WAVE-bd - a large observational ambispective study: comparative
results between the Romanian cohort and the total study population
Mirela Manea1, Ioana Micluția2, Cristi Ștefănescu3, Radu Teodorescu4, Eduard Vieta5
Bipolar disorder (BD) is a lifelong mood disorder characterized by the occurrence of manic, hypomanic and depressive episodes;
slow or incomplete recovery from acute episodes; risk of recurrence; and sustained morbidity over time. 1, 2
This multinational ambispective study of the clinical management and burden of BD (WAVE-bd study; NCT01062607) aimed to
address the limitations of longitudinal BD studies to date and to provide real-world data on BD management.
This analysis compares the characteristics of BD and its treatment patterns in a Romanian cohort with the total patient population of
this large observational study
Conclusions
Results show a higher mean age of diagnosis, a higher number of comorbidities and a more frequent occurrence of mixed relapses
and recurrences in Romanian patients vs. the total study population. From a disease perspective, the fact that the Romanian patients
tend to be diagnosed with BD later might be explained by a variety of factors, either patient- or physician-related: patients lack
knowledge about disease and treatment opportunities4 or are not seeking medical attention or the first psychiatric diagnosis might be
different from BD.
In Romania, anticonvulsants and antipsychotics had the highest rates of use, with small differences in ranking depending on the
polarity of the episodes.
Introduction
Bipolar disorder (BD) is a lifelong mood disorder characterized
by the occurrence of manic, hypomanic and depressive episodes;
slow or incomplete recovery from acute episodes; risk of
recurrence; and sustained morbidity over time.1, 2
Treatment guidelines are generally in agreement with regard to
the clinical management and pharmacological therapy of BD.
The most reliable sources of evidence for guidelines
recommendations are the results of published randomized
clinical trials and meta-analyses. When viewed in the context of
the entire disease population and real-world practice, the design
and structure of RCTs have limitations, as typically, severely ill
patients with multiple comorbidities and complex treatments are
excluded. 3
This multinational ambispective study of the clinical
management and burden of BD (WAVE-bd study;
NCT01062607) aimed to address the limitations of longitudinal
BD studies to date and to provide real-world data on BD
management.
This analysis compares the characteristics of BD and its
treatment patterns in a Romanian cohort with the total patient
population of this large observational study.
Relapse and recurrence have been specifically defined:
Relapse was defined as a mood episode of any polarity within
8 weeks of the end of previous mood episode during the study
period.
Recurrence was defined as a mood episode of any polarity
after 8 weeks from the end of the previous mood episode
during the study period.
Results
Of the 2896 patients included in the final analysis, 183 (6.3%)
were recruited from Romania. Patientsʼ’ demographics were
broadly similar between countries and between BD-I and BD-II.
This could be a place for your table.
Primary study objective
To describe clinical management and clinical outcomes related
to BD in real-life settings in multiple countries and to evaluate
the variability between countries.
Methods
WAVE-bd (Multinational ambispective study of the clinical
management and burden of Bipolar Disorder) was a
multicenter, non-interventional, longitudinal study of patients
diagnosed with type I or II bipolar disorder who had
experienced at least one mood episode in the preceding 12
months.
Retrospective data collection was carried out from study index
event to enrollment, followed by a minimum of 9 prospective
follow-up months (Fig. 1) in 8 European and 2 South American
countries: Austria, Belgium, Brazil, France, Germany, Portugal,
Romania, Turkey, Ukraine and Venezuela.3
The study included descriptive analyses of demographics,
diagnosis, medical history and clinical management.
Treatment records documented any type of pharmacological or
non-pharmacological treatment prescribed for any phase of the
disease, including euthymia.
Figure 1. Study design
The most frequent reported polarity of the index episode was
depressive for both Romanian and total population. Romanian
cohort presented with the highest proportion of mixed episodes
(22.4% as compared with 6.6% in the total study population).
Relapses were reported by 18.2% (n=526) of patients from the
total study population, with 19.1 % (n=35) Romanian patients
reporting relapses during the study. The most frequent relapse
was depressive for both total study population and Romania.
Recurrences were reported by 45.0% of patients during the
study (n=1173), with half of the Romanian cohort reporting
recurrences (50.8%; n=93). Of note, depressive recurrence was
the most common type reported, while for Romania, the most
common type recurrence was mixed recurrence.
In Romania, anticonvulsants and antipsychotics had the highest
rates of use, with small differences in ranking depending on the
polarity of the episodes.
1. Kupfer DJ (Ed.) Epidemiology and clinical course of bipolar disorder. In: Bipolar Depression: The Clinicianʼ’s Reference Guide (BD-CRG). Kupfer
DJ (Ed.), Montvale, NJ: Current Psychiatry, LLC, 2004; 2.Pini S, et al. Eur Neuropsychopharmacol. 2005, 15(4):425–434;3.Vieta E, et al. Int J
Neuropsychopharmacol, 2013, 16(8):1719-32;4.Florescu S et al, Management in health, 2009, 13(3):22 – 30.
