Migraine treatment patterns and patient satisfaction with prior therapy: a substudy of a multicenter trial of rizatriptan effectiveness

BACKGROUND: Migraine is a common, chronic, often disabling neurologic condition that is underdiagnosed and undertreated. OBJECTIVE: We undertook this questionnaire-based study as a substudy of a multicenter trial of rizatriptan effectiveness. Our goal was to assess the history of acute migraine medication use and the relationship between different migraine medication regimens and patient satisfaction with prior therapy. METHODS: This study was conducted at 85 neurology clinics throughout Spain from March Lo December 2001. It was planned prospectively as part of the screening visit for a multicenter trial of the effectiveness of rizatriptan therapy for migraine. Male and female patients >/=18 years of age were eligible for the primary trial, and hence for this study, if they had a history of migraine attacks and did not have a contraindication for triptan use. At the screening visit for the primary trial, a questionnaire was used by clinicians to record past and current use, and duration and order of use, of analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), ergot derivatives, and triptans; satisfaction with treatment was scored on a 5-point scale ranging from "very dissatisfied" to "very satisfied." RESULTS: Of 712 patients completing the questionnaire (mean [SD] age, 34 [10] years; range, 18-69 years), 75% were women and 94% experienced moderate or severe functional disability during migraine attacks. Analgesics were used by the majority of patients (81%) and for the longest mean [SD] duration (8.8 [7.6] years) but were associated with the least satisfaction (10% of patients "very satisfied" or "somewhat satisfied"). Triptans were used by the fewest patients (32%) and for the shortest mean duration (18 [1.6] years) but were associated with the highest rate of satisfaction (66%) compared with NSAIDs (27%) and ergot derivatives (31%). Regardless of duration or order of drug use, or sex or age of the patient, the likelihood of satisfaction with triptans was significantly greater (P < 0.001) than with nontriptan regimens, with an adjusted odds ratio (95% CI) of 16.8 (11.4-24.9) versus analgesics, 5.1 (3.6-7.1) versus NSAIDs, and 4.1 (2.8-6.0) versus ergot derivatives. CONCLUSIONS: Our results showed that analgesics, NSAIDs, and ergot derivatives were used for long durations but provided low satisfaction among patients. Triptans were rarely used as a first treatment choice; however, patients reported the highest treatment satisfaction scores after triptan therapy compared with ergot derivatives, NSAIDs, or analgesics.     

A pilot Phase II trial of concurrent radiotherapy,chemotherapy, and hyperthermia for locally advanced cervical carcinoma

BACKGROUND: Five randomized studies have demonstrated a benefit derived from adding cisplatin (CDDP)-based chemotherapy to radiotherapy (RT) for treatment of cervical carcinoma. The Dutch Phase III pelvic tumor trial demonstrated a survival and local control benefit due to the addition of hyperthermia (HT) to RT. The authors evaluated response and toxicity in patients with locally advanced cervical carcinoma (LACC) who were treated with concurrent weekly CDDP, HT, and RT (whole pelvis [n=7] and whole pelvis and paraaortic nodes [n=5]). METHODS: From August 1998 through December 2000, 12 patients with LACC or locally recurrent cervical carcinoma (LRCC) following hysterectomy were enrolled on a pilot study combining weekly CDDP, HT, and RT. RESULTS: Ten patients were treated at initial diagnosis. All achieved clinical complete response and durable local control. Two of the 10 experienced recurrence outside the pelvis; 1 of these patients had pulmonary metastasis, and the other had isolated paraaortic nodal involvement. Two patients treated for LRCC experienced local and systemic progression and died of disease within 6 months. CONCLUSIONS: In this small series, trimodality therapy resulted in an excellent clinical response and was well tolerated. The addition of HT to chemoradiotherapy represents a promising new strategy that warrants multiinstitutional collaborative efforts to confirm its efficacy.     

Activity of weekly irinotecan (CPT-11) in patients with advanced non-small cell lung cancer pretreated with platinum and taxanes

Irinotecan (CPT-11), a semisynthetic derivative of camptothecin, is active in the treatment of non-small cell lung cancer (NSCLC). In this report we describe our experience with this drug when used as a single agent in patients with advanced NSCLC refractory to chemotherapy with platinum and taxanes. Nineteen NSCLC patients (thirteen males and six females; 53% adenocarcinoma and 26% squamous cell carcinoma) with a median age of 52 years (range 34–71) and a Karnofsky performance status of 60% (60–80%) were included in the study. At baseline, the patients had a median of two disease sites and had been treated with a median of two prior regimens. Irinotecan was given at a dose of 100mg/m² i.v.) weekly for 4 weeks followed by 1 week of rest. A total of 123 weekly infusions were administered, and each patient received a median of 4 weeks of treatment (range 1–32). All patients were evaluated by intention-to-treat analysis for efficacy and safety. Main toxicities reported were grade 3 neutropenia (10% of patients), diarrhea (10% of patients), and grade 4 thrombocytopenia (5% of patients). The overall clinical response rate was 16% (95% CI: 8–24) with three partial responses and 9 (47%) patients with stable disease. The median time to progression and the median survival time were 7 and 15 weeks, respectively. In conclusion, weekly irinotecan showed antitumoral activity and minimum toxicity in NSCLC patients refractory to platinum and taxanes.     

