Open Multicenter Study Research Articles

Long-term effects of St. John's wort (Hypericum perforatum) treatment: A 1-year safety study in mild to moderate depression

Long-term safety and the effects of a St. John's wort (SJW) extract Ze 117 (Hypericum perforatum) were evaluated in the treatment of patients with depression. An open multicentre safety study with 440 out-patients suffering from mild to moderate depression according to ICD-10 was conducted. Patients were treated for up to 1 year with 500 mg St. John's wort extract per day (Ze 117). Evaluation criteria were safety (adverse event frequency) and influence on depression (HAM-D, CGI). Two hundred and seventeen (49%) patients reported 504 adverse events, 30 (6%) of which were possibly or probably related to the treatment. Gastrointestinal and skin complaints were the most common events associated with treatment. No age-related difference in the safety of the applied medication was found. The long-term intake of up to 1 year of the study medication did not result in any changes in clinical chemistry and electrocardiogram recordings. Body mass index (BMI) did not change either. Mean HAM-D scores decreased steadily from 20.58 at baseline to 12.07 at week 26 and to 11.18 at week 52. Mean CGI scores decreased from 3.99 to 2.20 at week 26 and 2.19 at week 52. Therefore, St. John's wort extract ZE 117 is a safe and effective way to treat mild to moderate depression over long periods of time, and therefore seems especially suitable for a relapse prevention.

Intérêt d’une nouvelle préparation infantile dans la prise en charge des régurgitations du nourrisson

The purpose of this open multicenter study was to evaluate the value of a new starch-thickened formula in infants with regurgitations in ambulatory pediatric practice. The study population comprised full-term infants with an age at inclusion of 1-90 days, who were bottle-fed and presented regurgitations. The formula tested was an infant formula-thickened with starch (2g/100mL). The primary endpoint was the frequency of bottles regurgitated, expressed in percentage of meals per day after 15 days of feeding with the preparation studied. Secondary endpoints were the assessment of regurgitations using the Vandenplas' score, as well as the daily increase in weight, height, and cranial circumference, overall and gastrointestinal tolerance, and formula acceptability. Sixty-four infants presenting regurgitation were included. The frequency of bottles regurgitated estimated at 80.3% at inclusion significantly decreased at D3, D15, and D30 to 40.1, 40.2 and 37.2% (P<0.0001), respectively. Thirty percent of infants did not present regurgitations at all at D30. Similarly, a significant decrease in the Vandenplas' score was observed from 1.9 at D0 to 0.9 at D30 (P<0.0001). Infant growth was similar to the French and European growth curves. The results showed rapid and lasting improvement in decreasing the frequency of feeding-bottles regurgitated by 50% from the first 3 days of using this new starch-thickened formula (2g/100mL). These satisfying results encourage the use of the tested formula in cases of infant regurgitation, in line with the European Society of Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommendations.

Interest of the association retinaldehyde/glycolic acid in adult acne

Topical retinoids have been successfully used in the treatment of acne vulgaris but may induce irritation when used twice daily. The association of retinaldehyde (RAL) with glycolic acid (GA) have complementary activities, which could be of interest for adult women with acne because of a better tolerance/efficacy ratio. The aim of this study was to evaluate the tolerance and the efficiency of RAL (0.1%)/GA (6%) in adult women with acne when used alone or in combination with their usual acne products except retinoids. Three hundred ninety-seven women with acne (aged between 30 and 40 years old) were included in this open multicentric study. They had to apply cream containing RAL/GA for 90 days without stopping their previous acne treatment (except topical retinoids). The tolerance was the main criteria and the second one is the efficacy, which was assessed by counting inflammatory and retentional lesions after 30 and 90 days of treatment. Used alone or in association with other anti-acne treatments, RAL/GA was considered to be highly tolerated. A significant decrease in both inflammatory and retentional lesions between day 0 and day 90 indicates that RAL/GA can be used as monotherapy for mild acne or could potentate the efficiency of other anti-acne products used at the same time by patients suffering from moderate acne. Complaints about side-effects were rare. The subjective evaluation of the preparation's efficacy by investigators and patients was strongly favourable. These data show that a combination of RAL 0.1% and GA 6% may be used in association with other topical anti-acne treatments with an excellent tolerance.

