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1.
Nagoya J Med Sci ; 83(4): 851-860, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34916727

RESUMO

Falls are common in elderly patients, and prevention of fall is important for safety and for reduction of health care costs. Sleep medications are among many potential causes of fall. In this study, we examined relationship of sleep medication with fall from January 2017 to December 2017. 726 falls occurred in 442 patients, and the average age at the time of fall was 60.7 ± 23.8 years. Fall was most common in patients with neurological disease, followed by gastroenterological, ophthalmological, respiratory, and orthopedic conditions. Sleep medication was used in 223 falls (31%). Fall occurred at all times of day, but with a different distribution in patients with and without use of sleep medication. Thus, the rate of falls from 22:00 to 6:00 was significantly higher in patients using sleep medication (62% vs. 18%, p<0.01). There was also a significantly higher rate of multiple falls in patient using sleep medication (p<0.01). Zolpidem (25%, n=63), a non-benzodiazepine, was the most frequently used sleep medication, followed by brotizolam (16%, n=41) and etizolam (13%, n=32), which are both benzodiazepines. Multiple falls from 22:00 to 6:00 occurred significantly more frequently in patients using ≥2 types of sleep medications compared to one (53% vs. 17%, p<0.01). Taking multiple sleeping pills makes it easier to fall, and even drugs with a short half-life, which are considered to be safe, can cause falls at night in elderly patients. The results of this study show that careful selection of sleep medications is required to prevent fall in elderly patients.


Assuntos
Acidentes por Quedas/estatística & dados numéricos , Fármacos do Sistema Nervoso Central/efeitos adversos , Pacientes Internados/estatística & dados numéricos , Acidentes por Quedas/prevenção & controle , Idoso , Custos de Cuidados de Saúde , Hospitalização , Humanos , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversos , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/efeitos adversos , Sono/fisiologia
2.
J Clin Pharm Ther ; 45(4): 774-782, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32390248

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Tolperisone is a centrally acting muscle relaxant under development in the United States as a treatment for acute and painful symptoms of muscle spasms. The objective of this three-way, randomized, blinded, three-period crossover study was to assess the safety and cognitive effects of tolperisone compared to placebo and the widely used muscle relaxant cyclobenzaprine in healthy volunteers. METHODS: Subjects were randomized to 1 of 3 treatment arms to receive tolperisone (150 mg), cyclobenzaprine (10 mg) or placebo 3 times per day (TID) in 3 separate study periods. Subjects completed a driving test on the Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim), a validated driving simulator, on day 1 at time to maximum plasma concentration, on day 2 before the morning dose of study drug and on day 3 at steady state following the morning dose. Subjects were assessed on various driving parameters and on a computer-administered digit-symbol substitution test (CogScreen symbol digit coding test). The driving scenario is a monotonous 100 km highway route on which subjects are instructed to maintain speed and lane position. RESULTS AND DISCUSSION: The performance of subjects who had received tolperisone was not significantly different from those who had received placebo in terms of the primary end point: standard deviation of lateral position, a measure of weaving. Subjects who had received tolperisone also performed comparably to those who had received placebo on a range of secondary measures assessing driving ability, cognition and psychomotor performance. In contrast, subjects who had received cyclobenzaprine showed significant impairment compared to placebo (P < .01) on the primary end point of standard deviation of lateral position and on the majority of the secondary end points of driving ability. Despite their markedly poorer driving performance after receiving cyclobenzaprine, few subjects reported feeling unsafe to drive on day 1 (10.3%) and day 2 (3.4%). The incidence of adverse events was similar for tolperisone (36.4%) and placebo (29.0%) and was greater for cyclobenzaprine (45.4%). WHAT IS NEW AND CONCLUSION: Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).


Assuntos
Amitriptilina/análogos & derivados , Condução de Veículo , Cognição/efeitos dos fármacos , Relaxantes Musculares Centrais/efeitos adversos , Tolperisona/efeitos adversos , Adulto , Amitriptilina/efeitos adversos , Estudos Cross-Over , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desempenho Psicomotor/efeitos dos fármacos , Autorrelato , Tolperisona/farmacocinética
3.
Drug Alcohol Depend ; 205: 107693, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31751873

