Chance Of Treatment Success Research Articles

Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world

BackgroundAnti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who...

Motivational Factors and Barriers for Infertile Patients and Their Partners to Seek Consultation and Treatment in Australia

Background: Individuals and couples frequently wait years prior to seeking out medical advice and treatment for infertility, decreasing their chances of treatment success. The causes of delays to diagnosis, treatment and pregnancy are not well established amongst patients or their partners. Aim: To understand the key drivers and barriers for infertile patients and their partners to see an infertility specialist and subsequently undergo treatment. Method: An online quantitative survey collected data from 200 respondents in Australia in 2019. Average age was 35.7y (±10.5), 66% of patients were female, 47% of partners were female, 63% were married and 86% were heterosexual. Results: Average time to diagnosis was 3.1y (±2.4), followed by an average 1.4y (±1.4) attempting natural conception before consultation, and an average 1.4y (±1.4) of treatment before successful couples achieved pregnancy. The most frequently reported driver for considering treatment in respondents with a consultation (N=109) was an equal desire within couples to have a child by any means necessary (47%), followed by being comfortable with the treatment options and recommendations presented to them (45%). Among partners, 29% cited transparency of information from HCPs about treatment expectations as an important driver. Of respondents not seeking treatment after consultation (n=20), the most frequent reason was perceived cost (40%). Post consultation, only 15% of respondents not seeking treatment (n=20) reported that their HCP offered supportive services, compared to 55% of respondents seeking treatment (p[Formula: see text]0.002). 30% of respondents not seeking treatment agreed that their HCP provided resources to find a suitable infertility specialist, compared with 68% among those receiving treatment (p[Formula: see text]0.003). 30% of respondents not seeking treatment agreed that their HCP provided them with resources about their diagnosis, compared with 67% among those receiving treatment (p[Formula: see text]0.004). Conclusion: There were significant differences in perceived HCP services among respondents seeking treatment versus not seeking treatment.

A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder.

This is a summary of a study originally published in Neurourology and Urodynamics. Overactive bladder is a medical condition that causes an urgent need to urinate, which can cause accidental urination. Fesoterodine is a medication used to treat overactive bladder. Because we don't know how likely it is that an individual patient will achieve a level of improvement in their overactive bladder symptoms, researchers analyzed results of 6 studies of patients with overactive bladder who were treated with fesoterodine. Although complete resolution of all symptoms was rare with fesoterodine treatment, a resolution of accidental urination was more common, which is the most important treatment goal for many patients. After taking fesoterodine, episodes of accidental urination were more likely to be reduced or completely absent than episodes of an urgent need to urinate. These results can help patients with overactive bladder understand their own chances of treatment success with fesoterodine and can help doctors support their patients on what to expect regarding their specific symptoms and concerns. ▪Toviaz (fesoterodine) is approved to treat the condition that is discussed in this summary. Approval varies from country to country; please check with your local health provider for more details. ▪This summary reports the combined results of 6 studies. The results of individual studies may vary from the combined study results presented here. Individuals should make treatment decisions based on all available evidence. ClinicalTrials.gov NCT number: NCT01302054, NCT01302067, NCT00444925, NCT00611026, NCT00220363, and NCT00138723.

The impact of immediate in-brace 3D corrections on curve evolution after two years of treatment: preliminary results.

For the brace treatment of adolescent idiopathic scoliosis (AIS), in-brace correction and brace-wear compliance are well-documented parameters associated with a greater chance of treatment success. However, the number of studies on the impact of sagittal and transverse correction on curve evolution in the context of bracing is limited. The objective of this work was to evaluate how immediate inbrace correction in the three anatomical planes is related to long-term curve evolution after two years of bracing. We performed a retrospective analysis on 94 AIS patients followed for a minimum of two years. We analyzed correlations between in-brace correction and two-year out-of-brace evolution for Cobb and apical axial rotations (ARs) in the medial thoracic and thoraco-lumbar/lumbar regions (MT & TL/L). We also studied the association between the braces' kyphosing and lordosing effect and the evolution of thoracic kyphosis (TK) and lumbar lordosis (LL) after two years. Finally, we separated the patients into three groups based on their curve progression results after two years (corrected, stable and progressed) and compared the 3D in-brace corrections and compliance for each group. Coefficients were statistically significant for all correlations. They were weak for Cobb angles (MT: -0.242; TL/L: -0.275), low for ARs (MT: -0.423; TL/L: -0.417) and moderate for sagittal curves (TK: 0.549; LL: 0.482). In-brace coronal correction was significantly higher in corrected vs stable patients (p=0.004) while compliance was significantly higher in stable vs progressed patients (p=0.026). This study highlights the importance of initial in-brace correction in all three planes for successful treatment outcomes.

