Christopher Allen

Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine

Rizatriptan (MAXALTTM, Merck & Co., Inc.) is a selective 5-HT1B/1D receptor agonist with rapid oral absorption and early onset of action for the acute treatment of migraine. This randomized, double-masked, double-dummy, placebo-controlled study compared rizatriptan 10 mg to naratriptan (NARAMIGTM, AMERGETM, both Glaxo Wellcome plc) 2.5 mg in 522 patients treating a single migraine attack. Rizatriptan was more effective than naratriptan. Rizatriptan provided earlier headache relief than naratriptan (hazard ratio 1.62, p < 0.001), acting as early as 30 min. More patients were pain free at 2 h on rizatriptan than on naratriptan (44.8 vs. 20.7%, p < 0.001). Rizatriptan also provided earlier relief of associated migraine symptoms within 2 h than naratriptan and more patients had normal function at 2 h (39.3 vs. 22.6%, p < 0.001). Both active treatments were effective compared to placebo. Both active treatments were well tolerated. The most common side effects with rizatriptan were dizziness, asthenia/fatigue, nausea and somnolence, while the most common side effects with naratriptan were dizziness and asthenia/fatigue.

Comparison of rizatriptan 10 mg vs. zolmitriptan 2.5 mg in the acute treatment of migraine

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.

Crossover Comparison of Efficacy and Preference for Rizatriptan 10 mg versus Ergotamine/Caffeine in Migraine

Rizatriptan is a selective 5-HT1B/1D receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This randomized double- blind crossover outpatient study assessed the preference for 1 rizatriptan 10 mg tablet to 2 ergotamine 1 mg/caffeine 100 mg tablets in 439 patients treating a single migraine attack with each therapy. Of patients expressing a preference (89.1%), more than twice as many preferred rizatriptan to ergotamine/caffeine (69.9 vs. 30.1%, p ≤ 0.001). Faster relief of headache was the most important reason for preference, cited by 67.3% of patients preferring rizatriptan and 54.2% of patients who preferred ergotamine/caffeine. The co-primary endpoint of being pain free at 2 h was also in favor of rizatriptan. Forty-nine percent of patients were pain free 2 h after rizatriptan, compared with 24.3% treated with ergotamine/caffeine (p ≤ 0.001), rizatriptan being superior within 1 h of treatment. Headache relief at 2 h was 75.9% for rizatriptan and 47.3% for ergotamine/caffeine (p ≤ 0.001), with rizatriptan being superior to ergotamine/caffeine within 30 min of dosing. Almost 36% of patients taking rizatriptan were pain free at 2 h and had no recurrence or need for additional medication within 24 h, compared to 20% of patients on ergotamine/caffeine (p ≤ 0.001). Rizatriptan was also superior to ergotamine/caffeine in the proportions of patients with no nausea, vomiting, phonophobia or photophobia and for patients with normal function 2 h after drug intake (p ≤ 0.001). More patients were (completely, very or somewhat) satisfied 2 h after treatment with rizatriptan (69.8%) than at 2 h after treatment with ergotamine/caffeine (38.6%, p ≤ 0.001). Recurrence rates were 31.4% with rizatriptan and 15.3% with ergotamine/caffeine. Both active treatments were well tolerated. The most common adverse events (incidence ≧5% in one group) after rizatriptan and ergotamine/caffeine, respectively, were dizziness (6.7 and 5.3%), nausea (4.2 and 8.5%) and somnolence (5.5 and 2.3%).

Coprescription of triptans with potentially interacting medications: a cohort study involving 240,268 patients.

Background Little information exists about the actual prescription of triptans within large, geographically diverse populations, in terms of demographic characteristics and co‐prescriptions with other medications with potential interactions.