RESUMO

BACKGROUND: High-risk combinations of controlled medications, such as those involving opioid analgesics, are under increased scrutiny because of their contribution to the opioid epidemic in the United States. Responsible prescribing guidelines indicate that the triple drug combination--opioids, benzodiazepines and skeletal muscle relaxants, especially carisoprodol--should not be concurrently prescribed. METHODS: This pharmacoepidemiologic study was designed to primarily examine the characteristics of patients receiving this triple combination compared to the group receiving only opioids and benzodiazepines. RESULTS: Results show that, while the number of exposed patients has declined since 2012, approximately 17,000 Floridians were prescribed this combination in 2017 alone. Demographically, recipients of these prescriptions were younger, more likely to be female, and geographically-localized. Furthermore, these patients were more frequently associated with a prescriber in the top 1% of opioid and/or benzodiazepine prescribing, have more multiple provider episodes ("doctor shopping"), and receive higher mean daily opioid dosages. CONCLUSIONS: These findings raise important questions as to how frequently prescribers are checking prescription drug monitoring programs, following US Centers for Disease Control and Prevention opioid prescribing guidelines, and/or handling the clinical challenges associated with pharmaceutical management of patients with complex, painful health conditions.


Assuntos
Analgésicos Opioides/administração & dosagem , Benzodiazepinas/administração & dosagem , Carisoprodol/administração & dosagem , Relaxantes Musculares Centrais/administração & dosagem , Padrões de Prática Médica/tendências , Programas de Monitoramento de Prescrição de Medicamentos/tendências , Adolescente , Adulto , Idoso , Analgésicos Opioides/efeitos adversos , Benzodiazepinas/efeitos adversos , Carisoprodol/efeitos adversos , Overdose de Drogas/epidemiologia , Overdose de Drogas/prevenção & controle , Prescrições de Medicamentos/normas , Quimioterapia Combinada , Feminino , Florida/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/efeitos adversos , Dor/tratamento farmacológico , Dor/epidemiologia , Padrões de Prática Médica/normas , Programas de Monitoramento de Prescrição de Medicamentos/normas , Adulto Jovem
4.
Ter Arkh ; 90(6): 81-88, 2018 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-30701909

RESUMO

AIM: The "PARUS" program included investigation of the analgesic, muscle relaxant and sedative effects of Mydocalm-Richter which acts as central muscle relaxant in patients with myofascial pain syndrome, taking into account its registered indication for use - the hypertonus and cross-striated muscle spasm. MATERIALS AND METHODS: Fifty patients with myofascial trigger points, the mean age of 41.67±11.86 years, have been enrolled in the study. All patients had undergone clinical examination that allowed the diagnosis of myofascial pain syndrome. The intensity of pain syndrome was evaluated using the pain visual analogue scales and McGill pain questionnaire. Visualization of area in spasm and evaluation of blood circulation was carried out using the ultrasound scan of target muscle. In order to objectively evaluate any conceivable hypotensive and sedative effects of Mydocalm-Richter we used the orthostatic test, Schulte's test for attention span and perfor-mance distribution and Munsterberg's test for attention discrimination and concentration. RESULTS: The analgesic and muscle relaxant effects of Mydocalm-Richter become apparent by day 3 post-injection, and the muscle relaxation effect is reaching its maximum on day 10 post-injection. Cardiovascular function following administration of Mydocalm-Richter was evaluated using the orthostatic test which revealed good orthostatic tolerance. Single injection of tolperisone hydrochloride possessing a central muscle relaxant activity has no sedative effect and does not influence patient response time. The ultrasound examination data demonstrated the improvement and in some cases restoration of blood circulation in the myofascial trigger points. CONCLUSION: Clinical study "PARUS" conducted in patients with myofascial pain has demonstrated a positive muscle relaxant and analgesic effect of Mydocalm-Richter that resulted in restoration of peripheral circulation in the myofascial trigger pointsconfirmed by ultrasound examination. An important benefit of this drug product is the absence of sedative effect and arterial hypotension.


Assuntos
Relaxantes Musculares Centrais , Síndromes da Dor Miofascial , Tolperisona , Adulto , Humanos , Injeções Intramusculares , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/efeitos adversos , Músculo Esquelético , Síndromes da Dor Miofascial/tratamento farmacológico , Medição da Dor , Tolperisona/administração & dosagem , Tolperisona/efeitos adversos
6.
Eur Neurol ; 72 Suppl 1: 15-9, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25278119