Case reports of athletes affected by rhabdomyolysis: A systematic review

Objective To analyze intensity levels, modalities, types of physical activities, ambient temperature, and hydration levels during stimuli performed in training and competitionof studies that reported episodes of rhabdomyolysis in athletes. Method We conducted a systematic review following the PRISMA guidelines and registered on PROSPERO, as number CRD42020126107. MedLine (via PubMed), Cochrane, LILACS, SciELO, Web of Science, Scopus, CINAHL, SPORTDiscus, ScienceDirect, and PEDro databases were searched for case reports in which professional athletes, who had a technical team as support, were affected by rhabdomyolysis induced by the practice of physical activity. The descriptors and their synonyms “rhabdomyolysis”, “exercise”, and “athletes”, available in the Health Sciences Descriptors (DeCS) and Medical Subject Headings (MeSH), were used. Results After the screening process, 10 studies were includedand analyzed according to the CAse REport (CARE) guidelines.The sports of the case reports were soccer, football, swimming, wrestling, 24-hour cross-country skiing, and mixed martial arts (MMA).The age range of the athletes varied between 16 to 41 years old. The case reports described a total of 17 athletes (14 male and three female).The main aspects related to the diagnosis of rhabdomyolysis were ambient temperature, creatine kinase (CK) levels, the occurrence of renal impairment, and one or more signs of the classical triad (myalgia, dark urine, and muscle weakness). Conclusion It was observed difficulty in identifying concrete parameters to prevent and diagnose the rhabdomyolysis of premature form, however, controlling these variables may increase the chances of treatment success and decrease the risk of sequels.

New advances in prostate cancer screening and monitoring.

Prostate cancer is the most commonly diagnosed cancer in the UK, with more than 57 100 cases in 2018. It is therefore of increasing importance to identify men with the greatest risk of developing the disease, to diagnose as early as possible, and to be able to offer effective, personalised therapies with the best chance of treatment success and optimal patient outcomes.

Alcohol Induced Wernicke Encephalopathy with Atypical MRI Findings

Wernicke encephalopathy is a neurological complication of thiamine deficiency, usually in the setting of poor diet, classically with alcoholism. Patients present with acute onset of encephalopathy, oculomotor dysfunction, gait ataxia and memory impairment. If untreated, the disorder can result in severe morbidity and possibly death; patient outcomes are entirely dependent on prompt diagnosis and administration of parenteral thiamine. Although diagnosed clinically, the radiologist may be able to alert the referring clinician to the possibility of the disease when imaging features are observed, thereby improving the chance of treatment success. Although various imaging features have been ascribed to alcohol and non-alcohol related forms of Wernicke encephalopathy, recent literature suggests that such a distinction is not reliable, and that the causes of Wernicke encephalopathy are not readily distinguishable on MRI, as in the index case presented here.

PCV153 - ELICITING PUBLIC PREFERENCES FOR REORGANIZATION OF VASCULAR SERVICES IN THE UK

The organisation of vascular services in the NHS is currently in a state of flux, with various options for reorganisation being considered. The aim of the proposed research is to elicit preferences from members of the public for: (1) treatment processes, as they have the option to undergo either keyhole surgery or open surgery for the repair of abdominal aortic aneurysms and (2) travelling distances for treatment. Telephone interviews were conducted with members of the public without a significant vascular condition. These participants were recruited from 15 different NHS Trusts in the UK. The interview involved participants being asked to trade-off the chance of a vascular treatment being successful against how far they would be willing to travel for treatment. The study included 202 participants (median age 55y; 68% female). Of these, 165 (81.7%) preferred the keyhole surgery, 36 (17.8%) preferred the open surgery and one person had no preference. When participants were told that they would have to travel to a specialist hospital that is up to 60 miles further away, 41 people refused to travel even if the chance of success for treatment was higher at the specialist hospital. In contrast, 163 people were willing to travel to the specialist hospital, even when they were told that the chance of success was no different to their local hospital. The remaining participants were willing to travel to the specialist hospital contingent upon a 3% increase in chance of treatment success. This study shows that participants preferred the keyhole surgery because of the less invasive nature of the procedure (i.e. less time in hospital, less pain and quicker recovery). Moreover, we found that the vast majority of people are willing to travel to access specialist services.