Comparison of Preference for Rizatriptan 10-mg Wafer versus Sumatriptan 50-mg Tablet in Migraine

Rizatriptan (MAXALTTM, a registered trademark of Merck & Co. Inc.) is a selective 5-HT1B/1D receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This randomized, open-label, crossover outpatient study assessed the preference of 481 patients for rizatriptan 10-mg rapidly disintegrating tablets versus sumatriptan (IMIGRANTM, a registered trademark of GlaxoWellcome PLC) 50-mg tablets in the treatment of a single migraine attack with each therapy. Almost twice as many patients preferred rizatriptan 10-mg rapidly disintegrating tablet to sumatriptan 50-mg tablet (64.3 vs. 35.7%, p ≤ 0.001). Faster relief of headache pain was the most important reason for the preference, cited by 46.9% of patients preferring rizatriptan and 43.4% of patients who preferred sumatriptan. Headache relief at 2 h was 75.9% with rizatriptan and 66.6% with sumatriptan (p ≤ 0.001), with rizatriptan being superior to sumatriptan within 30 min of dosing. Fifty-five percent of patients were pain free 2 h after rizatriptan, compared with 42.1% treated with sumatriptan (p ≤ 0.001), rizatriptan being superior within 1 h of treatment. Forty-one percent of patients taking rizatriptan were pain free at 2 h and had no recurrence or need for additional medication, compared to 32.3% of patients on sumatriptan. Rizatriptan was also superior to sumatriptan in terms of the proportions of patients with no nausea, phonophobia or photophobia, and patients with normal function 2 h after treatment intake (p < 0.05). More patients were (completely, very or somewhat) satisfied 2 h after treatment with rizatriptan (73.3%) than 2 h after treatment with sumatriptan (59.0%) (p ≤ 0.001). Additionally, 2 h after the dose, more patients found rizatriptan to be very convenient, convenient or somewhat convenient (87.2%) than they did sumatriptan (76.3%) (p ≤ 0.001). Both active treatments were well tolerated. The most common side effects with rizatriptan and sumatriptan were nausea (6.6 and 6.9% of patients, respectively), dizziness (6.1 and 5.8%) and somnolence (7.4 and 6.7%).

Rizatriptan wafer–sublingual vs. placebo at the onset of acute migraine

Rizatriptan wafer is a 5HT1B/1D agonist for use in the acute treatment of migraine. It is a freeze-fried formulation, approved for oral administration, which dissolves on the tongue and is swallowed with saliva. In this study the efficacy of sublingually administered rizatriptan 10-mg wafer was evaluated in a randomized, double-blind, placebo-controlled, out-patient study involving 39 migraineurs. Patients were instructed to treat a migraine at the onset of pain in order to evaluate time of onset of pain relief and pain relief at 1 h. The average time to onset of relief was 25 min for patients treated with rizatriptan wafer and 27 min for patients treated with placebo. At 1 h, 50% of the patients receiving rizatriptan wafer and 50% of the patients receiving placebo experienced significant relief. Implications and potential reasons for a high placebo response are discussed.

Preference for rizatriptan 10‐mg wafer vs. eletriptan 40‐mg tablet for acute treatment of migraine

Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more (P ≤ 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P ≤ 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies.

Association between extended-release niacin treatment and glycemic control in patients with type 2 diabetes mellitus: analysis of an administrative-claims database

