TABLE 5.
Studies that mentioned side effects
| References | Side effects |
|---|---|
| Ahearn EP et al., 201311 | NR |
| The BALANCE investigators and collaborators, 201013 | Most participants who responded to (lithium [95%, N = 52], valproate [92%, N = 48], combination [100%, N = 57]) reported at least one non‐serious adverse event during follow‐up. |
| Bowden CL et al., 201219 | NR |
| Carlson BX et al., 201221 | The three most common adverse events were akathisia [10.8%, 6.1% for ARI + LTG and PCB + LTG, respectively; number needed‐ to‐harm (NNH) = 22], insomnia (7.4%, 11.5%), and anxiety (7.4%, 3.6%). Mean weight change was 0.43 kg and 1.81 kg, respectively (last observation carried forward, p = 0.001). Rates of ≥7% weight gain with ARI + LTG and PCB + LTG were 11.9% and 3.5%, respectively (NNH = 12). |
| Geddes JR et al., 201622 | No side effects related to CT group are mentioned. |
| Kemp DE et al., 200914 | 10% (N = 15) discontinued during the open‐label phase because of AE; weight gain (33%), gastrointestinal discomfort (27%), tremors (20%), dizziness (7%), cognitive difficulties (7%), and polyuria/polydipsia (7%) the most common AE; tremors and polyuria/polydipsia, in both treatment groups. A significant increase in alanine transaminase levels occurred in the Li+ and VPA CT group (+19.60 U/L) compared to the LI + monotherapy group (−30.83 U/L; p = 0.029). |
| Maina G et al., 200818 | Over 20% of subjects receiving LTG (N = 5) experienced an increase in tension and inner unrest; of them, one also experienced an increase in anxiety symptoms and another reported a reduced duration of sleep; 2 of the 3 subjects with an increase in anxiety symptoms also reported a reduced duration of sleep, while 2 of the 4 patients with reduced duration of sleep also reported an increase in anxiety symptoms; 34.8% of patients (N = 8) had at least one of the above‐mentioned AEs in the LTG group. |
| Missio G et al., 201915 | Side effects differed significantly between groups only in the first week of treatment (p = 0.021), and there were more side effects in the Li/VPA group. Also, the Li/VPA group gained weight (+2.1 kg), whereas the Li/CBZ group presented slight weight loss (−0.2 kg). |
| Solomon DA et al., 199716 | No side effects related to CT group are mentioned. |
| Szegedi A et al., 201220 | 5% or more of asenapine patients (sedation, somnolence, depression/depressive symptoms, oral hypoesthesia, and increased weight) in the 12‐week core study. Adjunctive asenapine to lithium or valproate was well tolerated for up to 52 weeks. |
| Van der Loos MLM et al., 201117 | No difference between LTG and PCB in the prevalence of any AE. The total amount of AEs in both groups was remarkably low for a 68‐week follow‐up. |
| Wingard L et al., 201912 | NR |
AE, Adverse Event; ARI, Aripiprazole; CBZ, Carbamazepine; CT, Combination Therapy; Li+, Lithium carbonate; LTG, Lamotrigine; NNH, Number needed‐to‐harm; NR, not reported; PCB, Placebo; SAE, Serious Adverse Event; VPA, Valproate.