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Common Side Effects (common + side_effects)
Selected AbstractsImprovement of Postfractional Laser Erythema with Light-Emitting Diode PhotomodulationDERMATOLOGIC SURGERY, Issue 5 2009TINA S. ALSTER MD BACKGROUND The most common side effects of fractional laser skin treatment are erythema and edema. Low-level light therapy and light-emitting diode (LED) devices have been used to stimulate fibroblast activity and hasten wound healing. OBJECTIVE To determine whether LED treatment immediately after fractional laser skin resurfacing affects the severity and duration of postoperative eythema. MATERIALS AND METHODS Twenty patients received treatment with a 590-nm wavelength LED array to randomly selected facial halves immediately after undergoing full-face fractional laser skin resurfacing with a 1,550-nm erbium-doped fiber laser. Differences in erythema between LED-treated and untreated facial halves were recorded at 24, 48, and 96 hours post-treatment. RESULTS The LED-treated facial halves were less erythematous in all 20 patients 24 hours postoperatively. The six patients who received the highest mean energy densities during fractional laser treatment continued to exhibit decreased erythema in the LED-treated areas at 48 hours. At 96 hours post-treatment, no discernible differences between facial halves were observed in any patient. CONCLUSIONS Photomodulation with a 590-nm-wavelength LED array can decrease the intensity and duration of postfractional laser treatment erythema. [source] Laser Lipolysis Using a Novel 1,064 nm Nd:YAG LaserDERMATOLOGIC SURGERY, Issue 2 2006KAREN H. KIM MD BACKGROUND We studied the safety and efficacy of a 1,064 nm Nd:YAG laser with a 300 ,m fiber for the reduction of small unwanted fat areas. METHODS Thirty subjects with focal areas of fat less than 100 cm3 were enrolled. Ten subjects were treated with laser lipolysis and had magnetic resonance imaging (MRI) at baseline and 3 months post-treatment. Ten subjects had laser lipolysis followed by biweekly treatments with the Tri-active system. The last group of 10 subjects served as control. Patients were seen at baseline, 1 week, 1 month, and 3 month follow-up visits. RESULTS Twenty-nine patients completed the study. Self-assessment evaluations reported an improvement of 37% at the 3-month follow-up visit. MRI demonstrated an average 17% reduction in fat volume. Smaller baseline volume areas, such as the submentum, showed better results, suggesting a dose-response relationship. The most common side effects were mild bruising and swelling resolving within 2 weeks. CONCLUSION Laser lipolysis using the 1,064 nm Nd:YAG laser with 300 ,m fiber appears to be a very promising procedure that delivers good, reproducible results safely and effectively. The advantages include excellent patient tolerance, quick recovery time, as well as the benefit of dermal tightening. [source] Monoclonal antibodies: a morphing landscape for therapeuticsDRUG DEVELOPMENT RESEARCH, Issue 10 2006Nicholas C. Nicolaides Abstract The concept of using antibodies as therapeutics to cure human diseases was postulated nearly 100 years ago by Paul Ehrlich and subsequently enabled by the discovery of hybridoma technology by Kohler and Milstein in 1975. While the use of monoclonal antibodies (mAbs) as drugs that can specifically target a disease-associated antigen is compelling, it has taken a quarter century for these molecules to be adopted as bona fide therapeutic agents. Despite their slow pursuit in drug development during the pioneering years, it is now estimated that there are nearly 500 mAb-based therapies in development. Major factors that have influenced the acceptance of monoclonal antibodies as therapeutics include their drug safety profiles, technological advancements for facilitating mAb discovery and development, and market success. Early on, it was demonstrated that antibodies could elicit clinical benefit by antagonizing a specific antigen without the common side effects that are prevalent with small chemical entities due to their nonspecific effects on homeostatic biochemical pathways. In addition, the significant technological advances that the biotechnology industry has established for developing and producing monoclonal antibodies at commercial scale in a more efficient and cost-effective manner has broadly enabled their use as therapeutics. However, despite the beneficial pharmacologic advantages and technological advances, it has been the sheer market success that monoclonal antibody products have achieved over the past few years that has propelled their vast pursuit by the biopharmaceutical industry in light of their value-creating potential. Here we provide an overview of the monoclonal antibody industry and discuss evolving technologies and strategies that are being pursued