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Long-term Efficacy (long-term + efficacy)

Distribution by Scientific Domains

Medical Sciences	97%
2 Other Domains	3%

Distribution within Medical Sciences

Gastroenterology & Hepatology	12%
Dermatology	8%
Cardiovascular Disease	7%
Gastroenterology	5%
General & Internal Medicine	4%
Diabetes	3%
Allergy & Clinical Immunology	2%
18 Other Subdomains	30%

Selected Abstracts

Long-Term Efficacy of Subcutaneous Sweat Gland Suction Curettage for Axillary Hyperhidrosis: A Prospective Gravimetrically Controlled Study

DERMATOLOGIC SURGERY, Issue 9 2008
STEPHANIE DARABANEANU PHD
BACKGROUND Subcutaneous sweat gland suction curettage (SSGSC) is gaining acceptance as a therapy for axillary hyperhidrosis. Despite its acceptance, there remains a lack of prospective data describing the efficacy and long-term outcome of SSGSC. OBJECTIVE We examined the sweat rates and patients' satisfaction of 12 months following SGSC in 28 patients with axillary hyperhidrosis. METHODS Axillary sweat rates were determined by semiquantitative gravimetry. A questionnaire was used to determine patients' satisfaction. RESULTS A 58% reduction in sweat rate under resting conditions and an 85% reduction during aerobic exercise in sweat rates was observed. A subdivision of patients into three groups based on their baseline preoperative sweat rates (<25, 25,50, and >50 mg/min) showed that patients with resting sweat rates over 25 mg/min benefited particularly from this procedure, whereas patients with less than 25 mg/min did not. CONCLUSION SSGSC produces a significant reduction in the preoperative sweat rates. A low complication rate and a high degree of patient satisfaction were observed. Long-term follow-up evaluations demonstrate a low number of relapses, making SSGSC a convenient and satisfactory method of treating axillary hyperhidrosis. It should be considered in patients refractory to conventional therapies with baseline sweat rates greater than 25 mg/min. [source]

(647) Evaluation of the Long-Term Efficacy and Safety of Transdermal Fentanyl in the Treatment of Noncancer Pain: The Interim Analysis

PAIN MEDICINE, Issue 2 2000
Article first published online: 25 DEC 200
Authors: K Milligan, South Cleveland Hospital, L Haazen and L Bijnens, Janssen Research Foundation Aim of Investigation: To document long-term efficacy and safety of transdermal (TTS) fentanyl for the management of noncancer pain. Methods: The study was an open-label, international, multi-center, phase III trial in 532 patients (mean age 51.5 years) with a median pain duration of 6 years. Two hundred sixty-two patients (50%) had neuropathic pain and 367 (70%) had predominantly somatic, nociceptive pain. TTS-fentanyl was started at an equi-analgesic dose to the pretrial opioid, and given for 12 months. Main outcome measures were weekly assessment of pain control, global treatment satisfaction and quality of life scores. Results: At interim analysis, 120 patients had completed the trial, 211 were continuing treatment, and 201 patients had discontinued. The mean dose of TTS-fentanyl increased from 48 ,g/h to 105 ,g/h over 12 months, with most increases occurring in the first months. During treatment the number of subjects reporting very good, good, or moderate pain control remained stable at 65% (range 61% to 75%). Global satisfaction (very good or good) was also stable at 42% (range 38% to 46%). Eighty-six percent of patients reported preference for TTS-fentanyl over their previous treatment, stating the main reason as better pain relief. SF-36 scores improved from baseline for physical pain and physical summary measurements. The most frequently occurring adverse events were nausea (28%), sonmolence (17%), constipation (15%), vomiting (15%), and increased sweating (14%). Conclusions: Long-term treatment with TTS-fentanyl provides a stable degree of pain control in the majority of patients with moderate-to-severe noncancer pain. It was preferred by the majority of subjects to their previous medication and favorably improved their quality of life. Acknowledgments: Supported by the Janssen Research Foundation. [source]

Safety and Long-Term Efficacy of Eculizumab in a Renal Transplant Patient with Recurrent Atypical Hemolytic,Uremic Syndrome

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 11 2009
V. Chatelet
No abstract is available for this article. [source]

Renal Transplantation in Indo-Asian Patients in the UK

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 4 2006
M. D. Dooldeniya
Membership of some ethnic groups has an effect on renal transplant outcome but little is known about the impact of Indo-Asian ethnicity, despite this group's high incidence of renal disease. We compared outcomes in Indo-Asians and Caucasians at the Hammersmith Hospital (Indo-Asians, N = 46; Caucasians, N = 90), in the Long-Term Efficacy and Safety Surveillance (LOTESS) database of cyclosporin-treated renal transplant recipients (Indo-Asians, N = 254; Caucasians, N = 4262) and the National Transplant Database held by UK Transplant (Indo-Asians, N = 459; Caucasians, N = 4831). The baseline demographic and co-morbid characteristics of the two ethnic groups were comparable, save for more diabetes in the Indo-Asian community. Following transplantation, the incidence of delayed graft function and steroid-resistant acute rejection were also comparable, as were graft and patient survival (out to 5 years) and graft function. In addition, post-transplant blood pressure, levels of cholesterol and triglycerides and exposure to corticosteroids and cyclosporin were comparable. However, when patients who were not diabetic before transplantation were studied separately, there was an increased incidence of diabetes in the Indo-Asian community (Hammersmith data: Indo-Asians 10.9% vs. Caucasians 3.3%, p = 0.02; LOTESS data Indo-Asians 5.5% vs. Caucasians 1.6%, p < 0.0001). Subsequent management of this group should pursue immunosuppressive regimens less likely to impair post-transplant glucose tolerance. [source]

