HRQL Scores Research Articles

Chemotherapy-induced dermatological toxicity: frequencies and impact on quality of life in women’s cancers. Results of a prospective study

The study aimed to determine the prevalence of dermatological side effects and its impact on quality of life in patients receiving systemic chemotherapy for women's cancers. A prospective study was conducted on patients with histologically confirmed advanced women's cancers who were deemed candidates for adjuvant or palliative chemotherapy. Patients were systemically examined for skin, hair, and nail side effects. The impact of those side effects on their quality of life was assessed using the health-related quality of life score (HRQL). Between April 2001 and October 2001, 91 patients received 1 to 17 (median 4) courses of chemotherapy. Malignancies included breast cancer (n = 39, 43%), ovarian cancer (n = 32, 35%), cervical cancer (n = 12, 13%), endometrial cancer (n = 5, 6%), fallopian tube cancer (n = 2, 2%), and vaginal cancer (n = 1, 1%). Chemotherapy agents included taxanes (n = 42, 46%), PEG doxorubicin (n = 17, 7%), other anthracyclines (epirubicin and doxorubicin; n = 6, 19%), topotecan (n = 13, 14%), and other agents (n = 13, 14%). Overall incidence of skin, nail, and hair side effects was 86.8% (n = 79). Seventeen patients (18.7%) developed a palmo-plantar erythrodysesthesia (PPE), and nine of those (53%) were of grade 3 in common toxicity criteria scale (NCI). Twenty-one patients (23.1%) developed nail changes such as subungual hematomas, onycholysis, and leukonychias or nail loss, while 69 (75.8%) developed hair loss. There was a higher incidence of PPE in patients receiving chemotherapy for palliation rather than cure (percent over percent, p < 0.001, Fisher's exact test). Using the HRQL score, skin changes were the most frequently reported unpleasant side effect (34.1%), and of those patients who developed PPE, this was reported by n = 8 (47%) as the most unpleasant. Dermatological chemotherapy side effects are frequent after treatment of women's cancers and have a major impact on quality of life as assessed by HRQL. Counseling of patients with women's cancers and the profile of side effects of chemotherapeutic agents should be considered before considering an adjuvant or palliative chemotherapy regimen.

A new criterion by which to discriminate between patients with moderate allergic rhinitis and patients with severe allergic rhinitis based on the Allergic Rhinitis and its Impact on Asthma severity items

Allergic Rhinitis and its Impact on Asthma (ARIA) differentiates mild from moderate/severe patients on the basis of 4 severity items. The high prevalence of moderate/severe patients suggests the need to differentiate between them. To identify the categorization that maximizes discrimination between moderate and severe allergic rhinitis (AR) by using ARIA guidelines. Observational, cross-sectional study. Clinical characteristics, nasal symptoms (Total Symptom Score 4), and health-related quality of life (HRQL; Rhinoconjunctivitis Quality of Life Questionnaire and Short Form 12) were assessed. The association of severity items (sleep, daily activities/sport, work/school, and troublesome symptoms) with symptoms and HRQL was analyzed using linear regression models. ANOVA and effect sizes were used to assess differences in symptoms and HRQL among groups defined by the number of affected ARIA items. Nontreated patients (N = 141) with moderate/severe AR were studied. All severity items showed a similar independent association with symptoms and HRQL scores, and there were no interaction effects, indicating that categorization of patients into moderate and severe could be based only on the number of items affected. Effect sizes were highest between patients with 4 affected ARIA items and those with 3, 2, or 1 affected item (effect sizes greater than 0.8 in all comparisons using Rhinoconjunctivitis Quality of Life Questionnaire and Short Form 12 Physical Composite Summary, and greater than 0.5 using the Total Symptom Score 4; P < .001). Using ARIA severity items, the criterion that best discriminates AR severity is considering moderate those with 1 to 3 affected items and severe those with 4. Discrimination between patients with moderate and severe AR should help to obtain homogeneous populations for both research and clinical purposes.