to overcome challenges in the changing marketplace. Drug Dev. Res. 67:781,789, 2006. © 2007 Wiley-Liss, Inc. [source] Outcome predictors, efficacy and safety of Botox and Dysport in the long-term treatment of hemifacial spasmEUROPEAN JOURNAL OF NEUROLOGY, Issue 3 2009A. R. Bentivoglio Background and purpose:, To review the clinical characteristics and the long-term outcome of patients with hemifacial spasm (HFS) who received botulinum neurotoxin (BoNT) over the past 10 years. Results:, A total of 108 patients received 665 treatments. Mean latency of clinical effect was 5.4 ± 5.3 days for Botox and 4.9 ± 4.6 days for Dysport (P > 0.05). Mean duration of clinical improvement was higher after the injection of Dysport than Botox: 105.9 ± 54.2 and 85.4 ± 41.6 days respectively (P < 0.01). The percentage of treatment failures was 6.5% for Botox and 4.6% for Dysport (P > 0.05). The doses of Botox significantly increased over time (, = 0.35, P < 0. 001) whilst Dysport dose remained unchanged (, = 0.16, n.s.). The duration of clinical benefit slightly increased with Botox (, = 0.12; P < 0.01), but remained constant for Dysport. Side effects occurred in 17.4% of treatments: 16.7% of patients who had received Botox, and in 19.7% who had received Dysport (P > 0.05). The most common side effects were palpebral ptosis and lacrimation; ptosis and lagophtalmos was more common in Dysport treatments (P < 0.005). Conclusions:, Both brands are effective and safe in treating HFS; efficacy is long-lasting. The differences in outcome and side effects confirm that, albeit the active drug is the same, Botox and Dysport should be considered as two different drugs. [source] Topiramate as an Adjunctive Treatment in Migraine ProphylaxisHEADACHE, Issue 10 2003Héctor R. Martínez MD Background.,Anticonvulsants now are commonly used for headache prevention. Topiramate, one of the newer anticonvulsants, recently has been demonstrated to be effective as monotherapy for migraine prophylaxis. Objective.,To assess the efficacy, safety, and tolerability of topiramate as adjunctive prophylactic therapy for migraine. Material and Methods.,A prospective trial involving patients with more than 3 migraine attacks per month was performed. Patients continued their usual prophylactic treatment. Baseline analgesic use and frequency and duration of migraine attacks were recorded. A 4-point visual analog scale evaluated severity. Laboratory tests, electrocardiogram, and computed tomography or magnetic resonance imaging were performed before study entry. After informed consent was obtained, patients were instructed to take 25 mg of topiramate per day, with 25- to 50-mg weekly increments to a maximum of 100 mg per day. Safety was assessed at the first month; tolerability and efficacy were assessed every week for the first month and then every month for 3 months. Effectiveness was assessed by comparing baseline and on-treatment migraine status, and data were analyzed by the Fisher exact test. Results.,Twenty-five women and 11 men (mean age, 44 years) were evaluated. Existing prophylactic treatment was either propranolol or flunarizine (or both) in 80% of the patients. At 3 months of therapy with topiramate, headache frequency decreased from 17 to 3 episodes per month, headache duration from 559 to 32 minutes, and intensity from 9 to 1 by visual analog scale (P < .001). Improvement in frequency and severity of migraine was observed in 83% of patients. Slight or no changes in headache were observed in 6 patients. Tolerability was good in 30 patients. The most common side effects were acroparesthesias, weight loss, sleepiness, and headache worsening. No adverse interaction with propranolol or flunarizine was observed. Conclusions.,These results suggest that topiramate is efficacious and safe as an adjunctive treatment in patients with migraine whose prior response to prophylactic management has been less than satisfactory. [source] Cardiac side effects of psychiatric drugs,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue S1 2008Paul Mackin Abstract This review describes the common effects of psychotropic drugs on the cardiovascular system and offers guidance for practical management. Selected reports from the literature describing common side effects associated with psychotropic drugs are reviewed, and suggestions for further reading are given throughout the text. Orthostatic hypotension is the most common adverse autonomic side effect of antipsychotic drugs. Among the atypical antipsychotics the risk of orthostatic hypotension is highest with clozapine and among the conventional drugs the risk is highest with low potency agents. Rarely, orthostatic hypotension may result in neurocardiogenic syncope. QTc prolongation can occur with all antipsychotics but an increased risk is seen with pimozide, thioridazine, sertindole and