RESUMEN
OBJECTIVE: This study aimed to compare the analgesic efficacy of topical ibuprofen and topical piroxicam for acute musculoskeletal injuries. METHODS: In this prospective, randomized, controlled, double-blinded study, geriatric patients were assigned to groups to receive either topical ibuprofen (n = 70) or topical piroxicam (n = 69). The first dose of gel was applied in the emergency department and the remaining doses were self-administered at home by the patients thrice daily for 72 h. For each patient, the initial baseline visual analog scale (VAS) score (V 0) was compared with the VAS scores at the 60 min (V1), 120 min (V2), 24 h (V3) and 72 h (V4) time points. The decreases in VAS scores, clinical effectiveness of the treatments, and incidence of adverse events were evaluated. RESULTS: In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001). The results were as follows: V0 -V: 1.08, 95% CI: 0.56-1.61; V0 -V2: 1.09, 95% CI: 0.49-1.69; V0 -V3: 1.44, 95% CI: 0.81-2.07; V0 -V4: 1.59, 95% CI: 0.91-2.26. The mean percentage decrease in the VAS scores in the topical ibuprofen group was significantly higher than that in the topical piroxicam group (p < .001). The clinical effect of treatment was found to be significantly higher for the ibuprofen gel group (p < .001). There was no substantial difference in treatment-related adverse events between the groups (p > .05). CONCLUSION: Ibuprofen gel, which is a safe treatment option for geriatric patients, is more clinically effective than piroxicam gel. Response to Reviewers.
Asunto(s)
Analgésicos/normas , Manejo del Dolor/normas , Heridas y Lesiones/tratamiento farmacológico , Administración Tópica , Anciano , Anciano de 80 o más Años , Analgésicos/administración & dosificación , Analgésicos/uso terapéutico , Método Doble Ciego , Femenino , Geriatría/instrumentación , Geriatría/métodos , Geriatría/normas , Humanos , Ibuprofeno/administración & dosificación , Ibuprofeno/normas , Ibuprofeno/uso terapéutico , Masculino , Manejo del Dolor/métodos , Manejo del Dolor/estadística & datos numéricos , Dimensión del Dolor/métodos , Piroxicam/administración & dosificación , Piroxicam/normas , Piroxicam/uso terapéutico , Estudios Prospectivos , Heridas y Lesiones/complicacionesRESUMEN
The mandatory strategy of using internal standard in HPLC is still controversial. Despite that the introduction of internal standard methodology in the early stage of development of HPLC technology was used to improve method accuracy and precision, there are still practical situations in which a simple external standard quantification is adequate. The aim of the study is to compare the determination of meloxicam (MXC) in human plasma by HPLC with or without using an internal standard according to some key points related to the reason of introducing the internal standardization such as the reducing of sample preparation errors or variability for low injection volumes. The HPLC analysis was performed on reversed phase with UV detection after protein precipitation. Piroxicam (PXC) was used as an internal standard. The two methods are compared in terms of accuracy and precision over the same concentration range. The stability of the analyte has been proved. According to the results, the quantitative determination of MXC in human plasma after simple protein precipitation by using PXC as an internal standard does not bring any significant improvement of accuracy and precision of the experimental measurements.
Asunto(s)
Cromatografía Líquida de Alta Presión/métodos , Cromatografía Líquida de Alta Presión/normas , Estabilidad de Medicamentos , Humanos , Meloxicam/sangre , Meloxicam/química , Piroxicam/análisis , Piroxicam/normas , Estándares de Referencia , Reproducibilidad de los ResultadosRESUMEN
A polarographic study about how three anti-inflammatories, such as Aceclofenac, Tenoxicam and Droxicam behave, using tast polarography (TP) and differential pulse polarography (DPP) was carried out. These studies were always carried out in a media formed by Methanol-Britton-Robinson aqueous buffer (0.1M) (4:96 (v/v)) due to the low solubility of these drugs in water. A strong influence of pH on analytical signals was observed, showing that the optimal pH values were between 4 and 5. Using DPP in the optimal experimental conditions, a detection limit of 10 ppb for Tenoxicam and Droxicam and 52 ppb for Aceclofenac was reached. The DPP proposed method was successfully applied to the determination of the active compounds in commercial drugs.
Asunto(s)
Antiinflamatorios no Esteroideos/análisis , Diclofenaco/análogos & derivados , Diclofenaco/análisis , Metanol/química , Piroxicam/análogos & derivados , Piroxicam/análisis , Polarografía/métodos , Piridinas/análisis , Agua/química , Antiinflamatorios no Esteroideos/química , Antiinflamatorios no Esteroideos/normas , Diclofenaco/química , Diclofenaco/normas , Piroxicam/química , Piroxicam/normas , Piridinas/química , Piridinas/normas , Control de Calidad , SolubilidadRESUMEN
The British Pharmacopoeia defines 2-aminopyridine (2-AP) as a potential impurity in piroxicam (PX) and tenoxicam (TX). Selective spectrofluorimetric determination of 2-AP in PX and TX, within or near the pharmacopoeial level, 0.2%, was developed, based on the measurement of the native fluorescence either in aqueous 0.1N sulfuric acid or in dioxane. Accordingly, this approach was followed for confirming purity of PX and TX in bulk and pharmaceutical preparations. The study was also extended to include simultaneous determinations of PX/2-AP and TX/2-AP systems based on selective fluorescence measurements in the cited solvents.
