The Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) formally reclassified sildenafil citrate 50 mg tablets as a pharmacy medicine (sildenafil-P) in 2017 for adult men with erectile dysfunction (ED). A one-year prospective real-world observational study was conducted to track men's health behavior, particularly their healthcare resource utilization (HCRU) and quality of life (QoL) before and after the availability of sildenafil-P.
Adult men with ED aged ≥18 years provided data at baseline (prior to launch of sildenafil-P) and every three months after the launch. Demographics, health characteristics, treatments at baseline and HCRU, including number of pharmacist and physician/nurse practitioner visits over time are reported. QoL-related outcomes were assessed via the Self-Esteem and Relationship Questionnaire (SEAR), 2-Item Patient Health Questionnaire, and ratings of sexual satisfaction. Generalized linear models were used to assess the association of sildenafil-P use with total physician/nurse practitioner and pharmacist visits and QoL-related outcomes at 12 months.
Overall, 1162 men completed the survey at all 5 time points. The mean ± SD age was 59.02 ± 12.06 years; 55.42% reported having a moderate-to-severe ED. Hypertension (37.52%) and hypercholesterolemia (31.50%) were the most common risk factors for ED. At baseline, 62.99% were not using any ED treatment. After adjusting for baseline visits/other covariates, mean physician/nurse practitioner (3.68 vs 2.87; P = .003) and pharmacist visits for any reason (2.10 vs 1.34; P < .001) at 12 months were significantly higher among sildenafil-P users than those who never used sildenafil-P. Sildenafil-P users also had significantly higher SEAR total and domain (sexual relationship and self-esteem) scores at 12 months.
Following the reclassification to a pharmacy medicine in the UK, sildenafil-P was associated with a higher number of physician/nurse practitioner and pharmacist visits for any reason. Sildenafil-P use was also associated with better QoL, although group differences were small in magnitude.
International journal of clinical practice. 2020 Nov 21 [Epub ahead of print]
Lauren J Lee, Terence A Maguire, Martine C Maculaitis, Birol Emir, Vicky W Li, Mara Jeffress, Jim Z Li, Kelly H Zou, Shaantanu S Donde, David Taylor
Patient and Health Impact, Pfizer Inc, New York, NY, USA., School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland., Health Division, Kantar, New York, NY, USA., Statistical Research and Data Center, Global Product Development, Pfizer Inc, New York, NY, USA., Health Division, Kantar, Los Angeles, CA, USA., Medical Analytics & Insights, R&D and Medical, Upjohn Division, Pfizer Inc, San Diego, CA, USA., Medical Analytics & Insights, R&D and Medical, Upjohn Division, Pfizer Inc, New York, NY, USA., Upjohn Division, Pfizer Inc, Surrey, UK., School of Pharmacy, University College London, London, UK.