Validation of a Portuguese version of a generic health quality-of-life questionnaire for children with neurological and neuropsychiatric disorders, including epilepsy

Purpose: To validate a Portuguese version of a generic HRQL instrument already used for children with epilepsy. To analyze differences of scores among children with epilepsy and co-morbidities in contrast to other neurological and neuropsychiatric diagnosis, especially Attention Deficit and Hyperactivity Disorder (ADHD). Methods: A total of 194 children (64 with epilepsy, 94 with ADHD and 38 with other neurological or neuropsychiatric diagnosis) were consecutively seen in a neuropaediatric ambulatory unit. Parents or caregivers responded to a Portuguese version of ICIS (Impact of Childhood Illness Scale). The questionnaire was analyzed for internal consistency and face validity. Clinical and socio-demographic variables were also analyzed. Results: Internal consistency, analyzed by Cronbach’s α showed good results for total and combined scores and all sections of ICIS, except for the section “impact of illness and its treatment”. The diagnostic categories differed in several ICIS sections, with the worst scores for children with epilepsy and co-morbidities. Children who only had epilepsy had a worse score on the section about treatment impact compared with children with ADHD, but better scores in relation to disease impact in development and parents/family. In the epilepsy group, HRQL scores were worst for symptomatic epilepsy, whilst seizure control and socioeconomic factors affected each section of the instrument in different ways. Conclusions: ICIS Portuguese version has good psychometric properties. It is a useful tool for analyzing HRQL in children with epilepsy and other neurodevelopmental and psychiatric disorders. Epilepsy and psychiatric co-morbidity seems to have an additive impact on a child’s HRQL. This result is clinically important since epilepsy management must include not only seizure control but also mental health support.

Quality of life as a potential predictor for morbidity and mortality in patients with metastatic hormone-refractory prostate cancer

The association between HRQL measures with outcomes in patients with metastatic hormone-refractory prostate cancer (HRPC) is unclear. Baseline and 12-week HRQL was collected using the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy - Prostate (FACT-P). Outcomes included: (1) survival; (2) time to disease progression and (3) time to bone pain. Cox proportional hazards regression models were used. The relative predictive performance of each HRQL instrument and domain was compared. Baseline HRQL scores and 12-week change scores > the median were significant predictors of all clinical outcomes but varied by domain. For example, the hazard of death for a change in FACT-P Grand Total Score > median was 49% of the hazard for a change < or = the median. Including baseline or 12-week change in HRQL resulted in improvement in prediction performance. Patients with better baseline HRQL have better predicted survival, time to disease progression and pain prognosis than those with worse HRQL. In addition, the 12-week change in HRQL appears to improve predictive accuracy for most clinical outcomes. It appears that greater deterioration in HRQL is prognostic for rapid disease progression.

Prospective evaluation of quality of life in patients with localized oesophageal cancer treated by multimodality therapy or surgery alone

Health-related quality of life (HRQL) outcomes are important in assessing new approaches to the treatment of cancer. Neoadjuvant therapy is being used increasingly before surgery in patients with localized oesophageal cancer. This prospective non-randomized study evaluated HRQL in patients treated by preoperative chemotherapy and radiation therapy followed by surgery (multimodal therapy) or by surgery alone. Data from European Organization for Research and Treatment of Cancer quality of life questionnaires QLQ-30 and QLQ-OES24 were collected prospectively. Questionnaires were completed at diagnosis, after chemoradiotherapy where applicable, and at 3, 6 and 12 months after surgery. The study included 202 consecutive patients with oesophageal cancer considered suitable for curative (R0) resection at the time of staging. Eighty-seven patients received chemotherapy combined with external-beam radiotherapy before surgery. At baseline, 75 (86 percent) of 87 patients in the multimodal group completed questionnaires, compared with 72 (62.6 percent) of 115 in the surgery-alone group. There were no significant differences in baseline global HRQL scores between groups. Preoperative chemoradiotherapy significantly reduced physical (P=0.004) and role (P=0.007) functioning before surgery, despite a significant (P=0.043) improvement in the dysphagia score. Oesophageal resection had a negative impact on global, functional and symptom HRQL scores at 3 months in both groups. Most variables had recovered by 6 months in the two groups, but at 12 months physical and role functioning remained impaired in the surgery-alone group, and social functioning and financial worries in the multimodal group. Although the multimodal regimen had a negative impact on HRQL before surgery, postoperative quality of life in patients who had multimodal therapy was similar to that in those who had surgery alone.