Ferrum Picricum: A Multicentric Clinical Verification Study conducted by CCRHFNx01

Ferrum picricum is mentioned in the homoeopathic literature for diseases/complaints like anaemia, malaria fever, impaired hearing, vertigo, epistaxis, tinnitus, loss of voice, indigestion, headache, tired feeling, sexual excesses, loss of blood, constipation, prostate enlargement, warts and corns2. These indications needs clarification. An open multicentric clinical study at various Institutes / Units under Central Council for Research in Homoeopathy was conducted to confirm the use of Ferrum picricum as mentioned in homoeopathic materia medica and to add to its drug picture. For this 3,465 patients were enrolled in the study. The study not only confirms the therapeutic use of the drug in headache, vertigo, epistaxis, tinnitus aurium, loss of voice, constipation, enlargement of prostate, cough, corns, warts and debility, as mentioned in the homoeopathic literature, but also delineates the characteristics which could help in differentiating Ferrum picricum from other similar remedies. Beside, a set of new symptoms also emerged as clinical symptoms increasing the scope of use of this medicine in clinical practice and suggest a comprehensive proving to get full picture of the drug.

EDUC’AVK: Reduction of Oral Anticoagulant-related Adverse Events After Patient Education: A Prospective Multicenter Open Randomized Study

Long-term oral anticoagulation treatment is associated with potential morbidity. Insufficient patient education is linked to poorly controlled anticoagulation. However the impact of a specific educational program on anticoagulation related morbidity remains unknown. To evaluate the effect of an oral anticoagulation patient education program in reducing both hemorrhagic and recurrent thrombotic complications. We conducted a prospective, multicenter open randomized study, comparing an interventional group who received a specific oral anticoagulation treatment educational program with a control group. Eligible patients were older than 18 and diagnosed as having deep vein thrombosis or pulmonary embolism requiring therapy with a vitamin K antagonist for 3 months or more. Our primary outcome was the occurrence of hemorrhagic or thromboembolic events. During the 3-month follow-up the main outcome criteria were observed 20 times (6.6% of patients), 5 (3.1%) in the experimental and 15 (10.6%) in the control group. Consequently, in multivariate analysis, the cumulative risk reduction in the experimental group was statistically significant (OR 0.25, 95% CI 0.1-0.7, p < 0.01). Patient education using an educational program reduced VKA-related adverse event rates.

Strontium ranelate in the treatment of postmenopausal osteoporosis: results of administration in clinical practice

Система комплексной поддержки и сопровождения научного журнала Elpub позволяет запустить двуязычный сайт журнала со встроенной системой электронной редакции в соответствии с лучшими издательскими практиками, а так же предусматривает техническую и методическую поддержку со стороны специалистов НЭИКОН.

Nutriologische Maßnahmen bei Stress- und Säure-Basen- assoziierten Beschwerden

In der offenen, multizentrischen Anwendungsbeobachtung wurden der körperliche und der mentale Gesundheitszustand von 259 Probanden erhoben. Es wurde labordiagnostisch der mittlere Aziditätsquotient bestimmt, um die basischen Pufferreserven zu erfassen. Bei der Anamnese wurden Fragen zu Stress- und Säure-Basen-assoziierten Beschwerdebildern und zur gesundheitsbezogenen Lebensqualität gestellt. Nach der Eingangskontrolle erhielten die Studienteilnehmer über einen Zeitraum von vier Monaten ein komplexes nutriologisches, den Säure-Basen-Haushalt unterstützendes Prüfpräparat.

Treatment of heterogeneous forms of cervical dystonia with botulinum toxin A (500 U dysport ®)—First aspects of a multicentre open study

Although Dysport ® (botulinum toxin type A) has been used as a first-line therapy for cervical dystonia (CD) for many years, there are only few studies available on dose, efficacy and safety in the treatment of heterogeneous forms of CD. The aim of this study was to analyse effectiveness and safety in the treatment of the most frequent forms of CD, rotational torticollis and predominantly laterocollis with a standard initial dose of 500 U Dysport ® in a large representative group of patients as presented in typical dystonia clinics. Between November 2004 and January 2008, 514 de novo patients with CD were recruited by 81 study sites in Germany and Austria. Muscle selection for injection was based on clinical assessment taking into account direction of head deviation and occurrence of the additional components shoulder elevation and/or tremor, evaluated using the Tsui rating scale. These ratings permitted the desired individual treatment of the muscles affected and at the same time provided a structure of twelve CD subgroups for intra-individual first treatment. Results of a data monitoring analysis on the baseline values of different study criteria of the first 200 patients will be presented, showing the demographic characteristics, the proportions of the different subgroups and the mean Tsui score across these subgroups. This study with a large patient population will provide valuable insights for optimal initial treatment of heterogeneous forms of CD.