. Copyright © 2013 1”Carol Davila” University of Medicine and Pharmacy, Dental Medicine Faculty, Department of Psychiatry, Bucharest, Romania;2 “Iuliu Hațieganu” University of Medicine and
Pharmacy, Department of Psychiatry, Cluj-Napoca, Romania;“Grigore T. Popa” University of Medicine and Pharmacy, Department of Psychiatry, Iași, Romania;4 “Prof. Dr. Al. Obregia” Clinical Hospital
of Psychiatry, “Trepte” Center, Bucharest, Romania; Bipolar Disorders Program, Hospital Clínic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain
P.2.d.003
WAVE-bd - a large observational ambispective study: comparative results between the Romanian cohort and the
total study population
M. Manea 1, I. Miclutia 2, C. Stefanescu 3, R. Teodorescu 4
1aCarol Davilaa University of Medicine and Pharmacy, Dental Medicine Faculty Department of Psychiatry, Bucharest, Romania
2aIuliu Hatieganua University of Medicine and Pharmacy, Department of Psychiatry, Cluj Napoca, Romania
3aGrigore
T. Popaa University of Medicine and Pharmacy, Department of Psychiatry, Iasi, Romania
4aProf. Dr. Al. Obregiaa Clinical Hospital of Psychiatry, aTreptea Center, Bucharest, Romania
Purpose of the study: Bipolar disorder (BD) is a lifelong disease characterized by the presence of one or more
recurrent depressive, manic, and hypomanic episodes. This analysis compares the characteristics of BD and its
treatment patterns in a Romanian cohort with total patient population within a large observational study.
Methods: WAVE-bd (Multinational ambispective study of the clinical management and burden of Bipolar Disorder,
NCT01062607) was a multicenter, non-interventional, longitudinal study of patients diagnosed with type I or II
BD who had experienced at least one mood episode in the preceding 12 months. Retrospective data collection
was carried out from study index event to enrollment, followed by a minimum of 9 months' prospective follow-up
in 8 European and 2 South America countries [1].
Results: 2896 patients were included in the final analysis, 183 (6.3a) being recruited from Romania. More than
half of the patients were women in both Romanian cohort (58.4a) and in total population (62.0a). Mean age of
patients was higher in Romania – 49.0 years as compared to 46.6 years in the total population. Almost half of
all patients (49.0a) had co-morbidities or relevant history of a medical condition requiring chronic drug therapy.
This percentage tended to be similar for most countries, but it was the highest for patients in Romania (66.7a).
Mean (±SD) age for the onset of the first symptom compatible with BD was the highest in Romania: 38.7
(±12.88) years, as compared to 31.1 (±12.42) years in the total population. The difference is also reflected in
the mean (±SD) age of the patient diagnosed as bipolar, being as well highest for Romania: 40.6 (±13.17)
years vs. 34.9 (±12.81) years for the total group.
The most frequent reported polarity of the index episode was depressive for both Romanian and total population
in different percentages (38.2a vs. 53.4a), followed by mania (26.2a vs 21.9a), mixed (22.4a vs 6.6a) and
hypomania (13.1a vs 16.4a). Relapse (episode within 8 weeks of previous episode) rates were similar: 19.1a
for Romania vs. 18.2a for total population. Recurrence (episode occurring ≥8 weeks after previous episode)
recorded a rate of 50.8a for Romania and 40.5a in total population. Depressive relapse and recurrence were
the most common type of reported relapse and recurrence in all countries except for Romania, where the most
common were mixed relapses (13.1a) and mixed recurrences (25.7a).
Atypical antipsychotics were the most common specific treatment in patients with manic, hypomanic, depressive,
or mixed episodes. Treatments were generally similar between countries, although it is noteworthy that the
number of patients during manic episodes who were being treated with lithium tended to be exceptionally low in
Romania (3.4a due to poor drug availability).
Conclusions: These results show a higher mean age of diagnosis, a higher number of comorbidities and a more
frequent occurrence of mixed relapses and recurrences in Romanian patients vs. the entire study population.
Prompt, early detection of the first mood episode, an adequate and coherent treatment but also long term
management should be goals in influencing better outcomes.
1. Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, Moreno-Manzanaro M,
Gonzalez MA, Bellivier F. 2013 Clinical management and burden of bipolar disorder: results from a multinational
longitudinal study (WAVE-bd). Int J Neuropsychopharmacol16(8):1719–32.
Disclosure statement: Research funded by AstraZeneca.
Citation: Eur Neuropsychopharmacol. 2014;24aSuppl 2):S414
Keywords
Bipolar disorders
Neuroleptics & antipsychotics: clinical
Lithium and other mood stabilisers