Solifenacin Succinate

Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.

The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.

This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).

One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.

Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

To evaluate the efficiency of behavioral and drug therapy aimed at reducing the severity of storage symptoms, and to determine the influence of therapy with an anticholinergic drug and a beta-3-adrenergic receptor agonist on the severity of lower urinary tract symptoms (LUTS) and urodynamic parameters in patients with LUTS that persist after surgical treatment of benign prostatic hyperplasia (BPH).

A total of 115 patients with detrusor overactivity and LUTS that persisted one month after surgical treatment of BPH (IPSS score of 8 or more) were included in the study. Preoperatively, these patients, in addition to a standard examination, underwent urodynamic study (UDS), which revealed concomitant detrusor overactivity. Surgical procedures included transurethral resection of the prostate, endoscopic enucleation of the prostate gland (laser or bipolar), retropubic or laparoscopic simple prostatectomy. At inclusion in the study, patients were randomized into three groups. In group 1 (n=39), behavioral therapy was recommended. In Group 2 (n=39), M-anticholinergic (Solifenacin 5 mg once a day) was administered, while in Group 3 (n=37) a beta-3-adrenergic receptor agonist (Mirabegron 50 mg) was used. After two months of therapy, patients underwent repeated UDS and the severity of LUTS was assessed using the IPSS questionnaire.

After two months of therapy, in each group a significant decrease in the total IPSS score, the sum of the storage and voiding symptom scores, and the median Quality of Life (QoL) score was achieved (p<0.05). At the same time, in groups with drug treatment a lower average IPSS and storage symptom scores (7.7+/-3.6 and 5.8+/-2.3 for the behavioral therapy group, 6.1+/-2.7 and 4.3+/-2.1 for the M-anticholinergic group, 6.3+/-3.1 and 4.5+/-2.2 for the beta-3 agonist group, respectively, p<0.05 when comparing the behavioral therapy group with each of the drug therapy groups) was seen. According to the control UDS, detrusor overactivity persisted in 97.4% of patients in the behavioral therapy group, 89.7% in the M-anticholinergic group, and 91.9% in the beta-3 agonist group. In each group, a significant (p<0.05) increase in the maximum cystometric capacity, volume of occurrence of the first involuntary bladder contraction, and a decrease in the maximum detrusor pressure during involuntary contraction were found. In each group, surgical treatment allowed to alleviate bladder outlet obstruction (BOO). In those who received M-anticholinergic drug and a beta-3-adrenergic receptor agonist, the maximum detrusor pressure during involuntary contraction was lower than with behavioral therapy (32+/-15.5 in the M-anticholinergic drug group vs. 33.9+/-15.2 in the beta-3-agonist group vs. 40.5+/-20.6 in the behavioral therapy group). According to the control UDS, the maximum cystometric capacity, volume of occurrence of the first involuntary bladder contraction, and the BOO index were comparable in all groups. Mirabegron caused side effects less frequently than Solifenacin; there were only 3 adverse events (8.1%) in the Mirabegron group and 11 (28.2%) in the Solifenacin group. The rate of refusal to continue therapy in patients taking beta-3-agonist (2.7%; n=1) was also lower than for Solifenacin (7.7%; n=3).

The study demonstrated the high efficiency of behavioral therapy and monotherapy with M-anticholinergic and beta-3-agonist in the treatment of LUTS that persist after surgical treatment of BPH. At the same time, both options of drug therapy demonstrate significantly greater efficiency than behavioral therapy in reducing the severity of LUTS and storage symptoms in particular, as well as in reducing detrusor pressure during its involuntary contractions. Therapy with the beta-3-agonist Mirabegron has a better safety profile than therapy with the M-anticholinergic Solifenacin, which results in greater patient compliance.