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Angioedema urticaria [keywords]
- Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure. [JOURNAL ARTICLE]
- N Engl J Med 2014 Aug 30.
Background We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. In previous studies, enalapril improved survival in such patients. Methods In this double-blind trial, we randomly assigned 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of 10 mg twice daily), in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, but the trial was designed to detect a difference in the rates of death from cardiovascular causes. Results The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed. At the time of study closure, the primary outcome had occurred in 914 patients (21.8%) in the LCZ696 group and 1117 patients (26.5%) in the enalapril group (hazard ratio in the LCZ696 group, 0.80; 95% confidence interval [CI], 0.73 to 0.87; P<0.001). A total of 711 patients (17.0%) receiving LCZ696 and 835 patients (19.8%) receiving enalapril died (hazard ratio for death from any cause, 0.84; 95% CI, 0.76 to 0.93; P<0.001); of these patients, 558 (13.3%) and 693 (16.5%), respectively, died from cardiovascular causes (hazard ratio, 0.80; 95% CI, 0.71 to 0.89; P<0.001). As compared with enalapril, LCZ696 also reduced the risk of hospitalization for heart failure by 21% (P<0.001) and decreased the symptoms and physical limitations of heart failure (P=0.001). The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment, hyperkalemia, and cough than the enalapril group. Conclusions LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure. (Funded by Novartis; PARADIGM-HF ClinicalTrials.gov number, NCT01035255 .).
- The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Sep; 13(S1):1-8.
Objective: To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). Research design and methods: Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use. Results: We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization. Conclusions: The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.
- Oral allergy syndrome--the need of a multidisciplinary approach. [Journal Article]
- Acta Clin Croat 2014 Jun; 53(2):210-9.
Oral allergy syndrome (OAS) is one of the most common types of food allergy. The syndrome includes itching and swelling of the lips, palate and tongue, usually after consuming fresh fruits and vegetables. The underlying pathogenic mechanism is cross-reactivity between IgE antibodies specific to pollen, and antigens in food, such as fresh fruits, vegetables and nuts that are structurally similar to pollen. Both pollen and food antigens can bind to IgE and trigger type I immune reaction. Diagnosis is primarily based on the patient's history, and confirmed by skin tests, in vitro tests, and oral provocation tests. Differential diagnoses include many diseases (such as burning mouth syndrome, angioedema, hay fever, various other oral diseases, etc.), and for this reason a multidisciplinary approach is necessary, as different specialists need to be involved in the diagnostic procedure. Therapy includes avoiding, or thermal processing of, fruit and vegetables known to trigger a reaction, and antihistamine medications. If a more severe anaphylactic reaction develops, more aggressive therapy is required. The goal of this article is to present OAS, its etiopathogenesis, clinical picture, and symptoms, diagnostic approach and therapy for OAS.
- Sonographic appearance of angioedema in local allergic reactions to insect bites and stings. [Journal Article]
- J Ultrasound Med 2014 Sep; 33(9):1705-10.
Soft tissue infections and angioedema from insect bites and stings may be difficult to differentiate by inspection. We present sonographic findings of 4 cases of soft tissue swelling from insect bites and stings suggestive of angioedema. Sonographic features of soft tissue angioedema consist of thickened subcutaneous tissue layers with multiple linear, horizontal, striated, and hypoechoic lines following the tissue planes between soft tissue layers. In addition to the history and physical examination, sonographic findings may assist in differentiating between local allergic reactions and cellulitis in patients with insect bites and stings. Further study is warranted for clinical application.
- [Guidelines for the diagnosis and treatment of hereditary angioedema]. [English Abstract, Journal Article]
- Lijec Vjesn 2014 May-Jun; 136(5-6):117-29.
Hereditary angioedema (HAE) is a rare but potentially fatal genetic disorder with nonpitting, nonerythematous, and not pruritic swelling which can affect the hands, feet, face, genitals and visceral mucosa. The type, frequency, and severity of the attacks vary between patients, and over the lifetime of an individual patient. Efforts in Croatian counties have identified approximately 100 patients (but there must be more undiagnosed patients). The first global guideline for the management of HAE was developed by the World Allergy Organization HAE International Alliance and published in 2012. Based on that document the Working group of Croatian experts was assigned to propose guideline for HAE management in Croatia. HAE is is most often related to decreased or dysfunctional C1 inh with autoactivation of C1 and bradykinin accumulation leading to localized dilatation and increased permeability of blood vessels resulting in tissue swelling. A diagnosis of HAE can be confirmed by measuring complement and C1 inh quantitative and functional levels.Three HAE types could be differentiated: HAE type 1 (C1 inh level is low), HAE type 2 (C1 inh level is normal but dysfunctional), and HAE type 3 (normal level and function of C1 inh). All patients suspected to have HAE-1/2 should be assessed for blood levels of C4, C1 inh protein, and C1 inh function. All attacks that result in debilitation/dysfunction and/or involve the face, the neck, or the abdomen should be considered for on-demand treatment. It is recommended that attacks are treated as early as possible. HAE attacks are treated with C1 inh, ecallantide, or icatibant.If these drugs are not available, attacks should be treated with solvent detergent-treated plasma (SDP). If SDP is not available, then attacks should be treated with frozen plasma.Intubation or tracheotomy should be considered early in progressive upper airway edema. Patients with attacks could receive adjuvant therapy when indicated (pain management, intravenous fluids). All patients should have on-demand treatment for two attacks and carry their on-demand treatment at all times. The administration of short-term prophylaxis should be considered before surgeries (dental/intraoral surgery, where endotracheal intubation is required), where upper airway or pharynx is manipulated, and before bronchoscopy or endoscopy. Long-term prophylaxis should be considered in all severely symptomatic HAE-1/2 patients. C1 inh concentrate or androgens can be used. Screening children for HAE-1/2 should be deferred until the age of 12 months, and all offspring of an affected parent should be tested.
