Monday, April 3, 2017

Pregabalin for headache prevention

Bakhshandeh Bali M, Rahbarimanesh AA, Sadeghi M, Sedighi M, Karimzadeh P, Ghofrani M. Comparison of propranolol and pregabalin for prophylaxis of childhood migraine: a randomised controlled trial. Acta Med Iran. 2015;53(5):276-80.

Migraine involves 5-10% of children and adolescents. Thirty percent of children with severe migraine attacks have school absence and reduced quality of life that need preventive therapy. The purpose of this randomised control trial study is to compare the effectiveness, safety and the tolerability of pregabalin toward Propranolol in migraine prophylaxis of children. From May 2011 to October 2012, 99 children 3-15 years referred to the neurology clinic of Mofid Children's Hospital with a diagnosis of migraine enrolled the study. Patients randomly divided into two groups (A&B). We treated children of group A with capsule of pregabalin as children of group B with tablet of propranolol for at least 8 weeks. In this study, 99 patients were examined that 91 children reached the last stage. The group A consistsed of 46 patients, 12(26.1%) girls, 34 (73.9%) boys and the group B consisted of 45 patients, 14(31.1%) girls, 31 (68.9%) boys. Basis of age, gender, headache onset, headache frequency, migraine type, triggering and relieving factors there was no significant difference among these groups (P>0.05). After 4 and 8 weeks of Pregabalin usage monthly headache frequency decreased to 2.2±4.5 and 1.76±6.2 respectively. Propranolol reduced monthly headache frequency up to 3.73±6.11 and 3.34±5.95 later 4 and 8 weeks respectively. There was a significant difference between these two groups according to headache frequency reduction (P=0.04). Pregabalin efficacy in reducing the frequency and duration of pediatric migraine headache is considerable in comparison with propranolol.

Linde M, Mulleners WM, Chronicle EP, McCrory DC. Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013 Jun 24;(6)

Some antiepileptic drugs but not others are useful in clinical practice for the prophylaxis of migraine. This might be explained by the variety of actions of these drugs in the central nervous system. The present review is part of an update of a Cochrane review first published in 2004, and previously updated (conclusions not changed) in 2007.
To describe and assess the evidence from controlled trials on the efficacy and tolerability of gabapentin/gabapentin enacarbil or pregabalin for preventing migraine attacks in adult patients with episodic migraine.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2012, Issue 12), PubMed/MEDLINE (1966 to 15 January 2013), MEDLINE In-Process (current week, 15 January 2013), and EMBASE (1974 to 15 January 2013) and handsearched Headache and Cephalalgia through January 2013.
Studies were required to be prospective, controlled trials of gabapentin/gabapentin enacarbil or pregabalin taken regularly to prevent the occurrence of migraine attacks, to improve migraine-related quality of life, or both.
Two review authors independently selected studies and extracted data. For headache frequency data, we calculated mean differences (MDs) between gabapentin and comparator (placebo, active control, or gabapentin in a different dose) for individual studies and pooled these across studies. For dichotomous data on responders (patients with ≥ 50% reduction in headache frequency), we calculated odds ratios (ORs) and numbers needed to treat (NNTs). We also summarised data on adverse events from all single dosage studies and calculated risk differences (RDs) and numbers needed to harm (NNHs).
Five trials on gabapentin and one trial on its prodrug gabapentin enacarbil met the inclusion criteria; no reports on pregabalin were identified. In total, data from 1009 patients were considered. One trial each of gabapentin 900 mg (53 patients), and gabapentin titrated to 1200 mg (63 patients) and 1800 mg (122 patients) failed to show a statistically significant reduction in headache frequency in the active treatment group as compared to the placebo group, whereas one trial of gabapentin titrated to 1800 to 2400 mg (113 patients) demonstrated a small but statistically significant superiority of active treatment for this outcome (MD -0.80; 95% confidence interval (CI) -1.55 to -0.05). The pooled results of these four studies (MD -0.44; 95% CI -1.43 to 0.56; 351 patients) do not demonstrate a significant difference between gabapentin and placebo. One trial of gabapentin titrated to 1800 mg (122 patients) failed to demonstrate a significant difference between active treatment and placebo in the proportion of responders (OR 0.97; 95% CI 0.45 to 2.11), whereas one trial of gabapentin titrated to 1800 to 2400 mg (113 patients) demonstrated a small but statistically significant superiority of active treatment for this outcome (OR 2.79; 95% CI 1.09 to 7.17). The pooled results of these two studies (OR 1.59; 95% CI 0.57 to 4.46; 235 patients) do not demonstrate a significant difference between gabapentin and placebo. Comparisons from one study (135 patients) suggest that gabapentin 2000 mg is no more effective than gabapentin 1200 mg. One trial of gabapentin enacarbil (523 participants) failed to demonstrate a significant difference versus placebo or between doses for gabapentin enacarbil titrated to between 1200 mg and 3000 mg with regard to proportion of responders; there was also no evidence of a dose-response trend. Adverse events, most notably dizziness and somnolence, were common with gabapentin.
The pooled evidence derived from trials of gabapentin suggests that it is not efficacious for the prophylaxis of episodic migraine in adults. Since adverse events were common among the gabapentin-treated patients, it is advocated that gabapentin should not be used in routine clinical practice. Gabapentin enacarbil is not efficacious for the prophylaxis of episodic migraine in adults. There is no published evidence from controlled trials of pregabalin for the prophylaxis of episodic migraine in adults.

