ED Secondary to Treatment for Localized Prostate Cancer

ED Secondary to Treatment for Localized Prostate Cancer

Previous Page In This ArticleAbstract and IntroductionPathophysiology of Erectile DysfunctionRadiation TherapyCryotherapyRadical ProstatectomyTreatmentConclusionsTablesReferencesRelated Links

Conclusions

Despite significant advances in the management of localized prostate cancer, ED remains a common problem. However, several therapies are available. For every patient complaining of ED after being treated for clinically localized cancer prostate there is at least one potentially efficacious therapeutic alternative. Treatment should begin with oral drugs or intraurethral drug administration. Additional options include vacuum erection devices and intracavernous injection. Combinations of oral with intraurethral and/or intracavernous injections also may be effective.

Interventions to address treatment-induced impotence should start as early as possible to minimize anxiety and depression, which are common symptoms in patients with prostate cancer. It is likely that early introduction of medical therapy, particularly intracorporal injections, has resulted in a higher incidence of spontaneous return of erections.

The ideal pharmacotherapeutic agent is not yet available. Such a drug should be able to produce recovery of the endothelial and neurogenic potential to produce nitric oxide and thus erection and should provide on demand a sustained and reproducible penile erection with minimal side effects.Reprint Address

Address reprint requests to Cláudio Telöken, MD, PhD, Department of Urology, Fund Fac Federal Ciencias Medicas, cep 90480-003, Porto Alegre, Brazil. E-mail: cteloken@hotmail.comPrevious PageSection 7 of 7 
Cancer Control.  2001;8(6):540-545.  ©2001 H. Lee Moffitt Cancer Center and Research Institute, Inc.


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Sertraline

Sertraline

from Drugs & Therapy Perspectives

Differential features: Comparison of various features of selective serotonin re-uptake inhibitors (SSRIs) which have reportedly shown efficacy in patients with post-traumatic stress disorder (PTSD)[3,16,18]

FeatureSertralineFluoxetineFluvoxamineParoxetineUsual dosage (mg/day)50-20020-60100-30020-50Evidence of efficacy2 placebo-controlled trials in civilians2 placebo-controlled trialsUncontrolled studiesUncontrolled studiesPharmacokineticsHalf-life1 dayUp to 3 daysa1 day dayWash-out time required before MAOIs can be given2 weeks>/=5 weeks1 week2 weeksElderlyMinimally affected by ageMetabolised more slowlyMinimally affected by ageMetabolised more slowlyRelative potential for drug interactionsb++++++Relative incidence of adverse events:   Nausea/vomitingc+++++   Drowsinessc++++++   Tremorc++++++   Sweating & impotence or
   ejaculation failurec+++++   Treatment withdrawalc+++++Other specific adverse events Agitation, weight loss, dermatological reactions  

a Its active metabolite norfluoxetine has a half-life of 7 to 15 days.b On the basis of in vitro data.c On the basis of prescription event monitoring data from the UK. MAOI = monoamine oxidase inhibitor; + to ++ lesser or greater incidence compared with other SSRIs.

Section 7 of 7
Drug Ther Perspect 17(16):1-5, 2001. © 2001 Adis International Limited
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Study on treatments for Chronic Obstructive Pulmonary Disease

Study on treatments for Chronic Obstructive Pulmonary Disease

from Clinical Drug Investigation [TM]

Results

Subject Disposition

A total of 456 patients entered the study and 387 of these patients completed the trial. The demographic and baseline characteristics of these patients are presented in Table I. The disposition of the study participants is summarised in Table II. The dropout rate was slightly higher in the ipratropium bromide CFC treatment group (17.9%) than in the ipratropium bromide HFA group (13.8%); this difference was not statistically significant. There were no significant differences in the use of concomitant pulmonary medications between the two treatment groups during the randomised treatment period. Inhaled ß-adrenergic agonists (predominantly salbutamol) were used by 67% and 72%, and inhaled salmeterol by 13% and 14%, of patients in the ipratropium bromide HFA and the ipratropium bromide CFC groups, respectively, during the study. A similar proportion of patients received concomitant inhaled or oral corticosteroids (inhaled: 41% both groups; oral: ipratropium bromide HFA 29%, ipratropium bromide CFC 25%). Slightly more patients in the ipratropium bromide HFA group had taken concomitant pulmonary mediations in the 6 weeks prior to the screening visit (ipratropium bromide HFA 79.6%, ipratropium bromide CFC 74.8%); however, this difference was not statistically significant.Safety

The mean duration of exposure was 332 days for the ipratropium bromide HFA group and 325 days for the ipratropium bromide CFC group; the majority of patients (73% and 66%, respectively) received treatment for 359-372 days. The percentage of patients who reported taking their study medication more than four times a day between clinic visits ranged from 7.9% to 12.1% for ipratropium bromide HFA, and from 11.9% to 17.8% for ipratropium bromide CFC. Overall, the distribution of AEs was similar for both treatment groups (Table III). As expected in this patient population, respiratory system disorders were the most common class of AEs.

