Concomitant Antihistamine Research Articles

Identification of Risk Factors for Daptomycin-Associated Creatine Phosphokinase Elevation and Development of a Risk Prediction Model for Incidence Probability.

BackgroundIn this study, we investigated the risk factors for daptomycin-associated creatine phosphokinase (CPK) elevation and established a risk score for CPK elevation.MethodsPatients who received daptomycin at our hospital were classified into the non-elevated or elevated CPK group based on their peak CPK levels during daptomycin therapy. Univariable and multivariable analyses were performed, and a risk score and prediction model for the incidence probability of CPK elevation were calculated based on logistic regression analysis.ResultsThe non-elevated and elevated CPK groups included 181 and 17 patients, respectively. Logistic regression analysis revealed that concomitant statin use (odds ratio [OR], 4.45 [95% confidence interval {CI}, 1.40–14.47]; risk score 4), concomitant antihistamine use (OR, 5.66 [95% CI, 1.58–20.75]; risk score 4), and trough concentration (Cmin) between 20 and <30 µg/mL (OR, 14.48 [95% CI, 2.90–87.13]; risk score 5) and ≥30.0 µg/mL (OR, 24.64 [95% CI, 3.21–204.53]; risk score 5) were risk factors for daptomycin-associated CPK elevation. The predicted incidence probabilities of CPK elevation were <10% (low risk), 10%–<25% (moderate risk), and ≥25% (high risk) with total risk scores of ≤4, 5–6, and ≥8, respectively. The risk prediction model exhibited a good fit (area under the receiver operating characteristic curve, 0.85 [95% CI, .74–.95]).ConclusionsThese results suggested that concomitant use of statins with antihistamines and Cmin ≥20 µg/mL were risk factors for daptomycin-associated CPK elevation. Our prediction model might aid in reducing the incidence of daptomycin-associated CPK elevation.

Add-On Omalizumab for Inadequately Controlled Severe Pollinosis Despite Standard-of-Care: A Randomized Study

Cedar pollinosis (CP), a common form of seasonal allergic rhinitis (AR), is a substantial medical problem in Japan due to its high prevalence and severe symptoms. Omalizumab (anti-IgE therapy) has previously proven to be effective in CP/AR, but no studies for inadequately controlled severe CP/AR despite standard-of-care (SoC) have been conducted. To determine the efficacy of omalizumab added to SoC in patients with inadequately controlled severe CP in a randomized, double-blinded, placebo-controlled, phase III study. Adult/adolescent patients with severe CP whose symptoms were inadequately controlled despite nasal corticosteroids plus 1 or more oral medications in the previous 2 seasons were randomized to receive omalizumab (n= 162) or placebo (n= 175). All patients received concomitant antihistamines and nasal corticosteroids as SoC. The primary endpoint was the mean nasal symptom score during the severe symptom period. Secondary endpoints included mean ocular symptom score, quality of life (QoL), and safety. The SoC+ omalizumab treatment had statistically significantly and clinically important lower nasal (least squares mean difference,-1.03, P < .001) and ocular (-0.87, P < .001) symptom scores compared with SoC+ placebo, respectively. Differences in scores for individual components of nasal and ocular symptoms were also statistically and clinically significant. SoC+ omalizumab also improved QoL scores as overall and in all domains. No unexpected safety signals were observed. In patients with severe CP, omalizumab added to SoC demonstrated consistent efficacy in improving symptoms and QoL, and was well tolerated. These results indicate that omalizumab could be a promising therapeutic option for severe CP/AR.

Efficacy of Omalizumab Treatment with Concomitant Antihistamines as Needed for Moderate, Refractory Chronic Spontaneous Urticaria.

Efficacy of Omalizumab Treatment with Concomitant Antihistamines as Needed for Moderate, Refractory Chronic Spontaneous Urticaria.

Critical appraisal of the unmet needs in the treatment of chronic spontaneous urticaria with omalizumab: an Italian perspective.

