Repeated treatment with ≤ 5 cycles of onabotulinumtoxinA was effective, safe, and well tolerated in adults with chronic migraine.

Objective: To compare bimatoprost with timolol maleate in patients with glaucoma or ocular hypertension.Methods: In 2 identical, multicenter, randomized, double-masked, 1-year clinical trials, patients were treated with 0.03% bimatoprost once daily (QD) (n=474), 0.03% bimatoprost twice daily (BID) (n = 483), or 0.5% timolol maleate BID (n = 241).Main Outcome Measures: Diurnal intraocular pressure (IOP) at 8 AM, 10 AM, and 4 PM and safety variables (IOP was also measured at 8 PM at selected sites).Results: Bimatoprost QD provided significantly lower mean IOP than timolol at every time of the day at each study visit (PϽ.001). This was also true for bimatoprost CLINICAL SCIENCES

A multicenter, randomized, investigator-masked, parallel-group trial compared bimatoprost and latanoprost for efficacy and safety in patients with glaucoma or ocular hypertension. Patients received bimatoprost 0.03% (n = 119) or latanoprost 0.005% (n = 113) once daily in the evening for 3 months. Visits were at prestudy, baseline (day 0), week 1, and months 1, 2, and 3. Primary outcome measures were mean IOP and the percentage of patients achieving IOP of 17 mm Hg or lower at 8:00 AM. Secondary outcome measures were diurnal IOP measurements (8:00 AM, 12 noon, 4:00 PM, 8:00 PM) at month 3 and safety measures including adverse events. Mean IOP was lower with bimatoprost than with latanoprost at all time points during the 3-month follow-up, although the between-group difference was not always statistically significant. At month 3 at 12 noon, mean IOP was as much as 1.0 mm Hg lower with bimatoprost (P = .021). Target pressures of < or = 17 mm Hg were reached more often with bimatoprost than with latanoprost at 8:00 AM (53% vs 43%; P = .029). Over all diurnal measurements at month 3, low target pressures of < or = 13, < or = 14, and < or = 15 mm Hg were achieved significantly more often with bimatoprost (P < or = .006). Both drugs were safe and well tolerated. Conjunctival hyperemia was more common with bimatoprost, while headache was more frequent with latanoprost. Bimatoprost provided lower mean pressures than latanoprost at every time point throughout the study and was statistically superior in achieving low target pressures. More patients reached low target pressures with bimatoprost.

This meta-analysis evaluated the frequency of neutralizing antibody (nAb) conversion with onabotulinumtoxinA (BOTOX®; Allergan) across five studied indications. The analysis was based on large, controlled or prospective, open-label trials (durations 4 months to ≥2 years). Serum samples were analyzed for nAbs using the Mouse Protection Assay. Subjects who were antibody negative at baseline and had at least one analyzable postbaseline antibody assay result were included. The 16 clinical studies included 3,006 subjects; of these, 2,240 met the inclusion criteria for this analysis. Subjects received 1-15 treatments (mean 3.8 treatments) with onabotulinumtoxinA. Total doses per treatment cycle ranged from 10 or 20 units in glabellar lines to 20-500 units in cervical dystonia. The numbers of subjects who converted from an antibody-negative status at baseline to antibody-positive status at any post-treatment time point were: cervical dystonia 4/312 (1.28%), glabellar lines 2/718 (0.28%), overactive bladder 0/22 (0%), post-stroke spasticity 1/317 (0.32%), and primary axillary hyperhidrosis 4/871 (0.46%). Across all indications, 11/2,240 subjects (0.49%) converted from antibody negative at baseline to positive at one or more post-treatment time points, but only three subjects became clinically unresponsive to onabotulinumtoxinA at some point following a positive assay. Based on these large trials, the frequency of antibody conversion after onabotulinumtoxinA treatment is very low, and infrequently leads to loss of efficacy. © 2010 Movement Disorder Society.

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Objective.-This exploratory trial evaluated the safety and efficacy of multiple treatments of botulinum toxin type A (BoNTA; BOTOX , Allergan, Inc., Irvine, CA, USA) as prophylactic treatment of episodic migraine headaches.Design and Methods.-This was an 11-month randomized, double-blind, placebo-controlled, exploratory study. Patients were screened during a 30-day baseline period, and eligible patients with 4 or more migraine episodes and ≤15 headache days entered a single-blind 30-day placebo run-in period. Patients were classified as placebo nonresponders (PNR) if they had at least 4 moderate-to-severe migraine episodes and did not experience at least a 50% decrease from baseline in the frequency of migraine episodes following their placebo treatment. All other subjects were classified as placebo responders (PR). Patients were randomized within each stratum (PNR, PR) to 3 treatments with BoNTA (110 to 260 U of BoNTA per treatment cycle) or placebo at 90-day intervals using a modified follow-the-pain treatment paradigm. The primary efficacy outcome measure was the mean change from baseline in the frequency of migraine episodes for the 30 days prior to day 180 in the PNR group. Secondary efficacy measures included the proportion of patients with a decrease from baseline of 50% or more migraine episodes per 30-day period. Patients were allowed to take concomitant acute and prophylactic headache medications. Adverse events were reported.Results.-A total of 809 patients were screened and 369 patients (89.2% female; mean age, 45 years; range, 20 to 65 years) entered the placebo run-in period and were subsequently randomized to BoNTA or placebo. The mean total dose of BoNTA was 190.5 units (U) (range, 110 U to 260 U). The predetermined primary efficacy endpoint was not met. Substantial mean improvements of 2.4 and 2.2 fewer migraine episodes per month at day 180 in the PNR stratum treated with BoNTA and placebo, respectively, were observed (P > .999). From day 180 through the end of the study (day 270) at least 50% of all patients in each treatment group had a decrease from baseline of 50% or more migraine episodes per 30-day period. However, in the group of patients with ≥12 headache days at baseline (and ≤15 headache days), BoNTA patients experienced a mean change from baseline of −4.0 headache episodes at day 180 compared with −1.9 headache episodes in the placebo group (P= .048). The majority of treatment-related adverse events were transient and mild to moderate in severity. Only 7 patients (1.9%) discontinued the study due to adverse events (6 BoNTA, 1 placebo).

In patients with upper limb poststroke spasticity, increasing disability in the hygiene, dressing, and pain domains of the Disability Assessment Scale were associated with diminishing HRQoL. Furthermore, these patients required caregiver assistance proportionally related to the severity of their disability in the hygiene and dressing domains.

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