Favorable Safety Profile (favorable + safety_profile)

Distribution by Scientific Domains

Selected Abstracts

A 52-Month Summary of Results Using Calcium Hydroxylapatite for Facial Soft Tissue Augmentation

OBJECTIVES In this large-scale clinical review, we investigated the safety and efficacy of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds, marionette lines, and other areas of the face. METHODS After obtaining informed consent from the subjects, CaHA was injected in 1,000 patients (886 women and 114 men, ranging in age from 21 to 85 years) for a variety of facial aesthetic applications over a period of 52 months. Typically, CaHA was administered with a 27-gauge 1/2, or 1 1/4-inch needle. RESULTS The nasolabial folds were the most frequently treated site, followed by the marionette lines/oral commissure. More than 80% of patients reported persistence of results at 12 months. The most frequently reported adverse events were erythema and ecchymosis. The formation of nodules was rare and was chiefly confined to the lips. Only two patients experienced nodule formation outside the lips. CONCLUSIONS Over a period of more than 4 years, we found that CaHA performed well, with a favorable safety profile, high patient satisfaction, and good durability. [source]

A Multicenter, 47-Month Study of Safety and Efficacy of Calcium Hydroxylapatite for Soft Tissue Augmentation of Nasolabial Folds and Other Areas of the Face

OBJECTIVES Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group. METHODS After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle. RESULTS Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively. CONCLUSIONS In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction. [source]

Therapy with antioxidants in human diabetic neuropathy

D. Ziegler
Increased oxidative stress has been implicated in the pathogenesis of diabetic polyneuropathy (DPN). Antioxidant treatment with alpha-lipoic acid (ALA) has been shown to prevent or ameliorate experimental diabetic neuropathy, providing the rationale for treatment in humans. A recent meta-analysis including four controlled clinical trials provided evidence that treatment with ALA (600 mg/day i.v.) over 3 weeks is safe and significantly improves both neuropathic symptoms and deficits to a clinically meaningful degree in patients with symptomatic DPN. Moreover, oral treatment for 4,7 months tends to ameliorate neuropathic deficits and cardiac autonomic neuropathy. Clinical and postmarketing surveillance studies have revealed a highly favorable safety profile of this drug. Based on these findings, a pivotal long-term multicenter trial of oral treatment with ALA (NATHAN 1 Study) is under way aimed at slowing the progression of DPN. [source]

A randomized, double-blind study of certoparin vs. unfractionated heparin to prevent venous thromboembolic events in acutely ill, non-surgical patients: CERTIFY Study

Summary.,Background:,In medically ill patients, no contemporary double-blind head-to-head evaluation of low molecular weight heparin vs. unfractionated heparin (UFH) for the prevention of venous thromboembolic events is available. Objectives:,To compare the efficacy and safety of certoparin with those of UFH. Patients/Methods:,In this double-blind, randomized, controlled trial, acutely ill, non-surgical patients aged , 70 years were randomized to certoparin (3000 U of anti-factor Xa once daily) or to UFH (5000 IU t.i.d.). The primary endpoint was the composite of proximal deep vein thrombosis as assessed by bilateral compression ultrasonography, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death, and was assessed by a blinded central adjudication committee. Non-inferiority margins were set at 1.8 for the odds ratio (OR) and 3.45% for the absolute difference. Results:,Three thousand two hundred and thirty-nine patients aged 78.8 6.3 years were treated for 9.1 3.4 days. The incidence of the primary endpoint was 3.94% in the certoparin group and 4.52% in the UFH group, with a difference in proportions of , 0.59% [95% confidence interval (CI) ,2.09 to 0.92; P < 0.0001 for non-inferiority], and an OR of 0.87 (95% CI 0.60,1.26; P = 0.0001 for non-inferiority). Major bleeding occurred in 0.43% of certoparin-treated patients and 0.62% of UFH-treated patients (OR 0.69; 95% CI 0.26,1.83). Any bleeding occurred at 3.20% in certoparin-treated patients vs. 4.58% in UFH-treated patients (OR 0.69; 95% CI 0.48,0.99; P < 0.05), and 5.73% of certoparin-treated patients and 6.63% of UFH-treated patients experienced serious adverse events. All-cause mortality was 1.27% in certoparin-treated patients and 1.36% in UFH-treated patients. Conclusions:,In acutely ill, non-surgical elderly patients, thromboprophylaxis with certoparin (3000 U of anti-FXa once daily) was non-inferior to 5000 IU of UFH t.i.d., with a favorable safety profile. [source]

