| Author Year | Study outcomes Characteristics | Results |
|---|---|---|
| Augustin 2009 | Safety and efficacy in chronic idopathic Urticaria (CIU) N=9246, 62.5% female, mean age 43.2, mean duration of CIU 24.9 months % of patients with previous treatment with antihistamine: ceterizine 32.7%, loratadine 28.0%, fexofenadine 15.8%, “another” antihistamine 30.7% Mean duration of treatment: 40.4 yrs Intervention: Desloratadine Post marketing surveillance study | Change in Itching/pruritus at follow-up: p<0.0005 (% of patients) decreased severity of itching from baseline: 83.4% no change in itching from baseline: 15.3% worsening of itching at follow up: 1.3% Change in general state of urticaria at follow-up : p<0.0001 (% of patients) severe: 2.3%, moderate: 11.3%, mild: 43.2%. no: 43.2% % patients with no sleep disturbance due to CIU: (p<0.0001) No sleep disturbance: 70.3%, mild : 20.5%, moderate: 6.8%, severe: 1.9% Impairment of daily activtities due to CIU, change from baseline (p<0.0001) No impairment: 67.2%, mild 24.6%, moderate: 6.8%, severe: 1.5% Response to therapy-complete response: 42.7%, 5.6% had significant relief, moderate response: 11.7% AE: headache 0.13%, fatigue: 0.11%, dry mouth: 0.06%. therapy was stopped 0.2% |
| Craig-McFeely 2001 | Fexofenadine in UK prescription event monitoring cohort. Inclusion: Survey GPs with rxs Mar -Aug ‘97. Baseline 59% female, ages 36–39, AR 55%, CIU 4.3% (28.4% NR). Cohort 16,638 patients. | AE total: 40 (0.2%) in 27 patients, d/c <2%, 30 unrelated deaths. Cardiac: 8 non-serious, 1 irregular pulse w/possible grapefruit drug/food interaction. Other possible: 1 aggression, 1 neutropenia, resolved with d/c. Pregnancy-related: 47 total, of 30 exposed 1st trimester, 4 miscarriages, 1 therapeutic termination, 1 PE death, 1 unknown, 23 live births with 3 unrelated AE: premature/incompetent cervix, positional foot deformity and fetal distress |
| de Abajo 1999 | Cardiac Ventricular arrythmia and AH ACR, astemizole, cetirizine, loratadine, terfenadine, UK cohort. Inclusion: Patients <80 yrs, rx Jan ‘92-Sept.’96, 5 years. Exclusion: cancer, arrhythmias Baseline: Cohort 197,425 with 2.6 rx/patient, 151 events identified, 86 reviewed. | Arrythmia results: Total idiopathic (none fatal) 18 cases Any antihistamine: 9 cases (7 in 1st month); 1.9 per 10,000 person-years (95% CI 1.0–3.6), 4.2 times higher than non-use (95% CI 1.5–11.8). Second generation antihistamines- 1 case in 57,000 rxs, astemizole highest RR 19 (95% CI 4.8–76) cetirizine RR 7.9, (95% CI 1.6–39.3), loratadine RR 3.2 (CI NS) terfenadine RR 2.1. (CI NS) No interactions with P450Is (low ketoconazole use). |
| Finkle 2002 | Serious injury Diphenhydramine or loratadine at 1 month; cohort. Inclusion: Health care claims database Jan ‘91–Dec.’98. Baseline: diphenhydramine 12,106 pts; loratadine 24, 968 pts; ages 49–55, 53.1%–55.9% female. NS injury rates same time previous year | Diphenhydramine 308 injuries per 1000 patient years vs.137 in loratadine, age and gender adjusted RR 2.27 (95% CI 1.93, 2.66). |
| Gastpar 1993 | Long term efficacy and tolerability of patients with PAR, open uncontrolled design Initial 6 months: Azelastine nasal spray 0.56 mg/d N: 185, % male: 54.1%, age: 37.2 (13.0) Long term treatment for 30–60 weeks: Dose 0.56mg/day N: 35, male:48.6%, 34.0 (11.5) Mean TSC score at baseline: 11.56 | Initial 6 months total withdrawals N(%)/Withdrawals due to AE,N (%): 24 (13%)/5 (2.7%) Improvement in total rhinitis symptom score, p< 0.001 highest rate of improvement in 1st month-data in graph Global assessment of efficacy : 84.1% recorded “very good” or “good” Global assessment of tolerability:95.6% “very good” or “good” At wk 6, reduction from baseline in symptoms of: Stuffy nose 72.8, Itchy nose 69.4, Rhinorrhoea 64.6, Sneezing 57.3. Others reported in Table. Follow:up 30–60 wks Incidence of Hyperplasia N(%): 2/21 (9.5%) mean TSC score at month 21: 7 Global assessment of efficacy : 33 (94.3%) recorded “very good” or “Good” Global assessment of tolerability: 35 (100%) recorded “very good” or “good” |