- Progesterone Skin Test in Severe Attacks of Angioedema during Menstrual Cycle. [Journal Article]
- Iran J Allergy Asthma Immunol 2014 Oct; 13(5):375-7.
Progesterone hypersensitivity (PH) is a rare clinical condition that displays hypersensitivity to endogenous or exogenous progesterone. It is characterized by cyclic dermatologic manifestations at the end of the luteal phase that disappear some days after menses. We present a case of 24-year-old woman showing severe angioedema attacks occurring from the first day of her menstruation and continuing for 4-5 days and having positive progesterone intradermal test (IDT). To our knowledge, there is no case in the literature which is coupled with PH isolated angioedema attacks. In this case report we will discuss diagnostic value of progesterone IDT.
- Safety of ACE inhibitor therapies in patients with chronic kidney disease. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Aug 22.:1-13.
Introduction: ACE inhibitors are first-line therapy in patients with chronic kidney disease (CKD). The main adverse effects of ACE inhibitors are hypotension, renal function impairment and hyperkalemia. Areas covered: This paper reviews evidence from clinical studies regarding adverse effects of ACE inhibitors in patients with CKD. The safety aspects of ACE inhibitors are discussed in relation to their pharmacological action, drug-drug interactions, drug-diet interaction, precautions needed in certain clinical conditions and other adverse effects. Expert opinion: The main adverse effects of ACE inhibitors follow from their interaction with renin-angiotensin-aldosterone system (RAAS)-activity and volume depletion. This interaction can be turned into clinical benefit and increase efficacy of ACE inhibitors by reduction in dietary sodium or adding diuretics. Dual RAAS-blockade is no longer advocated in patients with CKD because of the safety issues, and combination of ACE inhibitors with moderate reduction in dietary sodium intake is a better alternative. The intensified treatment regimens based on ACE inhibitors can potentially improve renoprotection, but increase the risk of adverse effects. Better strategies to address safety concerns are needed. Introduction of clinical rules and safety indicators may help clinicians to identify hazardous co-prescriptions and adverse dietary habits and can decrease the frequency of adverse effects.
- Isolated oedema of the uvula induced by intense snoring and ACE inhibitor. [Journal Article]
- BMJ Case Rep 2014.
A case of snoring-induced angioedema of uvula is described in a patient who was treated with ACE inhibitor. The patient partially responded to complement C1-inhibitor concentrate and did not suffer any recurrences after the medication was withdrawn. When encountering a patient suffering from swellings of the orofacial area it should be considered whether the mechanism is mast-cell associated or not, as classical antiallergic treatment is ineffective in non-mast-cell-associated disease (ie, bradykinin-mediated angioedema). Other causes of uvular oedema are also discussed.
- Neprilysin inhibition in chronic kidney disease. [REVIEW]
- Nephrol Dial Transplant 2014 Aug 18.
Despite current practice, patients with chronic kidney disease (CKD) are at increased risk of progression to end-stage renal disease and cardiovascular events. Neprilysin inhibition (NEPi) is a new therapeutic strategy with potential to improve outcomes for patients with CKD. NEPi enhances the activity of natriuretic peptide systems leading to natriuresis, diuresis and inhibition of the renin-angiotensin system (RAS), which could act as a potentially beneficial counter-regulatory system in states of RAS activation such as chronic heart failure (HF) and CKD. Early NEPi drugs were combined with angiotensin-converting enzyme inhibitors but were associated with unacceptable rates of angioedema and, therefore, withdrawn. However, one such agent (omapatrilat) showed promise of NEP/RAS inhibition in treating CKD in animal models, producing greater reductions in proteinuria, glomerulosclerosis and tubulointerstitial fibrosis compared with isolated RAS inhibition. A new class of drug called angiotensin receptor neprilysin inhibitor (ARNi) has been developed. One such drug, LCZ696, has shown substantial benefits in trials in hypertension and HF. In CKD, HF is common due to a range of mechanisms including hypertension and structural heart disease (including left ventricular hypertrophy), suggesting that ARNi could benefit patients with CKD by both retarding the progression of CKD (hence delaying the need for renal replacement therapy) and reducing the risk of cardiovascular disease. LCZ696 is now being studied in a CKD population.