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Publicaciones sobre Bilastina

The Impact of Bilastine on Symptoms of Allergic Rhinitis and Chronic Urticaria: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

By | Articles about Bilastine, Publicaciones sobre Bilastina

Abdelshafy AM, Abdallah SY, Hassan AF, Mohamed HA, Kamal NM, Ali ST, Abdelhaleem IA

Am J Rhinol Allergy. 2022 May 20:19458924221097449. doi: 10.1177/19458924221097449. Epub ahead of print. PMID: 35593100

Allergic diseases are immunological reactions with symptoms that may impact quality of life. Bilastine, is a novel oral second-generation H-1 antihistamine, with high selectivity to H1 receptors and with anti-inflammatory properties, however there is not enough evidence regarding the drug efficacy.

The objective of this study was to assess the efficacy and safety of bilastine compared with placebo and other active antihistamines in patients with allergic rhinitis or chronic urticaria.

A literature search was made for randomized controlled trials which assessed bilastine effects on symptomatic hyper histaminic allergic conditions. Data on total symptoms scores (TSS), total nasal symptom scores (TNSS), discomfort associated with these allergic conditions measured by visual analog score (VAS), and quality of life (QoL) for allergic rhinitis and urticaria was collected. Other outcomes such as clinical global impression and safety profiles were reported. The studies were statistically analysed.

The analysis included 9 randomized controlled trials which included 3801 participants. The meta-analysis shown that bilastine was superior to placebo, improving TSS, TNSS, VAS, and QoL in participants with allergic rhinitis or chronic urticaria. Furthermore, bilastine was comparable to other antihistamines such as cetirizine, fexofenadine, and loratadine regarding these outcomes, with a safe and tolerable profile and with no difference in the incidence of adverse events.

In conclusion, bilastine improved TSS in hyper histaminic allergic conditions involving nasal symptoms in allergic rhinitis with a safe and effective manner. It decreased the discomfort associated with the condition resulting in better QoL of the participants.

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Efficacy and Safety of Bilastine in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

By | Articles about Bilastine, Publicaciones sobre Bilastina

Singh Randhawa A, Mohd Noor N, Md Daud MK, Abdullah B

Front Pharmacol. 2022 Jan 10;12:731201. doi: 10.3389/fphar.2021.731201. PMID: 35082662; PMCID: PMC8784885

Rhinitis is an inflammation of the nasal epithelium, leading to rhinorrhoea, nasal blockage, itching and sneezing. Allergic rhinitis is the most common form of rhinitis and occurs following exposure to allergens. Bilastine is one of the non-sedating second generation H1 oral antihistamines for allergic rhinitis. The objective of this study was to review the efficacy and safety of bilastine in treating allergic rhinitis.

This review was made after an electronic literature search of bilastine-related publications of randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy up to March 2021. The included studies had to have description of diagnosis of AR established by clinicians and the outcomes with a minimum of 2 weeks of follow-up period.

The primary outcomes evaluated were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QoL) and adverse events. The risk of bias and quality of evidence for all studies were also taken into consideration.

There were 135 records identified on the literature search after removal of duplicates. Following screening and review, 15 full-text articles were evaluated for eligibility. Five trials involving 3,329 patients met the inclusion criteria.

From the five trials included, bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QoL but demonstrated a comparable efficacy with other oral antihistamines in TSS, NSS, NNS, rhinitis discomfort score and QoL. The only adverse event where bilastine showed difference from placebo was in somnolence, and also with fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality.

In conclusion, bilastine is safe and effective in the treatment of overall symptoms of allergic rhinitis with comparable efficacy and safety with other antihistamines except somnolence: while bilastine has a comparable efficacy to cetirizine, somnolence is notably fewer in bilastine.

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A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine

By | Articles about Bilastine, Publicaciones sobre Bilastina

Shah B, Dhoot D, Choudhary A, Jangid N, Mistry D, Shah S, Kamat S, Barkate H

Clin Cosmet Investig Dermatol. 2022 Feb 18;15:261-270. doi: 10.2147/CCID.S350122.

Chronic spontaneous urticaria (CSU) is a common skin condition associated with angioedema, wheals, or both. Although second-generation antihistamines (SGAH) are first-line drugs in CSU, half of the patients do not respond to them. Guidelines recommendation for these patients is to up-dose SGAH or combine different antihistamines. The objective of this study was to examine the effectiveness and tolerability of up-dosing of bilastine and fexofenadine up to two times and combination of non-sedating second-generation antihistamines; levocetirizine and first-generation antihistamine; and hydroxyzine in patients with CSU.

This was a comparative, three-arm study, which randomized CSU participants to receive standard dose of either bilastine, fexofenadine, or levocetirizine for 2 weeks. After 2 weeks of treatment, non-responders received double dose of either bilastine or fexofenadine, while hydroxyzine 25 mg once daily was added in the levocetirizine group. Participants were assessed for better outcomes in CSU, quality of life, and somnolence.

The study included 110 participants with CSU. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine, and levocetirizine groups indicated improvement in urticaria symptoms. At week 2, the urticaria activity score improvement showed no statistical difference between any of the groups; however, at week 4, there was a statistical difference between the bilastine and levocetirizine groups (p<0.05). Somnolence was significantly lower in the bilastine group (p<0.05). Bilastine was statistically significant (p<0.05) in the improvement of quality of life as compared to both groups. There was no report of major adverse events during the study period; however, bilastine was related to significantly lower levels of adverse events compared to levocetirizine (p<0.05).