Major dispersion in etoposide systemic exposure in malignant lymphoma patients receiving BEAM high dose chemotherapy followed by ABMT: A multicentre study of the Groupe d’Etudes des Lymphomes de l’Adulte (GELA)

8537 Background: To analyze the pharmacokinetic (PK) parameters of etoposide in patients with malignant lymphomas receiving high dose chemotherapy (BEAM: carmustine, cytarabine, etoposide and melphalan) followed by ABMT. Methods: 91 patients were included in this open multicentre prospective study at first treatment line or at relapse. BEAM comprised etoposide 100 mg/m² twice daily for 4 days. We used a limited blood sampling strategy, allowing to estimate the patients’ PK parameters with acceptable precision. Individual etoposide concentrations versus time curves as well as individual etoposide clearance (etoCL) and Area Under the Curve (etoAUC) were modelized using the NONMEM program. The distribution of total etoAUC (over the 4-day treatment) was investigated according to population quartiles. Results: The inter-individual variability in etoCL was 26.3% (95% CI=20.6–30.9%). The median etoAUC was 906.5 mg/L.h for all patients (range: 547.5–2,271.6 mg/L.h) and was not influenced by treatment line. The total etoAUC upper bounds of 1st, 2nd and 3rd quartiles were 737.5, 906.5 and 1,096.2 mg/L.h respectively. No correlations were observed between body surface area and etoCL. Conclusions: Although all patients received the same etoposide dose calculated using body surface area, we observed a major inter-individual variability in AUC. Some patients had a more than 4 fold higher systemic exposure than other patients, which may have important consequences on treatment tolerance and efficacy. Data on clinical consequences of PK variability will be presented. Distribution of total etoAUC All patients 1st quartile (Q1) 2nd quartile(Q2) 3rd quartile(Q3) 4th quartile(Q4) Number of patients 91 23 23 22 23 Total etoAUC range [547,5–2271,6] [547.5–737.5] [737.5–906.5] [906.5–1096.2] [1096.2–2271.6] Ratio: Q25 etoAUC/Q75 etoAUC=0.67 No significant financial relationships to disclose.

The VenaTech LP Permanent Caval Filter: Effectiveness and Safety in the Prevention of Pulmonary Embolism—A European Multicenter Study

To evaluate (i) the appropriateness, safety, and patient outcomes after placement of the VenaTech LP caval filter and (ii) the success of filter insertion through various venous access routes. An open multicenter prospective observational study was conducted in 12 European centers, including an initial part limited to four centers. Patients with common indications were eligible for inclusion after approval by an independent ethics committee. Over a 42-month period, 106 patients (46 men [43.4%], 60 women [56.6%]), 72.2 years +/- 13.3 of age (range, 37-97 y), with poor prognoses were included. Patients were examined 2-5 days after the procedure, then at 30 days +/- 5 and 90 days +/- 15 for clinical follow-up and filter assessment. Evaluation criteria were based on occurrence of pulmonary embolism (PE), adverse events, death, filter position, and caval patency. Data were available in 101 case report forms at days 2-5, in 75 at day 30 +/- 5, and in 60 at day 90 +/- 15. Two patients (1.9%) were lost to follow-up. The overall mortality rate was 20.8%. PE was present in 71 patients (67.0%). History of venous thromboembolic disease (VTED) was noted in 32 patients (30.2%), and recently diagnosed VTED was present in 101 patients (95.3%). Partial caval thrombosis was present before the procedure. Filter tilting of 10-45 degrees was seen in 3.9% of cases at days 2-5, 4.3% of cases at day 30 +/- 5, and 1.9% of cases at day 90 +/- 15. Follow-up evidenced neither clinical signs of PE nor significant device-related events. In a prospective patient cohort with a projected 3-month mortality rate of nearly 21.0% as a result of severe prognoses, the success of insertion via various venous access routes and the appropriateness and safety of the VenaTech LP caval filter were assessed. Findings at 90-day follow-up were free of symptomatic PE and device-related adverse effects.

