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Concept: Rhinitis medicamentosa

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INTRODUCTION: Systemic and topical nasal decongestants are widely used in otorhinolaryngology and general practice for the management of acute rhinosinusitis and as an adjuvant in certain forms of chronic rhinosinusitis. These products, very effective to rapidly improve nasal congestion, are sometimes available over the counter and can be the subject of misuse, which is difficult to control. The Société Française d'ORL has recently issued guidelines concerning the use of these decongestants in the doctor’s office and the operating room. MATERIALS AND METHODS: The review of the literature conducted by the task force studied in detail the concepts of “rebound congestion” and “rhinitis medicamentosa” often reported in a context of misuse, particularly of topical nasal decongestants. The clinical and histopathological consequences of prolonged and repeated use of nasal decongestants have been studied on animal models and healthy subjects. RESULTS: Discordant results have been obtained, as some authors reported a harmful effect of nasal decongestants on the nasal mucosa, while others did not identify any significant changes. No study has been able to distinguish between inflammatory lesions induced by chronic rhinosinusitis and lesions possibly related to the use of nasal decongestants. DISCUSSION: The task force explained the rebound congestion observed after stopping nasal decongestant treatment by return of the nasal congestion induced by rhinosinusitis and rejected the concept of rhinitis medicamentosa in the absence of scientific evidence from patients with rhinosinusitis. CONCLUSION: Nasal decongestants are recommended for the management of acute rhinosinusitis to reduce the consequences of often disabling nasal congestion. They are also recommended during rhinoscopic examination and for preparation of the nasal mucosa prior to endonasal surgery.

Concepts: Sinusitis, Topical, Mucus, Pseudoephedrine, Nasal congestion, Topical decongestant, Rhinitis medicamentosa, Decongestant

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Phenylephrine hydrochloride (PE HCl) is widely used for the treatment of nasal congestion, but efficacy at the 10-mg dose is not known for certain. The Food and Drug Administration has requested that sufficiently powered, multicenter, dose-ranging studies be conducted to assess the efficacy and safety of PE HCl.

Concepts: Rhinitis medicamentosa, Phenylephrine

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Phenylephrine hydrochloride (HCl) is a decongestant available in over-the-counter (OTC) medicines. Previously marketed prescription products contained phenylephrine tannate, an extended-release salt, which allowed dosing every 8-12 h. Given the regulatory history that cold medicines marketed before 1962 had limited supporting clinical data, and with widespread replacement of pseudoephedrine by phenylephrine in OTC products over the last ten years, the need for contemporary studies grew. This exploratory crossover study evaluated effects of salt form, acetaminophen, and food on phenylephrine pharmacokinetics and metabolites in healthy adults. Test treatments were 25 mg phenylephrine tannate (equivalent to 10 mg phenylephrine HCl) combined with 200 mg guaifenesin, fasted; 10 mg phenylephrine HCl combined with 650 mg acetaminophen, fasted; and 10 mg phenylephrine HCl, fed. The reference treatment was 10 mg phenylephrine HCl, fasted. Plasma phenylephrine pharmacokinetics and urine metabolites were determined. Although the tannate salt slowed phenylephrine absorption compared with the HCl salt, terminal concentrations were similar, suggesting that products containing the tannate salt should not be dosed less frequently than those containing the HCl salt. The premise that acetaminophen increases phenylephrine bioavailability by competition for presystemic sulfation was corroborated by increased phenylephrine sulfate in urine. Food delayed phenylephrine absorption, but not the total amount absorbed.