zotepine. QTc prolongation is a marker of arrhythmic risk. Torsade de pointe, a specific arrhythmia, may lead to syncope, dizziness or ventricular fibrillation and sudden death. Heart muscle disease presents most commonly in the elderly as chronic heart failure, but myocarditis and cardiomyopathy, although relatively rare, are devastating, but potentially reversible complications of psychotropic drug therapy have been particularly linked to clozapine treatment. Patients with severe mental illness (SMI) are a ,high risk' population with regard to cardiovascular morbidity and mortality. It is probable that many patients accumulate an excess of ,traditional' risk factors for the development of cardiovascular disease, but other mechanisms including psychotropic drugs may also be influential in increasing risk in this vulnerable group. These risks need to be seen in the context of the undoubted therapeutic efficacy of the psychotropic armamentarium and the relief that these drugs bring to those suffering from mental disorder. Copyright © 2007 John Wiley & Sons, Ltd. [source] 5-Aminosalicylic acid (mesalazine) use in Crohn's disease: A survey of the opinions and practice of Australian gastroenterologistsINFLAMMATORY BOWEL DISEASES, Issue 8 2007Richard B. Gearry MD Abstract Background: The use of 5-aminosalicylate (5-ASA) drugs in Crohn's disease (CD) is controversial, with their continuing apparent widespread use despite high-level evidence indicating marginal benefit at best and international guidelines recommending limited indications. Methods: In order to understand how clinicians translate the evidence base into clinical practice, we surveyed a cross-section of Australian gastroenterologists to determine opinions and prescribing patterns of 5-ASA drugs in CD. Results: In all, 42% of 285 gastroenterologists who were sent a questionnaire by e-mail responded. Five (4%) never use 5-ASA drugs in CD. The drugs are most commonly prescribed for patients with colonic (96%) or ileocolonic (92%) disease location, inflammatory disease behavior (80%), and mild disease activity (97%). The majority (64%) use a dose of 1,3 g/day, but only 6% use over 4.5 g/day. Less than one-half use 5-ASA drugs as maintenance following surgical resection, but most use it for inducing remission alone (70%) or in combination with other drugs (90%), and continue its use for maintenance. Side effects are thought to be infrequent (62%) or rare (20%) and few common side effects are believed to be serious. Respondents estimated that over 90% of patients were nonadherent to prescribed 5-ASA regimens at least 50% of the time. While 84% believed that 5-ASA drugs were effective in CD, only 58% believed that they were cost-effective. Conclusions: In Australia 5-ASA drugs are extensively prescribed for CD at relatively low doses without expectation of patient adherence. Current evidence and guidelines has had little apparent impact on clinical practice. The cost implications are considerable. (Inflamm Bowel Dis 2007) [source] Simultaneous onset of acute inflammatory response, sepsis-like symptoms and intestinal mucosal injury after cancer chemotherapyINTERNATIONAL JOURNAL OF CANCER, Issue 2 2003Eiichi Tsuji Abstract Chemotherapy is 1 method for the treatment of cancer, but serious side effects can sometimes limit the dosage given. Mild fever and diarrhea are common side effects of cancer chemotherapy. Gastrointestinal injury induced by chemotherapeutic agents may result in bacterial/endotoxin translocation from the gut into the systemic circulation. An experimental study was therefore conducted to clarify the effect of systemic chemotherapeutic agents on gastrointestinal barrier function. Male Wistar rats were divided into a 5-fluorouracil (5-FU) group (100 mg/kg/day for 4 days; n = 27) and a control group (n = 5). All rats were fasted and central venous catheterization was performed for total parenteral nutrition and blood sampling. Intestinal tissue was also sampled for pathological examination. Plasma levels of interleukin-6 (IL-6) and tumor necrosis factor , (TNF,) were determined by ELISA, bacterial translocation was quantified by lymph node culture and plasma endotoxin content of portal blood was measured by the Limulus -amebocyte-lysate test. In the 5-FU group on day 4, a proportion of rats exhibited severe watery diarrhea (73.9%) and occasional vomiting (86.2%). The levels of plasma TNF, and IL-6 were seen to increase, peaking at day 6 (IL-6, 350.0 ± 67.8 pg/ml; TNF,, 26.1 ± 3.2 pg/ml). The pathological findings also changed on day 4. On day 6, 90% of the rats in the 5-FU group showed dramatic sepsis-like manifestations, whereas the control group did not. Within the 5-FU group, only at day 6 was bacterial translocation in the rat mesenteric lymph nodes or significantly elevated levels of endotoxin evident. These results suggest