Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

BACKGROUND: Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group. METHODS: Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years. RESULTS: The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days' treatment (day 6-7, end of therapy), and microbiological success rates after 3-4 days' treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption. CONCLUSION: This combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.

Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials.

Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo. Both clinical trials followed a similar methodology. Patients were randomized 1:1 to ozenoxacin or vehicle. One trial included retapamulin as an internal control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were evaluated. Ozenoxacin demonstrated superior clinical success versus vehicle after 5 days of therapy, superior microbiological success versus vehicle after 2 days of therapy, and was safe and well-tolerated. Ozenoxacin showed superior clinical and microbiological response versus vehicle in children as young as 2 months of age, and adults, with impetigo. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01397461 and NCT02090764; European Clinical Trials Database Number: 2011-003032-31 and 2014-000228-52. J Drugs Dermatol. 2018;17(10):1051-1057.

Clinical and resource utilization patterns in patients with refractory neuropathic pain prescribed pregabalin for the first time in routine medical practice in primary care settings in Spain.

CONTEXT AND OBJECTIVE: To describe clinical and resource utilization patterns in patients with refractory neuropathic pain (NeP) who were prescribed pregabalin for the first time in routine medical practice in primary care settings. METHODS: Post-hoc analysis of a 12-week prospective observational study including pregabalin naïve adult patients with refractory chronic NeP of at least 6-months duration. Self-reported pain intensity, disability, sleep disturbances, symptoms of anxiety and depression, disability, health-related quality of life (HRQoL), health care resource utilization, and corresponding costs were assessed in this post-hoc analysis. RESULTS: One thousand three hundred fifty-four patients were enrolled in the study, and three treatment groups were identified: (1) 598 patients replaced prior pain treatments with pregabalin as monotherapy; (2) 589 added pregabalin to their existing pain treatments; and (3) 167 other pain treatments were prescribed according with physician routine medical practice. Statistically significant differences were reported at baseline for intensity of pain, patient disability, severity of depressive symptoms, and HRQoL (P < 0.01 in all cases). No statistically significant differences were reported among the three treatment groups for anxiety severity or sleep disturbances. Subjects who received add-on pregabalin had greater use of direct and indirect resources vs the other groups, resulting in significantly higher quarterly overall costs per patient: €2,397 (2,308), €2,470 (1,857), and €3,110 (2,496), respectively (P < 0.001). CONCLUSION: These findings suggest that primary care physicians chose pregabalin as an option for treating refractory patients who tended to have much more severe NeP profiles, costing society more than when they chose other therapeutic strategies not including pregabalin.

Costs and health resources utilization following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain: a post hoc analysis.

PURPOSE: To analyze the changes in pain severity and associated costs resulting from resource utilization and reduced productivity in patients with gabapentin-refractory peripheral neuropathic pain who switched to pregabalin therapy in primary care settings in Spain. PATIENTS AND METHODS: This is a post hoc analysis of a 12-week, multicentre, noninterventional cost-of-illness study. Patients were included in the study if they were over 18 years of age and had a diagnosis of chronic, treatment-refractory peripheral neuropathic pain. The analysis included all pregabalin-naïve patients who had previously shown an inadequate response to gabapentin and switched to pregabalin. Severity of pain before and after treatment with pregabalin, alone or as an add-on therapy, was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ) and its related visual analogue scale (VA). Healthcare resource utilization, productivity (including lost-workday equivalents [LWDE]), and related costs were assessed at baseline and after pregabalin treatment. RESULTS: A total of 174 patients switched to pregabalin had significant and clinically relevant reductions in pain severity (mean [SD] change on SF-MPQ VA scale, -31.9 [22.1]; P < 0.05 vs. baseline; effect size, 1.87). Reduction in pain was similar with both pregabalin monotherapy and add-on therapy. Significant reductions in healthcare resource utilization (concomitant drug use [in pregabalin add-on group], ancillary tests, and unscheduled medical visits) were observed at the end of trial. Additionally, there were substantial improvements in productivity, including a reduction in the number of LWDE following pregabalin treatment (-18.9 [26.0]; P < 0.0001). These changes correlated with substantial reductions in both direct (-652.9 ± 1622.4 €; P < 0.0001) and indirect healthcare costs (-851.6 [1259.6] €; P < 0.0001). CONCLUSIONS: The cost of care in patients with gabapentin-refractory peripheral neuropathic pain appeared to be significantly reduced after switching to pregabalin treatment, alone or in combination with other analgesic drugs, in a real-life setting.

