Valoración sobre la seguridad y eficacia de la pregabalina en pacientes viejos con dolor neuropático.

Valoración sobre la seguridad y eficacia de la pregabalina en pacientes viejos con dolor neuropático. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies. Semel D, Murphy TK, Zlateva G, Cheung R, Emir B. Pfizer Global Pharmaceuticals, New York, NY, USA.david.semel@pfizer.com BMC Fam Pract. 2010 Nov 5;11:85. Abstract BACKGROUND: Older patients are typically underrepresented in clinical trials of medications for chronic pain. A post hoc analysis of multiple clinical studies of pregabalin in patients with painful diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) was conducted to evaluate the efficacy and safety of pregabalin in older patients. METHODS: Data from 11 double-blind, randomized, placebo-controlled clinical studies of pregabalin in patients with DPN or PHN were pooled. Efficacy outcomes included change in Daily Pain Rating Scale score, ≥30% and ≥50% responders, and endpoint pain score ≤3. Safety was based on adverse events (AEs). Primary efficacy was analyzed by analysis of covariance with terms for treatment, age category, protocol, baseline pain, and treatment-by-age category interaction. RESULTS: 2516 patients (white, n = 2344 [93.2%]; men, n = 1347 [53.5%]; PHN, n = 1003 [39.9%]; pregabalin, n = 1595) were included in the analysis. Patients were grouped by age: 18 to 64 years (n = 1236), 65 to 74 years (n = 766), and ≥75 years (n = 514). Baseline mean pain and sleep interference scores were comparable across treatment and age groups. Significant improvements in endpoint mean pain were observed for all pregabalin dosages versus placebo in all age groups (p ≤ 0.0009), except for the lowest dosage (150 mg/day) in the youngest age group. Clinically meaningful pain relief, defined as ≥30% and ≥50% pain response, was observed in all age groups. The most common AEs were dizziness, somnolence, peripheral edema, asthenia, dry mouth, weight gain, and infections. The relative risks for these AEs increased with pregabalin dose, but did not appear related to older age or type of neuropathic pain. CONCLUSIONS: Pregabalin (150-600 mg/day) significantly reduced pain in older patients (age ≥65 years) with neuropathic pain and improvements in pain were comparable to those observed in younger patients. Titration of pregabalin to the lowest effective dose should allow for effective pain relief while minimizing AEs in older patients with neuropathic pain. Given the common use of polypharmacy in older patients, the absence of known drug-drug interactions makes pregabalin an important treatment option for older patients with pain of neuropathic origin http://www.biomedcentral.com/content/pdf/1471-2296-11-85.pdf  Análisis de las consecuencias del costo de pregabalina en el tratamiento de dolor neuropático periférico en la práctica rutinaria de primer nivel de atención A Cost-Consequences analysis of the effect of Pregabalin in the treatment of peripheral Neuropathic Pain in routine medical practice in Primary Care settings. Navarro A, Saldaña MT, Pérez C, Torrades S, Rejas J. Primary Care Health Centre Puerta del Ángel, Madrid, Spain.navarrosiguero@eresmas.com. BMC Neurol. 2011 Jan 20;11:7. Abstract BACKGROUND: Neuropathic pain (NeP) is a common symptom of a group of a variety of conditions, including diabetic neuropathy, trigeminal neuralgia, or postherpetic neuralgia. Prevalence of NeP has been estimated to range between 5-7.5%, and produces up to 25% of pain clinics consultations. Due to its severity, chronic evolution, and associated co-morbidities, NeP has an important individual and social impact. The objective was to analyze the effect of pregabalin (PGB) on pain alleviation and longitudinal health and non-health resources utilization and derived costs in peripheral refractory NeP in routine medical practice in primary care settings (PCS) in Spain. METHODS: Subjects from PCS were older than 18 years, with peripheral NeP (diabetic neuropathy, post-herpetic neuralgia or trigeminal neuralgia), refractory to at least one previous analgesic, and included in a prospective, real world, and 12-week two-visit cost-of-illness study. Measurement of resources utilization included both direct healthcare and indirect expenditures. Pain severity was measured by the Short Form-McGill Pain Questionnaire (SF-MPQ). RESULTS: One-thousand-three-hundred-fifty-four PGB-naive patients [58.8% women, 