C2 monitoring of cyclosporine in de novo liver transplant recipients: The clinician's perspective

Federico Villamil
Adjusting cyclosporine (CsA) dose based on blood concentration at 2 hours after dose (C2) has been shown in prospective clinical trials to reduce the risk of rejection compared with conventional trough monitoring. In addition, it provides equivalent efficacy to tacrolimus in liver transplant patients, with a favorable safety profile. Target C2 should be defined on an individual basis depending on adjunctive therapy and the level of exposure required. It appears less critical to achieve target C2 in the first few days after liver transplantation than was previously believed. Achieving target C2 exposure in the initial period after transplant requires that changes in the proportion of cyclosporine absorbed from the gut be taken into account to avoid risk of overexposure. In addition, if a starting dose of 10,15 mg/day is used, it is advisable to delay increasing the dose until a trend in C2 level indicates this to be necessary. Immediate dose reduction is required if C2 exceeds target range. In patients with low C2 values, cyclosporine concentration at a later time point should be measured to establish whether the patient is a poor absorber or a delayed absorber of C2, and dose adjustments should be undertaken accordingly. In conclusion, this more flexible approach to C2 monitoring allows the dose of cyclosporine to be individualized effectively for each patient, which results in significant efficacy benefits while minimizing the risk of toxicity. (Liver Transpl 2004;10:577,583.) [source]

Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases. (University of Pennsylvania Health System, School of Medicine, Pennsylvania, PA).

PAIN PRACTICE, Issue 4 2001
Arch Phys Med Rehabil.
Failed back surgery syndrome (FBSS) is a long-lasting often disabling, and relatively frequent (5% to 10%) complication of lumdosacral spine surgery. Epidural fibrosis is among the most common causes of FBSS, and it is often recalcitrant to treatment. Repeated surgery for fibrosis has only a 30% to 35% success rate, whereas 15% to 20% of patients report worsening of their symptoms. Long-term outcome studies focusing on pharmacologic management of chronic back pain secondary to epidural fibrosis are lacking in the literature. This report presented 2 cases of severe epidural fibrosis managed successfully with gabapentin monotherapy. In both cases, functional status improved markedly and pain was significantly diminished. Gabapentin has an established, favorable safety profile and has been shown to be effective in various animal models and human studies of chronic neuropathic pain. Conclude clinicians should consider gabapentin as a pharmacological treatment alternative in the management of FBSS caused by epidural fibrosis. [source]

Real-Life Safety and Efficacy of Vardenafil in the Treatment of Erectile Dysfunction,Results from 30,010 U.S. Patients

Eric Cheng MD
ABSTRACT Introduction., Clinical trials show that vardenafil produces effective and satisfactory first-dose success rates and reliability for erection and intercourse in men with erectile dysfunction (ED). Aim., This study was conducted to evaluate real-life efficacy, safety, and acceptance of vardenafil in men with ED. Methods., This open-label, prospective study, conducted in 6,740 U.S. centers, included an initial visit and one or two follow-up visits within a 2-month period of the first vardenafil dose. Vardenafil was administered in 5,20 mg doses. Main Outcome Measures., Efficacy variables included first-dose success rates for vaginal penetration, maintenance of erection, and satisfaction based on physician and patient assessments. Safety was assessed by adverse events (AEs). Results., A total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile function in 78% of men, with 75% rating overall efficacy as "satisfying" or "very satisfying." The overall rates of successful penetration and maintenance with vardenafil following the first dose were 78% and 68%, respectively. For men with mild and moderate ED, first-dose success rates for penetration were 89% and 82%, respectively, and for maintenance, 82% and 71%, respectively. First-dose penetration and maintenance of erection rates were 76% and 66%, respectively, for men with self-reported hypertension, and 70% and 60%, respectively, for men with diabetes mellitus. At study end, 67% of patients preferred to continue using vardenafil. The most frequently reported AEs were headache (4%) and flushing (2%). Vardenafil was well tolerated, with a "satisfied/very satisfied" tolerability rating in 75% of cases as assessed by the physician. Conclusions., This observational study demonstrated the tolerability and efficacy of vardenafil in men with ED and comorbidities. Vardenafil provided a high rate of first-dose intercourse success and a favorable safety profile in patients with and without comorbid disease. Cheng E. Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction,Results from 30,010 U.S. patients. J Sex Med 2007;4:432,439. [source]