Effect of pregabalin in the treatment of refractory neck pain: cost and clinical evidence from medical practice in orthopedic surgery and rehabilitation clinics.

BACKGROUND: The study aims to prospectively analyze the effect of adding pregabalin upon costs and consequences in the treatment of refractory neck pain under routine medical practice. METHODS: A secondary analysis was carried out including patients over 18 years, with 6-month chronic neck pain refractory from a prospective, naturalistic, 12-week two-visit study. The analysis compared patients adding pregabalin to its therapy vs. usual care. Severity of pain, healthcare resources utilization, lost workday equivalents (LWDE) because of pain, and related cost-adjusted reductions were assessed. RESULTS: A total of 312 patients (65.3% women, age 54.2 [12.1] years), 78.2% receiving pregabalin, were analyzed. Adding pregabalin was associated with higher adjusted reduction in pain severity: -3.2 (1.8) points, 55.4% responders (≥50% baseline pain reduction) vs. -2.3 (2.0) and 38.2%, respectively; P<0.001, yielding a higher reduction in mean LWDE: 20.1 (23.1) vs. 8.2 (22.4); P=0.014, which produced significant reductions in the indirect components of cost: €1,041.0 (1,222.8) vs. €457.3 (1,132.1), P=0.028. The costs of pregabalin (€309.8 [193.2] vs. €26.4 [79.6], P<0.001) was offset by higher numerical reductions in the other components of costs, producing similar direct cost reductions in both groups at the end of the study: €66.8 (1,080.8) and €143.5 (1,922.4), respectively; P=0.295. CONCLUSION: Compared with usual care, the addition of pregabalin to treat refractory neck pain seems to be associated with a higher reduction in pain severity and lost work-days equivalents, which in turn results in a greater reduction of the indirect components of cost while maintaining similar healthcare cost levels despite its higher price.

Changes in seizure severity and quality of life in patients with refractory partial epilepsy.

This 6-month observational, prospective, multicenter study assessed the influence of changes in seizure severity on quality of life in patients with refractory partial epilepsy. Patients (N = 262) diagnosed with partial epilepsy and receiving two antiepileptic drugs as determined by usual clinical practice were enrolled in this study. The primary endpoint was the mean seizure severity score obtained from the Seizure Severity Questionnaire. Reductions in seizure severity were detected from baseline to months 3 and 6 (P<0.0001). Improvements compared with baseline were found for several secondary measures: Hamilton Anxiety and Depression scales (P<0.0001), most Medical Outcomes Study-Sleep subscales (P<0.05), and seven subscales of the Quality of Life in Epilepsy Inventory-31 (QOLIE-31; P<0.0005). Seizure severity correlated directly with anxiety (P<0.0001) and inversely with QOLIE-31 measures (P<0.0001). In conclusion, reducing seizure severity with appropriate medication may lead to improvement in the overall quality of life of patients with refractory partial epilepsy.

Patient-reported-outcomes in subjects with painful lumbar or cervical radiculopathy treated with pregabalin: evidence from medical practice in primary care settings.

The objective of this study was to evaluate the effect of pregabalin in painful cervical or lumbosacral radiculopathy treated in Primary Care settings under routine clinical practice. An observational, prospective 12-week secondary analysis was carried-out. Male and female above 18 years, naïve to PGB, with refractory chronic pain secondary to cervical/lumbosacral radiculopathy were enrolled. SF-MPQ, Sheehan Disability Inventory, MOS Sleep Scale, Hospital Anxiety and Depression Scale and the EQ-5D were administered. A total of 490 (34%) patients were prescribed PGB-monotherapy, 702 (48%) received PGB add-on, and 159 (11%) were administered non-PGB drugs. After 12 weeks, significant improvements in pain, associated symptoms of anxiety, depression and sleep disturbances, general health; and level of disability were observed in the three groups, being significantly greater in PGB groups. In routine medical practice, monotherapy or add-on pregabalin is associated with substantial pain alleviation and associated symptoms improvements in painful cervical or lumbosacral radiculopathy.