| Layton 2006 | levoceterizine vs desloratadine N: 12367 vs 11828 Median age[interquartile range]: 37[22–55], 37[22–54] % female: 58.2 vs 59.9 allergic rhinitis with asthma and wheezing (%): 12.9 vs 15.3% (p<0.0001) allergic rhinitis without asthma and wheezing (%): 54.1 vs 52.3 other (%): 28.7 vs 28.0, not known (%): 4.3 vs 4.4 Use of antihistamine in previous 12 months: 31.9 vs 29.3 use of antihistamine in previous 12 months not known: 17.5 vs 18.6 | Levoceterizine vs desloratadine incidence of first ocurance of drowsiness/sedation: 0.37 vs 0.08, p<0.0001 Sex-adjusted OR for drowsiness sedation for patients with allergic rhinitis without asthma/wheezing: OR 6.75; 95% CI 2.37, 19.22, n=12,627, estimate-statistically significant Sex-adjusted Or for allergic rhinitis with asthma/wheezing: OR 3.51; 95% CI 0.71, 17.43, n=3347; estimate: NS Sex-adjusted OR for “other” indication: OR 3.11; 95% CI 0.86, 11.31, n=6725, estimate: NS |
| Layton 2009 | N=11828, median age 37 yrs, 59.9% female allergis rhinitis: 52.3%, allergic rhinitis with asthma/wheezing : 15.3%, urticaria: 17%, other conditions (e.g. allergy): 11% Desloratadine treatment 97% initially prescribed 5mg/day, 3% prescribed 10mg/day, <1% prescribed ≥ 15mg/day and 2.5mg/day | Most frequently reported events in first 2 months Drowsiness: 0.07%, headache 0.21%, Migraine 0.04%, Sedation 0.03%, Synocope (0.02%) |
| Mann 2000 | Sedation Loratadine vs cetirizine, fexofenadine, acrivastine, PEM UK cohort. Inclusion: May–Aug ‘89 cetirizine and loratadine, Mar–Aug ‘97 fexofenadine Baseline: 43,363 pts, 56%–62% female, 36%–49% <30yrs, 7–14% >60yrs. | Sedation vs. loratadine: significantly higher for cetirizine (odds ratio 3.52, 95% CI 2.17 to 5.71, p<0.0001), NS difference for fexofenadine (odds ratio 0.63 (95% CI 0.36–1.11, p=0.1); overall sedation was low with no correlation with accident or injury. |
| Pedersen 2006 | Risk of hypospadias after exposure to loratadine and other antihistamines Nested case-control design based on women enrolled in the Danish National Birth Cohort from 1998–2002 (n≈ 95,000 pregnant women) Data on maternal use of medicine in pregnancy were retrieved from questionnaires and telephone interviews, and outcome data were obtained from the National Hospital Discharge Registry A total of 203 cases of hypospadias, recorded within the first year post-partum, were identified. Ten male controls were randomly selected per case and matched by DOB (n=2030 controls) | Cases # (%)/Controls # (%) Exposure to loratadine*: 1 (0.5)/25 (1.2) 30 days before conception and 1st trimester: 1 (0.5)/12 (0.6) Second trimester: 0 (0)/8 (0.4) Third trimester: 0 (0)/13 (0.6) Exposure to other antihistamines*: 30 days before conception and 1st trimester: 4 (2.0)/48 (2.4) Second trimester: 2 (1.0)/37 (1.8) Third trimester: 2 (1.0)/11 (0.5) *Reported exposure during pregnancy or up to 30 days before conception In total, 146 of 203 cases were diagnosed with hypospadias within 6 months postpartum, and none had reported exposure to loratadine during the entire pregnancy or up to 30 days before conception The association between hypospadias recorded anytime postpartum and maternal use of antihistamines (adjusted OR* (95% CI): Exposure within the first trimester or up to 30 days before conception: Loratadine: 0.9 (0.1–6.4) Other antihistamines was 0.5 (0.1–1.9) Exposure within the entire pregnancy or up to 30 days before conception: Loratadine: 0.4 (0.1–2.8) Other antihistamines: 0.7 (0.3–2.1) *Adjusted for maternal age, maternal smoking, birth order, gestational age, preeclampsia, and use of ovulation-inducing drugs, anti-epileptics, or antibodies |