Rituximab for rheumatoid arthritis refractory to anti,tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks

ARTHRITIS & RHEUMATISM, Issue 9 2006
Stanley B. Cohen
Objective To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti,tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. Methods We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy,Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. Results Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. Conclusion At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies. [source]

Long-Term Efficacy and Safety of Cerivastatin 0.8 mg in Patients with Primary Hypercholesterolemia

CLINICAL CARDIOLOGY, Issue S4 2001
Jonathan Isaacsohn M.D.
Abstract Background: Statins are the agents of choice in reducing elevated plasma low-density lipoprotein cholesterol (LDL-C). Hypothesis: Cerivastatin 0.8 mg has greater long-term efficacy in reducing LDL-C than pravastatin 40 mg in primary hypercholesterolemia. Methods: In this double-blind, parallel-group, 52-week study, patients (n = 1,170) were randomized (4:1:1) to cerivastatin 0.8 mg, cerivastatin 0.4 mg, or placebo daily. After 8 weeks, placebo was switched to pravastatin 40 mg. Patients with insufficient LDL-C lowering after 24 weeks were allowed open-labeled resin therapy. Results: Cerivastatin 0.8 mg reduced LDL-C versus cerivastatin 0.4 mg (40.8 vs. 33.6%, p<0.0001) or pravastatin 40 mg (31.5%, p<0.0001), and brought 81.8% of all patients, and 54.1% of patients with atherosclerotic disease, to National Cholesterol Education Program (NCEP) goals. Cerivastatin 0.8 mg improved mean total C (-29.0%), triglycerides (-18.3%), and high-density lipoprotein cholesterol (HDL-C) (+9.7%) (all , 0.013 vs. pravastatin 40 mg). Higher baseline triglycerides were associated with greater reductions in triglycerides and elevations in HDL-C with cerivastatin. Cerivastatin was well tolerated; the most commonly reported adverse events were arthralgia, headache, pharyngitis, and rhinitis. Symptomatic creatine kinase > 10 × the upper limit of normal (ULN) occurred in 1,1.5, and 0% of patients receiving cerivastatin 0.8 mg, cerivastatin 0.4 mg, and pravastatin 40 mg, respectively. Repeat hepatic transaminases >3 × ULN occurred in 0.3,0.5,0.5, and 0% of patients, respectively. Conclusion: In long-term use, cerivastatin 0.8 mg effectively and safely brings the majority of patients to NCEP goal. [source]

Long-term efficacy of biologics in dermatology

DERMATOLOGIC THERAPY, Issue 1 2009
Leslie Castelo-Soccio
ABSTRACT Chronic dermatologic diseases affect millions of people. The long-term nature of these diseases creates psychological and financial burden as well as substantially impacts patients' quality of life. Biologics, including adalimumab, etanercept, alefacept, efalizumab, and infliximab, are the newest therapeutic agents in the treatment of moderate-to-severe psoriasis and psoriatic arthritis and have been used in a variety of other dermatologic diseases. These agents act relatively quickly and effectively in 12-week clinical trials. Because these agents are used to treat patients for longer than 12 weeks, there is a need to review the safety and efficacy of these agents over longer periods of time. Many levels of evidence are available for biologics including high level of evidence from large, randomized, double-blind, placebo-controlled clinical studies. This review focuses on the available data for efficacy and safety for greater than 24 weeks of therapy. The studies supporting the use of rituximab and intravenous immunoglobulin in autoimmune blistering diseases are also presented in this review. [source]

Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal,bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial

DIABETIC MEDICINE, Issue 4 2008
P. C. Bartley
Abstract Aims This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat-to-target concept. Methods Patients were randomized 2 : 1 to detemir (n = 331) or NPH (n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self-measured plasma glucose (PG) levels, aiming for pre-breakfast and pre-dinner targets , 6.0 mmol/l. A second basal morning dose could be added according to pre-defined criteria. Results After 24 months, superiority of glycated haemoglobin (HbA1c) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference ,0.22% points) [95% confidence interval (CI) ,0.41 to ,0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPGlab) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty-two per cent of patients treated with detemir reached an HbA1c , 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH (P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH (P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings. Conclusions Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA1c, with added benefits of less major and nocturnal hypoglycaemia and less weight gain. [source]

Long-term efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms , a placebo-controlled, double-blind, multicentre trial

FOCUS ON ALTERNATIVE AND COMPLEMENTARY THERAPIES AN EVIDENCE-BASED APPROACH, Issue 2004
N Lopatkin
[source]

Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen,positive chronic hepatitis B,

HEPATOLOGY, Issue 3 2008
Patrick Marcellin
Treatment of 171 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long-term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty-five patients given ADV 10 mg in year 1 elected to continue in a long-term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log10 copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 × upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log10 copies/mL and ,50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow-up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV. Conclusion: Treatment with ADV beyond 48 weeks was well tolerated and produced long-term virological, biochemical, serological, and histological improvement. (HEPATOLOGY 2008;48:750,758.) [source]

Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 10 2008
D. Lütjohann
Summary Objective:, To assess the long-term efficacy and safety profile of ezetimibe 10 mg/day in patients with homozygous sitosterolemia. Methods:, This was an extension of a multi-centre, randomised, double-blind, placebo-controlled base study in which patients with homozygous sitosterolemia and plasma sitosterol concentrations > 5 mg/dl were randomised 4 : 1 to ezetimibe 10 mg/day (n = 30) or placebo (n = 7) for 8 weeks. Patients who successfully completed the base study with > 80% compliance to study medication were eligible to enter two, successive, 1-year extension studies in which ezetimibe 10 mg/day was administered in an open-label manner. Patients remained on their current treatment regimen (e.g. bile salt-binding resins, statins and low-sterol diet) during the base and extension studies. Patients had to be off ezetimibe therapy for , 4 weeks prior to entering the first extension. Efficacy and safety/tolerability parameters were evaluated every 12 and 26 weeks in the first and second years respectively. The primary efficacy end-point was mean percentage change in plasma sitosterol from baseline to study end for the cohort of patients (n = 21) who successfully completed the second extension study. Results:, Treatment with ezetimibe 10 mg/day led to significant mean percentage reductions from baseline in plasma concentrations of sitosterol (,43.9%; p < 0.001), campesterol (,50.8%; p < 0.001), low-density lipoprotein (LDL) sterols (,13.1%; p < 0.050), total sterols (,10.3%; p < 0.050) and apolipoprotein (apo) B (,10.1%; p < 0.050). No significant changes from baseline were observed for lathosterol, high-density lipoprotein sterol, triglycerides or apo A-1. Maximal reductions in sitosterol and campesterol occurred within the first 52 weeks of treatment and were sustained for the duration of the study. For LDL sterol, total sterols and apo B, maximal reductions were achieved early (by weeks 4 or 16) and waned slightly through the remainder of the study. Overall ezetimibe 10 mg was well tolerated. Conclusion:, In patients with homozygous sitoserolemia, long-term treatment with ezetimibe 10 mg/day for 2 years was effective in reducing plasma plant sterol concentrations with an overall favourable safety and tolerability profile. [source]

Long-term efficacy of a fractional resurfacing device,,§

LASERS IN SURGERY AND MEDICINE, Issue 2 2010
Arisa E. Ortiz MD
Abstract Background and Objective Recently, there has been much debate regarding the long-term efficacy of fractional resurfacing devices. While pulsed CO2 laser resurfacing is considered a highly effective treatment, fractionated resurfacing is a newer modality and its long-term efficacy has yet to be assessed. We report the long-term outcomes of subjects previously treated with fractional CO2 resurfacing for photodamaged skin and acne scars. Study Design/Materials and Methods Ten subjects from our previous studies who received fractional resurfacing for the treatment of acne scarring and photodamage returned for long-term follow-up visits at 1 and 2 years, respectively. Investigators graded maintenance of improvement on a quartile scale based on clinical photography. Results Subjects maintained 74% of their overall improvement at their long-term visits compared to 3-month follow-up visits. While clinical improvement was maintained long-term, the results were not as remarkable as those seen at 3-month visits. The authors speculate that results seen at 3 months may be enhanced by persistent inflammatory changes, as evidenced by heat shock protein 47 activity and ongoing collagen remodeling seen in previous histologic studies. Relaxation of tightening is to be expected with any procedure along with the natural progression of aging. However, patient satisfaction was upheld long-term. Conclusion Fractional CO2 laser resurfacing does have long-term efficacy and persistence of improvement of acne scarring and photodamage compared to baseline. However, additional treatments may be necessary to enhance long-term results. Lasers Surg. Med. 42:168,170, 2010. © 2010 Wiley-Liss, Inc. [source]

Long-term efficacy of botulinum toxin A in treatment of various movement disorders over a 10-year period

MOVEMENT DISORDERS, Issue 6 2002
G-Y.R. Hsiung MD
Abstract Although botulinum toxin A (BTX) has been licensed in Canada for treatment of various movement disorders since 1990, few clinical studies regarding its long-term efficacy and side effects have been reported. We conducted a retrospective analysis of 235 patients who received BTX from our movement disorders clinic over a 10-year period (January 1990 to December 1999). A total of 2,616 treatment cycles (multiple injections) were administered to 235 patients with cervical dystonia (CD), hemifacial spasm (HS), blepharospasm (BP), and other movement disorders. Substantial benefit at 5 years was seen in most patients (90% in BP, 88% in HS, 63% in CD, 100% in jaw closing and lower limb dystonia, and 56% in writer's cramp). Benefit was maintained for up to 10 years in CD, HS, and BP data, with a 75.8% benefit reported. Twenty-eight percent of patients discontinued treatment during the follow-up period due to a variety of reasons. Of these, 9.1% of patients developed primary resistance, and 7.5% of patients secondary resistance. Adverse effects, mostly minor, developed in 27% of patients at any one time, occurring over 4.5% of treatment cycles. These were most frequently reported in blepharospasm (22 of 36 patients in 40 cycles), followed by hemifacial spasm (21 of 70 patients in 46 cycles), and cervical dystonia (17 of 106 in 28 cycles). Only 1.3% of patients discontinued therapy due intolerable adverse effects. The results show that BTX is a safe and effective treatment of various types of movement disorders, and most side effects are well tolerated. Discontinuation for any reason was also low after 5 years. Efficacy was maintained after long periods of treatment with high degree of patient satisfaction. © 2002 Movement Disorder Society [source]

