Clinical efficacy of rizatriptan for patients with migraine: efficacy of drug therapy for migraine accompanied by tension headache–like symptoms, focusing on neck stiffness

According to an epidemiological study in Japan, there are as many as 22 million patients with tension headache and 8.4 million with migraine. Furthermore, patients suffering from both types of headache concurrently are estimated to account for more than 50% of headache patients. We studied the efficacy of drug therapy for migraine accompanied by tension headache–like symptoms, focusing principally on neck stiffness. We evaluated the efficacy of rizatriptan by comparison of findings before and after therapy in 34 migraine patients, consisting of 16 without neck stiffness (migraine without neck factor: WONF) and 18 with it (migraine with neck factor: WNF), who received treatment at our neurology/internal medicine department from 1 March 2004 to 31 May 2005. In the study, all the patients were asked to keep a record of their migraine status. The severity of migraine was classified by physicians according to the International Headache Society diagnostic criteria, based on which drug efficacy was evaluated. We selected rizatriptan for migraine treatment in our study based on Dr. Ferrari’s report. In the efficacy study of rizatriptan, in the group of 34 migraine patients, the pain relief rate (79.4%) and pain–free rate (41.2%) at two hours after treatment were as high as those reported in the meta–analysis performed by Ferrari et al., indicating high efficacy of rizatriptan. In the efficacy comparison between the WONF and WNF groups, the painfree rates were 56.3% and 27.8%, and cumulative pain relief rates were 100% and 61.1%, respectively, with better results in the WONF group. A test result was also significantly better (p=0.0076) in the WONF group. Rizatriptan was proved effective in treating migraine patients accompanied by tension headachelike symptoms. Comparison of efficacy rates between patient groups with and without tension headache–like symptoms showed that the pain relief rate in the group without neck stiffness was higher.     

Comparison of rizatriptan 10 mg vs. zolmitriptan 2.5 mg in the acute treatment of migraine. Rizatriptan-Zolmitriptan Study Group

The efficacy and tolerability of rizatriptan (MAXALT) and zolmitriptan (ZOMIG) were compared in a randomized, double-blind, double-dummy, stratified (on prior use of rizatriptan and/or zolmitriptan), placebo-controlled, single attack study in 766 patients. Rizatriptan tended to provide freedom from pain sooner than zolmitriptan (hazard ratio 1.26, P = 0.075), acting within 60 min following dosing. More patients were pain free at 2 h on rizatriptan than on zolmitriptan (43.2% vs. 35.6%, P=0.041), while headache relief at 2 h was similar (70.5% vs. 66.8%). At 2 h, fewer patients on rizatriptan had symptoms of photophobia (35.6% vs. 43.5%, P = 0.029) and nausea (25.2% vs. 32.5%, P=0.046), and more patients on rizatriptan had normal function (45.4% vs. 37.0%, P=0.025) than zolmitriptan. Headache recurred in 28% of patients taking rizatriptan, 29% taking zolmitriptan and 26% taking placebo. Both active treatments were effective compared to placebo and were well tolerated. The most common side-effects with rizatriptan were asthenia/fatigue, somnolence and dizziness, while the most common side-effects with zolmitriptan were asthenia/fatigue and dizziness.     

Identification,isolation and characterization of process-related impurities in Rizatriptan benzoate

Three process-related impurities were observed in routine monitoring of the samples by HPLC. These impurities were identified by LC–MS. One of the impurities, Imp-3 [rizatriptan-2,5-dimer] was reported in literature. Other two impurities were isolated by preparative HPLC and characterized by NMR, Mass and IR. Pure impurities obtained by isolation were co-injected with Rizatriptan benzoate sample to confirm the retention times in HPLC. Structure elucidation of these impurities by spectral data has been discussed in detail. These impurities were identified as 4-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)ethyl)-1H-indol-1-yl)-4-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)ethyl)-1H-indol-2-yl)-N,N-dimethylbutan-1-amine [rizatriptan-1,2-dimer] and [4,4-bis-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)-ethyl)-1H-indol-2-yl)-N,N-dimethylbutan-1-amine [rizatriptan-2,2-dimer].     