59.5 (12.7) years old] were found eligible for this secondary analysis: 598 (44%) switched from previous therapy to PGB given in monotherapy (PGBm), 589 (44%) received PGB as add-on therapy (PGB add-on), and 167 (12%) patients changed previous treatments to others different than PGB (non-PGB). Reductions of pain severity were higher in both PGBm and PGB add-on groups (54% and 51%, respectively) than in non-PGB group (34%), p < 0.001. Incremental drug costs, particularly in PGB subgroups [€34.6 (80.3), €160.7 (123.9) and €154.5 (133.0), for non-PGB, PGBm and PGBadd-on, respectively (p < 0.001)], were off-set by higher significant reductions in all other components of health costs yielding to a greater total cost reductions: -€1,045.3 (1,989.6),-€1,312.9 (1,543.0), and -€1,565.5 (2,004.1), for the three groups respectively (p = 0.03). CONCLUSION: In Spanish primary care settings, PGB given either add-on or in monotherapy in routine medical practice was associated with pain alleviation leading to significant longitudinal reductions in resource use and total costs during the 12-week period of the study compared with non-PGB-therapy of patients with chronic NeP of peripheral origin. The use of non-appropriate analgesic therapies for neuropathic pain in a portion of subjects in non-PGB group could explain partially such findings. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037328/pdf/1471-2377-11-7.pdf     Uso inicial de Pregabalina, patrones de farmacoterapia relacionada al dolor y recursos sanitarios utilizados en ancianos con fibromialgia Initial use of pregabalin, patterns of pain-related pharmacotherapy, and healthcare resource use among older patients with fibromyalgia. Gore M, Sadosky A, Zlateva G, Clauw D. Avalon Health Solutions, Inc, 1518 Walnut St, Ste 1507, Philadelphia, PA 19102, USA. mgore@avalonhealthsolutions.com Am J Manag Care. 2010 May;16(5 Suppl):S144-53. Abstract OBJECTIVE: To characterize the comorbidities, pain-related pharmacotherapy, and healthcare resource use among older patients with fibromyalgia (FM) newly prescribed pregabalin in clinical practice. METHODS: Using the PharMetrics database, patients with FM aged 65 or more years (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) who were newly prescribed pregabalin (index event) on or after July 1, 2007, were identified (N = 98, mean age 72.4 +/- 6.4 years; 81.6% female). Prevalence of comorbidities, pharmacotherapy, and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 6-month preindex and postindex periods. RESULTS: Patients had a variety of comorbidities including various disorders generally associated with an older population, such as hypertension (41.8%), diabetes (22.5%), and coronary artery disease (15.3%). On average, patients received 3.3 +/- 2.3 pregabalin prescriptions; the average number of days of therapy was 121 +/- 88.9. Patients had a high medication burden in both the pre- and postindex periods; opioids were the most commonly prescribed medications (54.1% vs 59.2%); combination therapy was also common, with opioids and antidepressants the most frequent (35% in both periods). Except for the use of selective serotonin reuptake inhibitors, which decreased significantly in the postindex period (24.5% vs 19.4%, P = .0253), there were no changes in use of any of the other medications, including nonsteroidal anti-inflammatory drugs (36.7% vs 32.7%), tramadol (17.4% vs 24.5%), muscle relaxants (18.4% vs 21.4%), tricyclic antidepressants (21.4% vs 18.4%), serotonin and norepinephrine reuptake inhibitors (10.2% vs 12.2%), and anticonvulsants (17.4% vs 21.4%) after initiation of pregabalin therapy. There were decreases in the number of physician office visits and total outpatient visits (both P <.01) and in the proportion of patients with visits to physical therapists (21.4% vs 12.2%, P = .0201); however, there were no changes in healthcare costs (pharmacy, outpatient, inpatient, or total) from the pre- to postindex period. CONCLUSIONS: These results suggest a substantial medication and comorbidity burden in older patients with FM. Although it is not possible to establish cause-and-effect relationships in claims database studies, results also suggest that the initiation of pregabalin was cost-neutral. Further evaluation is warranted to characterize FM and determine appropriate management strategies in this fragile population. http://www.ajmc.com/media/pdf/A291_10may_Gore_S144to153.pdf