A cost-consequence analysis of pregabalin versus usual care in the symptomatic treatment of refractory low back pain: sub-analysis of observational trial data from orthopaedic surgery and rehabilitation clinics.

BACKGROUND: low back pain is one of the most common reasons for outpatient consultation in both the primary-care and specialized-care settings. However, few studies have explored the effect of pregabalin in this context. OBJECTIVE: to prospectively analyse the effect of adding pregabalin on costs and consequences in the treatment of refractory low back pain in routine medical practice. METHODS: a secondary analysis was carried out in patients aged >or=18 years with a 6-month history of chronic refractory low back pain who had participated in a previous prospective, naturalistic, 12-week, two-visit study (RADIO study). The analysis compared patients receiving pregabalin with those receiving usual care. Severity of pain, healthcare resources utilization, lost workday equivalents due to pain, and related cost-adjusted reductions were assessed. The year of costing for all cost data reported in the study was 2007. RESULTS: data from a total of 683 patients (49.5% women, mean age 55.0 years), 82.6% of whom were receiving pregabalin, were analysed. Pregabalin was associated with a higher covariable-adjusted reduction in severity of pain, i.e. mean (SD) -3.4 (2.0) compared with -2.0 (2.1) points with usual care on a 10-point neuropathic pain questionnaire (p < 0.001), and a 61.6% response rate (defined as >/=50% reduction in pain from baseline) compared with 37.3% with usual care (p < 0.001). This resulted in fewer lost workday equivalents in the pregabalin group versus usual care (27.8 vs 34.6, p = 0.002), which produced more significant adjusted reductions in indirect costs, i.e. mean (SD) -euro961.8 (euro1242.9) compared with -euro625.8 (euro1169.2) with usual care (p = 0.004). The cost of pregabalin, i.e. mean (SD) euro303.8 (euro175.8) compared with euro37.1 (euro97.0) for usual care (p < 0.001), was offset by larger reductions in the other cost components. While the adjusted total costs were substantially reduced in both groups, pregabalin-treated patients showed more significant reductions, i.e. mean (SD) -euro991.5 (euro1702.3) compared with -euro579.3 (euro2410.3) with usual care (p = 0.023). CONCLUSION: compared with usual care, addition of pregabalin to existing therapy for refractory low back pain was associated with a larger reduction in pain severity and lost workday equivalents. The acquisition cost of pregabalin was offset by a higher reduction in the indirect components of cost, resulting in a significant decrease in total costs.

A cost-consequences analysis of the effect of pregabalin in the treatment of painful radiculopathy under medical practice conditions in primary care settings.

PURPOSE: To analyze the effect of pregabalin (PGB) on pain relief, longitudinal utilization of health and nonhealth resources and derived costs in patients with refractory painful radiculopathy under routine medical practice in primary care settings (PCS). METHODS: Subjects over 18 years of age with painful radiculopathy (cervical/lumbar) refractory to at least one previous analgesic therapy were included in a prospective, naturalistic, 12-week study. Consumption of resources included both health-care and nonhealth-care resources. Pain severity was measured using the Short Form of the McGill Pain Questionnaire. RESULTS: One thousand three hundred and four PGB-naive patients (55.8% women, 56.7 [12.9] years) were analyzed: 473 (36%) switched to monotherapy with PGB (PGBm), 676 (52%) received add-on therapy with PGB (PGBadd-on), and in 155 patients (12%) the previous treatment was replaced by a schedule not including PGB (non-PGB). As compared with the non-PGB, both PGBm and PGBadd-on schedules showed a significantly greater reduction of pain severity (36.1%, 56.1%, and 49.6% reductions, respectively, P < 0.001 between groups) and consumption of resources. Additional costs of drugs, particularly in the PGB subgroups (euro15.4, euro148.6 and euro145.3, respectively, P < 0.001) were offset by significantly greater reductions of all other components of health-care and nonhealth-care cost, thus resulting in a substantial reduction of total cost: euro1,203.3, euro1,423.2, and euro1,429.2, respectively (P < 0.001). CONCLUSION: In PCS, either PGBadd-on or PGBm under routine medical practice was associated with pain alleviation leading to significant longitudinal reductions in resource use and total costs compared with non-PGB-therapy in subjects with painful refractory cervical or lumbar radiculopathy.