RESUMO

BACKGROUND: Individuals with multiple sclerosis (MS) spasticity present with a range of symptoms and disability levels that are frequently challenging to manage. Summary : Clinical case reviews in treatment-resistant MS spasticity were presented in five country-specific sessions conducted in parallel at the MS Experts Summit. Attendees at the Norwegian session discussed early response to new treatments for severe spasticity and highlighted the importance of titrating THC:CBD oromucosal spray (Sativex®) when adding it to baclofen. The French group focussed on MS symptoms and patient characteristics that interact with spasticity and agreed on a list of minimum ratings for diagnosis of MS spasticity symptoms. Attendees at the Spanish session concurred that THC:CBD oromucosal spray is effective and well tolerated as add-on therapy in treatment-resistant MS spasticity, particularly for pain, spasms and gait disturbances. The Italian group discussed the use of add-on THC:CBD oromucosal spray and other possible combination therapies for treatment-resistant MS spasticity. Attendees at the German session highlighted the need to address trigger factors for MS spasticity to reduce the potential for impact on activities of daily living (ADL) and quality of life (QoL). Three innovative studies of MS spasticity from the poster session were selected for closer review. The MOVE 1 EU epidemiological study indicated that, across western Europe, patients with MS spasticity continue to have unmet management needs. A literature review demonstrated that symptomatic relief of MS spasticity in patients who respond to THC:CBD oromucosal spray translates into sustainable improvements in ADL and QoL. Enriched-design studies of medications targeting the endocannabinoid system require careful interpretation due to possible pharmacodynamic 'priming', i.e. carry-over effects of successful active treatment during the enrichment phase. Key Messages: Sharing experiences of clinical practice, including experience with the use of THC:CBD oromucosal spray, may be useful to overcome some of the challenges in the overall management of patients with moderate to severe treatment-resistant MS spasticity.


Assuntos
Esclerose Múltipla/fisiopatologia , Esclerose Múltipla/terapia , Espasticidade Muscular/fisiopatologia , Espasticidade Muscular/terapia , Atividades Cotidianas , Canabidiol , Efeitos Psicossociais da Doença , Dronabinol , Combinação de Medicamentos , Europa (Continente) , Humanos , Esclerose Múltipla/diagnóstico , Esclerose Múltipla/epidemiologia , Relaxantes Musculares Centrais/efeitos adversos , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/diagnóstico , Espasticidade Muscular/epidemiologia , Extratos Vegetais/efeitos adversos , Extratos Vegetais/uso terapêutico , Qualidade de Vida
7.
J Sex Med ; 11(7): 1807-15, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24810799

RESUMO

INTRODUCTION: Intrathecal administration of baclofen (ITB) is widely recognized as an effective treatment for severe spasticity of both spinal and supraspinal origin with fewer side effects. The lower drug dosages used for spinal intrathecal administration, acting directly on the receptor sites, result in greater therapeutic efficacy with less systemic toxicity than with oral preparations. AIM: This study aims to prospectively evaluate the effects of ITB on erectile function in male patients affected by severe spasticity. METHODS: Twenty adult male patients, with a 34.85 ± 10.27 mean age, affected by severe spasticity mainly due to spinal cord lesions (10 traumatic, three vascular, six degenerative, and one congenital in origin) and treated with ITB, were enrolled in the study. All participants underwent specific clinical scales to evaluate force, muscle tone, cognition and mood, and specific sexual questionnaires, including an accurate semi-structured interview. MAIN OUTCOME MEASURE: The International Index of Erectile Function (IIEF) was used to evaluate sexual function before and after pump implantation. RESULTS: A comparative analysis of the neurological scales and psychometric scores at T1 (baseline) and T2 (follow-up) showed statistically significant differences before and after pump implantation. In particular, we noted a significant decrease in the IIEF median scores (from 0.42 ± 0.07 to 0.14 ± 0.02, P value < 0.0001) and a correlation between ITB dosage and IIEF scores (ρ = -0.60; P < 0.05). CONCLUSIONS: This study supports previous findings on a possible negative effect of ITB on sexual function, with regard to erection. Patients who are considering ITB for treatment of severe spasticity should be informed about possible but reversible sexual side effects, especially at higher dosage. Future studies with larger samples should be fostered to confirm these findings for a better management of these, often young, patients.