Tolérance de l’association de sucralfate / sels de Cu-Zn dans les radiodermites

The aim of this study was to evaluate the tolerance of topical application of the combination sucralfate / copper zinc salts in radiation dermatitis in women suffering from breast cancer and treated by radiotherapy. 47 patients (average age : 57,5 years) that have to be treated by radiation therapy on non lesional areas, were included into this open multicentric study. They had to apply Cicalfate cream twice a day, from the fi rst radiation therapy session and during 10 weeks. Patients were treated by photon- or electrontherapy (72 % et 28 %, respectively; cumulated total dose : 58,6Gy). Tolerance was considered to be excellent. The radiation dermatitis (score NCIC ≥ 2) was noted at the 3rd week of radiotherapy only in 5 % of the subjects and in 53 % of the subjects, the last week of treatment. Pruritus was significantly increased at D21. Pain and discomfort were increased at D28, but remained low intensity. The soothing effect of the combination of sucralfate/ copper zinc salts were considered satisfying or very satisfying by investigators and patients during the study, varying from 94 to 100 % of satisfaction. The impact of radiation therapy on the patients’quality of life, assessed by DLQI, evaluated at the end of the study was not statistically different from the score calculated at D7 (DLQI=0,8 et D7 versus DLQI=1 at D70). Thus, topical application of the combination sucralfate / copper zinc salts can be used in the indication radiation dermatitis.

Preliminary results of the Prostacox phase II trial in hormonal refractory prostate cancer

To assess in a phase II open multicentre study the efficacy and tolerance of docetaxel administered every 14 days combined with celecoxib, in patients with hormone-refractory prostate cancer (HRPC), and to test the hypothesis that this therapeutic combination would improve overall survival. In all, 48 patients were included with a mean age of 70.4 years and Gleason score of 7.5, all had a satisfactory Karnofsky performance-status score of 92% and a metastatic bone site was measurable in 77%. The mean delay between initial diagnosis and docetaxel administration was 45 months, with a median PSA level increase of 54.8 ng/mL. The therapeutic schedule was: docetaxel (50 mg/m(2)) administered every 14 days (one cycle of two injections at 2 week intervals (Day 1 = Day 28) with a total of six cycles) and simultaneously a daily oral fixed dose of celecoxib (800 mg). In all, 237 cycles of docetaxel were administered with a dose reduction in 23 patients at the beginning of a cycle (day 1) and 36 in the middle of a cycle (day 14). The haematological toxicity included anaemia grade 1-2 (78%) and only 10% neutropenia grade 3-4. However, there was only a 15% improvement of pain intensity. The response rate for the total PSA level was 45.5 (30.4-61.1)%, the mean time to progression was 9.3 months and the tumour-response rate was 26.3%. In all, 75% of patients had an overall survival of >14.6 months. Our results confirm the usefulness of docetaxel for HRPC treatment and show a significant reduction of haematological toxicity with bi-weekly docetaxel administration combined with celecoxib.

Results of a Multicenter Open Study of Photodynamic Therapy (Photofrin) in 49 Patients with Cholangiocarcinoma

Results of a Multicenter Open Study of Photodynamic Therapy (Photofrin) in 49 Patients with Cholangiocarcinoma

P788 Efficacy and safety of Uro-vaxom treatment for patients with recurrent cystitis: open multicentre study

P788 Efficacy and safety of Uro-vaxom treatment for patients with recurrent cystitis: open multicentre study

Distale Radiusfrakturen - Ätiologie, Behandlungsmethoden und Ergebnisse

Distal radius fractures were investigated in a retrospective open multicenter cohort study to assess aetiology, fracture pattern and treatment modalities and their influence on subjective and objective outcome. Demographic data, fracture history, course of fracture healing, functional and radiological parameters and the DASH-questionnaire were collected from 18 Austrian hospitals and analysed statistically. n = 707, 465 (65.8 %) female, 242 (34.2 %) male. Mean age: 52 (19 - 86) years; age group 1 (19 - 39 years) 26 %, age group 2 (40 - 59 years) 41 %, age group 3 (60 years and elder) 33 %. mean 5.8 (3.9 - 17) years; fall 65.1 %, sports 17.4 %, traffic accidents 8.9 %, fall from great height 7.5 %; others 1.1 %. Most frequent fracture patterns according to AO: A2 (26.6 %), C2 (22.2 %), A3 (16.1 %), C1 (12.7 %); according to PE: I-2 (44.8 %), I-1 (40.0 %), III-2 (4.4 %), II-2B (4 %). There was no significant correlation between fracture pattern and age groups for both fracture classifications. 57.9 % surgical, 42.1 % conservative. Radiological results: Depending on treatment, there were significant differences between the radial tilt and the palmar radial inclination, the dorsal and palmar ulnar variance and the width of the DRU-joint. DASH-questionnaire: Median 6.03 (90 - 0). There was a significant, minor positive correlation of bad results in the elderly and a minor positive correlation of bad results correlated to the palmar radial inclination as well as a minor negative correlation to the palmar DRUJ-value and the ulnar variance. The incidence of distal radius fractures was increased in females and in patients with the age between 40 - 59 years. The most frequent cause to sustain a distal radius fracture was a simple fall. 85 % of the fractures were dislocated dorsally. The most frequent fracture type was the dorsal intraarticular. There was no specific fracture type observed to be typical for one of the age groups and surgical treatment was almost as frequent as conservative. Surgical treatment improved reconstruction of the radial tilt, palmar inclination and the DRU-joint. Subjective outcome was worse in elderly patients. The radiological changes in the DRU-joint correlated to minor DASH values.