Safety and efficacy profile of ozenoxacin 1% cream in pediatric patients with impetigo.

BACKGROUND: Ozenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups. METHODS: Data for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range. RESULTS: Across studies, 644 pediatric patients with impetigo received ozenoxacin 1% cream (n = 287) or vehicle (n = 247). One study included retapamulin 1% ointment as the internal validity control (n = 110). The clinical success rate at the end of treatment and bacterial eradication rates after 3 to 4 days of treatment and at the end of treatment were significantly higher with ozenoxacin than vehicle (all p < .0001). The clinical and microbiologic success rates were higher with ozenoxacin than vehicle in the age groups of 0.5 to <2 years, 2 to <6 years, 6 to <12 years, and 12 to <18 years and were comparable to vehicle in the 2 to <6 months age group, although patient numbers were low (≤5 per treatment arm). No safety concerns with ozenoxacin were identified. Of the 362 plasma samples derived from 38 patients, four slightly exceeded the lower limit of quantification, indicating negligible systemic absorption. CONCLUSION: The results of this analysis suggest that ozenoxacin 1% cream is an effective and safe treatment for impetigo in pediatric patients aged 2 months to <18 years.

Cognitive impairment in patients with fibromyalgia syndrome as assessed by the mini-mental state examination.

BACKGROUND: This study evaluated the frequency of cognitive impairment in patients with Fibromyalgia syndrome (FMS) using the Mini Mental State Examination (MMSE). METHODS: We analyzed baseline data from all 46 patients with FMS and 92 age- and sex-matched controls per diagnosis of neuropathic (NeP) or mixed pain (MP) selected from a larger prospective study. RESULTS: FMS had a slight but statistically significant lower score in the adjusted MMSE score (26.9; 95% CI 26.7-27.1) than either NeP (27.3; 95% CI 27.2-27.4) or MP (27.3; 27.2-27.5). The percentage of patients with congnitive impairment (adjusted MMSE

Adiponectin plasma levels are increased by atorvastatin treatment in subjects at high cardiovascular risk.

Adiponectin can suppress atherogenesis by inhibiting the adherence of monocytes, reducing their phagocytic activity, and suppressing the accumulation of modified lipoproteins in the vascular wall. Contradictory data have been reported about the effect of statins on adiponectin plasma levels. In this work, adiponectin plasma levels were measured in 102 statin-free subjects from the Spanish population of the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST) study, a 12-week, prospective, multi-centre, open-label trial which enrolled subjects with coronary heart disease, coronary heart disease-equivalent or a 10-year coronary heart disease risk >20%. Subjects were assigned to atorvastatin (10-80 mg/day) based on low-density lipoprotein (LDL)-cholesterol concentration at screening. For comparison, age and gender-matched blood donors (N=40) were used as controls. Control subjects did not present hypertension, hypercholesterolemia, diabetes, metabolic syndrome and history of cardiovascular diseases. Adiponectin levels were diminished in patients at high cardiovascular risk compared with control subjects [4166 (3661-4740) vs 5806 (4764-7075) ng/ml respectively; geometric mean (95% CI); P<0.0001]. In the whole population, atorvastatin treatment increased adiponectin levels [9.7 (3.2-16.7);% Change (95% CI); P=0.003]. This increment was in a dose-dependent manner; maximal effect observed with atorvastatin 80 mg/d [24.7 (5.7-47.1); P=0.01]. Adiponectin concentrations were positively correlated with high-density lipoprotein-cholesterol both before and after atorvastatin treatment. No association was observed between adiponectin and LDL-cholesterol before and after atorvastatin treatment. In conclusion, atorvastatin increased adiponectin plasma levels in subjects at high cardiovascular risk, revealing a novel anti-inflammatory effect of this drug.

Health and non-health care resources use in the management of adult outpatients with drug-resistant epilepsy in Spain: a cost-of-illness study (LINCE study).