Long-term efficacy of the interleukin-1 receptor antagonist anakinra in ten patients with neonatal-onset multisystem inflammatory disease/chronic infantile neurologic, cutaneous, articular syndrome

ARTHRITIS & RHEUMATISM, Issue 1 2010
Bénédicte Neven
Objective Cryopyrin-associated periodic syndromes (CAPS) are a group of rare autoinflammatory diseases. Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic, cutaneous, articular syndrome (CINCA syndrome) is the most severe phenotype, with fever, rash, articular manifestations, and neurologic and neurosensory involvement. CAPS are caused by mutations in CIAS1, the gene encoding NLRP3, which plays a critical role in interleukin-1 (IL-1) processing. Anakinra, an IL-1 receptor antagonist, has been shown to be an effective treatment; however, data on long-term efficacy and safety have been sparse. This study was undertaken to assess the long-term efficacy and safety of anakinra treatment in patients with NOMID/CINCA syndrome. Methods We retrospectively analyzed the medical records of NOMID/CINCA syndrome patients referred to 2 centers, who had started anakinra treatment before June 2007. Results There were 10 patients with NOMID/CINCA syndrome who had been treated with anakinra. The patients' ages at the time anakinra treatment was initiated ranged from 3 months to 20 years. They had been followed up for 26,42 months. Sustained efficacy in the treatment of systemic inflammation and, in some cases, neurologic involvement and growth parameters, was achieved. The dosage of anakinra required for efficacy ranged from 1 to 3 mg/kg/day in the 8 oldest patients and from 6 to 10 mg/kg/day in the 2 youngest. Residual central nervous system inflammation and deafness persisted in some patients, especially if there had been a delay in diagnosis and treatment. Secondary amyloidosis persisted in cases in which it was present at treatment initiation, but no new lesions developed. No effect on overgrowth arthropathy was observed. Adverse events consisted of mild injection-site reactions. Conclusion The present results indicate that anakinra treatment is effective over the long term in NOMID/CINCA syndrome. However, treatment has to be initiated before irreversible lesions develop, and, particularly in very young patients, dosage adjustment is required. [source]

Long-term efficacy and safety results of the two-stage implantation technique in sacral neuromodulation

BJU INTERNATIONAL, Issue 9 2002
W.A. Scheepens
Objective ,To assess the long-term efficacy and safety of two-stage sacral neuromodulation with an implantable pulse generator (IPG) in patients treated for urinary urge incontinence (UI) and/or urinary retention (UR). Patients and methods ,The two-stage technique is used if patients have a good response during the acute phase of the percutaneous nerve evaluation (PNE) test, but have a poor response during the following 4,7 days (subchronic phase). In the first stage only the permanent electrode was implanted and connected to a temporary external stimulator, allowing patients to be assessed for longer. If the main symptoms improved by more than half the patient proceeded to the second stage, the insertion of the IPG. We reviewed all patients who underwent two-stage implantation; all had signed an informed consent and were asked to complete voiding diaries and a questionnaire to assess the subjective effects of the therapy. Safety was assessed from relevant medical events, management, and relative to the thera-py and resolution. Residual urine was assessed by self-catheterization. The long-term voiding diary results were compared with baseline estimates and analysed statistically using the two-sided Student's t -test. Results ,Between 1991 and 1998, 15 patients (13 women and two men, mean age 53 years, range 44,66) underwent the two-stage technique; the mean (median, range) follow-up was 4.9 (5.2, 2.5,7.5) years. Seven patients had UI and seven had UR, with one having both. The mean (range) number of PNEs undertaken in each patient was 2.1 (1,4) and these all failed in the subchronic phase. All patients underwent a first- and second-stage implant after a mean (range) screening period of 12.2 (2,29) days. One patient was explanted after implantation of only the first stage, and two others explanted in a later phase because the IPG was ineffective during the follow-up. The voiding diary results of the remaining 12 patients showed improvement in all the main variables, and in the subjective assessment 11 reported an improvement and were satisfied with the therapy. There were 17 adverse events, 14 of which were resolved and seven of which required surgical intervention. Conclusion ,The long-term results of the two-stage implantation show clinically and statistically significant improvements, probably because the implantation of the lead (first stage) more closely resembles the final therapy. If a temporary PNE test is not optimal (lead migration, longer testing needed), the two-stage technique can offer a good and safe alternative of comparable efficacy in the long-term. If the two-stage technique had not been available to these 12 patients they would not have been offered neuromodulation. [source]

Persistence and Improvement of Nasolabial Fold Correction with Nonanimal-Stabilized Hyaluronic Acid 100,000 Gel Particles/mL Filler on Two Retreatment Schedules: Results up to 18 Months on Two Retreatment Schedules

DERMATOLOGIC SURGERY, Issue 2008
RHODA S. NARINS MD
BACKGROUND Nonanimal-stabilized hyaluronic acid (NASHA) fillers are frequently used for facial soft tissue augmentation. Their long-term efficacy and the effects of different retreatment schedules are not well established. OBJECTIVE This is an 18-month interim analysis of a 30-month study to evaluate the efficacy and persistence of NASHA 100,000 gel particles/mL filler with two different retreatment schedules. METHODS This multicenter, randomized, evaluator-blinded study enrolled 75 patients with moderate to severe nasolabial folds. Patients were randomized to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months after correction of both folds at the initial visit. RESULTS Wrinkle Severity Rating Scale scores improved significantly (p<.001) from baseline, with mean improvements ranging from 1.1 to 1.7 grades. Almost all patients (97%) responded satisfactorily, and the efficacy of the retreatment schedules did not differ significantly. Adverse events, primarily swelling and bruising, occurred in 33% of patients; none were serious. CONCLUSION The improvements seen after initial treatment with NASHA 100,000 gel particles/mL filler persisted for up to 18 months with one retreatment. The response was equivalent for retreatment at 4.5 and 9 months. [source]

