tiotropium-bromide and Urinary-Retention

Study Type--Harm (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Inhaled anticholinergic drugs have been associated with the risk of acute urinary retention (AUR), but this association was never studied under real life circumstances nor was this risk ever quantified. Use of inhaled anticholinergic drugs increases the risk of AUR by 40%. The risk of AUR is highest in recent starters, in patients with benign prostatic hyperplasia (BPH), and in patients receiving their anticholinergic drugs via nebulizer. It might be advisable to consider alternatives for inhaled anticholinergic drugs in COPD patients with BPH.. • To investigate the association between the use of inhaled anticholinergic drugs and the risk of acute urinary retention (AUR) under real-life circumstances.. • We conducted a nested case-control study within a cohort of patients with chronic obstructive pulmonary disease (COPD; as AUR has been associated with the use of inhaled anticholinergic drugs, which are used as first-line treatment for COPD) from the Integrated Primary Care Information (IPCI) database. • The cohort consisted of all patients with COPD aged ≥45 years, registered between 1996 and 2006, with ≥12 months of valid history. Cases were patients with a first diagnosis of AUR. • To each case, controls were selected matched for age, gender and index date. • Multivariate conditional logistic regression analysis was used to calculate adjusted odds ratios (OR(adj)) with 95% confidence intervals (95% CI).. • Within the cohort of 22,579 patients with COPD, 209 cases were identified. • Current use of inhaled anticholinergic drugs was associated with a 40% increase in risk for AUR (OR(adj) 1.40; 95% CI 0.99-1.98) compared with non-users. • Among current users, the risk was highest for the recent starters (OR(adj) 3.11; 95% CI 1.21-7.98). The risk of long-acting anticholinergic drug tiotropium was not substantially different from that of the short-acting anticholinergic ipratropium. • The association was not dose-dependent, but changed by mode of administration, with nebulizers having the highest risk (OR(adj) 2.92; 95% CI 1.17-7.31). • In men with COPD and benign prostatic hyperplasia (BPH) the association was strongest (OR(adj) 4.67; 95% CI 1.56-14.0).. • Current use of inhaled anticholinergic drugs increases the risk of AUR, especially in patients with BPH or if administered via a nebulizer.

Topics: Acute Disease; Administration, Inhalation; Aged; Cholinergic Antagonists; Female; Follow-Up Studies; Humans; Ipratropium; Male; Middle Aged; Nebulizers and Vaporizers; Netherlands; Prevalence; Pulmonary Disease, Chronic Obstructive; Retrospective Studies; Risk Factors; Scopolamine Derivatives; Sex Factors; Tiotropium Bromide; Urinary Retention; Urination

Inhaled anticholinergic medications (IACs) are widely used treatments for chronic obstructive pulmonary disease (COPD). The systemic anticholinergic effects of IAC therapy have not been extensively studied. This study sought to determine the risk of acute urinary retention (AUR) in seniors with COPD using IACs.. A nested case-control study of individuals with COPD aged 66 years or older was conducted from April 1, 2003, to March 31, 2009, using population-based linked databases from Ontario, Canada. A hospitalization, same-day surgery, or emergency department visit for AUR identified cases, which were matched with up to 5 controls. Exposure to IACs was determined using a comprehensive drug benefits database. Conditional logistic regression analysis was conducted to determine the association between IAC use and AUR.. Of 565,073 individuals with COPD, 9432 men and 1806 women developed AUR. Men who just initiated a regimen of IACs were at increased risk for AUR compared with nonusers (adjusted odds ratio [OR], 1.42; 95% confidence interval [CI], 1.20-1.68). In men with evidence of benign prostatic hyperplasia, the risk was increased further (OR, 1.81; 95% CI, 1.46-2.24). Men using both short- and long-acting IACs had a significantly higher risk of AUR compared with monotherapy users (OR, 1.84; 95% CI, 1.25-2.71) or nonusers (2.69; 1.93-3.76).. Use of short- and long-acting IACs is associated with an increased risk of AUR in men with COPD. Men receiving concurrent treatment with both short- and long-acting IACs and those with evidence of benign prostatic hyperplasia are at highest risk.

Topics: Acute Disease; Administration, Inhalation; Aged; Canada; Case-Control Studies; Cholinergic Antagonists; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Risk Assessment; Safety Management; Scopolamine Derivatives; Tiotropium Bromide; Urinary Retention

Topics: Acute Disease; Administration, Inhalation; Aged; Case-Control Studies; Cholinergic Antagonists; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Reference Values; Risk Assessment; Safety Management; Scopolamine Derivatives; Tiotropium Bromide; Urinary Retention

Topics: Bronchodilator Agents; Cardiovascular Diseases; Cause of Death; Cholinergic Antagonists; Drug Therapy, Combination; Humans; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Scopolamine Derivatives; Tiotropium Bromide; Urinary Retention

Tiotropium is widely used for the treatment of chronic obstructive pulmonary disease (COPD), but it is not usually prescribed for patients with micturition disorder, such as benign prostatic hyperplasia (BPH), because of the potential to increase the risk of acute urinary retention through its anticholinergic effects. However, no data are available to prove a true causal relationship between tiotropium and lower urinary tract dysfunction (LUTD) using quantitative symptomatic scoring or objective parameters evaluated by uroflowmetry.. To clarify the effect of tiotropium on lower urinary tract functions in COPD patients with BPH.. This prospective pilot study comprised 25 male COPD patients with BPH as defined by the International Prostate Symptom Score (IPSS), the quality of life (QOL) index, maximum flow rate (Q-max) in uroflowmetry, and prostate volume. Patients were given tiotropium once a day for 3 months. At baseline and after treatment, lower urinary tract functions were assessed symptomatically by the IPSS and the QOL index, and objectively by urinary parameters, including Q-max, average flow rate (Q-ave), postvoid residual urine volume (PVR), and bladder voiding efficiency (BVE).. Acute urinary retention was not observed in any patients. Subjectively, no significant difference was found in the IPSS or the QOL index between baseline and after tiotropium treatment. Additionally, tiotropium treatment did not change Q-max, Q-ave, time to Q-max, or overall flow time compared to baseline (Q-max (mL/s), 9.66+/-3.63, 9.11+/-3.68 and 10.51+/-3.88, P=0.15; Q-ave (mL/s), 4.20+/-1.76, 4.14+/-1.55, and 4.71+/-1.81, P=0.31; time to Q-max (s), 12.1+/-8.0, 16.2+/-11.4, and 13.0+/-11.3, P=0.10; flow time (s), 39.4+/-19.6, 40.4+/-20.1, and 38.3+/-19.1; baseline, 1 month after treatment and 3 months after treatment, respectively). No significant increase was found in PVR or BVE (PVR (mL), 57.9+/-51.2, 55.4+/-47.2 and 66.1+/-52.7, P=0.36; BVE (%), 75.8+/-18.4, 73.3+/-19.1 and 73.9+/-17.3, P=0.67; baseline, 1 month after treatment, and 3 months after treatment, respectively).. In our preliminary study, tiotropium did not adversely affect lower urinary tract functions in COPD patients with BPH, suggesting the possibility that tiotropium can be safely given to those patients. This warrants future studies in a larger series of COPD patients to validate our observations.

Topics: Administration, Inhalation; Aged; Cholinergic Antagonists; Humans; Male; Pilot Projects; Prospective Studies; Prostatic Hyperplasia; Pulmonary Disease, Chronic Obstructive; Quality of Life; Scopolamine Derivatives; Tiotropium Bromide; Urinary Retention; Urinary Tract; Urodynamics