PURPOSE: The purpose of this study was to ascertain health care and non-health care resources use in the past 12-months and to estimate the cost-of-illness in adult outpatients with drug-resistant epilepsy (DRE) in Spain. METHODS: A cross-sectional and retrospective study was designed. Whole nation representative participants (epilepsy and general neurological clinics) were selected at random, but patients with drug-resistant epilepsy were included consecutively. We choose the societal perspective to compute total costs for this study. Estimation of costs was calculated by multiplying unitary costs by number of resources used. RESULTS: Seven hundred sixty-two consecutive patients (50.8% males) with mean (S.D.) age of 40.5 (13.5) years were included. Mean total yearly costs were euro6838 (euro8100) with health costs of euro4977 (euro6490), and indirect costs of euro1618 (euro4527). Gender and severity of seizures were significantly associated with costs; higher in males and subjects with severe seizures. Total annual costs showed a trend toward statistical significant association with age (lower costs in older patients), but costs were unrelated with level of care in Epilepsy or general neurological clinics. DISCUSSION: Health care, and to a lesser extend non-health care resources use, were high in patients with DRE in Spain, yielding a considerable burden to both the National Health System and the Society. Better planning of therapeutic strategies allowing alleviation of load and costs of this health problem should be considered from these findings.

A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder.

OBJECTIVE: To conduct the first randomized, controlled trial assessing the prophylactic efficacy of gabapentin in bipolar disorder. METHOD: We conducted a 1-year, double-blind, randomized, comparative, placebo-controlled, parallel-group, multicenter study. As this was a pure prophylactic trial, only euthymic bipolar I and II patients (DSM-IV) were randomly assigned in a 1:1 ratio to gabapentin (N = 13) or placebo (N = 12) added to the current treatment (lithium, valproate, carbamazepine, or any combination but not antipsychotics or antidepressants). Subjects participated in the study for 12 months. The primary efficacy parameter was the Clinical Global Impressions scale for Bipolar Illness, Modified (CGI-BP-M), which was assessed at all visits. Other assessments were the Young Mania Rating Scale (YMRS), Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the systematic collection of reported adverse events. Data were collected from May 1999 to February 2004. RESULTS: The change from baseline to month 12 in mean CGI-BP-M scores between groups was statistically significant (p = .0046). Mean score change from baseline to endpoint in the gabapentin group was -2.1, and the mean score change in the placebo group was -0.6. No emerging manic or depressive symptoms were seen in either group as measured with the YMRS, HAM-D, HAM-A, and PSQI. In the PSQI-6 subscale (use of sleeping medication), the mean score change at month 12 in the gabapentin group was 0.9, and the mean score change in the placebo group was 0.05 (p = .0267). Overall, gabapentin was well tolerated. CONCLUSION: This small, randomized clinical trial comparing the prophylactic efficacy of adjunctive gabapentin to placebo suggests that, despite lack of acute efficacy, treatment with gabapentin might provide some benefit on the long-term outcome of bipolar disorder.

The Memory Binding Test: Development of Two Alternate Forms into Spanish and Catalan.

BACKGROUND: The Memory Binding Test (MBT) is emerging as a promising tool for the detection of subtle memory impairment suggestive of Alzheimer's disease (AD). For such a test to be widely accessed and used, the availability of both alternate forms and language adaptations is required. OBJECTIVES: To develop a thorough methodology for obtaining alternate forms (A and B) of the MBT in Spanish and Catalan and to assess their equivalence. METHOD: According to the original development of the test, frequency was taken as the lexical variable of reference for the Spanish and Catalan adaptations. A crossed design protocol by form and language was used to compare the MBT results in a sample of 290 cognitively normal middle-aged participants. Pairwise Intraclass Correlation Coefficients (ICCs) were calculated among the six possible combinations. RESULTS: The Spanish and Catalan lists of words for the MBT A and B resulting from the adaptation process as well as the original lists in English are presented. ICC indices for the comparisons between forms and languages ranged from 0.56 to 0.82. CONCLUSION: The MBT A and B in Spanish and Catalan showed similar outcomes and can be considered equivalent. Moreover, the thorough methodology presented here for the transcultural adaptation and equivalence study, could serve as a model for future adaptations of the MBT and other verbal tests.

Psychometric Properties of the Memory Binding Test: Test-Retest Reliability and Convergent Validity.