Safety and tolerability of FOLFOX4 in the adjuvant treatment of colon cancer in Asian patients: The MASCOT study

Po-Huang LEE
Abstract Aims: The MOSAIC trial showed that FOLFOX4 improves overall survival as compared to 5-FU/LV and is feasible and safe in early stage colon cancer patients worldwide. Based on these positive results, the present study MASCOT (Multicenter Asia Study in adjuvant treatment of Colon cancer with Oxalipla Tin/5-FU/LV), aimed to evaluate the safety and tolerability of FOLFOX4 in postoperative adjuvant treatment of colon cancer in Asian patients. Methods: In this open-label, non-randomized, single arm feasibility study, stage II/III colon cancer patients who had undergone complete resection of a primary tumor were treated using the FOLFOX4 regimen (2 weeks/cycle, 12 cycles) and followed up for 12 months. Results: A total of 159 patients (28.3% stage II and 71.7% stage III) from 17 hospitals in five Asian countries were included in the study. Overall 130 (81.8%) patients completed all 12 planned treatment cycles. There were 60% and 11% patients who experienced , grade 3 pre-listed and non pre-listed toxicities, respectively. The incidences of grade 3 and 4 neuropathy were 5.7% and 0%, respectively. A total of 25 serious adverse events (SAE) were experienced by 21 (13%) patients, with one life-threatening SAE. At 12 months follow-up two patients were known to be dead due to disease relapse or recurrence. Conclusion: The MASCOT study demonstrates a favorable safety profile of FOLFOX4 in Asian patients. Based on these results and the safety and efficacy results from MOSAIC, FOLFOX4 may be considered a standard for the adjuvant treatment of colon cancer in the Asian population. [source]

Combination therapy with rituximab and intravenous or oral fludarabine in the first-line, systemic treatment of patients with extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue type,,

CANCER, Issue 22 2009
Antonio Salar MD
Abstract BACKGROUND: Currently, there are no consensus guidelines regarding the best therapeutic option for patients with extranodal marginal zone lymphomas of the mucosa-associated lymphoid tissue (MALT) type. METHODS: Patients with systemically untreated or de novo extranodal MALT lymphoma received rituximab 375 mg/m2 intravenously on Day 1 and fludarabine 25 mg/m2 intravenously on Days 1 through 5 (Days 1-3 in patients aged >70 years) every 4 weeks, for 4 to 6 cycles. After the first cycle, oral fludarabine could be given orally at 40 mg/m2 on the same schedule. After 3 cycles, a workup was done. Patients who achieved a complete remission (CR) received an additional cycle, and patients who achieved a partial remission (PR) received a total of 6 cycles. RESULTS: Twenty-two patients were studied, including 12 patients with gastric lymphoma and 10 patients with extragastric MALT lymphoma. Six patients (27%) had stage IV disease. In total, 101 cycles were administered (median, 4 cycles per patients). After the third cycle, 13 patients (62%) achieved a CR, and 8 patients (38%) achieved a PR. Primary extragastric disease was an adverse factor to achieve CR after 3 cycles of chemotherapy (hazard ratio, 23.3; 95% confidence interval, 2.0-273.3). At the end of treatment, the overall response rate was 100%, and 90% of patients achieved a CR. The progression-free survival rate at 2 years in patients with gastric and extragastric MALT lymphoma was 100% and 89%, respectively. Toxicities were mild and mainly were hematologic. CONCLUSIONS: Combination therapy with rituximab and fludarabine is a very active treatment with favorable safety profile as first-line systemic treatment for patients with extranodal MALT lymphoma. Cancer 2009. 2009 American Cancer Society. [source]