Calandre EP, Garcia-Leiva JM, Rico-Villademoros F, Vilchez JS, Rodriguez-Lopez CM. Pregabalin in the treatment of chronic migraine: an open-label study. Clin Neuropharmacol. 2010 Jan-Feb;33(1):35-9.

Studies concerning the prophylactic treatment of chronic migraine are scarce, with topiramate being the most thoroughly studied drug at this respect. The aim of our study was to assess if pregabalin could be useful in the preventive management of chronic migraine.
Thirty consecutive chronic migraine patients, 24 women and 6 men, aged 24 to 75 years and not receiving any other prophylactic medication, were treated with pregabalin for 12 weeks. The initial daily dosage was 75 mg, subsequently adjusted according to the drug's efficacy and the individual patients' tolerability at 2-week intervals. Patients kept a headache diary from 4 weeks before drug administration until the study ended, and headache impact test (HIT-6) was administered at baseline and at 4-week intervals. The main outcome variable was the change from baseline to end point in headache frequency. The secondary outcome variables included changes in headache severity, rescue medication intake, HIT-6 scores, and adverse reactions to pregabalin.
Pregabalin treatment was associated to significant decreases in headache frequency (P < 0.0001) and severity (P = 0.0005), rescue medication intake (P < 0.0001), and HIT-6 scores (P < 0.0001). Patients with daily headache performed worse than those with nondaily headache, showing no change in headache frequency and less relevant reduction of HIT-6 scores. The most frequent adverse reactions were dizziness (40%), somnolence (29%), abnormal thinking (16.7%), constipation and fatigue (13.3%).
Despite the limitations of an open-label design, our data suggest that pregabalin may be a useful alternative prophylaxis for chronic migraine. These promising results should be confirmed in randomized clinical trials.

Rizzato B, Leone G, Misaggi G, Zivi I, Diomedi M. Efficacy and tolerability of pregabalin versus topiramate in the prophylaxis of chronic daily headache with analgesic overuse: an open-label prospective study. Clin Neuropharmacol. 2011 Mar-Apr;34(2):74-8.

Medication-overuse headache is one of the most disabling headaches. Antiepileptic drugs have been considered a promising strategy as prophylactic treatment in these patients, even if their use often has been limited by low tolerability or safety. The objective of this study was to evaluate the efficacy and safety of pregabalin compared with topiramate for the prophylaxis of chronic daily headache with medication overuse using an open-label prospective study.
After a 2-month baseline period (T0), 100 consecutive patients with medication overuse headache were assigned to receive 150 mg/d pregabalin or 100 mg/d topiramate. After a titration period of 4 weeks, a follow-up visit was scheduled every 2 months (T1 and T2) to evaluate headache frequency, the amount of rescue medication intake, and disability.
Of the 46 pregabalin-treated patients, the mean monthly headache frequency significantly decreased from 21.8 ± 4.8 (T0) to 5.1 ± 3.8 (T2), and the monthly number of days with medication intake decreased from 15.1 ± 4.8 (T0) to 2.9 ± 1.9 (T2). Similarly, of the 42 topiramate-treated patients, the mean monthly headache frequency decreased from 21.8 ± 4.9 (T0) to 5.3 ± 3.5 (T2), and the mean monthly number of days with medication intake decreased from 15.1 ± 3.7 (T0) to 2.6 ± 1.5 (T2). A significant improvement of disability score was reported in both groups.

Similar to topiramate, pregabalin seems to be an effective and well-tolerated preventive therapy in chronic headache and a new option in the management of withdrawal from abused drugs in patients with analgesic overuse, a difficult-to-treat population.


1 comment:

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