Atentamente Anestesiología y Medicina del Dolor www.anestesia-dolor.org

Desenvolvimento de superbactérias ameaça futuro da medicina

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Segunda-feira, 04/04/2011

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Desenvolvimento de superbactérias ameaça futuro da medicina

Cada vez mais microorganismos mostram resistência aos antibióticos. Incapacidade de matar bactérias pode fazer a medicina retroceder

03/04/2011 | 17:13 | REUTERS

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David Livermore está numa corrida contra a evolução. Em seu laboratório no Norte de Londres, segura uma placa de culturas com um cheiro ruim, lambuzada de bactérias. Esta colônia, de tom amarelo e aspecto cremoso, é o inimigo: um novo tipo de germes, resistente aos mais poderosos antibióticos já feitos pela humanidade.

Nas ruas, Steve Owen corre a mesma corrida – batendo pernas para atrair atenção para o problema das infecções resistentes às drogas.

Donald, pai de Owen, morreu há quatro anos de falência múltipla dos órgãos num hospital britânico. Ele tinha dado entrada para operar o joelho. Mas pegou Staphylococcus aureus resistente à meticilina (MRSA, na sigla em inglês), uma “superbactéria” que nenhuma das drogas receitadas pelos médicos conseguiu vencer. Depois de quase 18 meses de muita dor, a infecção chegou ao sangue dele, dominou os órgãos vitais e o matou.

Owen e sua esposa Jules se comprometeram a correr 12 corridas ao longo do mesmo número de meses para angariar fundos para uma instituição que trabalha para combater a MRSA. “Isso simplesmente não deveria ter acontecido”, diz Jules, enquanto o casal cuida das pernas doloridas, depois de uma meia-maratona. “Era o joelho – não é algo que deveria tê-lo matado”.

Suzanne Plunkett/Reuters

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Bem vindos a um mundo no qual as drogas não funcionam.

Depois que Alexander Fleming descobriu o primeiro antibiótico, a penicilina, rapidamente nos convencemos de que tínhamos a química para vencer as bactérias. É claro, elas evoluem e desenvolvem resistência. Mas por décadas os cientistas conseguiram desenvolver medicamentos para estar pelo menos um passo à frente do inimigo sempre mutante.

Agora, contudo, nossa estrada pode estar perto do fim. Estima-se que somente a MRSA mate cerca de 19 mil pessoas por ano nos EUA – bem mais que o HIV e a Aids – e um número semelhante na Europa. Outras superbactérias estão se espalhando. A tuberculose “com resistência abrangente às drogas” cresceu como uma praga nos últimos anos. Uma nova onda de “super superbactérias”, com uma mutação chamada NDM 1, que surgiu inicialmente na Índia, já está em todo o mundo, da Grã-Bretanha à Nova Zelândia.

É NDM 1 que está crescendo nas placas que Livermore segura com as mãos vestidas com luvas. “Não dá para vencer a evolução”, diz o cientista, que passa os dias monitorando a emergência de superbactérias num laboratório de referência nacional na Agência Britânica de Proteção à Saúde. “Tudo o que se pode tentar fazer é estar um passo à frente”.

Isso não está acontecendo no momento por uma série de razões. De início, as bactérias estão em todos os lugares, dando às bactérias incontáveis oportunidades de desenvolver rotas de escape. As drogas podem ser pegas sem prescrição por centavos em países como Tailândia, Índia e partes da América Latina. Embora o uso seja controlado no Ocidente, o sistema estimula os médicos a atirar nas bactérias primeiro e perguntar depois. Talvez mais preocupante seja o fato de que as duas maiores companhias farmacêuticas do mundo, deparadas com um retorno cada vez menor e com uma ciência cada vez mais cara e difícil, não só diminuíram seus esforços no desenvolvimento de antibióticos, como também estão abandonando esse campo.

Hoje, apenas duas grandes companhias – GlaxoSmithKline e AstraZeneca – ainda têm pesquisas e programas de desenvolvimento fortes e ativos em relação aos antibióticos, segundo a Sociedade de Doenças Infecciosas dos EUA. Nos anos 1990, havia cerca de 20.

O impacto sobre o modo como tratamos nossas doenças pode ser profundo. “Se alguns dos mais potentes tipos multirresistentes que conhecemos hoje se acumularem, então a medicina moderna – desde transplantes até tratamento de câncer, e mesmo cirurgias mais comuns – se torna insustentável”, diz Livermore. “Você precisa da capacidade de tratar infecções em pacientes vulneráveis. Perca isso e uma faixa da medicina moderna se torna instável”.

Estaríamos em via de começar a ir para trás, para uma era antes dos antibióticos, na qual próteses, quimioterapia e terapia intensiva eram simplesmente impossíveis? O medo é grande o suficiente para que Organização Mundial da Saúde dedicasse o Dia Mundial da Saúde deste ano (7 de abril) à resistência antimicrobial, numa tentativa de salvaguardar as drogas as futuras gerações.

“A medicina moderna não funciona sem antibióticos eficazes”, diz Derek Butler, presidente da instituição “MRSA Action UK”, para a qual Owen está angariando fundos. “Se perdermos essas balas mágicas, a medicina regredirá em mais de 80 anos”.

Um aspecto da corrida contra as bactérias mudou pouco desde a época de Fleming. A higiene hospitalar é o trabalho básico, mal pago e sem glamour que forma a primeira linha de defesa, vital contra os patógenos. Quando feita corretamente, diminui a demanda pelas drogas. Ainda assim,Steve Owen se lembra do pai contando que viu um rato correndo pela enfermaria – um choque para um hospital de um país desenvolvido.

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