that bacterial/endotoxin translocation might cause sepsis-like manifestations after systemic chemotherapy. © 2003 Wiley-Liss, Inc. [source] Pharmacotherapy Review: Calcium Channel BlockersJOURNAL OF CLINICAL HYPERTENSION, Issue 1 2006Domenic A. Sica MD As a drug class, calcium channel blockers encompass a heterogeneous group of compounds with distinctive structures and pharmacologic characteristics. These agents are widely used in the treatment of hypertension, chronic coronary ischemia, and/or supraventricular arrhythmias. Much of the early debate alluding to increased cardiovascular risk associated with calcium channel blocker use has been silenced by an array of outcomes trials that show these drugs to be both safe and effective in reducing hard cardiovascular end points. The most common side effects associated with calcium channel blockers are vasodilatory in nature and include a non-volume-dependent form of peripheral edema, flushing, and headache. Despite the sometimes discomforting side effects seen with calcium channel blocker therapy, their robust blood pressure-lowering effect makes them an important component of most multidrug regimens used for blood pressure control. [source] The PediSedate® device, a novel approach to pediatric sedation that provides distraction and inhaled nitrous oxide: clinical evaluation in a large case seriesPEDIATRIC ANESTHESIA, Issue 2 2007WILLIAM T. DENMAN MD FRCA Summary Background:, Pediatric sedation is of paramount importance but can be challenging. Fear and anticipatory anxiety before invasive procedures often lead to uncooperativeness. A novel device (PediSedate®) provides sedation through a combination of inhaled nitrous oxide and distraction (video game). We evaluated the acceptability and safety of the PediSedate® device in children. Methods:, We enrolled children between 3 and 9 years old who were scheduled to undergo surgical procedures that required general inhalational anesthesia. After the device was applied, he/she played a video game while listening to the audio portion of the game through the earphones. Nitrous oxide in oxygen was administered via the nasal piece of the headset starting at 50% and increasing to 70%, in 10% increments every 8 min. Treatment failures, vital signs, arterial oxygen saturation, depth of sedation, airway patency, side effects, acceptance of the device and parental satisfaction were all evaluated. Results:, Of 100 children included, treatment failure occurred in 18% mainly because of poor tolerance of the device. At least 96% of the children who completed the study exhibited an excellent degree of sedation, 22% had side effects, and none experienced serious airway obstruction. Nausea and vomiting were the most common side effects and no patients had hemodynamic instability. Conclusions:, The PediSedate® device combines nonpharmacologic with pharmacologic methods of sedation. Most of the children we evaluated were able to tolerate the PediSedate® device and achieved an adequate degree of sedation. [source] Vinorelbine, doxorubicin, and prednisone in androgen-independent prostate cancerCANCER, Issue 5 2006Lester S. Borden Jr. MD Abstract BACKGROUND. Ultimately, patients with metastatic prostate cancer progress on androgen ablation therapy. The investigation of new chemotherapeutic regimens for the treatment of androgen-independent prostate cancer (AIPC) is essential. The authors conducted a Phase II trial with vinorelbine, doxorubicin, and daily prednisone (NAP) to investigate the antitumor activity and palliative response of this regimen in patients with AIPC. METHODS. Forty-six patients entered this Phase II combination chemotherapy trial. Patients were treated with both vinorelbine and doxorubicin at doses of 20 mg/m2 on Days 1, 8, and 15 every 28 days and prednisone 5 mg twice daily. Endpoints included prostate-specific antigen (PSA) response and palliation, as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument, the Brief Pain Inventory Scale, and a narcotic analgesic log. RESULTS. The median follow-up for all 46 patients was 13.4 months. Fifty-two percent of patients had impaired performance status at baseline. One responding patient remained on NAP and was progression-free at 11.5 months. Thirty-nine patients progressed, 3 patients died prior to response assessment, and 3 patients refused therapy. The median overall survival was 57 weeks (95% confidence interval [95% CI], 36,76 weeks), and the median time to disease progression was 17 weeks (range, 11,24 weeks). The PSA response among the 36 patients who completed 3 cycles of NAP was 42% (95% CI, 26,59%). There was a statistically significant improvement in quality of life measured both by the FACT-General instrument (P = .03) and the FACT-P instrument (P = .0006) over the 3 months compared with baseline measurements. Pain medicine use also