| 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
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| 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.
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| 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.
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