| Weber-Schoendorfer 2008 | Safety of cetirizine during 1st trimeser of pregnancy Inclusion: women whose physician contacted teratology information service (TIS) reporting 1st trimester exposure to cetirizine between 1992–1996 Data was collected via questionnaires administered during early pregnancy and 8 weeks after expected delivery date, and a pediatric exam was conducted at 6 weeks n=196 pregnant women with first trimester exposure to cetirizine n=1686 controls cetirizine/controls median age (y): 31/31 | Major birth defects were not more common in the cetirizine group than in the control group (OR 1.07, C 0.21–3.59). The study also compared the crude rate of spontaneous abortions (OR 0.97, CI 0.54–1.65), of preterm deliveries (OR 1.07, CI 0.35–1.5), and the birth weight of term newborns (p=0.13) Pregnancy Outcomes: cetirizine (%)/controls(%)/exposed vs controls OR (CI)/exposed vs controls p-value Exposed pregnancies: 196/1686/-/- Spontaneous abortion-crude rates: 8.9/9.1/0.97 (0.54–1.65)/1.00 Preterm births: 5.6/7.3/0.76 (0.35–1.5)/0.54 All birth defects: 7.7/5.7/1.36 (0.7–2.45)/0.32 Major birth defects: 1.7/1.6/1.07 (0.21–3.59)/0.76 Mean gestational age at delivery (weeks), term births: 39.82/39.81/-/0.89 Mean birth weight (grams), term births: 3413/3473/-/0.13 |
| Wober 1997 Arzneim-Forsch/Drug Res. | Efficacy and safety of a nasal spray containing azelastine Post-marketing drug surveillance program n=211 children under 13 years of age Median age: 11 years (range 3–12) Gender (% male): 59 | All-symptom-sum-score subgroups: Mean score/Score in the lowest subgroup (%) Baseline visit: 11.03/4 Control visit: 3.21/84 A decrease of the all-symptom score was seen in 98.2% of patients and an increase was seen in 1.8% of cases. Nose-symptom-sum-score subgroups: Mean total score/Score in the lowest subgroup (%) Baseline visit: 7.64/13 Control visit: 2.31/91 A decrease of the total nasal score was seen in 98% of patients and an increase was seen in 2% of cases. Eye-symptom-sum-score subgroups: Mean total score/Patients with no ocular symptoms (%) Baseline visit: 2.25/34 Control visit: 0.48/79 A decrease of the total ocular score was seen in 62% of patients and an increase was seen in 1 patient There were no signicifant differences in the changes of either the total symptom scores, total nasal scores, or total occular scores, when stratified by age, sex, pretreatment, and concomitant medication Frequency of adverse events: n (%)/n azelastine discontinued Pruritis: 5 (2.4)/1 Headache: 2 (1)/1 Parasthesia:2 (1)/0 Dry mouth: 1 (0.5)/0 Earache: 1 (0.5)/0 Taste perversion: 6 (2.8)/1 Rhinitis: 5 (2.4)/1 Not specific: 2 (1)/1 Total: 24 (11.4)/6 |
| Wober 1997 Curr. Med. Res. Opin | Efficacy and tolerability of azelastine nasal spray Post-marketing surveys to rate symptoms and answer treatment questions were administered at 14 days (study 1) and 31 days (study 2) Study 1 n=3680 Recruitment: January–July 1993 Median age: 31 years (range 7–90) Gender (% male): 48.8 Study 2 n=4002 Recruitment: October 1993–January 1994 Median age; 31 years (range 3–85) Gender (% male): 50.9 | Efficacy Sum score means (±SD) for symptoms before and after treatment: Study 1 Before/After/X2 Total symptoms: 13.3 (±5.3)/2.9 (±3.4)/2073.1 Nose symptoms: 8.5 (±2.8)/2.0 (±2.2)/1984.3 Eye symptoms: 3.1 (±2.41)/0.6 (±1.17)/871.7 Study 2 Before/After/X2 Total symptoms: 11.0 (±4.9)/3.0 (±3.4)/2008.5 Nose symptoms: 7.9 (±2.8)/2.3 (±2.3)/1929.2 Eye symptoms: 2.0 (±2.2)/0.4 (±1.1)/492.1 Tolerability Incidence of all adverse reactions reported during treatment: Study 1/Study 2 Number (%) Total:260 (7.1)/350 (8.7) Taste disturbance:88 (2.4)/97 (2.4) Rhinitis: 77 (2.1)/159 (4.0) Application site reaction: 52 (1.4)/47 (1.2) Somnolence: 17 (0.5)/12 (0.3) Headache: 13 (0.4)/6 (0.1) Epistaxis: 8 (0.2)/13 (0.3) Dry mouth: 6 (0.2)/13 (0.3) |
From: Evidence Tables
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