Social benefits of non-criminal genetic databases: missing persons and human remains identification

A Missing Persons Genetic Identification Program (Phoenix Program) was implemented in Spain in order to try to identify cadavers and human remains that could not be identified using traditional forensic approaches; to our knowledge, this is the first database ever implemented and in function in the world. Two separate mitochondrial DNA (mtDNA) databases have been generated and comparisons can be made automatically to match identical or similar sequences contained in both databases. One database is called the Reference Database (RD), which contains mtDNA sequences from maternal relatives of missing persons that provide the samples voluntarily after informed consent. The other database is called the Questioned Database (QD) and is comprised of mtDNA data on unknown remains and cadavers that could not be unequivocally identified. The combined database is a civil database designed solely for human identification and because of the informed consent and voluntary donation of reference samples is different from other databases now used to solve criminal cases. It is timely and incumbent on other willing countries to begin an international collaboration so compatibility and full utility can be enjoyed with this kind of non-criminal database. Received: 21 November 2000 / Accepted: 19 July 2001     

Intracranial metastasis or meningioma? An uncommon clinical diagnostic dilemma

BACKGROUND: Cerebral metastases are the most frequent brain tumors in adults and they may occasionally present as an isolated meningeal mass, suggesting a meningioma. Because of the prognostic relevance in discriminating both tumors, we review the literature and analyze four patients in whom the diagnosis of meningioma was initially made. CASE DESCRIPTION: Four cases of isolated meningeal metastases are presented and in all of them a meningioma was considered as the main preoperative diagnosis. Only one patient had a history of previous cancer. The primary tumors found after pathological testing of the lesions were thyroid carcinoma, prostate adenocarcinoma, breast adenocarcinoma, and hypernephroma.The clinical and neuroimaging features as well as the differential diagnoses are discussed. The literature regarding these forms of meningeal metastases was reviewed. CONCLUSIONS: Although they are uncommon, dural metastases can be mistaken for meningiomas. Our experience in these cases has led us to consider ordinary metastases as a differential diagnosis even when a meningioma is suspected. The definitive diagnosis of a meningioma should be established only after the histopathological report has been analyzed.     

The potential of ESSG spondyloarthropathy classification criteria as a diagnostic aid in rheumatological practice

OBJECTIVE: The European Spondylarthropathy Study Group (ESSG) criteria for the classification of spondyloarthropathies (SpA) were developed with the aim of unifying and facilitating international medical communication. We assessed the potential of ESSG criteria as a diagnostic aid for rheumatology practices in terms of sex and prevalence rate. METHODS: Data from 2 similarly designed and developed studies conducted in France and Spain were examined. Data were obtained from 3,494 patients seen at rheumatology outpatient services (28 in each country). The sensitivity and specificity of each ESSG criterion (except the radiological one) were assessed in terms of sex and country. Patients were divided into 4 groups according to number of criteria present at the time of the study: Group I had neither inflammatory spinal pain (ISP) nor synovitis; Group 2 had ISP and/or synovitis; Group 3 ISP and/or synovitis plus one additional criterion; Group 4 ISP and/or synovitis plus more than one additional criterion. The predictive value was determined by using different prevalence rates. RESULTS: A prevalence of 27.6% for male and 8.0% for female patients was found at Spanish services; prevalence in French services was 9.1% males and 3.2% females. No significant differences in sensitivity and specificity for each sex between French and Spanish individuals were detected; the overall sensitivity and specificity were similar for men and women. By contrast, there were differences between patients from the 2 countries regarding individual ESSG criteria; thus, inflammatory spinal pain and synovitis were less specific in the female and male Spanish patients, respectively, relative to the French patients. CONCLUSION: ESSG criteria can be used meaningfully to aid diagnosis when the prevalence of SpA exceeds 10% and the patient meets more than one of the additional criteria, or when prevalence exceeds 30% and the patient meets only one additional criterion.     

Gynecomastia and sexual impotence associated with methotrexate treatment

Methotrexate (MTX) is the disease modifying antirheumatic drug most frequently used for rheumatoid and psoriatic arthritis (PsA). Several reports associate sexual dysfunction to MTX use. We describe 2 cases of sexual impotence and gynecomastia in patients with PsA treated with MTX. Although the mechanism underlying MTX induced sexual dysfunction is unknown, the potential consequences should be taken in account in view of the steady increase in the number of patients.     

Biological properties of arginine-based gemini cationic surfactants

Biological properties of novel gemini (double-chain/double-head) cationic surfactants, Nalpha,Nomega-bis(Nalpha-acylarginine)alpha,omega-alkylendiamides, so-called bis(Args), are reported. The effect of both the alkyl (10 and 12 carbon atoms) and the spacer chain (from 2-10 methylene groups) of bis(Args) on their antimicrobial activity, acute toxicity on Daphnia magna and Photobacterium phosphoreum, and aerobic biodegradability is studied. These surfactants constitute a novel class of chemicals of low toxicity with excellent surface properties and considerable antimicrobial activity. The aquatic toxicity of these compounds is lower than that of the conventional Monoquats. As regards the biodegradation test, the molecules with a spacer chain < or =6 methylene groups can be considered as ready biodegradable. The increase of hydrophobicity in the bis(Args) is a negative structural parameter for their environmental behavior.