Six-month therapy of CGRP monoclonal antibodies in real-world clinical practice: an interim analysis of efficacy and safety data

Introduction. Migraine is one of the most common disabling neurological disorders. Recently developed monoclonal antibodies to calcitonin gene-related peptide (CGRP) or its receptor are the first targeted medication for preventive therapy of both episodic and chronic migraine. They have been thoroughly investigated in clinical trials; however, there is little data from real-world clinical practice available to date. The aim of this study is to assess the efficacy and safety of 6 months of treatment with erenumab in real-world clinical practice and investigate the effect of the drug on the patients’ sensitivity to medicines for migraine headaches relief and patient satisfaction after treatment.Materials and methods. Our observational cohort prospective study included patients in our Headache Clinic prescribed monoclonal antibodies blocking the  CGRP-receptor  – erenumab. During the  investigation, we evaluated the  previous preventive therapy and its efficacy, the number of days with migraine per month, adverse events occurring during the erenumab treatment, depression and anxiety (HADS), migraine disability (MIDAS), the presence of allodynia (ACS-12) and improved response to acute therapy after treatment. A total of 42 patients participated in the study: 6 men, 36 women, the average age was 43.9 ± 12.2. Of them, 38 patients (90%) had chronic migraine. Thirty-two patients (76%) had previously been prescribed preventive therapy, which proved ineffective, and 10 patients (24%) had not once received any type of migraine prevention.Results. Among our patients, we identified 11 patients with resistant migraine and one patient with refractory migraine. During the study, two patients dropped out due to adverse events (constipation). Thirty patients continued the administration of erenumab 70 mg for at least six months. The average number of migraine days per month before treatment was 22.8, and after six months of treatment, it dropped to 7.3. Twenty-nine patients (72.5%) also noted that the response to acute headache treatment improved after the therapy.Conclusion. The results of our study are consistent with the international experience of using erenumab and confirm its effectiveness for migraine preventive therapy, including difficult-to-treat migraine cases. However, further studies with more participants and evaluation of predictors of successful monoclonal antibody therapy are still needed

Diagnosis and management of migraine in ten steps

Migraine is a disabling primary headache disorder that directly affects more than one billion people worldwide. Despite its widespread prevalence, migraine remains under-diagnosed and under-treated. To support clinical decision-making, we convened a European panel of experts to develop a ten-step approach to the diagnosis and management of migraine. Each step was established by expert consensus and supported by a review of current literature, and the Consensus Statement is endorsed by the European Headache Federation and the European Academy of Neurology. In this Consensus Statement, we introduce typical clinical features, diagnostic criteria and differential diagnoses of migraine. We then emphasize the value of patient centricity and patient education to ensure treatment adherence and satisfaction with care provision. Further, we outline best practices for acute and preventive treatment of migraine in various patient populations, including adults, children and adolescents, pregnant and breastfeeding women, and older people. In addition, we provide recommendations for evaluating treatment response and managing treatment failure. Lastly, we discuss the management of complications and comorbidities as well as the importance of planning long-term follow-up

Efficacy of tolperisone versus meloxicam in the treatment of nonspecific acute neck pain

Neck pain is a widespread disease that significantly impairs quality of life in patients. General approaches to managing patients with acute neck pain are generally consistent with the recommendations for the treatment of acute back pain: its pharmacotherapy includes nonsteroidal antiinflammatory drugs (NSAIDs) and muscle relaxants.Objective of the observational program: to compare the efficiency of treatment for nonspecific acute neck pain with tolperisone 150 mg/day, followed by dose escalation up to 450 mg/day, versus meloxicam 15 mg/day for 14 days.Patients and methods. The observational program covered 37 patients aged 18–65 years who were diagnosed with acute nonspecific neck pain; of them 19 patients made up Group 1 and 18 formed Group 2. Group 1 was prescribed tolperisone (Calmirex) as tablets: 150 mg/day on day 1, 300 mg/day on day 2, and 450 mg/day on day 3 until the end of therapy. On day 1 of the investigation, Group 2 received meloxicam 15 mg/day in two divided doses (7.5 mg in the morning and evening). At baseline and on days 7 and 14 days of therapy, the investigators assessed the dynamics of pain using a visual analogue scale (VAS), as well as its intensity at rest and during movement; neck disability index (NDI) and recorded adverse events.Results and discussion. The two groups showed a significant decrease in pain intensity on both 7 and 14 days of therapy. The rate of effect onset was significantly faster in the meloxicam group. On day 14 of treatment, both patient groups showed a considerably better functional state in terms of activity limitations due to neck pain (NDI); patients' perceptions of therapy were rated as good and excellent in most cases. On 14 days of therapy, the degree of pain reduction in the meloxicam group was higher, but the differences with that in the tolperisone group did not reach statistical significance, which can indicate the comparable efficacy of the drugs.Conclusion. The data of this observational program are consistent with the recommendations for the treatment of nonspecific acute neck pain, which indicate NSAIDs and muscle relaxants as drugs for the treatment of this disease