Concepts: Pharmacology, Over-the-counter drug, Pseudoephedrine, Rhinitis medicamentosa, Decongestant, Phenylephrine, Sudafed, Decongestants

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Rosacea is a chronic dermatologic condition with limited treatment options, particularly for persistent erythema. This pivotal phase 3 study evaluated oxymetazoline, an a1A-adrenoceptor agonist, for the treatment of moderate to severe persistent erythema of rosacea. Eligible patients were randomly assigned 1:1 to receive oxymetazoline cream 1.0% or vehicle applied topically to the face once daily for 29 days. The primary efficacy outcome was ≥2-grade improvement from baseline on both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Digital image analysis of rosacea facial erythema was evaluated as a secondary efficacy outcome measure. Safety assessments included treatment-emergent adverse events (TEAEs) and dermal tolerability. Patients were followed for 28 days posttreatment to assess worsening of erythema (1-grade increase in severity from baseline on composite CEA/SSA in patients with moderate erythema at baseline; rebound effect). The study included 445 patients (mean age: 50.3 years; 78.7% female); most had moderate erythema at baseline (84.0% on CEA; 91.5% on SSA). The proportion of patients achieving the primary efficacy outcome was significantly greater with oxymetazoline versus vehicle (P=0.001). Similar results favoring oxymetazoline over vehicle were observed for the individual CEA and SSA scores (P less than 0.001 and P=0.011, respectively). Median reduction in rosacea facial erythema on day 29 as assessed by digital image analysis also favored oxymetazoline over vehicle (P less than 0.001). Safety results were similar between oxymetazoline and vehicle; discontinuations due to TEAEs were low (2.7% vs 0.5%). Following cessation of treatment, 2 (1.2%) patients in the oxymetazoline group and no patient in the vehicle group had rebound effect compared with their day 1 baseline score. Topical oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in the treatment of moderate to severe persistent facial erythema of rosacea.

J Drugs Dermatol. 2018;17(3):290-298.

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Concepts: Clinical trial, Effectiveness, Assessment, Flushing, Face, Erythema, Rebound effect, Rhinitis medicamentosa

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An unmet need exists for a safe, tolerable, effective treatment for moderate to severe persistent facial erythema in patients with rosacea. This pivotal phase 3, multicenter, double-blind study evaluated the efficacy and safety of topical oxymetazoline in patients with facial erythema associated with moderate to severe rosacea. Patients were randomly assigned to treatment with oxymetazoline hydrochloride cream 1.0% or vehicle applied once daily for 29 days, and were followed for 28 days posttreatment. The primary efficacy outcome was having at least a 2-grade decrease from baseline on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment for rosacea facial redness (SSA) scales (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Safety assessments included treatment-emergent adverse events (TEAEs) and posttreatment worsening of erythema (composite CEA/SSA increase of 1-grade severity from baseline; rebound effect). A total of 440 patients (mean age, 49.5 years; 78.9% females) were randomized (oxymetazoline, n=222; vehicle, n=218); most had moderate erythema. On day 29, significantly greater proportions of oxymetazoline recipients achieved the primary efficacy outcome at each time point (P less than 0.02) and overall (P less than 0.001) compared with vehicle recipients. The incidence of discontinuation due to TEAEs was low in both groups (oxymetazoline group, 1.8%; vehicle group, 0.5%). The most common TEAEs reported during the entire study period were application-site dermatitis, application-site erythema, and headache in the oxymetazoline group (1.4% each), and headache (0.9%) in the vehicle group. Following cessation of treatment, low proportions of patients experienced rebound effect (oxymetazoline group, 2.2%; vehicle group, 1.1%). Oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in patients with moderate to severe persistent facial erythema of rosacea.

J Drugs Dermatol. 2018;17(1):97-105.