Anatomopathological Evaluation of Fecal Peritonitis Complications in Horses Treated with Peritoneal Lavage

Background: Reproductive management in horses when performed with malpractice or by an unqualified person can cause many lesions of various degrees. When the rectum is affected it can compromise the mucous layer of the rectal ampulla and may even cause total perforation of this intestinal segment. Once the rectum ruptured, its contents gets into the abdominal cavity and generates severe abdominal infection, which may cause intense adhesions between organs and even to the abdominal wall and requires a particular intensive intervention. This work reports the use of peritoneal lavage protocol in three horses with septic peritonitis caused by rectal laceration, correlating with post-mortem findings.Cases: Three horses were referred to the Veterinary Hospital Rancho Belo Vista, in the city of Serra - ES, with an accident report during reproductive management in different properties. In all cases, blood loss and loss of continuity of the rectal mucosa were reported by the technicians. Patients were referred at different post-accident times. When they arrived at the hospital, they were examined and a sample of blood and peritoneal fluid were collected and sent to the laboratory. They presented intense apathy, mucosa coloration ranging from hyperemic to pale with halo toxemia, high cardiac and respiratory rate, reduction of globular volume and prolonged time of capillary refill. Patients were given fluid therapy support with lactated Ringer’s solution and systemic therapy protocols such as antibiotic therapy, peritoneal lavage with antibiotic containing solution and anticoagulant, and other supportive treatments were instituted. Peritoneal lavages were instituted every eight hours, in the first 48 hours and every twelve hours, until five days were completed. All patients had to be sacrificed. Euthanasia occurred at different times according to response to treatment and onset of clinical signs of shock. Significant variations were observed among patients at necropsy. The patient submitted to fewer wash cycles had severe adhesions. The other two patients who underwent more wash cycles presented less severe adhesion and less fibrin deposition in the abdominal viscera.Discussion: The use of peritoneal lavage associated with systemic treatment has been shown to be beneficial for the treatment of peritonitis since the initial condition and alteration in the results of laboratory tests. However, the time elapsed between rectal laceration and referral to a specialized technical unit was a decisive factor, together with the severity of the lesion, that were determinant for the increased response and consequent chance of treatment success and chances of survival. Although they received a combination of systemic therapy with broad-spectrum antibiotics and peritoneal lavage associated with daily washing cycles, the patients were euthanized, reiterating the lethality of the disease. At necropsy it was possible to evaluate the extent of contamination and adhesions, as well as to find the lacerated segment, the main source of contamination of the peritoneum. The difference between the degrees of adhesion is evident when compared to the patients who went through more cycles of peritoneal lavage with the ones that went through fewer cycles. Thus, it is possible to estimate that the patients who received a greater number of peritoneal lavage cycles with the drugs used in the same route presented a reduced number of adhesions between similar structures (same organs) and between the organs and the abdominal wall. There is a need for more controlled studies to evaluate the effectiveness of serial peritoneal lavage treatments in horses, as well as the application of drugs that seek to reduce abdominal inflammation, fibrin production and adhesions.

Internal granuloma with perforation – 2 case report

Abstract Internal resorption was associated with long-term chronic inflammation of the pulp (chronic granulomatous pulpitis). When internal resorption is radiographically confirmed, endodontic treatment becomes a necessity. Vital teeth internal resorption appears radiographically as an oval enlargement of the pulp chamber and root canal with smooth, symmetrical outline. Internal granuloma is assumed to be an effect of the trauma, or pulp inflammation, the ailment is rare, asymptomatic and might progress rapidly, causing perforation. It is difficult to remove the pulp tissue from the resorptive defect, since this area is not easily accessible for instrumentation. The delay of the endodontic treatment may lead the internal resorption to perforation, thus decreasing the chances of treatment success. In the following paper, we present a total of two clinical cases with internal granuloma with perforation that have benefited of specific endodontic treatment.

