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PRESCRIBER, Issue 19 2008
Article first published online: 16 OCT 200
ARBs less effective than ACE inhibitors? The efficacy of angiotensin-II receptor blockers (ARBs) in preventing cardiovascular events in high-risk patients has been challenged by the findings of a large randomised trial (Lancet 2008 published online; doi 10.1016/ S0140-6736(08)61242-8). In the TRANSCEND trial, 5926 patients with cardiovascular disease or diabetes with end-organ damage who could not tolerate ACE inhibitor therapy were randomised to placebo or telmisartan (Micardis) 80mg per day in addition to standard therapies. After 56 months, mean blood pressure was lower with telmisartan (by 4.0/2.2mmHg) but there were no significant differences between telmisartan and placebo in the risk of cardiovascular events , a composite of cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure. Hospitalisation for cardiovascular reasons were slightly but significantly reduced by telmisartan (33 vs 30 per cent). MHRA: fentanyl patch errors potentially fatal Errors in dosing, accidental exposure and enhanced absorption from heat exposure have resulted in life-threatening and fatal incidents with transdermal fentanyl, warns the MHRA in its latest Drug Safety Update (September 2008). There is also evidence that fentanyl patches are being prescribed for nonlicensed indications, including treatment of opioid-naive patients. Other topics in this issue include managing adverse reactions to HPV vaccine and an update on new cases of progressive multifocal leucoencephalopathy associated with natalizumab (Tysabri). Call for DURG research The Drug Utilisation Research Group is inviting abstracts for oral and poster presentations at its 20th annual meeting on 5 February 2009. The theme of the morning session is ,Whose prescribing budget is it anyway?'. Abstracts will be accepted on any drug utilisation research studies and will be published in the Journal of Pharmacoepidemiology and Drug Safety. Information is available at the deadline for submissions is 1 December. Early bromocriptine no benefit in Parkinson's Initiating treatment of Parkinson's disease with the dopamine agonist bromocriptine offers no long-term benefit compared with levodopa, the UK Parkinson's Disease Research Group trial has shown (Neurology 2008;71:474-80). After 14 years' follow-up of 166 patients, there were no differences in the prevalence of motor complications, dementia or mortality, but levodopa was associated with superior scores of disability and physical functioning. The authors say the belief that early dopamine agonist treatment is neuroprotective in Parkinson's disease should be abandoned. Ezetimibe with statin cancer risk ,not credible' Analysis of data pooled from two large trials provides ,no credible evidence' that ezetimibe (Ezetrol) is associated with an increased risk of cancer when added to statin therapy (N Engl J Med 2008 published online; doi 10.1056/NEJMsa0806603). A possible link with increased risk of cancer with ezetimibe plus simvastatin was suggested by the SEAS trial (N Engl J Med 2008 published online; doi 10.1056/NEJMoa 0804602). This hypothesis was tested in two trials involving more than 20 500 patients over 1.0-2.7 years. There was no excess of cancer overall or at particular sites; cancer deaths were more numerically but not significantly higher with ezetimibe and there was no evidence of increased risk with duration of treatment. Telmisartan provides no advantage after stroke Adding telmisartan (Micardis) to standard treatment after ischaemic stroke does not reduce morbidity, US investigators report (N Engl J Med 2008 published online; doi 10.1056/NEJMoa 0804593). A total of 20 332 patients with recent ischaemic stroke were randomised to placebo or telmisartan 80mg per day in addition to antiplatelet therapy and antihypertensive agents. After 2.5 years, blood pressure was 3.8/2.0mmHg lower in patients taking telmisartan but there were no significant differences from placebo in the risks of recurrent stroke, cardiovascular events or new-onset diabetes. Copyright © 2008 Wiley Interface Ltd [source]

Review article: Paediatric supracondylar humeral fractures: Emergency assessment and management

Stephen R Allen
Abstract Supracondylar humeral fractures in children are common presentations to the ED but might be challenging to both diagnose and assess clinically. The ED has a critical role in accurately assessing the child, the limb's neurovascular status and initiating treatment. A specific approach to the clinical assessment of such a child is required as failure to detect neurovascular compromise can delay appropriate treatment and result in serious consequences. Most children can be investigated with X-ray radiograph alone with further treatment directed by severity of the fracture, commonly described using the Gartland classification. Our review article provides an overview of supracondylar humeral fractures and a suggested clinical approach to leave the emergency physician better equipped to assess and manage these fractures. [source]

