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A randomized, double-blind, placebo-controlled trial was conducted to determine the efficacy and safety of Epidiolex in treating drug-resistant seizures in the Dravet syndromeReference 576. After a 4-week baseline period, a total of 120 affected children and young adults (2.3 to 18.4 years old) were randomized (1:1) to receive either 20 mg/kg/day CBD oral solution or placebo, in addition to standard antiepileptic treatment, for 14 weeks (2 weeks of dose escalation and 12 weeks of dose maintenance). At the end of the treatment period there was a 10-day taper period (10% in dose reduction per day) followed by a 4-week follow-up period. The most common type of convulsive seizure was generalized tonic-clonic (78%) followed by secondarily generalized tonic-clonic seizures (21%). Nonconvulsive seizures were reported by 61% of the patients in the CBD group and 69% in the placebo group. Treatment with CBD decreased the median frequency of convulsive seizures per month (primary endpoint) from 12.4 (range: 3.9 to 1,717) to 5.9 (range: 0.0 to 2,159), while placebo had no effects (from 14.9 to 14.1). The adjusted median difference between the CBD and placebo groups in change in seizure frequency was -22.8 percentage points (95% CI = -41.1 to -5.4; p = 0.01). The effects of CBD on convulsive seizures were seen in the first month of the maintenance period. In the CBD group, 43% of the patients had at least a 50% reduction in the frequency of convulsive seizures compared to 27% in the placebo group (OR, 2.00; 95% CI = 0.93 to 4.30; p = 0.08). During the treatment period, 3 patients (5%) in the CBD group and no patients in the placebo group became seizure-free (p = 0.08). CBD decreased from 24.0 to 13.7 the median frequency of seizures per month (adjusted reduction 28.6%), while placebo decreased it from 41.5 to 31.1 (adjusted reduction 9.0%), for a significant adjusted median difference between groups of -19.2 percentage points (p = 0.03). There was no significant difference between groups for reduction in nonconvulsive seizures (p = 0.88). Common adverse events (>10% frequency) in the CBD group were somnolence (36%), diarrhea (31%), decreased appetite (28%), fatigue (20%), vomiting (15%), pyrexia (15%), lethargy (13%), upper respiratory tract infection (11%), and convulsion (11%). Most of them were mild or moderate in severity (84% in the CBD group) and considered related to the trial agent (75%). In the CBD group, 8 patients withdrew from the trial because of adverse events, compared with 1 in the placebo group. A total of 12 patients in the CBD group and 1 in the placebo group had elevated aminotransferase levels; they were all also taking valproate. Of the 9 patients who continued taking CBD (3 patients withdrew from the trial), enzyme levels returned to normal during the trial, suggesting transient metabolic stress on the liver. Differences in unpalability between the active treatment and placebo could have affected blinding in a small number of patients. The length of the trial did not allow for the assessment of the potential development of tolerance so additional data are needed to determine the long-term efficacy and safety of CBD for the Dravet syndromeReference 576.
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An eco-evolutionary feedback loop is defined as the reciprocal impacts of ecology on evolutionary dynamics and evolution on ecological dynamics on contemporary timescales. We experimentally tested for an eco-evolutionary feedback loop in the green peach aphid, Myzus persicae, by manipulating initial densities and evolution. We found strong evidence that initial aphid density alters the rate and direction of evolution, as measured by changes in genotype frequencies through time. We also found that evolution of aphids within only 16 days, or approximately three generations, alters the rate of population growth and predicts density compared to nonevolving controls. The impact of evolution on population dynamics also depended on density. In one evolution treatment, evolution accelerated population growth by up to 10.3% at high initial density or reduced it by up to 6.4% at low initial density. The impact of evolution on population growth was as strong as or stronger than that caused by a threefold change in intraspecific density. We found that, taken together, ecological condition, here intraspecific density, alters evolutionary dynamics, which in turn alter concurrent population growth rate (ecological dynamics) in an eco-evolutionary feedback loop. Our results suggest that ignoring evolution in studies predicting population dynamics might lead us to over- or underestimate population density and that we cannot predict the evolutionary outcome within aphid populations without considering population size.
The fitness of an existing phenotype and of a potential mutant should generally depend on the frequencies of other existing phenotypes. Adaptive evolution driven by such frequency-dependent fitness functions can be analyzed effectively using adaptive dynamics theory, assuming rare mutation and asexual reproduction. When possible mutations are restricted to certain directions due to developmental, physiological, or physical constraints, the resulting adaptive evolution may be restricted to subspaces (constraint surfaces) with fewer dimensionalities than the original trait spaces. To analyze such dynamics along constraint surfaces efficiently, we develop a Lagrange multiplier method in the framework of adaptive dynamics theory. On constraint surfaces of arbitrary dimensionalities described with equality constraints, our method efficiently finds local evolutionarily stable strategies, convergence stable points, and evolutionary branching points. We also derive the conditions for the existence of evolutionary branching points on constraint surfaces when the shapes of the surfaces can be chosen freely. Copyright 2016 Elsevier Ltd. All rights reserved.