The humanized anti-IgE antibody omalizumab has been available for patients with chronic spontaneous urticaria (CSU) in Italy since 2015. This review summarizes the unresolved issues and unmet therapeutic needs associated with omalizumab and discusses practical recommendations for its use in the management of CSU. Although modern second-generation H1-antihistamines are the standard of care for patients with CSU, adjunctive treatments (including omalizumab) may be required for effective control of symptoms in many patients. Evidence from clinical trials and experience from daily clinical practice suggest that the use of omalizumab in patients with CSU who have inadequate response to H1-antihistamines remains challenging. Based on current international guidelines, omalizumab labelling information and our experience in clinical practice, we provide treatment recommendations regarding the use of omalizumab in patients with CSU. These include: optimal treatment duration, the use of concomitant antihistamine therapy, the definition and management of disease relapse after treatment, and the management of patients with late or no response to treatment.

Impact of Co-Prescribed Glatiramer Acetate and Antihistamine Therapy on the Likelihood of Relapse Among Patients with Multiple Sclerosis

We conducted a retrospective database study to examine the risk of relapse among patients with multiple sclerosis (MS) who were simultaneously prescribed glatiramer acetate (GA) and antihistamine (AH) therapy. Medical and pharmacy claims data were culled from the PharMetrics Patient-Centric Database from January 1997 to March 2004. GA users were identified and followed until discontinuation or end of health-plan enrollment. Patients receiving concomitant prescription AH therapy were identified; because over-the-counter AH (OTC-AH) use was not detectable but represented a potential exposure of interest, the presence of allergy-related medical encounters (i.e., use of allergy medications or visits to allergists or immunologists) was used as a proxy. The outcome of interest was the rate of MS relapse (i.e., hospitalization for MS or an outpatient encounter followed by steroid taper). A recurrent-event adaptation of Cox proportional hazards regression was used for adjusted relapse risk estimates. A total of 4,334 patients receiving GA therapy were identified and followed for 10 months on average; 537 (12.4%) had concomitant AH use, and 1,015 (23.4%) were potential OTC-AH recipients. The mean (SD) age of the sample was 42.9 (9.6) years; 78% were female. The overall incidence of relapse was 169.1 events per 1,000 person-years. Concomitant AH use did not significantly affect relapse risk in recurrent-event modeling controlling for age, sex, OTC-AH use, and prior relapse (hazard ratio [HR] = 0.816; 95% confidence interval [CI] = 0.638, 1.043). A second model was specified excluding potential OTC-AH users; findings for AH were similar (HR = 0.962, 95% CI = 0.675, 1.373). In conclusion, our findings indicate that concomitant use of prescription AHs with GA therapy does not appear to significantly affect the risk of relapse among patients with multiple sclerosis.

Studies comparing the efficacy of nedocromil sodium eye drops with sodium cromoglycate and placebo in seasonal allergic conjunctivitis

Two multicentre, double-blind, placebo controlled group comparative studies were carried out in Finland, during the birch pollen seasons of 1987 and 1989, to compare the efficacy and tolerability of 2% nedocromil sodium eye drops (twice daily) with either 2% sodium cromoglycate eye drops (four times daily) and/or placebo, in patients with seasonal allergic conjunctivitis. Study 1 compared nedocromil sodium (64 patients) with placebo (62 patients) and showed that the opinions of treatment efficacy of both patients and clinicians were significantly in favour of nedocromil sodium (p = 0.003, patients; p = 0.006, clinicians). In addition, the placebo group used significantly more topical (p<0.05) and oral (p<0.01) concomitant antihistamine therapy. Diary card scores and clinical assessments showed trends for active treatment. Study 2 compared nedocromil sodium (60 patients) with sodium cromoglycate (61) and placebo (64). Symptomatology was low, in general, but patient diary card scores showed significant control of itching by both active treatments. Clinical assessments also showed some improvement with both active treatments, reaching statistical significance for grittiness and photophobia. Overall opinions demonstrated a high placebo effect. At the end of the trial, full or moderate control of symptoms was reported by 80% of patients (73% clinicians) receiving nedocromil sodium, 75% of patients (74% clinicians) receiving sodium cromoglycate and 73% of patients (69% clinicians) receiving placebo. Taken as a whole, these results suggest that twice-daily nedocromil sodium eye drops are as efficacious as four times daily sodium cromoglycate eye drops in controlling seasonal allergic conjunctivitis.