The impact of a worksite migraine intervention program on work productivity,productivity costs,and non-workplace impairment among Spanish postal service employees from an employer perspective

SUMMARY

Background: Migraine is associated with a significant productivity loss to employers, who may benefit from making a migraine intervention available to their employees.

Objective: To evaluate changes in migraine-related productivity and non-workplace impairment associated with a migraine intervention program from the employer perspective.

Methods: This was a pre-test post-test study of Spanish Postal Service employees with migraine. The intervention consisted of counseling from occupational health physicians and rizatriptan 10?mg for symptomatic treatment of two subsequent migraine headaches. Physicians also prescribed additional medications for migraine prophylaxis, treatment of tension headaches, and rescue medications. Migraine-related work loss and non-workplace impairment (interference with daily and social activities) were self-reported at baseline (pre-intervention) and separately following each migraine headache (post-intervention) with the aid of a diary. Migraine-related work loss was reported as work loss due to absenteeism, reduced productivity while at work, and the sum of the two (total lost work day equivalents [LWDE]). An employer perspective was taken for the cost analysis, and thus productivity costs were the only costs considered.

Results: A total of 436 patients comprised the population for analysis. The number of migraine-related LWDE per migraine attack were 0.48 days per migraine headache in the month before the intervention, decreasing to 0.20 days and 0.07 days per migraine headache during the first and second migraine headaches following the intervention (^?p?<?0.0001 vs. baseline). Total migraine-related productivity costs per migraine headache were €34/patient before the intervention, decreasing to €14/patient and €5/patient during the first and second headaches following the intervention (?p < 0.0001).

Non-workplace activity impairment was also significantly reduced (?p < 0.0001) following the intervention. The main limitations of the study were the lack of a parallel control group and the potential for differential recall bias between the usual care and the intervention periods. In addition, the results may not be generalizable to other employers or other countries.

Conclusion: This study documents the value of a workplace migraine intervention program, which focused on migraine prevention and rizatriptan-based symptomatic treatment. It also highlights the important role occupational health clinics can play in helping employers and employees reduce the burden of migraine.     

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind,randomized, cross-over,multicenter, Italian,comparative study versus rizatriptan

The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.01) lower with frovatriptan (10 vs. 32% rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.     

Rizatriptan <Emphasis Type="Italic">vs.</Emphasis> ibuprofen in migraine: a randomised placebo-controlled trial

The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with <8 attacks/months were included. One hundred and fifty-five migraine patients were randomised to rizatriptan 10 mg (53), ibuprofen 400 mg (52) and placebo (50). Efficacy was assessed by headache relief, and headache freedom at 2 h and 24 h. Two-hour headache relief, was noted in 73% in rizatriptan, 53.8% in ibuprofen and 8% in placebo groups. Headache freedom was achieved in 37.7% in rizatriptan, 30.8% in ibuprofen and 2% in placebo groups. Rizatriptan was superior to ibuprofen and placebo in relieving headache at 2 h but not at 24 h. Side effects were noted in 9 patients in rizatriptan, 8 in ibuprofen and 3 in placebo, all of which were nonsignificant. Rizatriptan and ibuprofen are superior to placebo. Rizatriptan is superior to ibuprofen in relieving headache, associated symptoms and functional disability.     

A New extractive spectrophotometric method for determination of rizatriptan dosage forms using bromocresol green

Background and the purpose of the study

Rizatriptan is used effectively for the treatment of migraine headache. In this study, a simple, rapid and low cost spectrophotometric method based on the ion-pair complexation is proposed for the determination of rizatriptan in raw material and dosage forms.

Methods

The ion-pair complexation using bromocresol green as reagent was performed in a buffer solution and the absorbance was measured by a spectrophotometer. The ion-pair formation conditions were optimized and the accuracy and precision of the method were calculated.

