Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: This study's aim was to describe and evaluate outcomes of medical strategies used for lower urinary tract symptoms (LUTS) treatment in general practice and to assess impact of LUTS on patients' general health-related quality of life (HRQoL). METHODS: This cross-sectional observational study was conducted by French general practitioners. Eligible patients were males aged ≥50 years, diagnosed for at least one year and currently treated for LUTS due to benign prostatic hyperplasia (BPH). Several validated questionnaires were documented by patients to assess severity of LUTS (IPSS), specific quality of life (IPSS-Q8), impact of LUTS (BII), LUTS evolution (VNS) and general HRQoL (EQ-5D). RESULTS: Among 1,098 patients included, 82.7% were treated with monotherapies and 17.3% with combinations. Mean treatment duration was 5.2 ± 3.2 years, and 47.2% of patients had at least one treatment modification since initiation. Patients reported diminished quality of life (IPSS-Q8 ≥3) (42.3%), persisting symptoms (IPSS-score ≥12) (35.5%), symptoms worsening (VNS-score ≤-1) (18.8%) and high bother (BII-score ≥9) (2.6%). Globally, 52.8% had at least one of these unsatisfactory outcomes. Regarding general HRQoL, mean EQ-5D utility significantly decreased with LUTS severity (mild: 0.90 ± 0.12; moderate: 0.81 ± 0.21; and severe symptoms: 0.73 ± 0.25; P < 0.001). As well, all five-dimensions of EQ-5D were significantly altered in patients with moderate-to-severe LUTS (<0.001), especially 'Pain/Discomfort' and 'Anxiety/Depression'. In multivariate analyses including age and comorbidities, EQ-5D utility index remained negatively associated with each additional unit in the IPSS-score. CONCLUSIONS: This study shows that around half of BPH patients medically treated report unsatisfactory outcomes, suggesting consequential unmet medical needs in general practice. Also, moderate-to-severe LUTS significantly impact on general HRQoL.

[Factors determining treatment strategies for patients with benign prostatic hyperplasia. The DUO study]. / Facteurs déterminant le choix thérapeutique des urologues pour la prise en charge des patients ayant une hypertrophie bénigne de la prostate. L'étude DUO.

OBJECTIVES: The DUO study sought to identify the factors determining diagnostic and treatment strategies for benign prostatic hyperplasia (BPH) in daily practice. METHODS: Observational study conducted in France (from June 2004 through March 2005) among a representative sample of French urologists. RESULTS: Two hundred two urologists included 1027 BPH patients (mean age: 68 years +/-9), 856 of whom were seen again six months later. The mean International Prostatic Symptom Score (IPSS) was 14.9 (+/-6.7) at inclusion and 10.5 (+/-6.7) at the follow-up visit. At inclusion, pharmacologic treatment was prescribed to 84% of patients, surgery was recommended to 13% and no treatment to 3%. Factors favoring surgery (versus drugs) were BPH severity (OR=2.5 for IPSS>or=20), patient choice (OR=2.5), expected quality of life improvement (OR=2.2), post-void residual (OR=2.1) and dribbling (OR=1.6). This choice was not associated with patient age, prostatic volume or active sex life. Choice of a 5alpha reductase inhibitor (versus alpha-blocker) was associated with large prostatic volume (OR=7.6), PSA results (OR=5.8), and patient age (OR=5.5 for >or=74 years, OR=2.1 for >or=68 years). Prescription of a combination of alpha-blocker plus 5alpha-reductase inhibitor (versus alpha-blocker alone) was associated with severity of BPH (OR=7.9), prostatic volume (OR=7.8), prevention of complications (OR=3.1), patient age (OR=3.0 if >or=74 years) and post-void residual (OR=2.3). DISCUSSION: Both medical and surgical treatment of BPH resulted in improved IPSS scores at 6 months. Patient age and prostatic volume are reasons urologists prescribe 5alpha reductase inhibitors, but they do not affect the decision about surgical treatment. Surgery is performed in severe BPH or when patients choose surgery in the expectation of improving their quality of life. The factors determining treatment strategies identified in this study are patient age, BPH severity, prostatic volume, patients' wishes, PSA results and post-void residual.

Improvement in quality of life after initiation of lamotrigine therapy in patients with epilepsy in a naturalistic treatment setting.