Assuntos
Baclofeno/efeitos adversos , Disfunção Erétil/induzido quimicamente , Relaxantes Musculares Centrais/efeitos adversos , Espasticidade Muscular/tratamento farmacológico , Adolescente , Adulto , Humanos , Injeções Espinhais , Masculino , Pessoa de Meia-Idade , Tono Muscular/efeitos dos fármacos , Estudos Prospectivos , Resultado do Tratamento , Adulto Jovem
8.
Pharmacoepidemiol Drug Saf ; 23(9): 911-7, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24872151

RESUMO

PURPOSE: In 2005, the Food and Drug Administration approved Qualaquin (quinine) for treatment of malaria and later ordered unapproved quinine formulations off the market. In 2009, labeling for Qualaquin added a warning for use for leg cramps, as serious hematologic reactions could occur. We examined quinine use trends among Medicare beneficiaries focusing on indications for use and associations with adverse hematologic outcomes. METHODS: Medicare beneficiaries, aged 65 years and older, in 2006-2012, were included in incident quinine or comparator, diltiazem, cohorts if 183 days prior to dispensing, they were enrolled in Medicare, had no dispensing of quinine, diltiazem, ticlodipine, clopidogrel, and sulfonamide drugs, and had no diagnoses of thrombocytopenia, immune thrombocytopenic purpura (ITP), thrombotic microangiopathy (TMA), or hemolytic-uremic syndrome (HUS). Diagnoses of malaria or leg cramps were observed during 183 days prior to index dispensing. Outcomes of ITP, TMA, or HUS in inpatient or emergency room settings were then observed during drug use. RESULTS: Prevalent use of quinine decreased by 99%, from 419 675 to 6036 users during 2006-2012. Of 88 066 quinine users, 9 had diagnoses of malaria and 36 218 had leg cramps. Incidence rates (per 1000 person-years) for ITP were quinine 1.67 and diltiazem 0.40 [incidence rate ratio 4.2 (95% confidence interval 2.5, 6.5)], for TMA were quinine 0.23 and diltiazem 0.03 [incidence rate ratio 6.9 (95% confidence interval 1.3, 24.0)], and for HUS were quinine 0 and diltiazem 0.01. CONCLUSIONS: Use of quinine decreased substantially, although diagnoses of leg cramps persist. To our knowledge, this is the first demonstration of an association for quinine and ITP and TMA in claims data.


Assuntos
Malária/tratamento farmacológico , Cãibra Muscular/tratamento farmacológico , Relaxantes Musculares Centrais/uso terapêutico , Quinina/uso terapêutico , Idoso , Centers for Medicare and Medicaid Services, U.S. , Bases de Dados Factuais , Diltiazem/efeitos adversos , Diltiazem/uso terapêutico , Aprovação de Drogas , Rotulagem de Medicamentos , Humanos , Incidência , Medicare , Relaxantes Musculares Centrais/efeitos adversos , Púrpura Trombocitopênica Idiopática/epidemiologia , Quinina/efeitos adversos , Microangiopatias Trombóticas/epidemiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration
9.
Mult Scler ; 17(5): 623-9, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21282321

RESUMO

The majority of patients with multiple sclerosis (MS) have symptoms of spasticity that increasingly impair function as the disease progresses. With appropriate treatment, however, quality of life can be improved. Oral antispasticity medications are useful in managing mild spasticity but are frequently ineffective in controlling moderate to severe spasticity, because patients often cannot tolerate the adverse effects of increasing doses. Intrathecal baclofen (ITB) therapy can be an effective alternative to oral medications in patients who have a suboptimal response to oral medications or who cannot tolerate dose escalation or multidrug oral regimens. ITB therapy may be underutilized in the MS population because clinicians (a) are more focused on disease-modifying therapies rather than symptom control, (b) underestimate the impact of spasticity on quality of life, and (c) have concerns about the cost and safety of ITB therapy. Delivery of ITB therapy requires expertly trained staff and proper facilities for pump management. This article summarizes the findings and recommendations of an expert panel on the use of ITB therapy in the MS population and the role of the physician and comprehensive care team in patient selection, screening, and management.


Assuntos
Baclofeno/administração & dosagem , Esclerose Múltipla/tratamento farmacológico , Relaxantes Musculares Centrais/administração & dosagem , Baclofeno/efeitos adversos , Baclofeno/economia , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Bombas de Infusão Implantáveis , Infusões Parenterais , Esclerose Múltipla/complicações , Esclerose Múltipla/economia , Esclerose Múltipla/fisiopatologia , Relaxantes Musculares Centrais/efeitos adversos , Relaxantes Musculares Centrais/economia , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Espasticidade Muscular/fisiopatologia , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Qualidade de Vida , Resultado do Tratamento
10.
Therapie ; 65(6): 511-8, 2010.
Artigo em Francês | MEDLINE | ID: mdl-21176757