Four-Year Follow-up on Endovascular Radiofrequency Obliteration of Great Saphenous Reflux

DERMATOLOGIC SURGERY, Issue 2 2005
Robert F. Merchant MD
Background Endovascular radiofrequency obliteration has been used since 1998 as an alternative to conventional vein stripping surgery for elimination of saphenous vein insufficiency. Objective To demonstrate the long-term efficacy of this treatment modality. Methods Data were prospectively collected in a multicenter ongoing registry. Only great saphenous vein above-knee treatments were included in this study. Eight hundred ninety patients (1,078 limbs) were treated prior to November 2003 at 32 centers. Clinical and duplex ultrasound follow-up was performed at 1 week, 6 months, and 1, 2, 3, and 4 years. Results Among 1,078 limbs treated, 858 were available for follow-up within 1 week, 446 at 6 months, 384 at 1 year, 210 at 2 years, 114 at 3 years, and 98 at 4 years. The vein occlusion rates were 91.0%, 88.8%, 86.2%, 84.2%, and 88.8%, respectively; the reflux-free rates were 91.0%, 89.3%, 86.2%, 86.0%, and 85.7%, respectively; and the varicose vein recurrence rates were 7.2%, 13.5%, 17.1%, 14.0%, and 21.4%, respectively, at each follow-up time point at 6 months, and 1, 2, 3, and 4 years. Patient symptom improvement persisted over 4 years. Conclusions Endovascular temperature-controlled radiofrequency obliteration of saphenous vein reflux exhibits an enduring treatment efficacy clinically, anatomically, and hemodynamically up to 4 years following treatment. ROBERT F. MERCHANT, MD, AND OLIVIER PICHOT, MD, ARE PAID CONSULTANTS TO VNUS MEDICAL TECHNOLOGIES, WHICH PROVIDED FINANCIAL SUPPORT FOR THIS STUDY. [source]

Laser Hair Removal: Long-Term Results with a 755 nm Alexandrite Laser

DERMATOLOGIC SURGERY, Issue 11 2001
Sorin Eremia MD
Background. Hypertrichosis is a common problem for which laser hair removal is becoming the treatment of choice. Optimal wavelength, pulse duration, spot size, fluence, and skin cooling parameters for various skin types have not yet been firmly established. Objective. To evaluate the long-term efficacy and safety of a 3-msec 755 nm alexandrite laser equipped with a cryogen cooling device for patients with Fitzpatrick skin types I,V. Methods. Eighty-nine untanned patients with skin types I,V underwent a total of 492 treatments of laser hair removal over a 15-month period. Each patient in the study underwent a minimum of three treatment sessions spaced 4,6 weeks apart (mean treatments 5.6). Retrospective chart review and patient interviews were used to establish hair reduction results. Treatment sites included the axillae, bikini, extremities, face, and trunk. A 3-msec pulse width, 755 nm alexandrite laser equipped with a cryogen spray cooling device was used in this study. Spot sizes of 10,15 mm were used. A spot size of 10 mm was used for fluences greater than 40 J/cm2, a spot size of 12 mm was used for fluences of 35,40 J/cm2, and spot sizes of 12 and 15 mm were used for fluences less than 30 J/cm2. Fluences ranging from 20 to 50 J/cm2 (mean fluence 36 J/cm2) were used. Results. The patients had a mean 74% hair reduction. Skin type I patients had an average of 78.5% hair reduction using a mean fluence of 40 J/cm2 (35,50 J/cm2) and a 10,12 mm spot size (12 mm in more than 95% of treatments). Skin type II patients had a mean 74.3% hair reduction using a mean fluence of 38 J/cm2 (30,40 J/cm2) and a 12,15 mm spot size. Skin type III patients had a mean 73.4% hair reduction using a mean fluence of 37 J/cm2 (25,40 J/cm2) and a 12,15 mm spot size. Skin type IV patients had a mean 71.0% hair reduction using a mean fluence of 31 J/cm2 (25,35 J/cm2) and a 12,15 mm spot size. A patient with skin type V had a 60% hair reduction using a mean fluence of 23 J/cm2 (20,25 J/cm2) and a 12,15 mm spot size. The efficiency of hair removal directly correlates significantly with the fluence used. Rare side effects included transient postinflammatory hyperpigmentation (n = 9; 10%), burn with blisters (n = 1; 1%), and postinflammatory hypopigmentation (n = 2; 2%). All complications resolved without permanent scarring. Conclusion. The 3-msec cryogen cooling-equipped alexandrite laser can safely and effectively achieve long-term hair removal in patients with skin types I,V. The best results are achieved in untanned patients with skin types I,IV. [source]