Quality of life is impaired in patients with epilepsy and can be improved by effective therapy. Randomised clinical trials have shown that lamotrigine treatment is associated with improved quality of life. However, little information is available on quality of life or treatment effects in patients with epilepsy in the general population. The objective of this study was to estimate the impact of lamotrigine on quality of life in a naturalistic treatment setting. The study included adult patients with epilepsy in whom lamotrigine therapy was initiated. Each subject completed the Quality of Life in Epilepsy Inventory (QOLIE)-31 quality of life questionnaire at inclusion and at a follow-up visit in the next 4 months. Demographic information and medical history were provided by the investigator. These were evaluated as potential determinants of change in quality of life using logistic regression. Three hundred and forty-one patients were evaluated, 192 starting lamotrigine in combination with another drug, 90 as a first-line monotherapy, 45 as a switch from another drug and 14 as a reduction to monotherapy from a previous combination. Baseline scores on the QOLIE-31 ranged from 53.8 in the combination group to 69.5 in the first-line group. 34.6% of patients were considered to be responders, with no significant differences between treatment regimen. Most improvement was seen for the energy-fatigue and medication effects subscales and, for the first-line group, seizure worry. Seizure type was the only determinant of improvement of quality of life identified. In conclusion, lamotrigine treatment is associated with improved quality of life, regardless of treatment regimen.

Longitudinal assessment of histology surrogate markers (FibroTest-ActiTest) during lamivudine therapy in patients with chronic hepatitis B infection.

OBJECTIVES: The noninvasive serum markers, FibroTest-ActiTest (FT-AT), are an alternative to liver biopsy in patients with chronic hepatitis C and B. The aim was to use these markers in a prospective study of patients treated with lamivudine in order to assess the impact of treatment, as well as the factors associated with fibrosis progression. METHODS: Two hundred and ninety-eight patients were included in a prospective longitudinal study in 50 hospitals across France. FT-AT were measured at baseline, and then after 6, 12, and 24 months of lamivudine 100-mg treatment. Epidemiological, clinical, and virologic characteristics were analyzed by univariate and multivariate analysis. RESULTS: Two hundred and eighty-three patients were included for analysis. The accuracy of FT-AT versus biopsy was validated with the area under the ROC curve, 0.77 (SE = 0.03) for bridging fibrosis and 0.75 (SE = 0.06) for severe activity (A3). At baseline, bridging fibrosis (METAVIR stages F2-F3-F4) was highly associated (p < 0.001) in multivariate analysis with male gender and age and marginally associated with anti-HBe presence (p= 0.05) and non-Asian ethnic origin (p= 0.046). Lamivudine treatment had a very significant impact overall. FT decreased significantly from 0.51 at baseline to 0.37 at 24 months (p < 0.001), and 85% of patients had improvement at 24 months. AT also decreased significantly from 0.56 to 0.13 (p < 0.0001), and 91% of patients had improvement at 24 months. A three-phase kinetics was observed for both fibrosis and activity; there was a marked improvement during the first 6 months, followed by a plateau between 6 and 12 months, and another improvement between 12 and 24 months. The occurrence of a YMDD variant does not entirely explain these three-phase variations. The first phase impact on fibrosis rates was higher in Asian patients (p= 0.01) and in patients younger than 40 yr (p < 0.001). CONCLUSIONS: In patients with chronic hepatitis B, a 24-month course of lamivudine treatment leads to a significant decrease in necroinflammatory grades and fibrosis stages as assessed by noninvasive markers, with the occurrence of a three-phase kinetics. FT-AT should be useful in the noninvasive follow-up of lamivudine treatment.

Prevalence of irritable bowel syndrome in the French population according to the Rome I criteria.

BACKGROUND: Irritable bowel syndrome (IBS) is a common functional gastro-intestinal disease. In the absence of specific markers, definition and hence diagnosis depend on clinical presentation. Of the various attempts to set criteria for IBS, the most recent are Rome I and Rome II classifications. AIMS: To estimate in a general population the prevalence of IBS using the modified Rome I criteria, and to investigate socio-demographic criteria, symptoms and management. METHODS: A total of 11,131 people aged 18 years and over, representative of the French population, were surveyed. A diagnostic questionnaire based on the modified Rome I criteria was used to identify IBS sufferers, who were then questioned further about the symptoms and medical management of their IBS. RESULTS: Of the 5,299 men and 5,832 women interviewed, 445 had IBS according to the Rome I criteria, a prevalence of 4% (95% CI: 3.6%-4.4%). IBS was more frequent in women (5.3%) than in men (2.5%), with a sex ratio (F/M) of 2.3. In 9.1% of sufferers, onset had occurred less than 12 months ago, a yearly incidence of 3.6 per 1,000 of the population. In 32.3% of IBS sufferers diarrhoea was predominant, and in 34.6% constipation was predominant. Of IBS sufferers 83.7% had consulted a physician for their condition, and 87.6% had taken medication for their IBS symptoms over the previous 12 months. CONCLUSION: The prevalence of IBS observed in this study in France was close to the lower limit in published data (3 to 20%). Our results suggest that the Rome I criteria are not sensitive enough to detect all IBS patients in a population not actively seeking health care intervention for the condition. In this regard, the refined classification (Rome II) which was established after our study was carried-out should be evaluated.