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New drug Salmecort in the basic therapy of bronchial asthma

The main anti-inflammatory drugs for the treatment of asthma are inhaled glucocorticosteroids (ICS). Controlled studies conducted taking into account the requirements of evidence-based medicine have shown the effectiveness of ICS in terms of improving respiratory function, reducing airway hyperresponsiveness and severity of symptoms, reducing the frequency and severity of exacerbations (level of evidence, A) [6–8].

In the 1970s Selective β2-receptor agonists entered clinical practice, which had a predominant effect on bronchial smooth muscle and clinically insignificant activity against α- and β1-receptors. Patients who regularly took short-acting β2-agonists before taking ICS demonstrated greater clinical efficacy of therapy than those who took these drugs only as needed. This led to the development of selective long-acting β2-agonists (LABAs). In the treatment of BA, inhaled salmeterol or formoterol are used, which in combination with ICS are the basis of basic therapy for BA. Including them in the treatment regimen of patients whose asthma cannot be completely controlled with various doses of ICS allows one to achieve better control over the disease than simply increasing the dose of ICS by 2 times or more (level of evidence, A) [9–11]. ICS and LABA should be considered as synergists, due to their complementary effects at the molecular and receptor levels [12–15]. The high anti-inflammatory effect of the combined use of ICS and LABA is an argument in favor of using this therapeutic approach for BA, which is accompanied by inflammation of the bronchial mucosa, its swelling, plasma exudation (increased vascular permeability), hypertrophy of smooth muscle cells and desquamation of the epithelium.

In 2005, 2008 and 2010 The US Food and Drug Administration (FDA) has further assessed the safety of LABAs in asthma. From the data presented, it follows that the increased risk is observed primarily in a very specific group of patients - black Americans who did not receive therapy with inhaled hormonal drugs before starting LABA treatment. An increased risk of severe exacerbations was also noted in cases where treatment with this group of drugs was started against the background of a pronounced deterioration or an existing exacerbation of BA [16].

Long-acting β2-agonists can only be prescribed in addition to ICS. Regular use of LABAs for routine therapy requires their mandatory combination with ICS. Doctors should be aware that the use of monotherapy with β2-agonists causes the development of the phenomenon of down-regulation of β2 receptors, which can lead to serious consequences for patients, including the development of asthmatic conditions.

A combination of fluticasone propionate (FP) and salmeterol xinafoate (SAL). The components that make up these drugs have been used for quite a long time: FP - since 1993, SAL - since 1990.

FP is one of the most highly active anti-inflammatory drugs available today. The drug has low systemic bioavailability (~1%), and absolute bioavailability is 10–30% depending on the type of inhaler. FP has a high affinity for glucocorticoid receptors and has a long-lasting relationship with the receptor. To prevent hoarseness and the development of candidiasis, when taking FP, you should follow the same rules as when taking other ICS, i.e., rinse your mouth and throat with water after inhalation. Due to its high anti-inflammatory effect, FP is also indicated for patients with severe asthma and dependence on systemic steroids [17].

SAL is an inhaled LABA. Clinical studies have shown that LABAs have a stabilizing effect on mast cells and inhibit their IgE-mediated release of histamine, which leads to a decrease in its systemic and local concentrations [18]. SAL is prescribed only as a drug for basic therapy and is not used as needed, during exacerbation of the disease, asthmatic condition, or to relieve attacks of difficulty breathing. Only recommended doses should be used, and short-acting β2-agonists should be used to relieve symptoms. Note that SAL also has a number of unexpected properties - in particular, it causes a decrease in the pathogenicity of Pseudomonas aeruginosa and has a protective effect against Haemophilus influenzae in cultures of the respiratory tract epithelium [19–21]. SAL is a highly safe drug, as proven by numerous clinical studies.

The first fixed-combination drug was Seretide®, containing ICS AF and SAL and classified as a long-acting inhaled β2-agonist.