BACKGROUND: Episodic memory testing is fundamental for the diagnosis of Alzheimer's disease (AD). Although the Free and Cued Selective Reminding Test (FCSRT) is widely used for this purpose, it may not be sensitive enough for early detection of subtle decline in preclinical AD. The Memory Binding Test (MBT) intends to overcome this limitation. OBJECTIVES: To analyze the test-retest reliability of the MBT and its convergent validity with the FCRST. METHODS: 36 cognitively healthy participants of the ALFA Study, aged 45 to 65, were included for the test-retest study and 69 for the convergent analysis. They were visited twice in a period of 6 ± 2 weeks. Test-retest reliability was determined by the calculation of the intra-class correlation coefficient (ICC). Score differences were studied by computing the mean percentage of score variation between visits and visualized by Bland-Altman plots. Convergent validity was determined by Pearson's correlations. RESULTS: ICC values in the test-retest reliability analysis of the MBT direct scores ranged from 0.64 to 0.76. Subjects showed consistent practice effects, with mean amounts of score increasing between 10% and 26%. Pearson correlation between MBT and FCSRT direct scores showed r values between 0.40 and 0.53. The FCSRT displayed ceiling effects not observed in the MBT. CONCLUSIONS: The MBT shows adequate test-retest reliability and overall moderate convergent validity with the FCSRT. Unlike the FCSRT, the MBT does not have ceiling effects and it may therefore be especially useful in longitudinal studies, facilitating the measurement of subtle memory performance decline and the detection of very early AD.

Sertraline treatment of pathological gambling: a pilot study.

OBJECTIVE: Several open-label and double-blind studies have suggested that selective serotonin reuptake inhibitors may be useful in the treatment of pathological gambling. The purpose of this study was to evaluate the efficacy of sertraline in the treatment of pathological gambling. METHOD: Sixty patients meeting the DSM-IV criteria for pathological gambling were treated for 6 months in a double-blind, flexible-dose, placebo-controlled study of sertraline 50 to 150 mg/day. Data were collected from November 1998 to January 2001. The primary outcome measure assessing change in clinical status was the responder rate with respect to the Criteria for Control of Pathological Gambling Questionnaire (CCPGQ). Secondary measures included the Clinical Global Impressions scale (CGI) (Severity of Illness and Improvement subscales), and Visual Analogue Scales assessing gambling frequency, severity, amount, and improvement. Concomitant medication and psychotherapy were not allowed during the study. RESULTS: At the end of the study, 23 sertraline-treated subjects (74%) and 21 placebo-treated subjects (72%) were considered as responders on the CCPGQ (p = .9). Similar results were obtained when the CGI-Improvement scale limited to symptoms of pathological gambling was used as an outcome measure. Sertraline was well tolerated throughout the study. CONCLUSION: Sertraline was not statistically significantly superior to placebo in the overall sample. The power of the study was limited by the high placebo-response rate and the small sample size.

Doxazosin GITS versus standard doxazosin in mild to moderate hypertension.

BACKGROUND: The selective alpha 1-adrenoceptor antagonist doxazosin in both standard formulation and gastrointestinal therapeutic system (GITS) controlled-release formulation is effective for hypertension without having a negative impact on serum lipids. This study was designed to compare the relative efficacy of these two formulations of doxazosin on clinic and ambulatory blood pressure and serum lipids in patients with mild to moderate hypertension. METHODS: Hypertensive patients aged 18-70 years (n = 335) were evaluated in a multi-center prospective randomized study. Following a 2-week placebo run-in phase, patients were randomized to receive doxazosin 2 or 4 mg, with dose titration, or doxazosin GITS 4 mg, no dose titration, for 9 weeks. RESULTS: Both doxazosin formulations reduced clinic diastolic and systolic blood pressure from baseline (P < 0.0001). Doxazosin GITS and doxazosin 4 mg had similar blood pressure-lowering effects. Doxazosin GITS reduced sitting diastolic and systolic blood pressure compared with doxazosin 2 mg (P < 0.01 for both). A greater proportion of the doxazosin GITS group reached goal blood pressure (< or = 140/90 mm Hg) after 9 weeks compared with the doxazosin 2-mg group. All doses of doxazosin reduced 24-h and daytime (7:00 am to 10:00 pm) ambulatory blood pressure from baseline (all P < 0.01). Doxazosin GITS significantly reduced nighttime (10:00 pm to 7:00 am) ambulatory blood pressure from baseline. A neutral effect on serum lipids was observed with doxazosin. CONCLUSIONS: Doxazosin GITS and doxazosin were effective in reducing clinic and ambulatory blood pressure. The GITS formulation reduced the need for dose titration. Both doxazosin formulations were well tolerated.

