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Trospium Chloride: an Update on a Quaternary Anticholinergic for Treatment of Urge Urinary Incontinence

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Trospium Chloride: an Update on a Quaternary Anticholinergic for Treatment of Urge Urinary Incontinence View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by PubMed Central REVIEW Trospium chloride: an update on a quaternary anticholinergic for treatment of urge urinary incontinence David RP Guay Abstract: Trospium chloride is a quaternary ammonium compound, which is a competitive antagonist at muscarinic cholinergic receptors. Preclinical studies using porcine and human Department of Experimental and Clinical Pharmacology, College of detrusor muscle strips demonstrated that trospium chloride was many-fold more potent than Pharmacy, University of Minnesota, oxybutynin and tolterodine in inhibiting contractile responses to carbachol and electrical Minneapolis, MN, USA stimulation. The drug is poorly bioavailable orally (< 10%) and food reduces absorption by 70%– 80%. It is predominantly eliminated renally as unchanged compound. Trospium chloride, dosed 20 mg twice daily, is significantly superior to placebo in improving cystometric parameters, reducing urinary frequency, reducing incontinence episodes, and increasing urine volume per micturition. In active-controlled trials, trospium chloride was at least equivalent to immediate-release formulations of oxybutynin and tolterodine in efficacy and tolerability. The most problematic adverse effects of trospium chloride are the anticholinergic effects of dry mouth and constipation. Comparative efficacy/tolerability data with long-acting formulations of oxybutynin and tolterodine as well as other anticholinergics such as solifenacin and darifenacin are not available. On the basis of available data, trospium chloride does not appear to be a substantial advance upon existing anticholinergics in the management of urge urinary incontinence. Keywords: urge incontinence, trospium, anticholinergic, overactive bladder Introduction Urge urinary incontinence (UUI), the most frequent type of urinary incontinence (UI), has as typical symptoms incontinence associated with urinary frequency (> 8 micturitions/day) and urgency (sudden, strong desire to urinate). Nighttime frequency (nocturia) and nocturnal incontinence (enuresis) disrupt sleep. Although the etiology is known in some cases (eg, neurologic diseases such as stroke, Parkinson’s disease, multiple sclerosis, or spinal cord injury or bladder outlet obstruction due to benign prostatic hyperplasia or prostate cancer), in most cases the cause is unknown. UUI and stress UI frequently coexist as mixed UI (Rovner et al 2002). The most effective agents in suppressing inappropriate bladder contractions, enhancing bladder storage, and relieving UUI signs and symptoms are the anticholinergic/antispasmodic drugs (Rovner et al 2002; Herbison et al 2003), primarily oxybutynin and tolterodine. Other agents, such as tricyclic antidepressants, Correspondence: David RP Guay propantheline, dicyclomine, scopolamine, and flavoxate, are less effective, no safer, University of Minnesota, College of or have been inadequately studied and are generally not recommended (Rovner et al Pharmacy, Weaver-Densford Hall 7-115C, 308 Harvard Street SE, 2002). Propiverine is an anticholinergic also used in managing UUI but it is not Minneapolis, MN 55455, USA available in many countries. Tel +1 612 626 5981 Unfortunately, even oxybutynin and tolterodine are only moderately effective in Fax +1 612 625 3927 Email [email protected] UUI (Herbison et al 2003), and their systemic (non-urinary tract) anticholinergic Therapeutics and Clinical Risk Management 2005:1(2) 157–166 157 © 2005 Dove Medical Press Limited. All rights reserved Guay effects are bothersome, compromise adherence, and may limit efficacy by limiting dose escalation. The search for a “uroselective” anticholinergic agent has been intense within – + Cl the pharmaceutical industry. N The purpose of this paper is to profile trospium chloride. Trospium chloride has been available for many years in HO Europe, manufactured by Madaus AG (Cologne, Germany) O under the tradename Spasmo-lyt® and is also available as Uroplex® and SpasmoUrgenin®. This agent has recently been approved by the US Food and Drug Administration O (FDA) for the treatment of overactive bladder (symptoms of urinary frequency, urgency, and UUI) under the tradename ® Sanctura (Odyssey Pharmaceuticals, East Hanover NJ and Figure 1 Chemical structure of trospium chloride. Indevus Pharmaceuticals, Lexington, MA, USA). A MEDLINE/PUBMED search was conducted to at final drug concentration in bath). For porcine tissue, identify pertinent articles in the English language. Additional trospium chloride was significantly more potent than references were obtained from the bibliographies of these oxybutynin (EC50 values of 0.006 and 25 µmol/L and Rmax articles. In addition, proceedings of the Incontinence Society, values of 100 [at 0.1 µmol/L] and 76.2 ± 8%, respectively). European Association of Urology, American Urological Corresponding values for EC50 and Rmax in human tissue Association, and American College of Obstetrics and were 0.003 and 10 µmol/L and 86 ± 13 (at 0.1 µmol/L) and Gynecology meetings were reviewed for relevant abstracts. 