Efficacy In Daily Clinical Practice Research Articles

The Efficacy and Safety of Cinnarizine in the Treatment of Vertigo in a Sample of Iraqi Patients in Al-Diwaniyah Province

Background: Vertigo is acoomon vestibular disorder in daily clinical practice that is frequently described as rotational sensation by patients and caused by a variety of causes that can be central or peripheral in origin. Treatment should be directed toward underlying etiology, but symptomatic relief is required to improve patients’ quality of life. Cinnarizine is frequently prescribed to relieve symptoms associated with vertigo; however little is known about its efficacy in daily clinical practice in Al-Diwaniyah province.Aim of the study: To evaluate the safety and efficacy of cinnarizne in the treatment of vertigo in patients visiting ENT unit at Al-Diwaniayh teaching hospital.Patients and method: The present cohort study included 66 patients of vertigo who were treated medically by cinarrizine (stugeron) and followed up for treatment response evaluation. The study was carried out in Ear Nose and Throat (ENT) unit in Al-Diwaniyah Teaching Hospital, Mid-Euphrates region, Iraq. The study started on June 2018 and ended on July 2019. The main variables included in the study were age, residency, level of education, occupation, other associated ENT manifestations and chronic illnesses. The primary outcome was response to treatment classified into satisfactory and unsatisfactory.Results: Mean age of patients with satisfactory response was significantly less than that of patients with unsatisfactory response, 45.73 ±13.31 years versus 54.95 ±15.67 years, respectively (P = 0.016). Response to treatment was not significantly associated to gender, residency, occupation and education (P > 0.05). Response to treatment was not significantly associated to bilateral ear wax, acute otitis media, chronic suppurative otitis media, Meniere’s disease and common cold (P > 0.05); however, it was significantly in the absence of hearing impairment and tinnitus (P 0.05), but significantly better in the absence of diabetes mellitus and hypertension (P < 0.05).

ETNA-AF study: Italian baseline data and comparison with the European population in atrial fibrillation patients treated with edoxaban

The introduction of direct oral anticoagulants (DOACs) has been the main therapeutic revolution in the last 20 years. Four molecules have been approved for the thromboembolic prophylaxis in patients with non-valvular atrial fibrillation (AF). After the publication of phase 3 clinical trials, many studies evaluating DOAC safety and efficacy in daily clinical practice have been published. Edoxaban is the latest DOAC available on the market, based on the results of the ENGAGE AF-TIMI 48 trial. The phase 4 ETNA-AF (Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation) observational study was designed with the aim to confirm the results of the pivotal clinical trial in routine care in unselected patients with AF. This registry involved several sites and enrolled a large population in Europe and in Italy (13 980 and 3512 patients, respectively). The broad spectrum of patients will allow to have an overview of the characteristics of the AF population and to make a comparison with previous national registries and between different European realities.

Treatment of blepharospasm and Meige's syndrome with abo- and onabotulinumtoxinA: long-term safety and efficacy in daily clinical practice.

Thirty years after their approval, botulinum toxin injections still are the first-line therapy for blepharospasm. The aim of our study was to analyze long-term data concerning safety and efficacy in a large cohort over decades. Treatment data of all patients with blepharospasm and Meige´s syndrome in our outpatient clinic having undergone at least three subsequent treatment sessions with current onabotulinumtoxinA or abobotulinumtoxin A were analyzed with respect to the course of dose, effect duration, side effects, patients´ satisfaction and occurrence/reasons for treatment discontinuation. The observation period was up to 18years for onabotulinumtoxinA and 29 years for abobotulinumtoxinA with a total of 1778 and 9319 treatment sessions in 69 patients with onabotulinumtoxinA, 281 with abobotulinumtoxin A and 2 of these having used both products. The dose increased in the first years followed by a stable dose in the following years. The mean dose was 39.1/198.7 mouse units (onabotulinumtoxinA/abobotulinumtoxinA). In over 25% of all sessions, inhibition of the eyelid opening was effectively treated with pretarsal injections. The most common adverse events included ptosis (4%/5%), epiphora/sicca (4%/5%), double vision (1%/1%) and facial asymmetry (1%/1%). Reasons for therapy discontinuation were change to a nearby doctor, age, other diseases, spontaneous improvement, side effects or possible treatment failure. Only one patient was tested positive for neutralizing antibodies against botulinum toxin A. The treatment of blepharospasm and Meige's syndrome with onabotulinumtoxinA and abobotulinumtoxinA is safe and effective, also over a long observation period of up to 29years.