Severe drug-induced headache with its possible recurrent statuses in a patient with chronic tension headache

The paper deals with the actual problem of managing patients with drug-induced headache (DIH) in patients with primary headaches. It describes a clinical case of extremely severe DIH in a patient with chronic tension headache (TH). The paper analyzes the typical and atypical manifestations of DIH and discusses the role of prolonged stress in the development of TH. Special attention is paid to the problems with therapy and compliance during a long-term follow-up of the patient. Based on the clinical features of pain syndrome in the described patient, the authors suggest for the first time that the use of extremely high number of daily doses of combined narcotic analgesics for many years can result in recurrent DIH statuses. The paper discusses whether it is expedient to introduce the concept “DIH severity” and whether an additional clinical parameter “the number of doses of painkillers per month” can be of informative value, which has not been proposed yet in the literature. All the issues given in the paper are conjectural and are raised by the authors for further investigation of the DIH problem

EVALUATION OF THE EFFECTIVENESS OF A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SELECTION ALGORITHM BASED ON THE ANALYSIS OF RISK FACTORS FOR DRUG-INDUCED COMPLICATIONS IN REAL CLINICAL PRACTICE: THE RESULTS OF THE ALL-RUSSIAN PRINCIPLE PROJECT (APPLICAT

To enhance the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs), a class of essential medications used to treat acute and chronic pain, is an important and urgent task. For its solution, in 2015 Russian experts provided an NSAID selection algorithm based on the assessment of risk factors (RFs) for drug-induced complications and on the prescription of drugs with the least negative effect on the gastrointestinal tract and cardiovascular system. The PRINCIPLE project was implemented to test the effectiveness of this algorithm.Subjects and methods. A study group consisted of 439 patients (65% were women and 35% – men; their mean age was 51.3±14.4 years) with severe musculoskeletal pain, who were prescribed NSAIDs by using the above algorithm. The majority of patients were noted to have RFs: gastrointestinal and cardiovascular ones in 62 and 88% of the patients, respectively. Given the RF, eight NSAIDs were used; these were aceclofenac, diclofenac, ibuprofen, ketoprofen, meloxicam, naproxen, nimesulide, and celecoxib, the latter being prescribed most commonly (in 57.4% of cases). NSAID was used in combination with proton pump inhibitors in 30.2% of the patients. The follow-up period was 28 days. The investigators evaluated the efficacy of therapy (pain changes on a 10-point numeric rating scale (NRS)) and the development of adverse events (AE). Results and discussion. Pain was completely relieved in the overwhelming majority (94.9%) of patients. There were no significant differences in the efficacy of different NSAIDs according to NRS scores. The number of AE was minimal and did not differ between different NSAIDs, with the exception of a higher frequency of dyspepsia caused by diclofenac (15.7%). There were no serious complications or therapy discontinuation because of AE.Conclusion. The use of the NSAID selection algorithm allows for effective and relatively safe therapy with these drugs in real clinical practice

RATIONAL USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. CLINICAL GUIDELINES

In 2015, the experts from various medical associations of Russia elaborated the clinical guidelines “Rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) in clinical practice”. These guidelines were drawn up to improve the use of NSAIDs, our country’s most popular agents to treat pain in acute and chronic diseases. The main purpose of this paper was to reduce the frequency of potentially dangerous class-specific adverse events (AE) that may arise from the use of NSAIDs. To do this, the authors proposed a NSAID choice algorithm based on the assessment of risk factors for AE, the individual characteristics of various representatives of this drug group, and the possibility of prevention of AE.Since then, new data on the efficacy and safety of NSAIDs have been obtained. This has necessitated the revision and addition of a number of provisions in the 2015 guidelines. It seems that the new version of the guidelines, which has been drawn up based on the analysis of a large number of clinical and epidemiological studies, their meta-analysis, by taking into account the clinical experience and opinion of the world’s leading experts, presents more fully the main aspects of the use of NSAIDs in real clinical practice.The guidelines are intended for physicians of all specialties