Astellas Pharma Europe Ltd., the European subsidiary of Tokyo-based Astellas Pharma Inc.(Tokyo:4503), announced the results of two separate studies at the annual European Association of Urology (EAU) congress. Both sets of results indicate combination therapy should be considered to treat the symptoms of a condition that affects thousands of men in Europe. A European survey found that up to 93% of all patients with both storage and voiding symptoms associated with lower urinary tract symptoms (LUTS) / benign prostate hyperplasia (BPH) may not be receiving optimal therapy.1 In a separate study, NEPTUNE II, a fixed-dose combination tablet (FDC) of the antimuscarinic solifenacin (Soli) and the a-blocker tamsulosin OCAS™ (TOCAS) for men with both storage and voiding symptoms, was found to maintain improvements in total IPSS, micturition and quality of life for up to 52 weeks.2
"The results of the survey highlight how the medical profession has been too focussed on voiding symptoms when managing urinary problems in men, ignoring the storage symptoms that probably have an even greater impact on quality of life," commented Mr Marcus Drake, Consultant Urological Surgeon at Southmead Hospital, Bristol and Lead Investigator of the NEPTUNE II trial. "Combination treatment is needed to ensure that both these types of symptoms are managed effectively. The results of NEPTUNE II demonstrate that combination therapy is effective and well-tolerated, both in the short and longer term. Therefore, it is appropriate for any man with poorly-controlled symptoms of LUTS/ BPH to be considered for combination treatment, when both storage and voiding symptoms are present."
EAU guidelines recommend consideration of combination treatment of an a-blocker and antimuscarinic for men with moderate to severe LUTS associated with BPH, if monotherapy has failed to relieve symptoms sufficiently. The survey of 481 physicians and their 3,977 male patients found that only 7% of 2,624 patients who were potentially eligible for combination treatment, were currently receiving both therapy classes.1 Furthermore, of the total 1,940 patients on monotherapy, 55% had at least one indicator of inadequate control.1
Separately to this, NEPTUNE II, the open-label flexible-dosing extension of the 12 week Phase 3 NEPTUNE study, aimed to assess the long term efficacy and tolerability of the FDC Soli (6 and 9 mg) and TOCAS (0.4 mg) in 1,066 male patients with both storage and voiding LUTS. Results showed that the mean total IPSS was reduced by 9.0 points from baseline in the NEPTUNE study to end of treatment during the NEPTUNE II study, and the mean number of micturitions per 24 hours was reduced by 2.5.2
In terms of quality of life, the mean IPSS QoL score was reduced by 1.9 points from baseline to end of treatment.2 OAB-q symptom bother and HRQoL scores improved with FDC treatment after four weeks, and improvements were maintained for up to 52 weeks.2 The majority of patients (78%) were satisfied with both the efficacy and safety of up to 52 weeks treatment with FDC Soli 6 or 9 mg + TOCAS.2
LUTS are common in men and include symptoms of voiding (e.g. hesitancy, intermittency), storage (frequency, urgency, nocturia) and post-micturition (feeling of incomplete bladder emptying).3 LUTS can have a significant negative impact on quality of life, including work, social activities and sexual relationships.4
In a study of 14,139 men aged 40 years and over, 71% reported at least one LUTS.5 49% of the men with LUTS reported both storage and voiding symptoms.5 α-blockers are currently first-line treatment for voiding symptoms in men with LUTS/BPH but often do not adequately relieve storage symptoms, indicating a clear need for an additional therapeutic option in these patients.6 Storage symptoms are the most bothersome to the patient and can have a significant impact on quality of life.7,8
Astellas Pharma Europe Ltd. is an established leader in urology in Europe, committed to improving the lives of patients with urological conditions. Its current urology portfolio includes treatments for benign prostatic hyperplasia (BPH), overactive bladder and prostate cancer. With a strong emphasis on research and development, Astellas is dedicated to finding new treatments to meet unmet medical needs and has a number of treatments for urological conditions in development. As part of its ongoing commitment to the field, Astellas also provides and supports a wide range of educational opportunities for those working in the field of urology, designed to progress professional expertise and improve patient outcomes.