Topical tacrolimus in the management of atopic dermatitis in Japan

DERMATOLOGIC THERAPY, Issue 2 2006
Masutaka Furue
ABSTRACT:, Atopic dermatitis (AD) is a common, chronic, relapsing, severely pruritic, eczematous skin disease. Topical steroids are the mainstay of treatment. However, the adverse effects of steroids on hormonal function are the major obstacle for their use as long-term topical therapy. Topical calcineurin inhibitors, such as tacrolimus, not only complement existing treatment options but also overcome some of the drawbacks of topical steroid therapy and fulfill the long-term needs of patients in preventing disease progression. Short- and long-term efficacy and safety of topical tacrolimus has been widely recognized and it is also accepted as a first-line treatment for the inflammation of AD. In order to reduce the possible long-term adverse effects, it is important to monitor the clinical dose in daily clinics. [source]

Why insulin sensitizers but not secretagogues should be retained when initiating insulin in type 2 diabetes

DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 1 2008
Philip Raskin
Abstract The stringent targets set for HbA1c levels in type 2 diabetes are currently achieved by fewer than half the patients in the United States. Failure to manage hyperglycaemia in the early stages of disease results in progressive loss of ,-cell function, which ultimately necessitates the initiation of insulin therapy. At this point, choices have to be made on whether to continue oral anti-diabetic drug therapy and, if so, with which agent(s). Historically, sulfonylureas have been the mainstay of oral anti-diabetic drug therapy; however, their long-term efficacy in patients with depleted ,-cell capacity is doubtful, and other classes of oral anti-diabetic drugs, notably the insulin sensitizers, may prove more reliable. These agents (metformin and thiazolidinediones) appear to provide various benefits over and above sustained glycaemic control, which may variably include reduced loss of ,-cell function as well as improvements to cardiovascular risk factors, morbidity, and mortality. Metformin also limits weight gain associated with insulin therapy. This manuscript presents the case that when insulin therapy is initiated it should be tailored to individual needs through combination with one or more insulin sensitizers rather than a secretagogue. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal,bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial

Long-term follow-up of achalasic patients treated with botulinum toxin

DISEASES OF THE ESOPHAGUS, Issue 2 2000
D'Onofrio
Botulinum toxin A (BoTx), a potent inhibitor of acetylcholine release from nerve endings both within the myenteric plexus and at the nerve,muscle junction, has been shown to decrease the lower esophageal sphincter (LES) pressure in patients with achalasia. Because of this property, the esophageal injection of BoTx has been suggested as an alternative treatment in achalasia. The objective of this study was to determine the long-term efficacy and safety of intrasphincteric injection of BoTx in a group of achalasic patients. Nineteen patients (mean age 56.1 ± 19.2 years) were enrolled in the study. All of them were injected endoscopically with 100 U of BoTx by sclerotherapy needle at different sites of the LES. Symptom score (dysphagia, regurgitation and chest pain, each on a 0,3 scale), esophageal manometer and esophageal radionuclide emptying were assessed before the treatment and at 4 weeks, 3 months and 1 year after BoTx injection. In case of failure or relapse (symptom score >2), the treatment was repeated. All but five patients (74%) were in clinical remission at 1 month. Mean symptom score after 1 month of BoTx decreased from 7.1 ± 0.9 to 2.2 ± 2.5 (p < 0.05). LES pressure decreased from 38.4 ± 13.7 to 27.4 ± 13.5 mmHg (p < 0.05) and 10-min radionuclide retention decreased from 70.9 ± 20.7% to 33.8 ± 27.0% (p < 0.05). Side-effects (transient chest pain) were mild and infrequent. At 12 months, the clinical score was 0.9 ± 0.5 (p < 0.05 vs. basal); mean LES pressure was 22.0 ± 7.1 (p < 0.05 vs. basal) and 10-min radionuclide retention was 15.8 ± 6.0% (p < 0.05 vs. basal). The efficacy of the first injection of BoTx lasted for a mean period of 9 months (range 2,14 months). At the time of writing (follow-up period mean 17.6 months, range 2,31), 14 patients (10 with one injection) were still in remission (74%). Our results showed that one or two intrasphincteric injections of BoTx resulted in clinical and objective improvement in about 74% of achalasic patients and are not associated with serious adverse effects; the efficacy of BoTx treatment was long lasting; this procedure could be considered an attractive treatment, especially in elderly patients who are poor candidates for more invasive procedures. [source]

Internet-based prevention for alcohol and cannabis use: final results of the Climate Schools course

ADDICTION, Issue 4 2010
Nicola C. Newton
ABSTRACT Aims To establish the long-term efficacy of a universal internet-based alcohol and cannabis prevention programme in schools. Methods A cluster-randomized controlled trial was conducted to assess the effectiveness of the Climate Schools: Alcohol and Cannabis Course. The evidence-based course, aimed at reducing alcohol and cannabis use, is facilitated by the internet and consists of 12 novel and curriculum consistent lessons delivered over 6 months. Participants A total of 764 year 8 students (13 years) from 10 Australian secondary schools were allocated randomly to the internet-based prevention programme (n = 397, five schools), or to their usual health classes (n = 367, five schools). Measures Participants were assessed at baseline, immediately post, and 6 and 12 months following completion of the intervention, on measures of alcohol and cannabis knowledge, attitudes, use and related harms. Results This paper reports the final results of the intervention trial, 12 months following the completion of the Climate Schools: Alcohol and Cannabis Course. The effectiveness of the course 6 months following the intervention has been reported previously. At the 12-month follow-up, compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge, a reduction in average weekly alcohol consumption and a reduction in frequency of drinking to excess. No differences between groups were found on alcohol expectancies, cannabis attitudes or alcohol- and cannabis-related harms. The course was found to be acceptable by teachers and students as a means of delivering drug education in schools. Conclusions Internet-based prevention programs for school-age children can improve student's knowledge about alcohol and cannabis, and may also reduce alcohol use twelve months after completion. [source]

