- Email: [email protected]
TREATMENT SATISFACTION WITH ANTIMUSCARINICS: WHICH TYPE OF DRUG IS DESIRABLE TO PATIENTS WITH OAB?
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
and overactive bladder (OAB) symptoms remains unclear. The aim of this study is to assess whether the serum levels of adiponectin and a B3-AR polymorphism are related to OAB symptoms and the variables obtained from bladder diaries in community-dwelling women 40 yrs of age or older in Japan. METHODS: A total of 337 women (mean age 61 years, range 40 to 84) in Japan were asked to complete a 3-day bladder diary and questionnaires to assess OAB. Standardized symptom indicators were used to define OAB syndrome. Serum adiponectin was measured by ELISA using a human adiponectin Acrp 30 immunoassay kit. B3-AR Trp64Arg was genotyped by PCR-RFLP. RESULTS: As for the bladder diary parameters in the OAB-Wet women, the serum adiponectin level had significant linear correlation to the average voided volume (r=0.63, p=0.02). The serum adiponectin level of the women with metabolic syndrome in the OAB group (4.4 ng/ ml) was significantly lower than that in the women without metabolic syndrome in the Normal group (8.6 ng/ml) (p=0.03), and in the women without metabolic syndrome in the OAB group (9.6 ng/ml) (p=0.048). The overall prevalence of OAB in the community-based elderly women was 11.9%. Out of 40 women with OAB, the B3-AR genotype was TrpTrp for 24 (60.0%), TrpArg for 14 (35.0%), and ArgArg for 2 (5.0%). On the other hand, out of 297 women without OAB, the distribution of the genotype was 193 (65.0%), 90 (30.3%), and 14 (4.7%), respectively. There was no significant difference in the B3-AR genotype distribution between the women with or without OAB. CONCLUSIONS: The population study revealed the possible correlation of OAB-Wet with metabolic syndrome. Low serum adiponectin might be one of the contributing factors for the pathophysiology of OAB. The evaluation of the serum adiponectin level could represent a novel target for the prevention and treatment of OAB. Source of Funding: None
1870 SAFETY AND EFFICACY CONCERNS IN SWITCHING PATIENTS WITH OVERACTIVE BLADDER (OAB) SYMPTOMS FROM BRANDED TO GENERIC ANTICHOLINERGIC MEDICATIONS Steven A Kaplan*, Doreen E Chung, Jaspreet S Sandhu, Alexis E Te, New York, NY INTRODUCTION AND OBJECTIVES: Generic substitutes are the fastest growing prescriptions in the Unites States and are commonly thought to be as safe and effective as branded medications (BRD) even though their regulatory approval is much less stringent. To date, there has been no study in patients with OAB to ascertain if this premise is true. This aim of this study was to ascertain the efficacy, safety, and tolerability of generic substitutes for branded anticholinergic medications. METHODS: The study population consisted of 156 consecutive patients with OAB (87 women, 69 men) who were switched from branded anticholinergic medications (Detrol LA, Vesicare, Enablex or Sanctura XR) to generic oxybutynin (OXB) by their primary care physician or insurance coverage. Patients completed 3-day diaries prior to baseline and at week 8. Efficacy was assessed by evaluating treatment-related changes from baseline to week 8 in diary endpoints, 24-hour daytime and nocturnal OAB micturitions, development of urge and / or urge incontinence (UI) and IPSS in men (total, storage and voiding components). Safety was assessed by changes in post void residual urine (PVR) and adverse events (AE). RESULTS: In women switched to OXB, there was an increase in frequency (+ 2.1), nocturia (+1.2) and UI (+46.3%). In men, there was an increase in frequency (+ 2.4), nocturia (+1.4), UI (+ 40.6%), and total IPSS (+3.7). (Table 1) PVR increased 14.7 ml and 19.7 ml in women and men, respectively. In addition, there were increased side effects in both genders (dry mouth: + 23.1% and +14.3%; constipation: + 32.1% and + 34.6%) in women and men respectively. Switching from Detrol LA and Vesicare to generic oxybutinin resulted in the greatest changes in safety and efficacy. (P < 0.01) CONCLUSIONS: In this preliminary analysis, conversion from branded anticholinergic medications to generic oxybutynin resulted in a significant diminution in both efficacy and safety. Given these findings
675
as well as the wide variability in generic preparations of oxybutynin, physicians and patients should be aware of this prior to accepting therapeutic alternatives for OAB. Table 1 BRD Female Generic OXB BRD Male Generic OXB N = 87 @ 8 weeks N= 69 @ 8 weeks Frequency / 24 hours
7.4
9.5***
6.9
9.3***
Nocturia
1.1
2.3***
1.5
2.9***
UI %
13.6
19.9*
3.2
4.5**
7.1
10.8***
39.8
59.5*
IPSS PVR (ml)
21.4
36.1*
Data are presented as mean values unless stated otherwise. * P < 0.5, ** P < 0.1, *** P < 0.001
Source of Funding: None