The aim of the study was to evaluate trends in antihyperglycemic agents (AHAs) use in patients with type 2 diabetes mellitus (T2DM) newly initiating extended-release niacin (ERN) compared with other lipid-modifying therapy (LMT). United States administrative-claims data identified adults with T2DM on AHAs who received a new prescription for ERN or another LMT between January 2001 and June 2003 (index date), and these adults were followed for 12 months. Inclusion criteria were (1) stable T2DM as defined by International Classification of Diseases, Ninth Revision, codes and also receiving at least 2 AHA prescriptions 12 to 24 months before initiating ERN or LMT treatment and (2) at least 2 prescriptions within 12 months before the onset of ERN or LMT. Trends in AHA prescriptions 12 months before (baseline) and after (follow-up) index date were defined as (1) no change (ie, stable T2DM), (2) increased (ie, worsening T2DM), or (3) reduced (ie, improved T2DM). Among 3799 patients with T2DM, 392 (10.3%) were treated with ERN and 3407 (89.7%) were treated with other LMT. In the ERN cohort, 82.1% of patients experienced no change in AHA prescriptions between baseline and follow-up compared with 79.4% of patients in the LMT cohort (P = .20); 13% of the ERN cohort and 16% of the LMT cohort (P = .17) experienced a dose increase or the addition of another AHA; and 5% of both cohorts were prescribed fewer AHAs or switched to a lower dose (P = .92). Treatment with ERN (vs other types of LMT) did not significantly increase AHA use, implying that T2DM status did not worsen in this cohort.

Promotional Review: Principles and Practice

Reviewing promotional materials for pharmaceutical products is important to help ensure their high quality and allow recipients to be well-informed about benefits and risks. This article provides an overview of control mechanisms that can influence the overall quality of the product combined with practical advice, based on personal US and international experience. US case reports are used to illustrate examples of promotional violations, and the consequences of government enforcement.

Shaping IFAPP’s Future

In 2010, ‘Shaping IFAPP’s Future’ is a ‘puzzle’ worth exploring (figure 1). After 35 years, how can the International Federation of Associations of Pharmaceutical Physicians (IFAPP) fit together the pieces of the puzzle that comprise its global organization in a way that responds to the ever changing and evolving landscape of Pharmaceutical Medicine? IFAPP was a driving force in implementing and establishing a new order within the medicine framework that is Pharmaceutical Medicine. IFAPP has been a creator and innovator, well ‘ahead of the game’. However as with any other organization, pharmaceutical corporation, industry body or academic institution, international groups like our Federation become less relevant if they do not accept and adapt to changing circumstances. That is, without some forethought, we risk going from being ‘ahead of the game’ to ‘behind the eight ball’. IFAPP is a nonprofit organization that was founded in 1975. The mission of IFAPP is ‘‘to promote Pharmaceutical Medicine by enhancing the knowledge, expertise and skills of pharmaceutical physicians world-wide, thus leading to the availability and appropriate use of medicines for the benefit of patients and the society.’’ Over the past 35 years, IFAPP has actively promoted the growth of the specialty of Pharmaceutical Medicine. It has fostered the development of postgraduate courses in Pharmaceutical Medicine, supported the national member associations (nMAs) to run the International Conference of Pharmaceutical Medicine (ICPM) every 2–3 years, established a Pharmaceutical Medicine Ethics Council and the Council for Education in Pharmaceutical Medicine, and developed communication channels through IFAPP World (www.ifapp.org/home/ifappworld) and its website (www.ifapp.org). In 2007, 30 nMAs were associated with IFAPP, representing 7000 members worldwide and worked to build, grow, expand, adapt and innovate for its members. IFAPP is a global organization representing many countries, cultures and capital (people and wealth) depending on the maturity and size of the nMA. With geographic and demographic boundaries merging, there will be an inevitable change in pharmaco-medico consolidation. This confronts our members, both pharmaceutical physicians and health professionals, with major challenges. At an executive meeting in Vienna in 2007, it was recognized that the PharmaceuticalMedicine landscape was changing and, as a result, the Federation was facing some significant ‘vulnerability’ over the coming decade. It was conceded that a lot of work was needed to move forward, so a path and process to redefine IFAPP was initiated (table I). To address such challenges, the IFAPP Executive Committee established the Global Strategy Working Party (GSWP) in June 2007. GSWP’s brief was to help IFAPP explore options, debate issues, think through implications, track metrics and identify possible solutions, so that informed decisions and Fig. 1. Apictorial representationof thePharmaceuticalMedicine landscape. EDITORIAL Pharm Med 2010; 24 (1): 7-1