and 12.6 per 1000 patient-years, respectively. A lower risk of hospitalization was observed for 5ARI compared to AB therapy (hazard ratio [HR] 0.46 and 0.23; p<0.0001). CT was associated with a reduced risk of hospitalization for BPH surgery (HR 0.94; p<0.0001) compared to AB. Discontinuation of drug treatment was an independent risk factor for hospitalization for BPH and BPH surgery (HR 1.65 and 2.80; p<0.0001) regardless of therapeutic group. Limitations include the paucity of clinical measures and the absence of patient-reported outcomes. CONCLUSIONS: Adherence to pharmacological therapy for BPH is low and could affect clinical outcomes. Long-term 5ARI and CT use was associated with an independent reduced risk of hospitalization for BPH surgery. Our findings suggest the need for new strategies to increase patient adherence to prescribed treatment and more appropriate prescribing by physicians. PATIENT SUMMARY: Our research shows that adherence to prescribed pharmacological therapy is crucial in the management of patients suffering from lower urinary tract symptoms. Moreover, pharmacological therapy can prevent disease progression.
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