Fabry disease: overall effects of agalsidase alfa treatment

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 12 2004
M. Beck
Abstract Background, Fabry disease is a rare X-linked disorder caused by deficient activity of the lysosomal enzyme ,-galactosidase A. Progressive accumulation of the substrate globotriaosylceramide in cells throughout the body leads to major organ failure and premature death. The Fabry Outcome Survey (FOS) is a European outcomes database which was established to collect data on the natural history of this little-known disease and to monitor the long-term efficacy and safety of enzyme replacement therapy (ERT) with agalsidase alfa. This paper presents the first analysis of the FOS database on the effects of ERT on renal function, heart size, pain and quality of life. Design, The effects of 1 and 2 years of ERT with agalsidase alfa on renal function (assessed by estimated glomerular filtration rate), heart size (assessed by echocardiography), pain (assessed by the Brief Pain Inventory) and quality of life (assessed by the European Quality of Life Questionnaire EQ-5D) were analyzed in a cohort of 545 patients, 314 of whom were receiving treatment (188 for at least 12 months and 92 for at least 24 months; mean duration of treatment, 17 months; maximum duration, 56 months). Results, Treatment with agalsidase alfa stabilized renal function in patients with a mild or moderate deterioration in renal function at baseline, reduced left ventricular size in patients who had an enlarged heart at baseline, and improved pain scores and quality of life. These improvements were similar in hemizygous men and heterozygous women with Fabry disease. Conclusions, Enzyme replacement therapy with agalsidase alfa leads to significant clinical benefits in patients with Fabry disease, and treatment is likely to alter the natural history of this disorder. [source]

Prevention of embolic stroke by catheter ablation of atrial fibrillation

EUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2008
C. Stöllberger
Background and purpose:, Radiofrequency-catheter-ablation of atrial fibrillation is now commonly performed. Aim of this short review is to summarize questions and uncertainties concerning radiofrequency ablation of atrial fibrillation with respect to therapeutic mechanisms, long-term efficacy and stroke-prevention. Results:, The majority of atrial fibrillation patients is too old for radiofrequency ablation. Candidates for radiofrequency ablation belong to a subgroup with a low embolic risk. The radiofrequency ablation procedure itself may increase the embolic risk, and at present it is uncertain how long this embolic risk persists after the procedure. Conclusion:, We doubt if radiofrequency ablation prevents embolism in atrial fibrillation. [source]

Glomus jugulare tumor: Tumor control and complications after stereotactic radiosurgery

HEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 4 2002
Robert L. Foote MD
Abstract Background We evaluated toxicity and long-term efficacy of stereotactic radiosurgery in patients with symptomatic or progressive glomus jugulare tumors. Methods Twenty-five consecutive patients (age, 30,88 years; 17 women, 8 men) who underwent stereotactic radiosurgery with the Leksell Gamma Knife (dose, 12,18 Gy) were prospectively followed. MRI and clinical examinations were performed at 6 months and 1, 2, and 3 years, and then every 2 years. Results None of the tumors increased in size, 17 were stable, and 8 decreased (median imaging follow-up, 35 months; range, 10,113 months). Symptoms subsided in 15 patients (60%); vertigo occurred in 1, but balance improved with vestibular training (median clinical follow-up, 37 months; range, 11,118 months). No other new or progressive neuropathy of cranial nerves V,XII developed. Conclusions Stereotactic radiosurgery can achieve excellent tumor control with low risk of morbidity in the treatment of glomus jugulare tumors. The lower cranial nerves can safely tolerate a radiosurgical dose of 12 to 18 Gy. © 2002 Wiley Periodicals, Inc. Head Neck 24: 332,339, 2002; DOI 10.1002/hed.10005 [source]

Large particle hyaluronic acid for the treatment of facial lipoatrophy in HIV-positive patients: 3-year follow-up study

HIV MEDICINE, Issue 3 2010
L Skeie
Objectives Facial lipoatrophy can be a stigmatizing side effect of antiretroviral (AVR) treatment for HIV-infected patients. We sought to evaluate the long-term efficacy and safety of a new formulation of hyaluronic acid that can be injected in larger amounts and into deeper skin layers during 3 years of follow-up. Methods Twenty patients received injections of Restylane SubQÔ. Refill treatment was offered at 12 and 24 months. Treatment effects were evaluated using ultrasound, the Global Aesthetic Improvement Scale, visual analogue scale (VAS) and the Rosenberg self-esteem scale. Results Seventeen patients remained at 36 months. Mean (± standard deviation) total cutaneous thickness increased from 6 ± 1 mm at baseline to 12 ± 1 mm (P<0.001) at 36 months. Response rate (total cutaneous thickness >10 mm) was 70%. Fifteen patients classified their facial appearance as very much or moderately improved. VAS increased from 39 ± 25 to 70 ± 20 (P<0.05) and higher self-esteem scores were reported. Local swelling and tenderness after treatment was common. Persistent papules found in several patients after treatment were removed effectively with hyaluronidase injections. Three patients, treated only at baseline, still had higher total cutaneous thickness scores at 36 months. Conclusions Our results indicate that a large particle hyaluronic acid formulation is a durable and well-tolerated dermal filler for treating HIV-positive patients with facial lipoatrophy. [source]