What Constitutes an "Adequate" Trial in Migraine Prevention?

Comprehensively assessing the quality of prior preventive treatment attempts often reveals modifiable variables that may account for treatment failure. Similarly, a comprehensive and systematic approach when planning a preventive medication trial is critical for optimizing the chances of treatment success. In this review, we summarize the key elements to be included when assessing the adequacy of a preventive treatment trial. We have developed and included checklists that can be used by providers to improve their assessments of prior preventive treatment trials and to assist with planning a high-quality treatment trial with a new migraine preventive medication.

Acquired Resistance in Unipolar Depression

It has been proposed that depressive episodes could be “neurotoxic”, decreasing memory skills and/or regularly increasing neurocognitive retardation with the repetition of episodes. We describe two protocols which could reinforce the likelihood of this neurotoxic hypothesis, and a study showing that it is indeed possible to reduce the time before getting treatment response. On the first protocol a large sample of depressed outpatients was tested for narrative delayed memory (Weschleer paragraph), before and after antidepressant treatment (Gorwood et al., 2008). Delayed memory skills after treatment response was strongly correlated to the length and the number of past depressive episodes. The second protocol assessed neurocognitive retardation during a depressive episode and after clinical remission is obtained. Once again we observed that neurocognitive retardation (TMT-A and -B) in remitted patients was highly correlated to the number of past depressive episodes (Gorwood et al., 2014). We then tested if treatment resistance could be detected a bit earlier than the 4 to 6 weeks observation usually considered as required. Indeed, we found that a two weeks observation is enough to decide if we should continue or change the present treatment. We furthermore saw that assessing emotions rather than depressive symptoms might be even more predictive of the chances of treatment success. These studies reinforce the concept of neurotoxicity of depressive disorder, wich means that an important part of treatment resistence is acquired during the process of the disorder, and therefore stress the importance of treating early and completely each depressive episode, not only for an acute relief, but also to improve the long term prognosis of mood disorders.

Yogurt for treating acute gastroenteritis in children: Systematic review and meta-analysis

In May 2014, the updated guidelines for the management of acute gastroenteritis (AGE) were published. The use of yogurt in the nutritional management of AGE was not addressed, although it is frequently used in many countries for this purpose. We aimed to systematically evaluate the efficacy of yogurt consumption for the management of AGE in children. In this systematic review, a number of databases, including MEDLINE, EMBASE, and the Cochrane Library, with no language restrictions, were searched up to July 2014 for randomized controlled trials (RCTs) evaluating the effect of yogurt consumption in children with AGE. The risk of bias was assessed using the Cochrane risk of bias tool. Four RCTs (n = 448) that were generally low in methodological quality, all performed in hospital setting, were included. Compared with placebo/no intervention, yogurt consumption had no significant effect on stool volume. The data on the effect of yogurt consumption on the duration of diarrhea and stool frequency were not consistent. The chance of treatment success (or failure) was similar in both groups. Compared with placebo, the duration of hospitalization was shorter in children who received yogurt, but the difference was of a borderline significance. Total weight gain increased for those treated with yogurt. The consumption of yogurt had a positive effect on weight gain, but no consistent effect on AGE outcomes in hospitalized children. Given the limited data and the methodological limitations of the included trials, the evidence should be viewed with caution. The effect of yogurt consumption in the ambulatory setting is unknown.

Response-guided Peginterferon Therapy for HBeAg-positive and HBeAg-negative Chronic Hepatitis B using Hepatitis B Surface Antigen Levels: A Review

Hepatitis B surface antigenemia (HBsAg) is the hallmark of HBV infection. Serum levels of HBsAg appear to reflect the degree of immune control over the virus: lower levels signify a higher level of immune control. One year of peginterferon (PEG-IFN) therapy results in a decline of HBsAg in serum that is sustained off-treatment. Patients who achieve a sustained virological response to PEG-IFN have more pronounced on-treatment HBsAg decline. HBsAg levels during therapy can be used to predict the chance of treatment success. Among HBeAg-positive patients, the probability of response is extremely low in patients with HBsAg levels >20,000 IU/mL at week 24 of treatment and therapy discontinuation is indicated. Similarly, therapy cessation is indicated in HBeAg-negative patients without HBsAg decline at week 12 if HBV DNA has not been reduced by at least 2 log IU/mL.

