Abstract
Objectives:
To compare the prevalence rates of clinical conditions related to subependymal giant cell astrocytomas (SEGAs) before and after SEGA surgery among patients with tuberous sclerosis complex (TSC).
Methods:
Based on three US national claims databases, we analyzed and compared the prevalence rates of 21 SEGA-related conditions (including seizures, hydrocephalus, headaches and stroke or hemiparesis) in the six months preceding surgery with the rates in the second through sixth post-surgery months and in the seventh through twelfth post-surgery months among TSC patients who underwent SEGA surgery during 2000–2009. Repeated measures analysis with a bootstrapping method was used to assess the surgery impact.
Results:
Patients (N = 47) had a mean age of 11.5 years at their first SEGA surgery, and 66% were male. Compared with the six months preceding surgery, the post-surgery prevalence rates increased by 23–26% for seizures, 21–26% for hydrocephalus, 17–19% for headache and 6–9% for stroke or hemiparesis (all p < 0.05). Repeated measures analysis confirmed the impact of surgery on the prevalence rate of these five conditions (all p < 0.05).
Conclusions:
SEGA surgery has its important role in SEGA treatment. However, after SEGA surgery this group of TSC patients had increased prevalence rates of seizures, hydrocephalus, vision disorders, headaches, stroke or hemiparesis, and autism. Future research to examine the causes of these symptoms is imperative.
Limitations:
The study results have limitations in data source representativeness, coding accuracy, and study design.
Transparency
Declaration of funding
The funding of this project was provided by Novartis Pharmaceutical Corporation.
Declaration of financial/other relationships
P.S. has disclosed that he is employed by Kailo Research Group, a company that received unrestricted research grants from Novartis. J.L., A.G. and J.R. have disclosed that they are employed by Novartis, and own company stocks. D.K. and M.K. have disclosed that they are consultants to Novartis.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.