AEs that were possibly drug related were reported by 30 patients (9.8%) in the ipratropium bromide HFA group and five patients (3.3%) in the ipratropium bromide CFC group. The incidence of AEs considered characteristic of the anticholinergic class assessed as possibly drug related was low: dry mouth - four patients (1.3%) in the ipratropium bromide HFA group and one patient (0.7%) in the ipratropium bromide CFC group. Four patients (1.3%) in the ipratropium bromide HFA group remarked upon the different taste of the test formulation compared with the CFC formulation received during the run-in period. Patients in the ipratropium bromide CFC group received the same formulation in the run-in period and the study period, therefore, as expected, no patients in this group remarked upon a taste change.

Similar numbers of patients in each group dis-continued treatment due to AEs; 22 patients (7.2%) in the ipratropium bromide HFA group and 11 (7.3%) in the ipratropium bromide CFC group. The most common AEs leading to patient discontinuation were respiratory disorders, which led to dis-continuation of six patients (2.0%) in the ipratropium bromide HFA group and five patients (3.3%) in the ipratropium bromide CFC group.

The incidence of serious adverse events (SAEs) was similar in both treatment groups. The most common SAEs were COPD exacerbation (ipratropium bromide HFA 15 patients [4.9%], ipratropium bromide CFC 13 patients [8.6%]) and pneumonia (ipratropium bromide HFA 14 patients [4.6%], ipratropium bromide CFC six patients [4.0%]). None were judged as possibly related to the study drug.

There were seven deaths (1.5%) during the course of the study: four (1.3%) in the ipratropium bromide HFA group (cause of death: lung cancer, renal failure, cardiac arrest, and metastatic adeno-carcinoma with worsening renal function) and three (2.0%) in the ipratropium bromide CFC group (cause of death: intra-abdominal catastrophe, squamous cell carcinoma, and COPD exacerbation with respiratory failure). None of the seven deaths were considered to be related to the study drug.

Comparison of the incidence of AEs during the 2-week run in with the 2 weeks immediately after randomisation revealed that the incidence of all AEs was higher in both groups (ipratropium bromide HFA 72 [23.6%], ipratropium bromide CFC 30 [19.9%]) compared with the run-in period (70 patients [15.4%]). A slightly higher incidence of AEs was recorded in the ipratropium bromide HFA group than in the ipratropium bromide CFC group. However, no individual AEs were reported to occur significantly more frequently in the ipratropium bromide HFA group.

There were no clinically significant differences in vital signs, laboratory findings or ECGs between the treatment groups.Efficacy

Bronchodilator Response. Over the course of the study, mean FEV1 baselines on test days ranged from 0.95L to 0.97L in the ipratropium bromide HFA group, and 1.01L to 1.06L in the ipratropium bromide CFC group. Within each treatment group, baseline FEV1 was generally consistent over time. On each of the four pulmonary function test days, the majority of patients in both treatment groups had clinically significant bronchodilator responses as shown by increases in FEV1 volume from test day baseline (Table IV). There were no statistically significant differences in peak response between the two treatment groups (figure 1).

Figure 1. (click image to zoom) Adjusted mean forced expiratory volume in 1 second (FEV1) change from baseline at visits 1, 3, 5 and 7. Visit 1 responses are to a single test dose of medication; visits 3, 5 and 7 responses correspond to 12, 26 and 52 weeks on treatment, respectively. Means are adjusted for centre and treatment-by-centre interaction. Test day baseline is used as a covariate. CFC = chlorofluorocarbon; HFA = hydrofluoroalkane.

FEV1 AUC0-6 results for each pulmonary function test day are presented in Table V. There were no statistically significant differences in FEV1 AUC0-6 between the two treatment groups on visits 1, 5 and 7. On visit 3, an isolated, higher mean FEV1 AUC0-6 was recorded in the CFC group. The between-treatment difference at this visit was 37mL (p = 0.03). This difference was not considered to be clinically significant. The majority of patients in each treatment group achieved a therapeutic response to ipratropium bromide treatment on each pulmonary function test day (defined as a 15% increase in FEV1 from baseline; Table IV). The median time to onset of a 15% increase in FEV1 ranged from 14.0 minutes to 21.0 minutes for ipratropium bromide HFA, and from 15.0 minutes to 27.0 minutes for ipratropium bromide CFC on the four pulmonary function test days. Median time to peak response ranged from 60 minutes to 90 minutes for ipratropium bromide HFA, and was 90 minutes for ipratropium bromide CFC; these differences were not considered to be clinically significant. The duration of response was generally similar in the two treatment groups and differences on individual test days were not statistically significant.

FVC results were similar to those observed with FEV1. No clinically or statistically significant differences between the two formulations were seen on any of the test days based on FVC AUC0-6 and peak response.

Other Efficacy Variables. Physician's global evaluation scores for both treatment groups ranged from 4.9 to 5.4, representing a rating of 'good to fair', and COPD symptom scores ranged from 'not present' to 'moderate' in severity. Physicians' global evaluation and COPD symptom scores did not change over time and there were no statistically significant differences between the two treatment groups. There were no statistically significant differences in the percentage of patients who reported using their study drug more often than four times a day (range for ipratropium bromide HFA of 7.9% to 12.1%, and for ipratropium bromide CFC of 11.9% to 17.8%).

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