In conclusion, a two-fold up-dosing of bilastine improves CSU symptoms with no changes in safety as compared to two-fold up-dosing of fexofenadine and combination of first- and second-generation antihistamines.

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Experience with bilastine in the management of urticaria: Original Real-world cases of Bilastine In Treatment (ORBIT) in Asia

By | Articles about Bilastine, Publicaciones sobre Bilastina

Cheong WK, Chan AWM, Ch’ng CC, Chung WH, Gabriel MT, Godse K, Mitthamsiri W, Nguyen HT, Tiongco-Recto M, Nagrale D

Drugs Context. 2022 Mar 15;11:2021-12-2. doi: 10.7573/dic.2021-12-2. PMID: 35371270; PMCID: PMC8932249

People with urticaria have a compromised quality of life and sleep, and school/work due to its incapacitating condition. It presents with red and itchy rash with characteristic wheals, and/or angioedema. Current guidelines recommend second generation H1-antihistamine as first-line treatment of urticaria. Bilastine is a second-generation H1-antihistamine indicated in children aged ≥6 years and adults (Europe) for the symptomatic treatment of urticaria and allergic rhino-conjunctivitis. It has a well-documented efficacy and safety profile, with a rapid onset and a prolonged duration of action and a low sedative potential.

The objective of the Original Real-world cases of Bilastine In Treatment (ORBIT) study was to evaluate real-world cases published from the Asia-Pacific region in adults and children using bilastine for the long-term management of urticaria.

Eight cases diagnosed and classified according to international guidelines as chronic spontaneous urticaria or inducible urticaria were presented:

  • Case 1: 35-year-old man complaining of an itchy skin rash for the previous 6 months
  • Case 2: 10-year-old boy who developed recurrent hives over the past 3-4 years
  • Case 3: 54-year-old woman with poorly controlled chronic urticaria and intolerance to sedating antihistamines
  • Case 4: 33-year-old woman with cholinergic urticaria
  • Case 5: 20-year-old woman with intensely itchy rash
  • Case 6: 61-year-old woman with atopic (allergic rhinitis) with new-onset urticaria
  • Case 7: An elderly man with recalcitrant CSU unresponsive to second-generation antihistamines
  • Case 8: Chronic rash in an elderly man with multiple comorbidities

Although this was a small and diverse group of patients with urticaria considered difficult to treat, the administration of bilastine as per the approved label was well tolerated and effective in the long-term management of urticaria.

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Bilastine 10 and 20 mg in paediatric and adult patients: an updated practical approach to treatment decisions

By | Articles about Bilastine, Publicaciones sobre Bilastina

Amalia Leceta, Aintzane García, Ander Sologuren, Cristina Campo

Drugs Context . 2021 Aug 10;10:2021-5-1. doi: 10.7573/dic.2021-5-1. eCollection 2021

Bilastine is a non-drowsy H1-antihistamine for treating allergic conditions such as rhinoconjunctivitis and urticaria in people of all ages. This review aims to update a former article, focusing on recent clinical data on the use of bilastine in children and adults.

Data was collected from recent clinical studies in children and adults from Faes Farma. Most of the new information was updated on paediatric and elderly use. The European Medicines Agency approval took place in 2017 following a Paediatric Investigation Plan from 2009. Faes Farma received questions related to drug interactions involving bilastine and other concomitant medicines and the use of bilastine in special populations or for the treatment of specific conditions. The summarized advice from specialists consisted of interactions involving the cytochrome P450 isozyme system, leading to changes in drug exposure and, therefore, clinical efficacy and safety. Elderly patients are at particular risk of drug-drug interactions due to the number of concurrent medicines and comorbidities. Of importance are also potential drug-drug interactions between bilastine and drugs with a narrow therapeutic index.

In conclusion, although bilastine has a favorable pharmacokinetic profile, decisions on its use should rely on evidence, expert opinions, and the SmPC of bilastine. Nevertheless, further studies are needed to answer specific questions regarding its use.

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Pharmacokinetics and Safety of a Bilastine Once-Daily, Preservative-Free, Ophthalmic Formulation

By | Articles about Bilastine, Publicaciones sobre Bilastina

Dolores Ochoa, Manuel Roman, Carmen Belmonte, Samuel Martin-Vilchez, Gina Mejia-Abril, Francisco Abad-Santos, Gonzalo Hernandez, Paula Arranz, Lorena Elgezabal, Nieves Fernandez

Adv Ther . 2021 Jun 12. doi: 10.1007/s12325-021-01801-y. Online ahead of print.

Bilastine is a second-generation H1 antihistamine for allergic conditions. A new ophthalmic formulation was developed based on the efficacy and safety profiles of the oral formulation. The aim of this study was to assess the safety and pharmacokinetics of ophthalmic bilastine (6 mg/ml) in adults after one and various doses.

This was an open-label, single-centre, phase 1, bioavailability study that included 12 healthy participants (aged 18-55 years old). Participants were administered one drop of the bilastine eye formulation in each eye for five days. Serum levels of bilastine were assessed by HPLC-MS/MS and adverse drug reactions registered during administration and follow-up.

After various admininistrations, bilastine blood levels were 2682,26 ± 1615,88 pg/mL at 2,5 hours. The half-life of bilastine was 7,88 ± 6,72 h. Area under the curve was 19512,51 ± 9248,76 h/pg/mL. Dysgeusia was the main adverse event, which was mild and transient.

The ophthalmic formulation has proved to be absorbed in low amounts to the bloodstream, showing a good safety profile after administration of various doses.

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