Detrol LA (Tolterodine Tartrate) - Summary

DETROL LA SUMMARY

Detrol^® LA
tolterodine tartrate
extended release capsules

DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist.

DETROL LA Capsules are once daily extended release capsules indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

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NEWS HIGHLIGHTS

Published Studies Related to Detrol LA (Tolterodine)

Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. [2009.09]
PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated... CONCLUSIONS: This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.

Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. [2009.09]
CONCLUSIONS: Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.

[Combination of tolterodine and tamsulosin for benign prostatic hyperplasia] [2009.07]
OBJECTIVE: Overactive bladder may coexist with bladder outlet obstruction induced by benign prostatic hyperplasia (BPH). This study aimed to evaluate the efficacy of the combined use of tolterodine and tamsulosin in the treatment of BPH accompanied by overactive bladder... CONCLUSION: Tamsulosin could quickly relieve BPH-induced lower urinary tract symptoms (LUTS) , while the combined use of tolterodine and tamsulosin could even better alleviate the LUTS and improve the QOL of BPH patients.

Continued symptom improvement in sexually active women with overactive bladder and urgency urinary incontinence treated with tolterodine ER for 6 months. [2009.04]
Improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) were assessed during a 24-week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). A 12-week, double-blind, randomized, placebo-controlled trial was followed by a 12-week open-label phase...

The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine. [2009.03.07]
BACKGROUND: Fesoterodine is a new antimuscarinic agent developed for the treatment of overactive bladder. Fesoterodine itself is inactive and is rapidly and extensively converted by ubiquitous esterases to its principal active moiety, 5-hydroxymethyl tolterodine (5-HMT). 5-HMT is formed via biotransformation of both fesoterodine and tolterodine, albeit by different metabolising enzymes, viz. esterases and CYP2D6 respectively. Tolterodine is a potent muscarinic receptor antagonist and has been used for the treatment of overactive bladder for over ten years. The objective of this study was to establish the pharmacokinetic profile of fesoterodine and to highlight ist potential pharmacokinetic advantages over tolterodine... CONCLUSIONS: Due to the esterase-mediated cytochrome P450-independent formation of 5-HMT and involvement of multiple metabolic and renal excretion pathways in the elimination of 5-HMT, the effects of patient-intrinsic and -extrinsic factors on the pharmacokinetics of fesoterodine are only modest, with some 2-fold higher 5-HMT exposure. Therefore, in contrast to tolterodine, no reduction of fesoterodine dosage is required under conditions of reduced elimination. In most cases of drug interaction or renal/hepatic impairment, the fesoterodine dose may be increased to 8 mg/day based on individual patients' response, or patients may be required to remain at the initial recommended dose of 4 mg/day.

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Clinical Trials Related to Detrol LA (Tolterodine)

Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet [Completed]
To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Effects Of Detrol LA On Memory And Cognition In Elderly Population [Completed]
The primary purpose of the trial is to show that tolterodine ER has no effect on memory and other cognitive abilities in an elderly population

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects [Completed]
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older

Detrol LA In Men With Overactive Bladder. [Completed]
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.

Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).

Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

Detrol (Tolterodine) Post Surgery for Benign Prostatic Hyperplasia [Recruiting]
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study. Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. The investigators hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as Detrol LA (tolterodine).

Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug tolterodine is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug.

A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. The investigators propose a double blind, randomized, placebo-controlled trial to evaluate the efficacy of Detrol LA 4mg, an anticholinergic in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. The investigators expect a total of 50 patients to be enrolled within 4 months. One arm will receive placebo, the other will receive Detrol LA 4 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an American Urological Association (AUA) symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, the investigators will see if there is a difference in symptoms, post-void residual, or maximum flow rate between the two arms at 6 months. The investigators will continue in an open-label manner after six months. If the Detrol LA arm has better outcomes, the investigators will offer the placebo group Detrol LA 4mg at the six month period and continue the study to evaluate long-term efficacy, dropout rate, and complications. No dosing adjustments will be allowed for the duration of the study.

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PATIENT REVIEWS / RATINGS / COMMENTS

Detrol LA review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		incontinence
Dosage & duration:		2mg taken once day for the period of 5 years
Other conditions:		quadriplegia
Other drugs taken:		oxybuiton, imipramine
		Reported Results
Benefits:		stopped my bladder incontinence when used in combination with my other bladder medications on my neurogenic bladder
Side effects:		drowsiness, urinary retention may have caused dry mouth but not as bad as using ditropan does
Comments:		This drug was added as I have very strong bladder spasms. It's side effects are better than ditropan and I would recommend people try it first

Detrol LA review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		overactive bladder
Dosage & duration:		4 mg taken once a day for the period of 6 months
Other conditions:		type 2 diabetes
Other drugs taken:		Premarin, ToprolXL, Acto+Met
		Reported Results
Benefits:		Less urinary urgency (worked as advertised).
Side effects:		The only side effect was a dry mouth.This was mildly annoying, but not serious.
Comments:		Although the drug was supposed to be good for 24 hours, it seemed to wear off during the second 24 hours. A switch to plain Detrol (2mg) twice a day proved to work much better.

Detrol LA review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Frequent and urgent urination
Dosage & duration:		4mg taken once a day for the period of 4 days
Other conditions:		MS, perioral dermatitis,allergies
Other drugs taken:		amitriptyline,ZyrtecD,Gabapentin,Requip,Baclofen,Veramyst,Copaxone
		Reported Results
Benefits:		Gabapentin worked extremely well for my leg neuropathy.A combination of Zyrtec and Veramyst works quite well for my allergies. Requip takes care of my restless legs which at times had me getting up and having to walk to relieve the discomfort. Baclofen helps with my spasticity. After taking amitriptyline I am able to go to sleep in an hour or so. As for the Copaxone who knows? I have had only one flare up since starting it.
Side effects:		The Detrol was horrible. My mouth was so dry my tongue literally stuck to the roof of my mouth making it difficult to speak. The Copaxone causes lumps and itching at the injection site.
Comments:		When Zyrtec alone didn't controll my allergies my doctor prescribed the Veramyst to try. This combination seems to be working, Zyrtec once a day and Veramyst twice daily. The Baclofen 10mg.is taken as needed one to four times a day. Sometimes I'm not bothered with spasticity too often but when I am I take the Baclofen and it works.Amitriptyline tabs 25mg are taken before bedtime.Requip tabs .5mg are taken in the evening. Gabapentin 300mg is taken 3-4 times a day depending on the severity of pain. Tetracycline HCL 250mg is taken once a day. The Copaxone 200mg is injected once a day. I discontinued the Detrol LA as I could not tolerate the extreme dry mouth.