Asunto(s)
Aminopiridinas/análisis , Contaminación de Medicamentos , Farmacopeas como Asunto/normas , Piroxicam/análogos & derivados , Piroxicam/análisis , Aminopiridinas/normas , Piroxicam/normas , Espectrometría de Fluorescencia/métodosRESUMEN
The efficacy of an NSAID (tenoxicam) in the treatment of acute low back pain (LBP) was assessed in a double blind controlled study by using an objective functional evaluation. Seventy-three patients consulting for acute LBP were randomized into two groups: Group I was treated with tenoxicam for 14 days and Group II was given a placebo. Trunk function was measured with a computerized isoinertial dynamometric trunk testing device (Isostation B200). Isometric and dynamic torques, range of motion and movement velocities were measured before treatment and after 14 days. Clinical evaluation was realized by the patient on a pain visual analogue scale (VAS) on days 1, 8 and 15 and by the investigator on a five-point scale on days 8 and 15. The functional evaluation showed significant differences in favour of the tenoxicam treatment for velocity and extension isometric torque. VAS and investigator evaluations showed a significant difference in favour of tenoxicam on day 8 but no difference on day 15. This study shows that the use of tenoxicam in acute LBP is of interest. Tenoxicam has an effect on pain during the first part of the treatment and may help to restore full function even if the symptoms have disappeared.
Asunto(s)
Antiinflamatorios no Esteroideos/normas , Dolor de la Región Lumbar/tratamiento farmacológico , Piroxicam/análogos & derivados , Adulto , Antiinflamatorios no Esteroideos/uso terapéutico , Método Doble Ciego , Femenino , Humanos , Incidencia , Dolor de la Región Lumbar/fisiopatología , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Dolor/epidemiología , Dolor/fisiopatología , Piroxicam/normas , Piroxicam/uso terapéuticoRESUMEN
OBJECTIVE: To obtain a better quantitative and qualitative estimate of the effect of tenoxicam (Tx) compared to piroxicam (Px), diclofenac (Dcl) and indomethacin (Ind) in the treatment of osteoarthritis (OA). METHODS: Relevant studies were identified using computerized Medline search, manual search of cited references and correspondence with investigators, colleagues and the manufacturer of Tx. Once the studies were selected and chosen on the basis of predetermined methodologic criteria, the required data were extracted by 2 authors, independently. Eighteen studies met the required eligibility criteria. Meta-analyses were undertaken on 12 studies of Tx vs Px, 3 studies of Tx vs Dcl, and 2 studies of Tx vs Ind. Efficacy was measured in 2 ways: (1) physician global rating scale and (2) pain scale. Safety was measured in 3 ways: (1) physician global rating scale, (2) number of patients with adverse events, and (3) dropouts due to adverse events. RESULTS: The following findings of the meta-analysis were statistically significant: In Tx vs Px comparisons, efficacy-(1), safety-(1) and safety-(3) were all better with Tx; in Tx vs Ind comparisons, safety-(1) and safety-(2) were better with Tx. All other findings showed no statistically significant differences between Tx and the comparison drug. CONCLUSIONS: Compared to Px, Tx performs better on physician assessment of efficacy and tolerability, but the other comparisons remain inconclusive. Compared to Dcl, there appears not to be a difference. Compared to Ind, Tx is safer.