improved: The median morphine equivalents among patients who were taking pain medications at the time of study enrollment showed a substantial decline after 1 cycle of treatment that was maintained. Pain (as assessed by the Brief Pain Inventory) improved compared with baseline pain at the 2nd-month assessment (worst pain, P = .08; least pain, P = .02; and average pain, P = .003). Overall, the regimen was tolerated well. The most common side effects were mild fatigue and gastrointestinal complaints (all of which were Grade 1 or 2 [according to Version 2.0 of the Expanded Common Toxicity Criteria]). Seventeen patients (37%) experienced Grade 3 or 4 neutropenia. Five patients (11%) developed a cardiac ejection fraction of <50% during treatment and had doxorubicin discontinued. No patients developed clinical congestive heart failure. CONCLUSIONS. The NAP combination produced substantive palliation and a moderate response rate in men with AIPC. Cancer 2006. © American Cancer Society. [source] Cancer patients' expectations of experiencing treatment-related side effectsCANCER, Issue 4 2004A University of Rochester Cancer Center-Community Clinical Oncology Program study of 938 patients from community practices Abstract BACKGROUND Adequate management of treatment-related side effects is important for patients and challenging for clinicians. Side effects generated by various treatments have been characterized reasonably well. However, to the authors' knowledge, less is known regarding what patients expect to experience regarding these side effects and how patient characteristics are related to these expectations. METHODS Patients with cancer (n = 1015 patients) from 17 Community Clinical Oncology Program (CCOP) institutions affiliated with the University of Rochester Cancer Center CCOP Research Base were surveyed regarding their expectations of experiencing side effects associated with cancer treatment, with 938 patients providing evaluable data. Patients responded to the item, "Indicate your expectations of having this side effect" for 12 common side effects. Patients rated their expectations using a 5-point Likert scale, from 1 ("I definitely will not have this") to 5 ("I definitely will have this"). RESULTS The median number of symptoms expected (characterized by any value other than one) was nine. The six most expected symptoms were fatigue, nausea, sleep disturbance, weight loss, hair loss, and skin problems. Patients age > 60 years expected to have fewer symptoms than younger patients; female patients expected more side effects than male patients; and patients who had some college education expected more side effects than patients who were high school graduates or had not completed high school. CONCLUSIONS Patients with cancer clearly exhibit expectations regarding treatment-related side effects; and age, gender, and education level appear to influence these expectations. Further careful characterization of patient expectations and how expectations relate to experience may lead to earlier and more effective management of side effects. Cancer 2004. © 2004 American Cancer Society. [source] Pharmacokinetics of enteric-coated mycophenolate sodium in stable liver transplant recipientsCLINICAL TRANSPLANTATION, Issue 3 2007Theodore W. Perry Abstract:, Introduction:, Mycophenolate mofetil (MMF) is one of the major immunosuppressive agents used in liver transplantation recipients. In an attempt to mitigate one of the most common side effects of MMF (gastrointestinal symptoms), enteric-coated mycophenolate sodium (EC-MPS) was developed. In this study, we report the pharmacokinetic profile of EC-MPS in stable liver transplantation recipients administered a single 720 mg dose. Methods:, Liver transplantation recipients more than one yr after transplantation were administered a single dose of 720 mg EC-MPS after which blood levels of MPA were measured at frequent intervals using a specific and validated LC-MS/MS assay. Results:, The characteristics of the 21 patients studied were: mean age was 55.9 yr, 13 were female, eight had hepatitis C, and 14 were on tacrolimus. The mean apparent half-life of MPA was 5.3 ± 4.3 h, (1.0,15.7). Mean tmax was 2.4 ± 1.1 h (1.0,5.0). The mean area-under-curve was 45.3 ± 23.1 ,g-h/mL (17.3,90.0). Trough level concentrations (C12 h) showed large inter-individual variability (0,9.2 ,g/mL). There was no difference in any of the pharmacokinetic parameters relative to: gender, HCV, administration of tacrolimus vs. cyclosporine or type of biliary anastomosis. Conclusions:, There is a wide variation in pharmacokinetic parameters in stable, long-term liver transplantation recipients receiving a single dose of EC-MPS. These data suggest that therapeutic drug monitoring with EC-MPS may have limited utility in liver transplantation recipients. [source] | ||||||||||||||||||||||