Patient and Health Impact, Pfizer Inc, New York, NY, USA.
School of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland.
Int J Clin Pract. 2021 Apr;75(4):e13849. doi: 10.1111/ijcp.13849. Epub 2020 Dec 5.
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 1-year prospective real-world observational study was conducted to track men's health behaviour, particularly their healthcare resource utilisation (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 3 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. Generalised 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 hypercholesterolaemia (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.
英国药品和保健品管理局(MHRA)于 2017 年正式将枸橼酸西地那非 50mg 片剂重新归类为药剂师配药(西地那非-P),用于治疗成年男性勃起功能障碍(ED)。本研究开展了一项为期 1 年的前瞻性真实世界观察性研究,旨在跟踪男性的健康行为,特别是他们在获得西地那非-P 前后的医疗资源利用(HCRU)和生活质量(QoL)。
年龄≥18 岁的 ED 成年男性在基线时(在推出西地那非-P 之前)和推出后每 3 个月提供一次数据。报告人口统计学、健康特征、基线治疗和 HCRU,包括随时间推移的药剂师和医生/护士从业者就诊次数。通过自尊和关系问卷(SEAR)、2 项患者健康问卷和性满意度评分评估 QoL 相关结局。使用广义线性模型评估 12 个月时西地那非-P 使用与总医生/护士从业者和药剂师就诊次数和 QoL 相关结局的相关性。
总体而言,1162 名男性在所有 5 个时间点完成了调查。平均年龄为 59.02±12.06 岁;55.42%报告有中度至重度 ED。高血压(37.52%)和高胆固醇血症(31.50%)是 ED 的最常见危险因素。基线时,62.99%的人未使用任何 ED 治疗。调整基线就诊/其他协变量后,与从未使用过西地那非-P 的患者相比,西地那非-P 使用者在 12 个月时的平均医生/护士从业者就诊次数(3.68 次 vs 2.87 次;P=.003)和任何原因的药剂师就诊次数(2.10 次 vs 1.34 次;P<.001)均显著更高。西地那非-P 使用者在 12 个月时的 SEAR 总分和领域(性关系和自尊)评分也显著更高。
在英国重新归类为药剂师配药后,西地那非-P 与更多因任何原因而就诊的医生/护士从业者和药剂师就诊次数相关。尽管组间差异幅度较小,但西地那非-P 使用与更好的 QoL 相关。