Reference Data of the Spanish Memory Binding Test in a Midlife Population from the ALFA STUDY (Alzheimer's and Family).

BACKGROUND: The Memory Binding Test (MBT) is a novel test based on the learning of two lists of words, developed to detect early memory impairment suggestive of Alzheimer's disease (AD). OBJECTIVE: To present and provide reference data of the Spanish MBT in a midlife population of mainly first-degree descendants of AD patients. METHODS: 472 cognitively unimpaired subjects, aged 45 to 65 and participants of the ALFA STUDY, were included. Raw scores were transformed to scaled scores on which multivariate regression analysis was applied adjusting by age, gender, and education level. A standard linear regression was employed to derive the scaled score adjusted. Sociodemographic corrections were applied and an adjustment table was constructed. RESULTS: Performance was heterogeneously influenced by sociodemographic factors. Age negatively influenced free recall. Education tends to have an influence in the results showing lower performance with lower education level. Women tend to outperform men in the learning of the first list and total recall. Only a few variables were unaffected by sociodemographic factors such as those related to semantic proactive interference (SPI) and to the retention of learned material. Our results point out that some vulnerability to SPI is expectable in cognitively healthy subjects. Close to 100% of the learned material was maintained across the delay interval. CONCLUSION: This study contributes with reference data for the MBT providing the necessary adjustments for sociodemographic characteristics. Our data may prove to be useful for detecting asymptomatic at-risk candidates for secondary prevention studies of AD.

Pain alleviation and patient-reported health outcomes following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain in routine medical practice.

BACKGROUND: It has been suggested that peripheral neuropathic pain (PNP) may affect up to 3% of the general population. PNP has a substantial negative impact on patient functioning and quality of life, including reduced productivity and increased consumption of healthcare resources. OBJECTIVE: The objective of this study was to analyse changes in pain and patient-reported health outcomes following switching to pregabalin treatment in patients with gabapentin-refractory PNP as part of routine clinical practice in Spanish primary-care settings. METHODS: This was an open-label, non-randomized, post hoc analysis of a 12-week, multicentre, non-interventional cost-of-illness study. The study involved primary-care physicians and was carried out between September 2005 and April 2006. Patients were aged at least 18 years and had chronic, treatment-refractory PNP. The analysis included all pregabalin-naïve patient switches that had previously shown an inadequate response to gabapentin. The following variables were assessed before and after pregabalin therapy: pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), disability level (Sheehan Disability Scale [SDS]), symptoms of anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), self-perceived sleep quality and quantity (Medical Outcomes Study [MOS] Sleep Scale), and health-related quality of life (EuroQol [EQ] five-dimension [5D] questionnaire). RESULTS: A total of 174 patients with an inadequate response to gabapentin switched to pregabalin at the beginning of the study. After 12 weeks of pregabalin therapy, alone or in combination with other analgesic drugs, significant and clinically relevant improvements were observed in pain severity [mean (SD) SF-MPQ change: -31.9 (22.1) points; 42.5% being responders (pain reduction ≥50%)], disability [SDS score: -7.5 (6.2) vs baseline], affective symptoms [HADS depression: -4.5 (3.9); HADS anxiety: -4.1 (3.7)], sleep [MOS summary index: -17.2 (16.6)], and health status [EQ-5D visual analogue scale (VAS): 27.3 (18.2)], with an overall gain of 0.040 (0.031) quality-adjusted life-years. CONCLUSION: These findings suggest that pregabalin could be a valid treatment alternative for the management of patients with gabapentin-refractory peripheral neuropathic pain in primary-care settings under real-life conditions of care. Our data show that patients who were switched to pregabalin, either as monotherapy or in combination with other analgesics, showed substantial and clinically relevant improvements in relieving pain and related symptoms.