RESUMO

Baclofen is an anti-spastic drug that acts as an agonist of GABA-B receptors. It also seems to decrease the appetence for alcohol (anti-craving effect), although this effect has not been certified by Authorities for drug approval in France (AMM). However, baclofen receives a great deal of demand by patients hoping to reduce their alcohol consumption. Nonetheless, the lack of AMM and the high doses of baclofen supposed to exert an anti-craving effect often discourage practitioners from prescribing this drug in current medical practice. Therefore, it is preferable for a drug like baclofen to be prescribed under specific regulations. As such, certain criteria similar to those required in clinical trials are necessary to protect patients as well as the prescribing doctors. The criteria that are proposed here are: the use of drugs without AMM approval as a last resort (all other treatments must have failed), the collegiate decision for the drug prescription, good knowledge of the potency of the drug as well as good record keeping of patients and proper supervision. The departments of addiction, pharmacology and pharmacovigilance of the University Hospital of Lille, France present here a medical process named "multidisciplinary consultations for resort treatments of addictions" (CAMTEA). This process is designed to meet all the above mentioned criteria and to allow the use of baclofen as an anti-craving drug in safest conditions. If this proves to be successful with baclofen, it is possible to extend the use of CAMTEA to other drugs without AMM approval in addictologic pathologies.


Assuntos
Alcoolismo/tratamento farmacológico , Baclofeno/uso terapêutico , Aprovação de Drogas , Prescrições de Medicamentos/normas , Agonistas GABAérgicos/uso terapêutico , Relaxantes Musculares Centrais/uso terapêutico , Uso Off-Label , Alcoolismo/psicologia , Baclofeno/administração & dosagem , Baclofeno/efeitos adversos , Administração de Caso , França , Agonistas GABAérgicos/administração & dosagem , Agonistas GABAérgicos/efeitos adversos , Guias como Assunto , Conhecimentos, Atitudes e Prática em Saúde , Hospitais Universitários , Humanos , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/efeitos adversos , Encaminhamento e Consulta , Transtornos Relacionados ao Uso de Substâncias/fisiopatologia , Transtornos Relacionados ao Uso de Substâncias/psicologia
11.
Ann Pharmacother ; 44(9): 1369-75, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20606016

RESUMO

BACKGROUND: In older adults, both muscle relaxants and benzodiazepines are associated with sedation and cognitive impairment. Although benzodiazepines have been linked to falls and fracture injuries, no studies have examined the risk of fracture associated with muscle relaxants. OBJECTIVE: To determine whether muscle relaxants identified in the Beers criteria are associated with an increased risk of fracture injuries and to compare this risk to that with benzodiazepine use. METHODS: We conducted a case-control study using both medical and pharmacy claims data from 1.5 million enrollees in the Medicare Advantage plans of a large health maintenance organization. We matched 8164 cases of fractures with 8164 controls based on age, sex, health plan, and comorbidities. We measured the use of muscle relaxants, short-acting benzodiazepines, and long-acting benzodiazepines. Adjusted odds ratios were estimated using conditional logistic regression. RESULTS: After adjusting demographic and clinical covariates, muscle relaxants, long-acting benzodiazepines, and short-acting benzodiazepines were associated with a high risk of fracture injuries, with odds ratios of 1.40 (95% CI 1.15 to 1.72; p < 0.001), 1.9 (95% CI 1.49 to 2.43; p < 0.001), and 1.33 (95% CI 1.15 to 1.55; p < 0.001), respectively. CONCLUSIONS: An elevated risk of fracture injuries was noted among older adults using muscle relaxants. Our findings provide evidence of an association between the risk of fractures and the use of centrally acting muscle relaxants in older adults. This association supports current recommendations advising extreme caution in prescribing muscle relaxants to older adults.


Assuntos
Acidentes por Quedas/estatística & dados numéricos , Bases de Dados Factuais , Fraturas Ósseas/induzido quimicamente , Medicare Part C/estatística & dados numéricos , Relaxantes Musculares Centrais/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Benzodiazepinas/efeitos adversos , Estudos de Casos e Controles , Feminino , Fraturas Ósseas/epidemiologia , Humanos , Masculino , Análise por Pareamento , Risco , Estados Unidos
12.
Spinal Cord ; 47(10): 751-6, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19333246