Evaluation of Cardio-Esophageal (CE) Junction of Asymptomatic Volunteers and Patients with Erosive and Non-Erosive Reflux Disease Using Conventional and Narrow Band Imaging Endoscopy

Background: Gastroesophageal reflux disease (GERD) can be diagnosed based on GERD HRQL score. Using light filters to increase the contrast of mucosal vasculature [Narrow band imaging (NBI)] enables a more detailed examination of the mucosa at the CE junction. Aim: We aimed to compare the CE junction of control and patients with GERD using conventional and NBI endoscopy. Methods: Patients with GERD symptoms and controls were recruited into the study. Those with GERD score of <10 were considered as controls.

Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease

Radiofrequency (RF) energy treatment is increasingly offered before invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD). Thirty-two patients undergoing the Stretta procedure were prospectively evaluated with upper endoscopy, manometry, 24-hour pH testing, SF-36 surveys, and GERD-specific questionnaires (GERD HRQL). Significant clinical improvement was observed in 91% of patients (29/32). Mean heartburn and GERD HRQL scores decreased (p = 0.001 and p = 0.003, respectively), and physical SF-36 increased (p = 0.05). At a minimum follow-up of 12 months, median esophageal acid exposure decreased (p = 0.79) and was normalized in eight patients. Median lower esophageal sphincter (LES) pressure was unchanged. Esophagitis healed in six of eight patients, but two patients with nonerosive disease developed asymptomatic grade A esophagitis during follow-up. At 12 months, 56% of patients were off proton pump inhibits. Morbidity was minimal. RF delivery to LES is safe and significantly improves symptoms and quality of life in selected GERD patients.

Safety and Efficacy of Enteryx for Treatment of GERD in Patients with GERD and Asthma: A Pilot Study

Enteryx™, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of Enteryx™ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. Bravo™ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of > 14.7. Six agreed to participate, one was excluded at the principal investigator's (PI's) discretion. All procedures were performed by the PI. Enteryx™ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of Enteryx™ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p < 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the Enteryx™ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the Enteryx™ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results. Enteryx™, a non-resorbing biocompatible polymer has been shown to facilitate the reduction or discontinuation of proton pump inhibitor (PPI) therapy in patients with chronic gastroesophageal reflux disease (GERD). There appears to be a strong association between GERD and asthma. Up to 45% of asthmatic patients experience at least one episode of symptomatic GERD per week vs. only 10% of non-asthmatic controls. In carefully selected patients with GERD and asthma, medical and surgical treatments have been shown to control GERD and in some cases improve asthma symptoms. The primary aim of this study was to evaluate the safety and efficacy of Enteryx™ in patients with GERD and asthma. Methods: 52 patients with GERD and asthma were identified in our Asthma Clinic. All patients were taking maintenance PPI therapy. Ten agreed to participate in the study. Bravo™ pH monitoring was performed in all ten. Eight had positive pH testing, defined as a DeMeester Score of > 14.7. Six agreed to participate, one was excluded at the principal investigator's (PI's) discretion. All procedures were performed by the PI. Enteryx™ was injected into the muscular layer of the esophagus under fluoroscopic guidance at or 1 cm below the z-line. 1cc minimum aliquots were placed with each injection. An average of 5.88 cc (range 3.7-7.2) of Enteryx™ was injected during each session. All patients received sedation with propofol administered by an anesthesiologist or nurse anesthetist. There were no serious adverse events associated with the procedure or the sedation. Mean procedure time was 38 minutes. Standardized health-related quality of life questionnaires (HRQL) for GERD and for asthma along with medication use were measured before implantation and at 1, 2, and 4 weeks after the procedure. Results: At week 4 a statistically significant (p < 0.05) improvement in HRQL for both GERD and asthma was demonstrated following the Enteryx™ procedures. A trend toward linear relationship between GERD and asthma HRQL was also noted. Conclusion: Based on the interim analysis of our data the Enteryx™ procedure appears to be safe and effective in carefully selected patients with GERD and asthma. A statistically significant improvement in both GERD and asthma HRQL scores was demonstrated. Moreover, a trend toward a direct relationship between the improvement in GERD HRQL and asthma HRQL scores was seen. Enrollment continues, we await the 6 and 12-month follow-up data to confirm our initial results.