Association between Health Systems Performance and Treatment Outcomes in Patients Co-Infected with MDR-TB and HIV in KwaZulu-Natal, South Africa: Implications for TB Programmes

ObjectiveTo improve the treatment of MDR-TB and HIV co-infected patients, we investigated the relationship between health system performance and patient treatment outcomes at 4 decentralised MDR-TB sites.MethodsIn this mixed methods case study which included prospective comparative data, we measured health system performance using a framework of domains comprising key health service components. Using Pearson Product Moment Correlation coefficients we quantified the direction and magnitude of the association between health system performance and MDR-TB treatment outcomes. Qualitative data from participant observation and interviews analysed using systematic text condensation (STC) complemented our quantitative findings.FindingsWe found significant differences in treatment outcomes across the sites with successful outcomes varying from 72% at Site 1 to 52% at Site 4 (p<0.01). Health systems performance scores also varied considerably across the sites. Our findings suggest there is a correlation between treatment outcomes and overall health system performance which is significant (r = 0.99, p<0.01), with Site 1 having the highest number of successful treatment outcomes and the highest health system performance. Although the ‘integration’ domain, which measured integration of MDR-TB services into existing services appeared to have the strongest association with successful treatment outcomes (r = 0.99, p<0.01), qualitative data indicated that the ‘context’ domain influenced the other domains.ConclusionWe suggest that there is an association between treatment outcomes and health system performance. The chance of treatment success is greater if decentralised MDR-TB services are integrated into existing services. To optimise successful treatment outcomes, regular monitoring and support are needed at a district, facility and individual level to ensure the local context is supportive of new programmes and implementation is according to guidelines.

Impact of Myomas on the Results of Transcervical Resection of the Endometrium

Study ObjectiveTo investigate long-term hysterectomy rates after transcervical resection of the endometrium (TCRE) performed by experienced surgeons in the presence and absence of intracavitary myomas. DesignMulticenter case-control study (Canadian Task Force classification II-2). PatientsThe study group comprised 456 women with myomas who met the inclusion criteria, and of these, 82 (17.98%) later underwent hysterectomy. The control group comprised 1438 women without myomas, and of these, 284 (19.75%) later underwent hysterectomy. MethodsFrom 2001 to 2004, standardized results were extracted from Hyskobase on the basis of a total of 1894 women aged 23 to 59 years. The women were identified as having or not having myomas, and data from both groups were statistically analyzed. Detailed information on myoma size and intramural involvement (type 0, 1, and 2) was collected. Measurements and Main ResultsAfter TCRE, women with type 2 myomas, compared with those with type 0 myomas, were found to have a significantly higher risk of undergoing hysterectomy (p = .04), and women, including controls, with myomas >3.6 cm in greatest diameter were found to have a significantly higher risk of undergoing hysterectomy than were those with smaller myomas (p = .01). There was no statistically significant difference in risk of hysterectomy between type 0 and type 1 myomas or between type 1 and type 2 myomas. When hysterectomy rates between the myoma and control groups were compared, there was an increased risk of hysterectomy in the control group (p = .008). Multiple-step multivariate regression analysis of uterine and procedural characteristics of TCRE demonstrated that factors that were positive predictors of hysterectomy within 66 months after resection were younger age, inaccessible uterine corners, enlarged uterus, and pretreatment using gonadotropin-releasing hormone agonists. ConclusionWhen performing TCRE in women with intracavitary myomas, the chance of treatment success is worsened if they are of type 2 or their diameter is >3.5 cm. In addition, younger age increases the risk of hysterectomy and the need for pretreatment with gonadotropin-releasing hormone agonists, or if the uterus is enlarged or the uterine corners are difficult to access during the procedure.