Determinants of response to first HAART regimen in antiretroviral-naïve patients with an estimated time since HIV seroconversion

HIV MEDICINE, Issue 1 2006
R Thiébaut
Objective To study the determinants of immunological and virological response to highly active antiretroviral therapy (HAART) in naïve patients, adjusting for time since HIV-1 seroconversion. Design Data from HIV-cohort studies where dates of seroconversion have been reliably estimated. Methods In previously untreated patients, short- and long-term marker responses from HAART initiation (three or more antiretroviral drugs) to the end of follow-up or any treatment modification were considered using mixed effects models accounting for undetectable HIV viral load and informative dropout. Results In total, 943 patients were treated with a first HAART regimen for a median of 29 months. In adjusted analyses, compared with a reference group of homosexual men without AIDS initiating treatment 4 years after seroconversion, injecting drug users (IDUs) were treated at similar CD4 and HIV RNA levels but had poorer short-term virological response (2.54 vs 2.13 log10 HIV-1 RNA copies/mL at 1.5 months, P=0.03) and poorer long-term immunological response (522 vs 631 cells/,L at 24 months, P<0.0001). Although individuals with AIDS at HAART initiation had lower CD4 counts (206 vs 382 cells/,L, P<0.0001), their immunological responses were similar to those of individuals without AIDS. Similarly, individuals further from seroconversion started HAART at lower CD4 counts (e.g. 311 vs 382 cells/,L at vs before 9 years from seroconversion, P<0.0001), but had similar CD4 responses. However, they experienced poorer long-term virological response (0.67 log10 copies/mL/year smaller decline, P<0.0001) compared to those treated before 9 years from seroconversion. Conclusion Taking into account the time elapsed since seroconversion, this study suggests that careful choices of initial treatment should be made and intensive follow-up carried out in high-risk subgroups such as IDUs who have poorer responses. [source]

Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients: Design and Implementation

ALCOHOLISM, Issue 2 2010
Shelly F. Greenfield
Background:, While the integration of alcohol screening, treatment, and referral in primary care and other medical settings in the U.S. and worldwide has been recognized as a key health care priority, it is not routinely done. In spite of the high co-occurrence and excess mortality associated with alcohol use disorders (AUDs) among individuals with tuberculosis (TB), there are no studies evaluating effectiveness of integrating alcohol care into routine treatment for this disorder. Methods:, We designed and implemented a randomized controlled trial (RCT) to determine the effectiveness of integrating pharmacotherapy and behavioral treatments for AUDs into routine medical care for TB in the Tomsk Oblast Tuberculosis Service (TOTBS) in Tomsk, Russia. Eligible patients are diagnosed with alcohol abuse or dependence, are newly diagnosed with TB, and initiating treatment in the TOTBS with Directly Observed Therapy-Short Course (DOTS) for TB. Utilizing a factorial design, the Integrated Management of Physician-delivered Alcohol Care for Tuberculosis Patients (IMPACT) study randomizes eligible patients who sign informed consent into 1 of 4 study arms: (1) Oral Naltrexone + Brief Behavioral Compliance Enhancement Therapy (BBCET) + treatment as usual (TAU), (2) Brief Counseling Intervention (BCI) + TAU, (3) Naltrexone + BBCET + BCI + TAU, or (4) TAU alone. Results:, Utilizing an iterative, collaborative approach, a multi-disciplinary U.S. and Russian team has implemented a model of alcohol management that is culturally appropriate to the patient and TB physician community in Russia. Implementation to date has achieved the integration of routine alcohol screening into TB care in Tomsk; an ethnographic assessment of knowledge, attitudes, and practices of AUD management among TB physicians in Tomsk; translation and cultural adaptation of the BCI to Russia and the TB setting; and training and certification of TB physicians to deliver oral naltrexone and brief counseling interventions for alcohol abuse and dependence as part of routine TB care. The study is successfully enrolling eligible subjects in the RCT to evaluate the relationship of integrating effective pharmacotherapy and brief behavioral intervention on TB and alcohol outcomes, as well as reduction in HIV risk behaviors. Conclusions:, The IMPACT study utilizes an innovative approach to adapt 2 effective therapies for treatment of alcohol use disorders to the TB clinical services setting in the Tomsk Oblast, Siberia, Russia, and to train TB physicians to deliver state of the art alcohol pharmacotherapy and behavioral treatments as an integrated part of routine TB care. The proposed treatment strategy could be applied elsewhere in Russia and in other settings where TB control is jeopardized by AUDs. If demonstrated to be effective, this model of integrating alcohol interventions into routine TB care has the potential for expanded applicability to other chronic co-occurring infectious and other medical conditions seen in medical care settings. [source]