Efficacy of Enteryx® in Post Fundoplication Patients

Objectives: This study was aimed to assess the efficacy of endoscopic implantation of nonresorbable biocompatible polymer (Enteryx®) in post fundoplication patients with recurrent/continued GERD. Methods: Physicians with experience using Enteryx were questioned about use in fundoplication patients. 19 GERD patients who had prior fundoplications were identified who underwent endoscopic Enteryx implantation. Most patients had refractory symptom while on high dose PPI therapy. Follow up HRQL symptoms and PPI used evaluations were performed at minimum 4 weeks later. Results: 19 patients had undergone a mean of 1.5 fundoplications/patient (range 1-3). Mean 24-hour pH total reflux time ≤4 was 27.4% pre treatment. Patients underwent a mean of 1.2 Enteryx implant sessions and received a mean of 6.9 ml Enteryx/session. All implantations were performed in standard fashion without apparent difficulty from the fundoplication wrap. Mean follow up time was 15 weeks (range 4-52). Of patients followed more than 4 weeks, 10/15 (66%) patients reduced dosage of PPI ≥ 50%. Heartburn and regurgitation HRQL scores mean were 19 and 9 before treatment on medication and were 14 and 6 post treatment at latest follow up on the same or reduced medication respectively. Overall 16/18 patients who answered the questionnaire reported “improved status.” Further treatment sessions are planned for several of these patients. Summary: Enteryx implantation is technically achievable in fundoplication patients without apparent difficulty. In this difficult to manage refractory symptom, postoperative group, partial improvement in PPI use and symptoms was seen. Conclusions: Enteryx is an available alternative therapy for treatment of GERD patients with continued symptoms after fundoplication. Longer-term follow up and prospective randomized controlled studies are awaited in this difficult patient management group.

Patient satisfaction and disease specific quality of life after uterine artery embolization

Objectives This study was undertaken to evaluate changes in fibroid specific symptom severity and health-related quality of life (HRQOL) after uterine artery embolization (UAE) and to consider the impact of these changes on satisfaction with the procedure. Study design A validated, fibroid specific, symptom, and HRQOL questionnaire was mailed to 80 women who had undergone UAE from 1998 through 2002. Pre- and postprocedure symptom severity and HRQOL scores were obtained. The primary outcome measure was change in fibroid symptoms and HRQOL after UAE. Secondary outcomes included objective measures of patient satisfaction, and the decrease in uterine volume after UAE. Results Questionnaires were completed by 64 women (80.0%) at a mean of 32.1 months from UAE (range: 57.5-6 months). After UAE, mean uterine volume decreased by 26.3% (95% CI 19.6-33.0), and 17 of 79 women (21.5%) underwent an additional procedure after a mean of 18.6 months. Symptom severity scores decreased by a mean of 35.2% (95% CI 29.3-41.1) and HRQOL scores increased by a mean of 35.7% (95% CI 28.9-42.4). Satisfaction with UAE was correlated with the change in symptom severity and HRQL scores ( P < .0001 and P = .0004, respectively) and the decrease in uterine volume after UAE ( P = .0196). Conclusion Women who undergo UAE have a significant decrease in symptom severity and increase in HRQOL, associated with high levels of satisfaction with the procedure, even when subsequent therapies are pursued.

Correlation between ankle brachial index, symptoms, and health-related quality of life in patients with peripheral vascular disease