Treatment of cervical dystonia with abo- and onabotulinumtoxinA: long-term safety and efficacy in daily clinical practice

Treatment with botulinum toxin A is the evidence-based first-line therapy of cervical dystonia. The aim of this study was to analyze long-term data of the most commonly used products concerning safety and efficacy in a big cohort over decades. We retrospectively analyzed the treatment data of all cervical dystonia patients in our outpatient clinic having at least three treatment sessions with current onabotulinumtoxinA or abobotulinumtoxinA. The observation period was up to 17years for onabotulinumtoxinA and 27years for abobotulinumtoxinA. We report on safety and efficacy, comparing parameters such as dose, treatment intervals, side effects, occurrence and reasons of primary or secondary non-response. We analyzed a total of 2592 and 6660 treatment sessions in 135 patients with onabotulinumtoxinA, 209 with abobotulinumtoxinA and 10 having received both preparations. We found a moderate increase of dosage in the first years which was succeeded by a stable mean dose (138 and 663 mouse units, respectively) and stable injection intervals from the beginning. The most frequent side effects were mild dysphagia (2/6%), muscle weakness (2/6%) and pain (2/2%). Reasons for therapy discontinuation were change to a nearby doctor, age, other diseases, spontaneous improvement, side effects or possible treatment failure. Of all patients, only two tested positive for neutralizing antibodies against botulinum toxin A. We show that treatment of cervical dystonia with the two most frequently used botulinum toxin A preparations is a safe and effective therapy even over a long treatment duration of up to 27years.

Computerized decision support systems: EBM at the bedside

One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making. The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice. The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits. The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable. CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.

Refractory chronic migraine: is drug withdrawal necessary before starting a therapy with onabotulinum toxin type A?

Onabotulinum toxin A (BT-A) is now one of the authorized prophylaxis treatments for chronic migraine (CM) thanks to previous clinical trials, which usually required a pharmacologic washout as a precondition for demonstrating its efficacy. Aim of our study was to assess the efficacy in daily clinical practice of BT-A injections in refractory CM patients, regardless of medication overuse without any standardized withdrawal protocol and without stopping the ongoing prophylaxis treatment as well. We treated 44 refractory CM patients (37 females and 7 males) trimonthly without any modification in symptomatic, or prophylactic drug therapy. Main efficacy variables included number of headache, or migraine days and episodes, total cumulative headache hours, MIDAS and HIT-6 scores; all items were assessed at baseline and at the 12-, 24-, and 36-week follow-up. All variables showed a statistically significant improvement at week 36. In general, more than 50% of patients had a good clinical outcome (including all improved patients, either partial or full responder) and that the percentage of drug abuser patients significantly decreased from 75 to 50%, thanks to a spontaneous reduction of the symptomatic drug intake. Adverse events were uncommon and did not require treatment discontinuation. Onabotulinum toxin A treatment in refractory CM patients with unsatisfactory prophylactic drug treatments and pharmacological abuse is effective in improving clinical outcome and quality of life. This result may be achieved through a flexible pharmacologic approach tailored to each patient's needs; moreover, the patient himself can be often expected to reduce drug consumption spontaneously.

The patient-physician relationship. Patient-physician communication during outpatient palliative treatment visits: an observational study.

Improving health-related quality of life (HRQL) is an important goal of palliative treatment, but little is known about actual patient-physician communication regarding HRQL topics during palliative treatment. To investigate the content of routine communication regarding 4 specific HRQL issues between oncologists and their patients and to identify patient-, physician-, and visit-specific factors significantly associated with discussion of such issues. Observational study conducted between June 1996 and January 1998. Outpatient palliative chemotherapy clinic of a cancer hospital in the Netherlands. Ten oncologists and 240 of their patients (72% female; mean age, 55 years) who had incurable cancer and were receiving outpatient palliative chemotherapy. Patient and physician questionnaires and audiotape analysis of communication regarding daily activities, emotional functioning, pain, and fatigue during an outpatient consultation using the Roter Interaction Analysis System. Physicians devoted 64% of their conversation to medical/technical issues and 23% to HRQL issues. Patients' communication behavior was divided more equally between medical/technical issues (41%) and HRQL topics (48%). Of the independent variables investigated, patients' self-reported HRQL was the most powerful predictor of discussing HRQL issues. Nevertheless, in 20% to 54% of the consultations in which patients were experiencing serious HRQL problems, no time was devoted to discussion of those problems. In particular, these patients' emotional functioning and fatigue were unaddressed 54% and 48% of the time, respectively. Discussion of HRQL issues was not more frequent in consultations in which tumor response was evaluated. Despite increasing recognition of the importance of maintaining patients' HRQL as a goal of palliative treatment, the amount of patient-physician communication devoted to such issues remains limited and appears to make only a modest contribution, at least in an explicit sense, to the evaluation of treatment efficacy in daily clinical practice.