RESUMO

STUDY DESIGN: Retrospective study. OBJECTIVES: To study the incidence and management of tolerance in patients treated with intrathecal baclofen (ITB) therapy. SETTING: Department of neurology and neurosurgery, University Medical Center Groningen, The Netherlands. METHODS: Medical records of all patients who had received an implantable ITB pump at our clinic during 1991-2005 were reviewed. RESULTS: A total of 37 patients (representing 116 pump years) were included. Mean follow-up time was 38 months (range 3-120 months). Baclofen dose increased in the first 18 months after implantation (P<0.05), and then stabilized around a mean dose of 350 microg per day. Eight patients (22%) developed tolerance, defined as a dose increase of >100 microg per year. No predictive factors for development of tolerance could be determined. Three different treatment regimens for tolerant patients were analyzed. Altering the infusion mode from simple to complex continuous (n=6) had no effect on the development of tolerance. Pulsatile bolus infusion (n=1) and a drug holiday (n=2) were both effective in reducing the daily baclofen dose. Patients who needed surgical revision of the pump system because of mechanical failures (n=11) showed a significant dose decrease during the first month after revision, indicating that the preoperative dose increase most likely had been caused by the pump failure. Pump-related complications occurred once per 10.5 years of ITB treatment. Drug-related side effects had an annual risk of 13.8%. The reported events were mostly mild. CONCLUSIONS: ITB therapy is effective and safe, also in the long term and causes tolerance in only 22% of the treated patients.


Assuntos
Baclofeno/administração & dosagem , Tolerância a Medicamentos/fisiologia , Agonistas GABAérgicos/administração & dosagem , Relaxantes Musculares Centrais/administração & dosagem , Espasticidade Muscular/tratamento farmacológico , Adolescente , Adulto , Idoso , Baclofeno/efeitos adversos , Estudos de Coortes , Relação Dose-Resposta a Droga , Feminino , Agonistas GABAérgicos/efeitos adversos , Humanos , Bombas de Infusão Implantáveis , Injeções Espinhais , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/complicações , Relaxantes Musculares Centrais/efeitos adversos , Espasticidade Muscular/etiologia , Espasticidade Muscular/fisiopatologia , Inibição Neural/efeitos dos fármacos , Inibição Neural/fisiologia , Receptores de GABA-B/efeitos dos fármacos , Receptores de GABA-B/metabolismo , Estudos Retrospectivos , Medula Espinal/efeitos dos fármacos , Medula Espinal/fisiopatologia , Traumatismos da Medula Espinal/complicações , Adulto Jovem , Ácido gama-Aminobutírico/metabolismo
13.
Clin Ther ; 29(10): 2222-5, 2007 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18042478

RESUMO

BACKGROUND: Carisoprodol is a muscle relaxant indicated as adjunctive therapy in acute, painful musculoskeletal conditions. Case reports of drug-seeking behavior and utilization of carisoprodol in combination with opioids have suggested abuse potential. OBJECTIVES: We undertook a retrospective review of claims data to identify and characterize potential indicators of abuse in long-term users of carisoprodol and to determine any continued use of the drug by former long-term users following prior authorization implementation. METHODS: The Idaho Medicaid pharmacy and medical claims database was queried from January 1 to December 31, 2005, to identify long-term users of muscle relaxants. Use of concomitant opioids and coded diagnoses relating to past drug abuse were analyzed and compared between patients who used carisoprodol and patients who used other muscle relaxants. Data from 11 of 30 surveys mailed to pharmacies filling prescriptions for long-term users of carisoprodol were also collected to determine the frequency of self-pay-continued use after Medicaid coverage of the drug was discontinued. RESULTS: Long-term users of carisoprodol (n = 340) and other skeletal muscle relaxants (SMRs) (n = 453) were identified from among 130,000 individuals in the Idaho Medicaid pharmacy and medical claims database in calendar year 2005. Patients in both groups were similar in terms of mean age (~47 years) and sex (71.5% female). Patients using carisoprodol used concomitant opioids more frequently (81.5% vs 59.8%; P < 0.01), more commonly had past diagnoses indicating other drug abuse (34.1% vs 21.4%; P < 0.01), and in 80% of reported cases, continued to pay out of pocket for carisoprodol when third-party coverage was discontinued. Taken together, these findings are consistent with published case reports suggesting the abuse potential of carisoprodol. CONCLUSIONS: The results from this review suggest that, compared with long-term users of other SMRs, carisoprodol patients utilized concomitant opioids more frequently and concomitant NSAIDs less frequently, more commonly had past diagnoses indicating other drug dependence or abuse, and continued to pay out of pocket for carisoprodol when third-party coverage was discontinued. While none of these issues alone may be direct indicators of abuse, collectively they suggest that patients who used carisoprodol long term displayed abuse potential characteristics more frequently than long-term users of other agents.