Introduction: In the absence of quality of life measurement, other measures such as ABIs and patient symptoms provide a basis for determining the need for invasive therapy for patients with peripheral vascular disease (PVD). The accuracy of these surrogates in representing HRQL is, however, untested. The purpose of this study was to determine the correlation of these measures to HRQL. Methods: 115 PVD patients (114 male:1 female; median-age 64yrs) referred for vascular evaluation, were enrolled in an IRB-approved, prospective study. All patients completed Short Form-36 (SF-36) and Walking Impairment Questionnaire (WIQ- validated, PVD specific HRQL measure). 102 patients had measurement of ABIs and all had documented PVD symptoms. Pearsons correlation and student’s t test were used to examine univariate associations. Linear regression was used to assess the significance of the association of ABIs or symptoms in explaining the variance in HRQL scores. Results: The average ABI was 0.54 (0.00–0.98). The maximal correlation between SF-36 and ABIs was Physical Component Summary score (r = 0.29, p = 0.003). WIQ scores also exhibited modest correlation with ABIs (maximal correlation noted [r = 0.30, p = 0.002] for stair climbing). Both SF-36 and WIQ exhibited a highly significant association with symptoms: in all cases patients with surgical indications (lifestyle-limiting claudication or chronic critical limb-ischemia) had reduced HRQL scores compared with non-surgical patients (non-lifestyle-limiting claudication). Multivariate analysis suggested that in each case, SF-36 and WIQ summary scores were better predicted by symptoms than ABI’s (see table). TABLE—ABSTRACT 2Summary scoresSymptoms coefficientABI coefficientSF36 Physical Component Score−5.8: p = 0.0015.3: p = 0.13WIQ Walking Distance−9.0: p = 0.0011.6: p = 0.77WIQ Walking Speed−6.3: p = 0.0046.8: p = 0.14Conclusions: HRQL in PVD patients correlates weakly with ABIs, but exhibits a closer association with vascular symptoms. This suggests that sole reliance on ABIs may not accurately reflect the impact of PVD on HRQL, or the potential benefit of vascular surgery in improving HRQL.

Development of a measure to evaluate satisfaction with treatment in patients with GERD

This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD.Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3–4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period.At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation.The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

Endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial

Objectives This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. Methods Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score ≤ 11 on PPI and ≥ 20 off PPI, and 24-hour PH probe with ≥ 5% total time at PH ≤ 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3–4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. Results At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months ( p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months ( p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy ( p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. Conclusions The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

Reduced Quality of Life in Survivors of Acute Respiratory Distress Syndrome Compared with Critically Ill Control Patients

DAVIDSON, TIMOTHY A.; CALDWELL, ELLEN S.; CURTIS, J. RANDALL; HUDSON, LEONARD D.; STEINBERG, KENNETH P. Author Information

PATIENT-PERCEIVED HEALTH-RELATED QUALITY OF LIFE AND SURGERY FOR LOW BACK PAIN

832 Although questionnaires are available to assess the impact of the conditions and their treatment, patient-centered outcomes, such as health-related quality of life [HRQL], are used infrequently by orthopedists. The Dallas Pain Questionnaire [DPQ] is a valid and reliable instrument designed to assess the impact of low back pain [LBP] and its treatment on patient HRQL. We investigate the association between baseline HRQL scores [calculated as a percentage with 100% = worst case] for both overall DPQ and the Daily Physical Activity domain [DPA] in patients with LBP and subsequent lumbar spine surgery [SS; n=124] or no spine surgery [NSS; n=509]. We also report 12 month follow-up HRQL scores in SS [n=52] and NSS [n=177] patients. Baseline HRQL scores consistently were worse [p<0.001] in SS than NSS patients [overall DPQ=53.2 vs 42.8; DPA=65.3 vs 52.0]. The improvement after 12 months follow-up was greater in SS than NSS patients [overall DPQ p<0.05; DPA p<0.001]. However, overall 12 month overall DPQ scores were still worse [p<0.05] in SS than NSS patients [46.7 vs 41.2], although there were no differences in DPA scores. Using baseline HRQL scores, clinical, and sociodemographic variables, forward stepwise regression models predicted only approximately 14% [DPQ=13.8%; DA=13.5%] of the variance observed between SS and NSS patients. Further, neither model included the respective baseline HRQL score as a predictor variable. Information on baseline HRQL, whether overall DPQ or specific DPA scores, appears to have limited value when making decisions about surgery for patients with LBP. Supported by NIA Grant #1 R15 AGO9059-01

Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice.

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin. Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modified) and a 20-item BPH specific HRQL score including three questions of sexuality (Urolife(TM) BPH QoL 20) were self-administered at baseline, 3, 6, 12, 18, 24, 30, and 36 months. Results: Two thousand five hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (-48.4%); HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months (+43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention. Conclusion: This medical outcomes study confirms the long-term safety profile of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.