Role of clofazimine in the treatment of multidrug-resistant tuberculosis: a retrospective observational cohort assessment

Results: Out of 144 MDR/XDR-TB patients, 44 were treated with clofazimine. Of these, none experienced major side effects attributed to clofazimine requiring discontinuations. However, 20 patients had the clofazimine reduced to manage adverse events. Outcomes were similar in patients treated with and without clofazimine, although clofazimine-treated cases had a more frequent history of previous treatment with a fluoroquinolone and an injectable agent (43.2% versus 20%, P,0.05). Patients treated with clofazimine took a long time for sputum culture conversion and achieved a low percentage of conversion overall. Conclusions: Clofazimine did not improve the chance of bacterial conversion, providing a chance of treatment success in MDR-TB cases. However, 100 mg of clofazimine once daily added to an individualized multidrug regimen was well tolerated in our study. It might be used as an alternative drug for the treatment of complicated MDR/XDR-TB patients.

Safety and efficacy of treatment for chronic hepatitis C with a focus on pegylated interferons: the backbone of therapy today and in the future

Introduction: Approximately 170 million people are infected with HCV. The efficacy of treatment for chronic hepatitis C has increased markedly over the last 2 decades. Optimal patient management requires thorough knowledge of the adverse effect profiles of drugs used for this condition and strategies to mitigate these effects.Areas covered: The efficacy, safety and tolerability data associated with IFN-based therapy, with particular attention given to the two licensed pegylated IFNs (peg-IFNs), are identified by focused searches of Medline. Recommendations for the management of adverse events are also given. Focused searches of PubMed are done using the terms peginterferon and chronic hepatitis C. The results of large randomized clinical trials are emphasized.Expert opinion: Patients receiving treatment with peg-IFN plus ribavirin for chronic hepatitis C must be monitored closely for adverse events. These events can be effectively managed to maximize patients' adherence and thus the chance of treatment success. Direct-acting antiviral agents are expected to be approved in the near future and will be used in select patients with a peg-IFN plus ribavirin ‘backbone’.

New Antiepileptic Drugs: Lacosamide, Rufinamide, and Vigabatrin

The treatment of epilepsy is complicated by the multiple seizure types and epilepsy syndromes needing therapy. In addition, seizures in up to 30% of epilepsy patients are resistant to available medications. The three newest antiepileptic medications (lacosamide, rufinamide, and vigabatrin) all putatively have novel mechanisms of action, which might increase the chance of treatment success in patients failing previous antiepilepsy drug trials and the chance of successful synergy with currently available medications. In our experience, all three drugs generally are well tolerated, although the risk for serious long-term complications with vigabatrin presents special challenges and precautions. Lacosamide is approved for the adjunctive therapy of complex partial seizures in adults and also is available in an intravenous formulation. Rufinamide is a new treatment option for seizures associated with Lennox-Gastaut syndrome, and although it is not FDA approved for partial seizures, it has shown efficacy for that indication as well. Vigabatrin has been approved in adults for drug-resistant complex partial seizures and in infants as a treatment option for infantile spasms.

A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis

Linezolid is used to treat patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-tuberculosis (TB) cases, although clinical data on its safety, tolerability and efficacy are lacking. We performed a retrospective, nonrandomised, unblinded observational study evaluating the safety and tolerability of linezolid at 600 mg q.d. or b.i.d. in MDR/XDR-TB treatment in four European countries. Efficacy evaluation compared end-points of 45 linezolid-treated against 110 linezolid-nontreated cases. Out of 195 MDR/XDR-TB patients, 85 were treated with linezolid for a mean of 221 days. Of these, 35 (41.2%) out of 85 experienced major side-effects attributed to linezolid (anaemia, thrombocytopenia and/or polyneuropathy), requiring discontinuation in 27 (77%) cases. Most side-effects occurred after 60 days of treatment. Twice-daily administration produced more major side-effects than once-daily dosing (p = 0.0004), with no difference in efficacy found. Outcomes were similar in patients treated with/without linezolid (p = 0.8), although linezolid-treated cases had more first-line (p = 0.002) and second-line (p = 0.02) drug resistance and a higher number of previous treatment regimens (4.5 versus 2.3; p = 0.07). Linezolid 600 mg q.d. added to an individualised multidrug regimen may improve the chance of bacteriological conversion, providing a better chance of treatment success in only the most complicated MDR/XDR-TB cases. Its safety profile does not warrant use in cases for which there are other, safer, alternatives.