1871 TREATMENT SATISFACTION WITH ANTIMUSCARINICS: WHICH TYPE OF DRUG IS DESIRABLE TO PATIENTS WITH OAB? Hironobu Akino*, Fukui, Japan; Mikio Namiki, Kouji Suzuki, Kanazawa, Japan; Hideki Fuse, Toyama, Japan; Osamu Yokoyama, Fukui, Japan INTRODUCTION AND OBJECTIVES: Drug treatment for overactive bladder (OAB) may fail because of non-adherence or discontinuation. In particular, the patient’s perception of drug effectiveness and tolerability may be a useful tool to predict whether patients will adhere to their treatment. Data demonstrating whether patients are satisfied with OAB treatment or indicating which antimuscarinic is desirable to patients in terms of efficacy and/or side effects are often lacking. In this study we investigated patient-reported satisfaction and clinical parameters during antimuscarinic treatment. METHODS: The subjects were 1,270 patients (mean age, 73.5 years; men, 58%) with OAB in a large, multicenter survey designed to assess patient satisfaction with antimuscarinics. Patients were assessed using the OAB symptom score (OABSS; Urology 68; 318, 2006), clinical efficacy scale, adverse event (dry mouth, constipation) score, and satisfaction scale. The efficacy scale contained four response options ranging from ‘very effective’ to ‘not effective’. The adverse event score consisted of the sum of the scores for dry mouth and constipation. The severity of each event was determined as ‘not at all’ (0) to ‘severe’ (4). In consideration of treatment efficacy and adverse events, patient satisfaction was determined as ‘very good’, ‘fairly good’, ‘neither good nor bad’, ‘fairly bad’, and ‘very bad’. Antimuscarinics were classified into two types, extended-release (ER; tolterodine, solifenacin, propiverine) and immediate-release (IR; oxybutynin, imidafenacin). RESULTS: About 80% of patients received antimuscarinics for the treatment of OAB, and 33.4% of them revealed a ‘fairly bad’ or ‘very bad’ level of satisfaction. There were no significant differences in OABSS or efficacy scale between patients treated with ER and IR. Dry mouth and constipation were less severe in patients treated with IR than in those treated with ER, and the difference was significant (p <0.001). The total mean score of adverse events in patients treated with IR was 1.78 ± 0.17, which was significantly lower than that in patients treated with ER (2.56 ± 0.06; p < 0.001). The number of patients with a satisfaction level of ‘very good’ and ‘fairly good’ was significantly higher in patients treated with IR than in those treated with ER (p <0.01). CONCLUSIONS: These results suggest that many OAB patients were dissatisfied with their treatment for OAB. IR antimuscarinics are likely to be preferable because of the low incidence of adverse events with their use. Source of Funding: None
Vol. 181, No. 4, Supplement, Wednesday, April 29, 2009
and overactive bladder (OAB) symptoms remains unclear. The aim of this study is to assess whether the serum levels of adiponectin and a B3-AR polymorphism are related to OAB symptoms and the variables obtained from bladder diaries in community-dwelling women 40 yrs of age or older in Japan. METHODS: A total of 337 women (mean age 61 years, range 40 to 84) in Japan were asked to complete a 3-day bladder diary and questionnaires to assess OAB. Standardized symptom indicators were used to define OAB syndrome. Serum adiponectin was measured by ELISA using a human adiponectin Acrp 30 immunoassay kit. B3-AR Trp64Arg was genotyped by PCR-RFLP. RESULTS: As for the bladder diary parameters in the OAB-Wet women, the serum adiponectin level had significant linear correlation to the average voided volume (r=0.63, p=0.02). The serum adiponectin level of the women with metabolic syndrome in the OAB group (4.4 ng/ ml) was significantly lower than that in the women without metabolic syndrome in the Normal group (8.6 ng/ml) (p=0.03), and in the women without metabolic syndrome in the OAB group (9.6 ng/ml) (p=0.048). The overall prevalence of OAB in the community-based elderly women was 11.9%. Out of 40 women with OAB, the B3-AR genotype was TrpTrp for 24 (60.0%), TrpArg for 14 (35.0%), and ArgArg for 2 (5.0%). On the other hand, out of 297 women without OAB, the distribution of the genotype was 193 (65.0%), 90 (30.3%), and 14 (4.7%), respectively. There was no significant difference in the B3-AR genotype distribution between the women with or without OAB. CONCLUSIONS: The population study revealed the possible correlation of OAB-Wet with metabolic syndrome. Low serum adiponectin might be one of the contributing factors for the pathophysiology of OAB. The evaluation of the serum adiponectin level could represent a novel target for the prevention and treatment of OAB. Source of Funding: None