Combined drug FP and SAL. In a study by S. Kirby et al. It has been shown that when using a combination of SAL and FP in healthy people, no systemic pharmacodynamic or pharmacokinetic interactions are observed [22]. The GOAL (Gaining Optimal Asthma control) study, the results of which formed the basis of the GINA control strategy (2006), demonstrates the benefits of combination therapy with ICS + LABA for moderate to severe asthma [23]. The results of the GOAL study are of important practical importance, since it formulates criteria for the effectiveness of asthma treatment. According to the GOAL study, about 40% of asthma patients treated with a fixed combination of SAL/FP achieved complete control of asthma after 12 months. treatment. It is equally important that in the group that received a fixed combination as basic therapy, there were significantly more patients who achieved complete control over BA than in the case of AF monotherapy. Thanks to the GOAL study, an important conclusion was made that treatment outcomes can be improved by choosing the most effective basic therapy.

A study by NC Barnes et al demonstrated that in patients with persistent asthma, initial treatment with SAL/AF compared with AF was 1.65 times more likely to achieve well-controlled asthma in patients with 2 signs of poor pre-treatment asthma control and 2.6 times more likely to achieve well-controlled asthma in patients with 3 signs of poor asthma control before treatment [24].

Original drugs and generics. The original drug with a fixed combination of AF and SAL, Seretide®, is widely and successfully used for the treatment of asthma and COPD using methiodized (MDI) and powder (Diskus) inhalers. The use of original drugs is possible only upon receipt of reliably proven results of clinical trials to study the safety and effectiveness of the drugs. Thus, at all stages of clinical trials, all adverse reactions are recorded; This also happens for a number of years after the drugs are introduced to the market. These conditions determine the price of original drugs. When the patent of original drugs expires, the most successful medications begin to be produced in the form of generics - copies of the original drug. Moreover, the copy must be complete, since the results of clinical studies of the original drug are automatically extrapolated to it. Generics are always cheaper than original drugs, which expands the possibilities of therapy. The WHO requirements for generics regarding pharmaceutical and therapeutic equivalence are quite stringent - the generic must act exactly the same as the original drug, have the same effectiveness and safety.

Currently, the drug Salmecort has been introduced to the market, in which a fixed combination of 2 active components - FP and SAL - corresponds in dosage to the original drug produced at MDI. In Russia, an open randomized multicenter study was conducted to test the hypothesis of non-inferior efficacy and safety of the drug Salmecort (25/250 mcg, in the form of a dosed inhalation aerosol) compared with the drug Seretide® (25/250 mcg, in the form of a dosed inhalation aerosol ) in the treatment of patients with persistent BA and in need of combination therapy with high doses of ICS and long-acting β2-adrenergic agonists.

Objectives of this study:

1. Comparative assessment of the level of asthma control and its dynamics during the study.

2. Comparative assessment of the safety and tolerability of Salmecort and Seretide®.

Doctors from 5 leading medical institutions in Russia took part in the study. The diagnosis of asthma was made by a physician in accordance with the practice of the medical institution. After signing informed consent to participate in the study, patients (113 people) were screened; the introductory period lasted an average of 14 days. During this time, the investigator assessed the patient's compliance with inclusion/non-inclusion criteria and disease stability. Then, 107 patients who met the inclusion/exclusion criteria were randomized into 2 treatment groups.

Patients of the 1st group (n=56) were prescribed Salmecort, 2 inhalations 2 times a day, patients of the 2nd group (n=51) were prescribed Seretide®, 2 inhalations 2 times a day. The first drug intake was carried out in the center under the supervision of medical personnel after spirometry was performed. The investigator instructed the patients how to administer the drugs correctly.