Long-term outcome of tenofovir disoproxil fumarate use against hepatitis B in an HIV-coinfected cohort

HIV MEDICINE, Issue 5 2009
G Alvarez-Uria
Objectives Tenofovir disoproxil fumarate (TDF) is active against hepatitis B virus (HBV) and HIV. However, the long-term efficacy of tenofovir disoproxil fumarate (TDF) is not well known and the appearance of resistance is a major concern. We have studied the efficacy of TDF against HBV in patients treated at an Infectious Diseases Unit. Methods We carried out a retrospective observational study of the efficacy of TDF against HBV replication in a cohort of 52 HIV-coinfected patients who received TDF for at least 6 months. Results The median duration of follow-up of TDF treatment was 34 months. Forty-one patients (79%) were positive for HBV envelope antigen (HBeAg) and 35 had received previous lamivudine monotherapy for a median duration of 32 months. Virological breakthrough was observed in nine cases (17%). At the end of the follow-up period, HBV DNA levels were <1000 copies/mL in 42 patients (81%) and <200 copies/mL in 31 patients (60%). There were no significant differences between the lamivudine-naïve and lamivudine-experienced groups. In the lamivudine-experienced group, the duration of previous lamivudine monotherapy was associated with failure to achieve HBV DNA levels <200 copies/mL (P=0.036). Adding lamivudine or emtricitabine to TDF did not improve virological suppression. In 39 patients who achieved <200 HBV DNA copies/mL during TDF treatment, virological breakthrough was seen only in two patients (5%) after a median follow-up duration of 39.7 months. Conclusions TDF was able to control HBV replication in most HIV-coinfected patients after a median follow-up duration of 34 months, regardless of previous lamivudine treatment. However, a sizeable proportion of patients developed virological breakthrough. [source]

Long-term assessment of nevirapine-containing highly active antiretroviral therapy in antiretroviral-naive HIV-infected patients: 3-year follow-up of the VIRGO study

HIV MEDICINE, Issue 7 2006
V Reliquet
Objectives Data on the durability of antiretroviral regimens over a 3-year period have only rarely been reported. The aim of this study was to evaluate the long-term efficacy and safety of one or two daily doses of nevirapine (NVP), in combination with stavudine (d4T) and didanosine (ddI), in HIV-infected patients. Methods This study was a follow-up of the VIR (amune) Grand Ouest (VIRGO) study, a 12-month open-label trial to assess the safety and immunovirological activity of NVP-d4T-ddI combination therapy in antiretroviral-naive HIV-1-infected adults with baseline CD4 counts ,200 cells/,L and plasma viral loads ,5000 HIV-1 RNA copies/mL. Of the 100 patients included in the study, the 67 patients remaining on the initial triple therapy at the end of the study (1 year) were offered an extra 24 months of follow-up. Results Of the 60 patients who extended follow-up, 46 were still being treated with d4T-ddI-NVP at month 36; 91% (39/43) had a plasma viral load <500 copies/mL (data were missing for three patients). CD4 cell counts increased over 36 months. Safety and tolerance were good with no unexpected long-term toxicity. Conclusion After 3 years of treatment with NVP-d4T-ddI, nearly half of the patients were still receiving the initial antiretroviral therapy with a sustained and durable immunovirological benefit. Long-term toxicity was mainly related to the nucleoside reverse transcriptase inhibitor components of the regimen. [source]

Efficacy of infliximab in refractory pouchitis and Crohn's disease-related complications of the pouch: A Belgian case series

INFLAMMATORY BOWEL DISEASES, Issue 2 2010
Marc Ferrante MD
Abstract Background: Up to 25% of inflammatory bowel disease (IBD) patients undergoing surgery with an ileal pouch,anal anastomosis (IPAA) will develop chronic pouchitis not responding to antibiotics. In case reports, thiopurine analogs and infliximab (IFX) have been proposed as effective therapy in this setting. We analyzed the long-term efficacy of IFX in Belgian patients with refractory pouch complications. Methods: We identified 28 IPAA patients who received IFX for refractory luminal inflammation (pouchitis and/or pre-pouch ileitis, n = 25) and/or pouch fistula (n = 7). Patients with elements of Crohn's disease after review of the colectomy specimen were excluded. Clinical response was defined as complete in case of cessation of diarrhea, blood loss, and abdominal pain, and as partial in case of marked clinical improvement. Fistula response was defined as complete in case of cessation and as partial in case of reduction of fistula drainage. Results: Eighty-two percent of patients were concomitantly treated with immunomodulatory agents. At week 10 following start of IFX, 88% of patients with refractory luminal inflammation showed clinical response (14 partial, 8 complete), while 6 patients (86%) showed fistula response (3 partial, 3 complete). The mPDAI dropped significantly from 9.0 (interquartile range [IQR] 8.0,10.0) to 4.5 (3.0,7.0) points (P < 0.001). After a median follow-up of 20 (7,36) months, 56% showed sustained clinical response while 3 out of 7 fistula patients showed sustained fistula response. Five patients needed permanent ileostomy. Conclusions: In this series, IFX was effective long-term in IPAA patients with refractory luminal inflammation and pouch fistula. These results warrant a prospective multicenter randomized controlled trial. Inflamm Bowel Dis 2009 [source]