1870 SAFETY AND EFFICACY CONCERNS IN SWITCHING PATIENTS WITH OVERACTIVE BLADDER (OAB) SYMPTOMS FROM BRANDED TO GENERIC ANTICHOLINERGIC MEDICATIONS Steven A Kaplan*, Doreen E Chung, Jaspreet S Sandhu, Alexis E Te, New York, NY INTRODUCTION AND OBJECTIVES: Generic substitutes are the fastest growing prescriptions in the Unites States and are commonly thought to be as safe and effective as branded medications (BRD) even though their regulatory approval is much less stringent. To date, there has been no study in patients with OAB to ascertain if this premise is true. This aim of this study was to ascertain the efficacy, safety, and tolerability of generic substitutes for branded anticholinergic medications. METHODS: The study population consisted of 156 consecutive patients with OAB (87 women, 69 men) who were switched from branded anticholinergic medications (Detrol LA, Vesicare, Enablex or Sanctura XR) to generic oxybutynin (OXB) by their primary care physician or insurance coverage. Patients completed 3-day diaries prior to baseline and at week 8. Efficacy was assessed by evaluating treatment-related changes from baseline to week 8 in diary endpoints, 24-hour daytime and nocturnal OAB micturitions, development of urge and / or urge incontinence (UI) and IPSS in men (total, storage and voiding components). Safety was assessed by changes in post void residual urine (PVR) and adverse events (AE). RESULTS: In women switched to OXB, there was an increase in frequency (+ 2.1), nocturia (+1.2) and UI (+46.3%). In men, there was an increase in frequency (+ 2.4), nocturia (+1.4), UI (+ 40.6%), and total IPSS (+3.7). (Table 1) PVR increased 14.7 ml and 19.7 ml in women and men, respectively. In addition, there were increased side effects in both genders (dry mouth: + 23.1% and +14.3%; constipation: + 32.1% and + 34.6%) in women and men respectively. Switching from Detrol LA and Vesicare to generic oxybutinin resulted in the greatest changes in safety and efficacy. (P < 0.01) CONCLUSIONS: In this preliminary analysis, conversion from branded anticholinergic medications to generic oxybutynin resulted in a significant diminution in both efficacy and safety. Given these findings
675
as well as the wide variability in generic preparations of oxybutynin, physicians and patients should be aware of this prior to accepting therapeutic alternatives for OAB. Table 1 BRD Female Generic OXB BRD Male Generic OXB N = 87 @ 8 weeks N= 69 @ 8 weeks Frequency / 24 hours
7.4
9.5***
6.9
9.3***
Nocturia
1.1
2.3***
1.5
2.9***
UI %
13.6
19.9*
3.2
4.5**
7.1
10.8***
39.8
59.5*
IPSS PVR (ml)
21.4
36.1*
Data are presented as mean values unless stated otherwise. * P < 0.5, ** P < 0.1, *** P < 0.001
Source of Funding: None
1871 TREATMENT SATISFACTION WITH ANTIMUSCARINICS: WHICH TYPE OF DRUG IS DESIRABLE TO PATIENTS WITH OAB? Hironobu Akino*, Fukui, Japan; Mikio Namiki, Kouji Suzuki, Kanazawa, Japan; Hideki Fuse, Toyama, Japan; Osamu Yokoyama, Fukui, Japan INTRODUCTION AND OBJECTIVES: Drug treatment for overactive bladder (OAB) may fail because of non-adherence or discontinuation. In particular, the patient’s perception of drug effectiveness and tolerability may be a useful tool to predict whether patients will adhere to their treatment. Data demonstrating whether patients are satisfied with OAB treatment or indicating which antimuscarinic is desirable to patients in terms of efficacy and/or side effects are often lacking. In this study we investigated patient-reported satisfaction and clinical parameters during antimuscarinic treatment. METHODS: The subjects were 1,270 patients (mean age, 73.5 years; men, 58%) with OAB in a large, multicenter survey designed to assess patient satisfaction with antimuscarinics. Patients were assessed using the OAB symptom score (OABSS; Urology 68; 318, 2006), clinical efficacy scale, adverse event (dry mouth, constipation) score, and satisfaction scale. The efficacy scale contained four response options ranging from ‘very effective’ to ‘not effective’. The adverse event score consisted of the sum of the scores for dry mouth and constipation. The severity of each event was determined as ‘not at all’ (0) to ‘severe’ (4). In consideration of treatment efficacy and adverse events, patient satisfaction was determined as ‘very good’, ‘fairly good’, ‘neither good nor bad’, ‘fairly bad’, and ‘very bad’. Antimuscarinics were classified into two types, extended-release (ER; tolterodine, solifenacin, propiverine) and immediate-release (IR; oxybutynin, imidafenacin). RESULTS: About 80% of patients received antimuscarinics for the treatment of OAB, and 33.4% of them revealed a ‘fairly bad’ or ‘very bad’ level of satisfaction. There were no significant differences in OABSS or efficacy scale between patients treated with ER and IR. Dry mouth and constipation were less severe in patients treated with IR than in those treated with ER, and the difference was significant (p <0.001). The total mean score of adverse events in patients treated with IR was 1.78 ± 0.17, which was significantly lower than that in patients treated with ER (2.56 ± 0.06; p < 0.001). The number of patients with a satisfaction level of ‘very good’ and ‘fairly good’ was significantly higher in patients treated with IR than in those treated with ER (p <0.01). CONCLUSIONS: These results suggest that many OAB patients were dissatisfied with their treatment for OAB. IR antimuscarinics are likely to be preferable because of the low incidence of adverse events with their use. Source of Funding: None