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Concepts: Pharmacology, Clinical trial, Effectiveness, Efficacy, Flushing, Erythema, Topical decongestant, Rhinitis medicamentosa

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This study was designed to prospectively evaluate the role of nebulized hyaluronic acid (HA) administered for 10 days as treatment for patients with rhinitis medicamentosa (RM). RM is a pathological condition of the nasal mucosa induced by prolonged, excessive or improper use of topical decongestants. It is characterized by persistent nasal congestion that can lead the patient to increase the frequency of application and the quantity of the substance being applied, resulting in dependence on topical nasal decongestants. Twenty-five patients were treated with HA nebulized via Spray-sol twice a day for 10-days (T1) (HA Spray-sol treatment group). Subsequently, after 3 days of washout, patients were treated with physiological saline nebulized via Spray-sol twice a day for 10 days. (T2) (saline Spray-sol treatment group). The HA Spray-sol treatment group (tp) significantly improved visual analogue scale (VAS) scores (T0=6.25±1.64 vs T1=3.91±1.30; p less than 0.05), whereas there was no statistically significant difference in the saline Spray-sol treatment group (tp) (p>0.05), results confirmed by the anterior active rhinomanometry (AAR) data (HA Spray-sol tp T0=1.193±0.83 vs T1=0.44±0.25, p less than 0.05; saline Spray-sol tp (p>0.05). An improvement in the Global Rhinitis Score (GRS) was recorded in both groups (T0=15.37±5.16 vs T1=5.54±3.23, p less than 0.05; saline Spray-sol tp T0=15.37±5.16 vs T2=10. 7±5.43; p less than 0.05). Both groups showed a significant reduction in mucosal oedema and nasal secretions. Patients treated with HA Spray-sol reduced or even eliminated (11/25 patients) the use of topical decongestant within 10 days of treatment with HA. The results of this study suggest nebulized topical 9-mg sodium hyaluronate plays a pivotal role in the management of RM.

Concepts: Statistical significance, Topical, Mucus, Pseudoephedrine, Topical decongestant, Rhinitis medicamentosa, Decongestant, Oxymetazoline

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It is common practice to prepare the nasal mucosa with decongestant in children undergoing lacrimal surgery. Xylometazoline 0.05% (Otrivine) nasal spray is commonly used. It has been reported to cause cardiovascular side effects. In the absence of formal guidelines on the safety of the use of nasal decongestants in children, we reviewed our practice to answer the question: How safe is preoperative use of xylometazoline in children undergoing lacrimal surgery? To our knowledge, this is the first study to address the potential side effects of the use of xylometazoline preoperatively in children undergoing lacrimal surgery.

Concepts: Scientific method, Philosophy of science, Mucus, Pseudoephedrine, Topical decongestant, Rhinitis medicamentosa, Decongestant, Topical decongestants

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Nasal blockage is the most bothersome symptom of acute rhinitis. Nasal decongestant sprays containing alpha-sympathomimetics, such as oxymetazoline and xylometazoline, have a rapid onset of action. However, this effect decreases with repeated application and, furthermore, the ciliary function of the nasal mucosa is practically paralyzed. Dexpanthenol promotes cell proliferation and protects the epithelium. Combining these two agents has demonstrated beneficial synergetic effects on the symptoms of acute rhinitis. In a post hoc analysis of a large-scale double-blind, active-controlled study including 152 patients, we could demonstrate that the benefit of added dexpanthenol appears as early as on the third day of the combined application of xylometazoline and dexpanthenol in terms of complete or near-to-complete freedom from symptoms. After 5 days, 47% of the patients were cured under the combined treatment compared with only 1% under xylometazoline monotherapy. These data show that the addition of dexpanthenol to an alpha-sympathomimetic nasal spray not only improves its tolerability but also further increases its effectiveness and leads to expedited cure.

Concepts: Disease, Medical terms, Symptoms, Symptom, Fatigue, Mucus, Nasal spray, Rhinitis medicamentosa

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We frequently recommend ipratropium nasal spray in our office, as it is an effective, non-addictive nasal decongestant.

Concepts: Nose, Topical decongestant, Rhinitis medicamentosa, Decongestant

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To report 3 patients with corneal decompensation and anterior uveitis within 24 hours of cataract surgery from a single ambulatory surgery center using intracameral lidocaine HCl 1% and phenylephrine 2.5% inadvertently preserved with 10% benzalkonium chloride.

Concepts: Ophthalmology, Chlorides, Rhinitis medicamentosa