Efficacy of doxepin in the treatment of chronic idiopathic urticaria

Doxepin hydrochloride, a tricyclic antidepressant, was evaluated in a double-blind, placebo-controlled crossover trial for the treatment of chronic idiopathic urticaria in 16 adults. Efficacy was evaluated by symptom scores, concomitant antihistamine use, and suppression of histamine-and codeine-induced wheal response. Doxepin-treated subjects experienced fewer lesions ( p < 0.001), less waking hours with lesions ( p < 0.01), lesser degree of itch and/or discomfort ( p < 0.001), and less swelling or angioedema ( p < 0.001) as compared to placebo-treated subjects. Doxepin-treated subjects required less daily concomitant antihistamine use (mean 0.13 tablets versus 1.48 tablets, p < 0.05). Doxepin also significantly suppressed histamine- and codeine-induced cutaneous wheal response as compared to placebo. Lethargy was commonly observed but diminished with continued use. Dry mouth and constipation were also commonly observed. We conclude that doxepin is an effective agent for the treatment of chronic idiopathic urticaria.

Efficacy and tolerance of fluocortin butyl administered twice daily in adult patients with perennial rhinitis

Fluocortin butyl (FCB) is a newly developed corticosteroid drug with no detectable systemic corticosteroid activity when it is used topically. Previous studies have demonstrated the therapeutic efficacy of FCB applied topically to the nasal mucosa three to four times a day for perennial rhinitis. The therapeutic efficacy of FCB used only twice daily, with total daily dosages similar to those previously found to be effective when these were applied more frequently, was studied in a multicenter, double-blind, placebo-controlled trial. This was a 4-week study with a 1-week observation (baseline) period and a 3-week period during which the response to three dosage regimens (2 mg per day, 4 mg per day, and 8 mg per day) of FCB and placebo were compared to baseline observations of rhinitis. Two hundred thirty-five patients from six centers were studied. Patients had perennial rhinitis of allergic, nonallergic, or combined etiology. Patients who received FCB exhibited significant amelioration of signs and symptoms of rhinitis as assessed by patients and physicians and had a greater reduction in the use of concomitant antihistamine and/or decongestant therapy compared to placebo-treated patients. Relief tended to occur early and was progressive during the 3 wk of therapy. There were no significant differences in response between the various dosages of FCB used. Side effects were minimal and insignificant and did not differ between FCB-treated and placebo-treated patients. FCB appears to be an effective well-tolerated topical steroid useful in the treatment of perennial rhinitis.

Treatment of ragweed hay fever with intranasally administered disodium cromoglycate*

In a double-blind study the therapeutic effect of a 4% disodium cromoglycate (DSCG) nasal solution was evaluated in thirty-nine patients with acute symptoms of ragweed hay fever. Patients were randomly assigned to the DSCG or placebo group as they presented with allergic rhinitis. Overall, the DSCG was not more effective than placebo in controlling the symptoms of rhinitis or in decreasing the need for concomitant antihistamines or corticosteroids. Among patients with the highest pretreatment serum ragweed-specific IgE (RW IgE) levels, drug-treated patients had some reduction in symptoms as compared to their placebo controls during the peak of the ragweed pollen season. DSCG treatment did not influence the usual seasonal rise in RW IgE. Side effects from both the active and placebo aerosols were frequent but mild. We conclude that DSCG nasal solution used for the treatment of seasonal ragweed allergic rhinitis is relatively ineffective.