Results and major conclusion

Best results were achieved by using 6 ml of the bromocresol green reagent in the presence of phosphate buffer (pH 3.0). The stoichiometry of the resulted complex was 1:1. The within-day and between-day precision values were lower than 2.9 and 1.8 percent for the calibration range of 0.5–50 and 10–100 μg/ml, respectively. The proposed method was successfully used for the determination of rizatriptan in dosage forms without any interference.     

剖宫产手术并发症对产妇性功能的影响分析

目的:分析剖宫产手术后并发症对产妇性功能的影响,探讨降低剖宫产手术并发症对策。方法:选择2013年3月至2016年3月在我院性剖宫产手术的62例患者作为研究对象。纳入产妇妊娠后建档时采用产后性功能障碍诊断量化及评分表测试均无性功能障碍,产后夫妇未分居,男方性功能正常。按照术后是否出现并发症将其分为两组,并发症组(n=26)和对照组(n=36),比较两组产妇术后3个月、6个月产后性功能障碍诊断量化及评分表,对两组患者产后性功能障碍患者进行分类,分析导致产妇产后性功能障碍的术后并发症方面的原因。探讨降低剖宫产产妇术后并发症的对策。结果:并发症组产妇与对照组产妇产后3个月性幻想、性欲望、谈论有关性问题、对男方性活动建议的反应、性高潮、性生活频度评价、性生活质量评分及性交痛评分及产后性功能障碍诊断量化及评分总分比较差异无统计学意义(P>0.05);6个月后并发症组产妇性幻想、性欲望、谈论有关性问题、对男方性活动建议的反应、性高潮、性生活频度评价、性生活质量评分、性交痛评分及产后性功能障碍诊断量化及评分总分均低于对照组产妇,组间比较差异有统计学意义(P<0.05)。6个月后并发症组产妇有20例(76.92%)判断为性功能障碍,对照组仅7例(19.44%)判断为性功能障碍,并发症产后6个月性功能障碍率显著高于对照组(P<0.05)。并发症组20例性功能障碍者以性交疼痛或性交困难为主15例占75.00%。结论:剖宫产产妇术后发生并发症对产妇术后的性功能具有非常重要的影响,对产妇围产期进行健康宣教,加强术后医疗护理质量,降低并发症率对提高剖宫产产妇性功能具有重要意义。     

苯甲酸利扎曲普坦治疗偏头痛的疗效观察

目的观察苯甲酸利扎曲普坦(欣渠)治疗偏头痛的疗效。方法将63例偏头痛患者随机分为欣渠组(31例)与复方对乙酰氨基酚(散利痛)组(32例),头痛发作开始时分别服用欣渠10mg及散利痛1片。观察患者服药后起效的时间,服药后0.5h、1h、2h、4h的有效率及服药后4h的视觉模糊评分(VAS),服药后完全止痛持续时间。结果与散利痛组比较,欣渠组起效时间显著缩短,完全止痛持续时间显著延长(P<0.01,P<0.05)。欣渠组服药后1h、4h的有效率(51.6%,80.6%)明显高于散利痛组(28.1%,56.3%)(均P<0.05);两组治疗后VAS均比治疗前显著降低(均P<0.01),两组间差异无统计学意义。两组各有3例出现轻微不适。结论欣渠治疗偏头痛疗效显著,能减轻偏头痛发作的程度,缩短发作时间。     

苯甲酸利扎曲普坦口腔速崩片的制备

目的 制备苯甲酸利扎曲普坦口腔速崩片.方法 选用微晶纤维素(MCC)和低取代羟丙基纤维素(LHPC)作为崩解剂,通过粉末直接压片工艺制备口腔速崩片.考察速崩片的性质.结果 当MCC/LHPC的比例为9:1时,其体外崩解时间在20 s以内,体内崩解时间在30 s以内.结论 所制片剂口感良好,优化的工艺可以工业化生产.