Assuntos
Carisoprodol/efeitos adversos , Revisão da Utilização de Seguros/estatística & dados numéricos , Sistemas Computadorizados de Registros Médicos/estatística & dados numéricos , Relaxantes Musculares Centrais/efeitos adversos , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/uso terapêutico , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/uso terapêutico , Carisoprodol/administração & dosagem , Carisoprodol/uso terapêutico , Quimioterapia Combinada , Revisão de Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Idaho , Masculino , Medicaid , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/administração & dosagem , Relaxantes Musculares Centrais/uso terapêutico , Estudos Retrospectivos
14.
Rehabil Nurs ; 31(4): 158-64, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16789674

RESUMO

Intrathecal baclofen (ITB) is a recognized therapy for severe spasticity of both spinal and cerebral origin, with documented positive clinical outcomes for many patients with multiple sclerosis (MS). This article reviews some specific considerations concerning the use of ITB in the MS population, based on the author's 10 years of clinical experience. The unpredictable and progressive nature of the disease affects the identification of appropriate goals, the patient's decision-making process, and the evaluation of the response to the treatment over time. Patients with MS may be more sensitive to intrathecal baclofen than patients with other diagnoses, and may need a lower dose for both the screening test and maintenance therapy. Subtle cognitive changes may affect the patient's ability to understand the education needed for successful management of ITB. Some practical strategies are offered for the nurse involved in the care of these patients in each stage of the therapy.


Assuntos
Baclofeno/uso terapêutico , Esclerose Múltipla/terapia , Relaxantes Musculares Centrais/uso terapêutico , Atividades Cotidianas , Atitude Frente a Saúde , Baclofeno/efeitos adversos , Transtornos Cognitivos/etiologia , Transtornos Cognitivos/prevenção & controle , Tomada de Decisões , Progressão da Doença , Esquema de Medicação , Monitoramento de Medicamentos , Necessidades e Demandas de Serviços de Saúde , Humanos , Bombas de Infusão Implantáveis , Injeções Espinhais , Programas de Rastreamento , Competência Mental , Esclerose Múltipla/complicações , Esclerose Múltipla/psicologia , Relaxantes Musculares Centrais/efeitos adversos , Papel do Profissional de Enfermagem , Relações Enfermeiro-Paciente , Avaliação em Enfermagem , Planejamento de Assistência ao Paciente , Seleção de Pacientes , Assistência Perioperatória/métodos , Assistência Perioperatória/enfermagem , Enfermagem em Reabilitação , Resultado do Tratamento
15.
Int J Clin Pract ; 59(7): 764-70, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15963201

RESUMO

Objectives of this study were to assess efficacy and effects on psychomotor performances of thiocolchicoside (TCC) and tizanidine (TZ) compared to placebo. Patients complaining of acute low back pain (LBP) associated with muscle spasm were enrolled in this randomised, double-blind clinical trial, comparing the effects of oral TCC, TZ and placebo on psychomotor performances assessed by a visual analogue scale of tiredness, drowsiness, dizziness and alertness and by psychometric tests after 2 and 5-7 days of treatment. The efficacy assessments, both TCC and TZ, were more effective than placebo in improving pain at rest, hand-to-floor distance, Schober test and decreased paracetamol consumption. There were significant differences among the treatment groups in favour of TCC compared to TZ in visual analog scale-parameters. TZ-induced reduction of psychomotor performances of the patients was confirmed by psychometric tests, which showed significant differences among groups. This study showed that TCC is at least as effective as TZ in the treatment of acute LBP, while it appears devoid of any sedative effect in contrast to TZ.


Assuntos
Agonistas alfa-Adrenérgicos/uso terapêutico , Clonidina/análogos & derivados , Colchicina/análogos & derivados , Dor Lombar/tratamento farmacológico , Relaxantes Musculares Centrais/uso terapêutico , Desempenho Psicomotor/efeitos dos fármacos , Doença Aguda , Agonistas alfa-Adrenérgicos/efeitos adversos , Adulto , Clonidina/efeitos adversos , Clonidina/uso terapêutico , Colchicina/efeitos adversos , Colchicina/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/efeitos adversos , Resultado do Tratamento
16.
Drug Saf ; 27(11): 799-818, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15350152