Efficacy and Safety of Uro-Vaxom Treatment for Patients with Recurrent Cystitis: An Open Multicenter Study

From the Daniel Urology Clinic, Department of Urology, College of Medicine, 1 The Catholic University of Korea, Seoul, 2 Hanyang University, Seoul, 3 Kyungpook National University, Daegu, 4 Kyung Hee University, Seoul, 5 Soonchunhyang University, Bucheon, 6 Chosun University, Gwangju, 7 Korea University, 8 Ewha Womans University, Seoul, 9 Chonbuk National University, Jeonju, 10 Yonsei University, Seoul, 11 Inje University, 12 Pusan National University, Busan, Korea

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

To confirm the usefulness of a combination therapy of interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) against metastatic renal cell carcinoma, the recommended dose of IFN-alpha to use in combination with low-dose IL-2 was determined (phase 1). Efficacy and safety at this dose was evaluated (phase 2). In phase 1, the dose of IL-2 was fixed at 0.7 x 10(6) Japan reference unit (JRU)/person for 5 days a week. The dose of IFN-alpha was increased from 3 x 10(6) IU for 3 days a week (level I) to 6 x 10(6) IU for 3 days a week (level II) and to 6 x 10(6) IU for 5 days a week (level III). In phase 1, 10 patients were registered, with 9 (3 at each level) able to be evaluated. Because grade 3 and grade 4 neutropenia were observed at level III in 1 patient each, level II was found to be the recommended regimen. The response rate in phase 1 was 44.4% (4/9). In phase 2, 46 patients were registered, with a response rate in 37 patients, classified as per protocol set (PPS), of 21.6% (8/37). Toxicities observed were primarily flu-like symptoms due to cytokines, and gastrointestinal symptoms. Leukocyte abnormalities were observed, but they were milder and tolerable. In the 46 patients evaluated in phase 1 and phase 2, the response rate was 26.1% (12/46), being highest in 38.7% (12/31) of those who were nephrectomized, and with only lung metastases.

Levels of Vancomycin in Cerebrospinal Fluid of Adult Patients Receiving Adjunctive Corticosteroids to Treat Pneumococcal Meningitis: A Prospective Multicenter Observational Study

Evidence from a recent randomized controlled trial suggests that dexamethasone as adjunct therapy in adult pneumococcal meningitis reduces mortality and neurological sequelae. However, adding dexamethasone has the potential to reduce penetration of vancomycin into the cerebrospinal fluid (CSF). We sought to determine concentrations of vancomycin in serum and CSF of patients with suspected or proven pneumococcal meningitis receiving dexamethasone to assess the penetration of vancomycin into the CSF during steroid therapy. In an observational open multicenter study, adult patients admitted to the intensive care unit because of suspected pneumococcal meningitis received recommended treatment for pneumococcal meningitis, comprising intravenous cefotaxime (200 mg per kg of body weight per day), vancomycin (administered as continuous infusion of 60 mg per kg of body weight per day after a loading dose of 15 mg per kg of body weight), and adjunctive therapy with dexamethasone (10 mg every 6 h). Vancomycin levels in CSF were measured on day 2 or day 3 of therapy and were correlated with protein levels in CSF and vancomycin levels in serum (determined at the same time as levels in CSF). Fourteen patients were included. Thirteen had proven pneumococcal meningitis; 1 patient, initially suspected of having pneumococcal meningitis, was finally determined to have meningitis due to Neisseria meningitidis. Mean levels of vancomycin in serum and CSF were 25.2 and 7.2 mg/L, respectively, and were positively correlated (r=0.6; P=.025). A positive correlation was also found between the ratio of vancomycin in CSF to vancomycin in serum and the level of protein in CSF (r=0.66; P=.01). Appropriate concentrations of vancomycin in CSF may be obtained even when concomitant steroids are used. Dexamethasone can, therefore, be used without fear of impeding vancomycin penetration into the CSF of patients with pneumococcal meningitis, provided that vancomycin dosage is adequate. This study is registered at http://www.ClinicalTrials.gov/ (registration number NCT00162578).