Generalized Erythrodermic Pemphigus Foliaceus in a Child and Its Successful Response to Rituximab Treatment

Elizabeth Alvarez Connelly M.D.
The nonendemic or sporadic form of this entity is rare in children and typically presents with a milder, more localized rash that usually follows a benign course of short duration. We describe an affected patient atypical in both her young age and the severity of skin findings. Our patient presented with a full body exfoliative erythroderma at 21 months of age. After an extensive work-up to determine the etiology of her exfoliative erythroderma, direct and indirect immunofluorescence studies confirmed the diagnosis of pemphigus foliaceus. Rituximab therapy was initiated based on the patient's refractory disease course to multiple immunosuppressive agents. Rituximab is a therapeutic monoclonal antibody targeting CD20, an integral membrane protein highly expressed on the surface of pre-B lymphocytes and activated mature B lymphocytes. The patient's skin exhibited marked clinical improvement after the start of rituximab infusions over 12 weeks. Her initial desmoglein 1 antibody level was greater than 1:1280, which decreased to 1:16 after seven rituximab treatments. She has had no skin flares since initiating treatment with rituximab therapy. Based on this clinical and serologic response, the use of rituximab may be helpful in the treatment of pediatric pemphigus foliaceus refractory to mainstays of therapy. [source]

Timing of initiation of enzyme replacement therapy after diagnosis of type 1 Gaucher disease: effect on incidence of avascular necrosis

Pramod K. Mistry
Summary Data from the International Collaborative Gaucher Group Gaucher Registry were analysed to assess the relationship between enzyme replacement therapy with imiglucerase (ERT) and incidence of avascular necrosis (AVN) in type 1 Gaucher disease (GD1), and to determine whether the time interval between diagnosis and initiation of ERT influences the incidence rate of AVN. All patients with GD1 enrolled in the Gaucher Registry who received ERT and did not report AVN prior to starting therapy (n = 2700) were included. The incidence rate of AVN following initiation of ERT was determined. An incidence rate of AVN of 13·8 per 1000 person-years was observed in patients receiving ERT. Patients who initiated ERT within 2 years of diagnosis had an incidence rate of 8·1 per 1000 person-years; patients who started ERT ,2 years after diagnosis had an incidence rate of 16·6 per 1000 person-years. The adjusted incidence rate ratio was 0·59 [95% confidence interval (CI) 0·36,0·96, P = 0·0343]. Splenectomy was an independent risk factor for AVN (adjusted incidence rate ratio 2·23, 95% CI 1·61,3·08, P < 0·0001). In conclusion, the risk of AVN was reduced among patients who initiated ERT within 2 years of diagnosis, compared to initiating treatment ,2 years after diagnosis. A higher risk of AVN was observed among patients who had previously undergone splenectomy. [source]

2327: Preservative free tafluprost 0.0015% in the treatment of patients with ocular hypertension and glaucoma: results of a multi-center open-label observational study

Purpose Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated. Methods Data were collected in a non-interventional prospective multi-center observational open label study. IOP readings were recorded for each eye at baseline (prior therapy or untreated) and 12 weeks after changing or initiating treatment with preservative-free tafluprost. Change in IOP was evaluated over the study period for all patients and for specific pre-treatment subgroups. Local comfort was measured using a 5 step scale. All adverse events were recorded. Results Data from 2123 patients with glaucoma or ocular hypertension were eligible for the final evaluation. In all patients preservative-free tafluprost lowered IOP from 19.5+4.4 mmHg at baseline to 16.4+2.9 mmHg after 12 weeks. Preservative-free tafluprost also lowered IOP significantly in all monotherapy-subgroups: Na,ve patients (N=440): 22.6+3.9 mmHg to 16.7+2.7mmHg; betablockers (N=307): 20.3+3.5 mmHg (baseline) to 16.7+2.6 mmHg (week 12); CAI's (N=158): 19.0+3.6 mmHg to 16.0+2.6 mmHg; PG's (N=447): 16.8+2.9 mmHg to 15.8+2.6 mmHg. Local comfort was rated as 'very good' or 'good' by 85.6% of patients at the final visit. Only few adverse events occurred during the treatment period. Conclusion Preservative-free tafluprost was effective, well tolerated and safe in a broad patient population. Local comfort and patient satisfaction improved after change of medical treatment in the vast majority of patients. Commercial interest [source]