RESUMO

Baclofen is used for treatment of the spasticity of spinal origin that is a common sequela of spinal cord injury and multiple sclerosis; spasticity occurs in about 50% of patients affected by these disorders. In open-label studies of oral baclofen, the drug improved spasticity in 70-87% of patients; additionally, improvement in spasms was reported in 75-96% of patients. In double-blind, crossover, placebo-controlled trials, baclofen was reported to be effective, producing statistically significant improvements in spasticity. Tizanidine is the antispasticity drug that has been most widely compared with oral baclofen; studies have generally found the two drugs to have equivalent efficacy. However, tizanidine has better tolerability, in particular weakness was reported to be occur less frequently with tizanidine than with baclofen. The main adverse effects of oral baclofen include: sedation or somnolence, excessive weakness, vertigo and psychological disturbances. The incidence of adverse effects is reported to range from 10% to 75%. The majority of adverse effects are not severe; most are dose related, transient and/or reversible. The main risks of oral baclofen administration are related to withdrawal: seizures, psychic symptoms and hyperthermia can occur. These symptoms improve after the reintroduction of baclofen, usually without sequelae. When not related to withdrawal; these symptoms mainly present in patients with brain damage and in the elderly. The limited data on baclofen toxicity in patients with renal disease suggest that administration of the drug in these persons may carry an unnecessarily high risk. Intrathecal baclofen is indicated for use in patients with spasticity of spinal origin unresponsive to treatment with maximum doses of oral baclofen, tizanidine and/or dantrolene. The benefits of continuous intrathecal baclofen infusion have been demonstrated: >80% and >65% of patients have improvement in tone and spasms, respectively. The main risks of intrathecal baclofen infusion are symptoms related to overdose or withdrawal; the latter is more important because of the associated severe effects on clinical status and the possibility of death, but it is responsive to rapid treatment. Overdose primarily arises from drug test doses or human error during refill and programming of the pump, and withdrawal most commonly occurs as a result of a problem with the delivery system. Since the adverse consequences do not exceed the benefits of oral and intrathecal baclofen for patients with spinal spasticity, the benefit/risk assessment is favourable.


Assuntos
Baclofeno , Esclerose Múltipla/complicações , Relaxantes Musculares Centrais , Espasticidade Muscular , Traumatismos da Medula Espinal/complicações , Administração Oral , Baclofeno/efeitos adversos , Baclofeno/farmacocinética , Baclofeno/uso terapêutico , Ensaios Clínicos como Assunto , Humanos , Injeções Espinhais , Relaxantes Musculares Centrais/efeitos adversos , Relaxantes Musculares Centrais/farmacocinética , Relaxantes Musculares Centrais/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Medição de Risco , Resultado do Tratamento
17.
Artigo em Inglês | MEDLINE | ID: mdl-10858839

RESUMO

OBJECTIVE: At a time of cost reduction in medical care efforts to manage the ever-increasing costs of new pharmaceutical drugs become increasingly important. Costs of four different muscle relaxant regimens including the new intermediate-acting neuromuscular blocking drugs (NMBD) cisatracurium and rocuronium will be analyzed. METHODS: Eighty patients undergoing laparoscopic cholecystectomy were prospectively studied. All patients received standardized general anaesthesia with desflurane/fentanyl. Muscle relaxation was achieved with atracurium, cisatracurium, vecuronium, or rocuronium with 20 patients in each group. Intraoperatively muscle relaxants were added to maintain two twitches of the train-of-four (TOF) assessment. RESULTS: There were no differences among the four groups regarding biometric data, duration of surgery and anesthesia, number of patients with reversal of neuromuscular blockade, and time of extubation. Length of stay in the postanesthesia care unit (PACU) and the incidence of side effects were similar in all groups. Total costs of used drugs were significantly lowest in the atracurium-treated patients (per patient: 18.27 Euro) and significantly highest in the cisatracurium group (26.71 Euro) compared with the other groups (vecuronium: 22.61 Euro; rocuronium: 22.63 Euro). CONCLUSION: It is summarized that the use of cisatracurium was associated with higher costs compared to a standard muscle relaxant regimen using atracurium, whereas patient outcome was the same in all study groups. The routine use of the newer NMBDs can only be justified economically, if considerable improvements to clinical practice can be demonstrated.


Assuntos
Anestesia/economia , Relaxantes Musculares Centrais/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Androstanóis/efeitos adversos , Androstanóis/economia , Anestesia/efeitos adversos , Atracúrio/efeitos adversos , Atracúrio/economia , Colecistectomia Laparoscópica , Custos de Medicamentos , Feminino , Humanos , Período Intraoperatório/economia , Masculino , Pessoa de Meia-Idade , Relaxantes Musculares Centrais/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/economia , Cuidados Pós-Operatórios/economia , Estudos Prospectivos , Rocurônio , Fatores de Tempo , Resultado do Tratamento , Brometo de Vecurônio/efeitos adversos , Brometo de Vecurônio/economia
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