Asunto(s)
Antiinflamatorios no Esteroideos/efectos adversos , Antiinflamatorios no Esteroideos/normas , Diclofenaco/efectos adversos , Diclofenaco/normas , Indometacina/efectos adversos , Indometacina/normas , Osteoartritis/tratamiento farmacológico , Piroxicam/análogos & derivados , Piroxicam/efectos adversos , Piroxicam/normas , Anciano , Antiinflamatorios no Esteroideos/uso terapéutico , Diclofenaco/uso terapéutico , Método Doble Ciego , Femenino , Humanos , Indometacina/uso terapéutico , Masculino , Persona de Mediana Edad , Piroxicam/uso terapéutico , Distribución AleatoriaRESUMEN
A meta-analysis was done with the final data from three trials that provided the first results relating to efficacy and safety of the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis (OA) of the knee. The studies were 4-week, double-blind, randomized, parallel-group comparisons of etodolac SR 600 mg (119 patients) against diclofenac SR 100 mg (54 patients), tenoxicam 20 mg (46 patients), or piroxicam 20 mg (18 patients). The primary efficacy parameters (assessed after 2 and 4 weeks of treatment) were physicians' and patients' overall assessments of patients' condition, night pain, and pain intensity. All patients had radiographic and clinical evidence of OA of the knee. For the meta-analysis, the data from the individual etodolac SR studies were pooled and compared with the pooled data for diclofenac SR, tenoxicam, and piroxicam. The homogeneity of the treatments across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance, including "study," "treatment," and "center within treatment" effects and their interaction. The analysis for the efficacy parameters was based on the final assessment during therapy (last visit). At baseline, the two treatment groups were comparable. Improvement rates were high in both groups (range, 68-81%), indicating that treatments were effective for most patients. No significant treatment difference was observed for the patients' overall assessment, night pain, or pain intensity. Both etodolac SR and the reference preparations were well tolerated. No clinically significant changes were noted in the laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)
Asunto(s)
Etodolaco/normas , Osteoartritis/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Análisis de Varianza , Antiinflamatorios no Esteroideos/efectos adversos , Antiinflamatorios no Esteroideos/normas , Antiinflamatorios no Esteroideos/uso terapéutico , Preparaciones de Acción Retardada , Diclofenaco/efectos adversos , Diclofenaco/normas , Diclofenaco/uso terapéutico , Método Doble Ciego , Etodolaco/efectos adversos , Etodolaco/uso terapéutico , Femenino , Humanos , Articulación de la Rodilla , Masculino , Persona de Mediana Edad , Osteoartritis/fisiopatología , Dolor/fisiopatología , Piroxicam/efectos adversos , Piroxicam/análogos & derivados , Piroxicam/normas , Piroxicam/uso terapéutico , Distribución AleatoriaRESUMEN
Worldwide experience with the conventional formulation of etodolac (300 mg b.i.d.) was reviewed in 12 randomized, double-blind, parallel-group studies in patients with osteoarthritis (OA) of the hip or knee. The studies were conducted in 13 countries at 59 sites, and 1289 patients were enrolled. The results of 9 comparative and 3 placebo-controlled clinical studies were examined to compare the efficacy and safety of etodolac versus piroxicam, naproxen, indomethacin, indomethacin sustained-release (SR), and diclofenac SR. Efficacy assessments were made at pretreatment screening, baseline, and every 2 weeks thereafter during treatment until study completion up to 4, 6, or 8 weeks. The primary efficacy assessments were the patient's and physician's global evaluations, pain intensity and night pain, or joint tenderness and walking pain. Safety was assessed with reference to study events, reports of laboratory results, and vital signs measurements. Patients in all active treatment groups showed prompt response to therapy. According to the physicians' global evaluation, at least 64% of all etodolac-treated patients and 62% of all active-reference preparation-treated patients had improved by the end of the study. Similar results were seen in the patients' global evaluation. All of the study drugs were well tolerated. Eight (8%) percent of the etodolac-treated patients withdrew because of study events. The proportions of patients treated with active reference preparations and placebos who withdrew because of study events ranged from 3% to 18%.(ABSTRACT TRUNCATED AT 250 WORDS)
Asunto(s)
Etodolaco/uso terapéutico , Osteoartritis/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Preparaciones de Acción Retardada , Diclofenaco/administración & dosificación , Diclofenaco/normas , Diclofenaco/uso terapéutico , Método Doble Ciego , Etodolaco/efectos adversos , Etodolaco/normas , Salud Global , Articulación de la Cadera/fisiopatología , Humanos , Indometacina/administración & dosificación , Indometacina/normas , Indometacina/uso terapéutico , Articulación de la Rodilla/fisiopatología , Persona de Mediana Edad , Naproxeno/efectos adversos , Naproxeno/normas , Naproxeno/uso terapéutico , Osteoartritis/fisiopatología , Dolor/fisiopatología , Piroxicam/efectos adversos , Piroxicam/normas , Piroxicam/uso terapéutico , Factores de TiempoRESUMEN
Generic drug products are marketed throughout the world and are generally regarded as being equivalent to the name brand product. Piroxicam is a widely prescribed nonsteroidal anti-inflammatory drug and is marketed under the Pfizer tradename Feldene or Felden . In countries with no patent laws or where the Feldene patent has expired, the drug is available under various trademarks by many different producers. Differences in formulations produced by different manufacturers can be assessed by measuring dissolution rate and potency. In this study, the United States Pharmacopeia (USP) dissolution and potency tests were applied to 85 generic piroxicam products obtained from 21 countries in an attempt to evaluate if the available formulations met standard quality assurance tests. The results show that of the 85 piroxicam products tested, 17 products met the USP dissolution standards and 68 products failed. Of the 85 products tested for potency as a percentage of label claim, 50 products failed the USP criteria. Overall, 91% of the generic piroxicam products evaluated failed to meet the routine in vitro USP quality assurance criteria for potency and/or dissolution. The substantial differences observed in this study regarding performance of piroxicam dosage forms available worldwide have possible implications in terms of product equivalency and standards at an international level. While these results cannot be used to draw clinical conclusions without bioavailability data, they should nonetheless be kept in mind by healthcare practitioners.(ABSTRACT TRUNCATED AT 250 WORDS)