Patients took the drugs daily for 12 weeks. They were systematically subjected to spirometry. Patients were required to keep a daily diary - in the morning and evening, record peak flow readings, as well as the presence of asthma symptoms and the need for bronchodilators. During the period of taking the study drugs, patients were scheduled for 3 visits to the center with a frequency of 4 weeks. After the final visit on the 85th day from the start of treatment, the patient’s participation in the study ceased, and further therapy was carried out by the attending physician.

When analyzing the effectiveness, it was revealed:

The number of patients with a positive response to treatment according to pulmonary function tests was 35 (64.81%) in the Salmecort group and 25 (49.02%) in the Seretide® group. The odds ratio for Salmecort/Seretide was 1.92 (0.88–4.2) and the relative risk was 1.32 (0.94–1.86). The one-sided 95% confidence interval within which the noninferiority hypothesis was tested was 0.99 for the relative risk and odds ratio.
When comparing BA control indicators (AST questionnaire) at visits 4 and 5, a statistically significant increase was noted in both groups, while the number of patients with an increase in score of at least 1 point was 45 in the Salmecort group and 40 in the Seretide® group (Fig. . 1).
There was an increase in peak expiratory flow rates according to patient diaries in the period preceding visit 5 compared to the period preceding visit 2.
During the study periods preceding Visits 4 and 5, a decrease in the total number of asthma attacks was noted. When comparing the drug groups Salmecort and Seretide®, a statistically significant decrease in the total number of asthma attacks was noted in the Salmecort group.
When assessing changes in the patient’s condition by the doctor at the 5th visit, no statistically significant differences were revealed between the study groups (Fig. 2).

An analysis of the incidence of adverse events, carried out using the “bootstrap” technique, did not reveal a statistically significant difference between treatment groups in this parameter.

In no case was the development of candidal lesions of the mucous membranes of the oropharynx observed during the use of the studied drugs.

The results of the study allowed us to draw the following conclusions:

The effectiveness of the drug Salmecort (25/250 mcg, in the form of a dosed inhalation aerosol) in 12-week treatment of patients with persistent asthma is not less than the effectiveness of the Seretide® drug (25/250 mcg, in the form of a dosed inhalation aerosol).
Based on the safety data obtained, it can be concluded that Salmecort has a favorable safety profile and tolerability.

It should be remembered that both Seretide® and Salmecort are not prescribed for the relief of asthma symptoms. For this purpose, it is preferable to prescribe short-acting β2-agonists. If it is necessary to increase the dose of ICS, the permissible dose of SAL should not be exceeded. In this case, the patient should be prescribed a drug with a higher content of FP.

Overdose

Signs and symptoms that can be expected in an overdose of salmeterol, typical of excessive stimulation with β2-agonists, include dizziness, tremor, headache, tachycardia, increased systolic blood pressure. If treatment with the drug must be discontinued as a result of an overdose of the β2-agonist included in the drug, appropriate steroid replacement therapy should be prescribed. Additionally, hypokalemia may occur, so serum potassium levels should be monitored and the need for potassium replacement therapy should be considered.

Features of application

Pregnant

Prescribing Airtek during pregnancy is advisable only in cases where the expected benefit to the mother outweighs the possible risk to the fetus. For the treatment of pregnant women, low effective doses of fluticasone propionate are prescribed to maintain adequate control of asthma symptoms.

Children

Children and adolescents under 16 years of age who are treated with high doses of fluticasone propionate (usually ≥1000 mcg/day) are at particular risk for systemic effects. Systemic effects are usually caused by treatment in high doses for a long time. Possible systemic effects include Cushing's syndrome, Cushingoid signs, adrenal suppression, acute adrenal crisis, growth retardation in children and adolescents, decreased bone mineralization, cataracts and glaucoma, less commonly possible mental disorders and behavioral changes, including psychomotor hyperactivity, sleep disturbances, agitation, depression or aggression.

It is recommended to regularly monitor the growth dynamics of children receiving inhaled GCS for a long time. The dose of inhaled corticosteroids should be reduced to the minimum effective dose to control asthma symptoms.