Exemestane (Exe) as primary treatment in hormonosensible early breast cancer of the elderly: Preliminary results of a phase II multicenter open Italian study

10689 Background: In the late 90s two large phase III trials (GRETA &amp; CRC) showed that tamoxifen as sole treatment was a possible alternative to surgery in old women. Two Phase III neoadjuvant trials showed recently that letrozole is superior and anastrozole is not inferior to tamoxifen.A few phase II and a small fase III trials showed interesting results also with the steroidal inactivator exemestane. Methods: We are running a fase II open trial in early breast cancer patients aged over 70 with receptor rich tumors, treated with exemestane 25 mgs/day for 6 months before surgery. Primary endpoints are clinical response, breast conservative surgery (BCS) rate and safety. Results: Of the planned 100 patients we report preliminary results on 50 patients (mean age 81 , range 70–92) evaluable for clinical and mammographic response. 33/50 had a partial response (66%), 2/50 PD on treatment. Clinical basal mean size of tumors was 4.4 cms (4,81 in responders) and 2,67 cms the final in responders patients. Eight patients refused surgery, 12 are too early, 23/30 underwent BCS where 17 of them (74%) were unfit for BCS at basal evaluation. No remarcable exemestane related toxicity was recorded. Conclusions: As expected from published data of phase III trials in metastatic and adjuvant setting, exemestane appears to be very active also in the neoadjuvant setting. Probably there is no more need of large phase III trials in order to consider exemestane in the preoperative setting in rich receptor tumors. In old and frail patients this could also be considered as sole treatment. [Table: see text]

Efficacité du latanoprost, donné en première ou deuxième intention, sur la pression intra-oculaire et la symptomatologie oculaire chez des patients présentant un glaucome à angle ouvert ou une hypertension oculaire simple

The aim of this study was to assess the changes in intraocular pressure (IOP) and ophthalmic symptoms with the Glaucoma Symptom Scale in patients suffering from open-angle glaucoma (OAG) or ocular hypertension (OHT) after 3 months of treatment with latanoprost.This multicentric open study was carried out in adult patients suffering from OAG or simple OHT (naive or previously treated with monotherapy) and needing a change or initiation of anti-glaucomatous treatment. One drop of latanoprost 0.005% was instilled every evening for 12 weeks in each affected eye. Efficacy was assessed by the variation in IOP and ophthalmic symptomatology at the end of treatment. Prognosis factors associated with a relative IOP reduction of at least 30% were sought (using a logistic regression model).A total of 920 patients suffering from OAG (54%) or OHT (44%), either previously treated (69%) or naive (31%), were included. The male:female ratio was 0.78 and the mean age was 63+/-13 years. At inclusion, the mean IOP was 22.1+/-3.8 mmHg. After treatment, IOP was significantly decreased by 5.1+/-4 mmHg, corresponding to a 22% reduction. IOP reduction was 7.1+/-4 mmHg, corresponding to 29% in naive patients and 4.2+/-4 mmHg, corresponding to 19% in previously treated patients. A relative IOP reduction of at least 30% was reached by 47% of naive patients and 21% of previously treated patients. In previously treated patients, a relative IOP reduction of at least 30% had a greater chance of being reached in men with previous ophthalmic history and high IOP at inclusion (above 21 mmHg). IOP reduction was similar in patients with OAG and OHT. A significant improvement in ophthalmic symptoms was observed after treatment in previously treated patients. A total of 7% of the patients presented an adverse event affecting the visual system: eye irritation (2%), eye pain (2%), or eye hyperemia (1%). Compliance was good for 94% of the patients.Latanoprost given as first or second-line treatment at the recommended dose effectively decreases IOP in patients with OAG or OHT. This treatment also improves visual and nonvisual symptoms in previously treated patients and presents a good safety profile.