79 ± 20% (both tissues, p < 0.05) (Uckert et al 1998). In Data over the time period of 1966 through June 2004 were human tissue, EC50 and Rmax values for trospium chloride, reviewed. oxybutynin, and tolterodine were 0.003, 10, and ≤ 1.0 µmol/L, respectively and 86 ± 13, 50 ± 7, and 70 ± 8%, respectively. Chemistry Corresponding IC50 and MI values were 0.05, 10, and Trospium chloride (Figure 1), also known as azonia-3-α- > 10 µmol/L and 80 ± 17, 53 ± 7, and 40 ± 16% (trospium benziloyloxy-8-spiro-1´-pyrrolidinium chloride, has the chloride vs comparators, p < 0.05). In the carbachol and molecular formula C25H30NO3Cl, and a molecular weight electrical field stimulation protocols, trospium chloride of 427.97. Its chemical name is spiro[8-azoniabicyclo- produced significant changes from control at all tested [3,2,1]octane-8,1´-pyrrolidinium]-3-[(hydroxydiphenyl- bath concentrations (1, 0.1, 0.01, 0.001, 0.0001, and acetyl)-oxy]chloride(1α,3β,5α)-(9CI). Solubility in water 0.00001 µmol/L) (Uckert et al 2000). The effects of trospium exceeds 50 mg per mL at room temperature while in light chloride were dose-dependent in both ex vivo studies mineral oil it is 9.2 × 10–3 mg/mL (Langguth et al 1997). Its (Uckert et al 1998, 2000). log partition coefficient between n-octanol and buffer at pH 7.4 is –1.22 (Langguth et al 1997). Synthesis and In vivo (animal) studies pharmacological activity of this compound were first The effect of trospium chloride on gastrointestinal (GI) described in 1966 (German language literature). motility in dogs was studied after single 0.1 and 0.5 mg/kg intravenous (IV) doses. At the 0.5 mg/kg dose level, Pharmacodynamics complete inhibition of gastric and intestinal motor activity Ex vivo studies occurred for up to 0.5 h post-dose, the gastric and jejunal Ex vivo studies have evaluated the effect of trospium motility indices (MoI) were substantially reduced, and chloride on the activity of porcine and human detrusor colonic contractions and the colonic MoI fell for 2.5 h post dose (Hatchet et al 1986). muscle strips. Parameters studied included EC50 (bath concentration inducing 50% reversion of carbachol-induced tension), Rmax (% relaxation at final drug concentration in In vivo (human) studies bath), IC50 (bath concentration causing 50% inhibition of In a placebo-controlled, crossover, double-blind trial maximum contractile response to electrical field conducted in 12 healthy human volunteers, the effect of stimulation), and MI (% inhibition of contraction amplitude trospium chloride on 24-h jejunal motility was evaluated. 158 Therapeutics and Clinical Risk Management 2005:1(2) Trospium chloride in overactive bladder Trospium chloride 15 mg orally thrice daily significantly significantly reduced by the drug (from 95% on placebo to prolonged the duration of irregular contractile activity after 60%, p < 0.01). Trospium chloride also significantly meals (from mean 324 to 368 min, p < 0.02) and decreased increased the latency to onset of secondary contractions its contraction frequency (from 2.24 to 1.08/min, p < 0.001) (from 7 s on placebo to 11 s, p < 0.05) and reduced their and amplitude (from 26.5 to 20.3 mm Hg, p < 0.001). In the amplitude (from 65 mm Hg on placebo to 25 mm Hg, fasting state, the cycle length of the migrating motor p < 0.01). The effects of trospium chloride were statistically complex was significantly prolonged (from 77 to 116 min, indistinguishable from those of biperiden in all comparisons. p < 0.01), due primarily to an extended phase I (motor Lastly, trospium chloride had no effect on esophageal evoked quiescence) (from 42 to 78 min, p < 0.025). Phase III was potentials. In summary, trospium chloride impairs significantly shortened (from 7.3 to 3.8 min, p < 0.005), and esophageal motility (Pehl et al 1998). showed a slower aboral migration velocity (from 8.4 to Lastly, the effect of trospium chloride on GI motility 4.7 cm/min, p < 0.005). Clustered contractions were was evaluated in 33 healthy volunteers participating in a significantly less frequent during postprandial (from 42 to double-blind, crossover, placebo-controlled trial 14 per 24 h, p < 0.01) and fasting periods (from 11 to 4 per (gallbladder N = 11, gastric emptying N = 12, gasto- 24 h, p < 0.01). Runs of clustered contractions were esophageal reflux and orocecal transit time N = 10). The 4 abolished by the drug. In summary, trospium chloride treatments were placebo and trospium chloride 10, 15, and significantly reduced jejunal motor activity in healthy 20 mg orally at 0600, 1400, and 2200 the day prior to study volunteers (Schmidt et al 1994). and at 0600 on the day of the study. Gallbladder ejection The effects of single 0.2, 0.5, 1, and 1.5 mg IV doses of fractions were significantly reduced by 10 and 20 mg trospium chloride on gallbladder contractility were evaluated doses compared with placebo (p < 0.025 and p < 0.01, in 6 female volunteers using a double-blind, crossover respectively), while the effects of the 10 and 20 mg doses design. Trospium chloride produced a dose-dependent were not significantly different.
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