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AIM: To compare the total medical costs and treatment outcomes in patients with primary hepatocellular carcinoma (HCC) according to their initial treatment, that is, hepatectomy or radiofrequency ablation (RFA), in real-world clinical practice in Japan. METHODS: This retrospective observational study was conducted using a medical claims database. Patients who underwent hepatectomy or RFA for primary HCC were matched using propensity score matching methods for available baseline characteristics. The average per-patient total medical costs from the date of initial treatment to up to 3 years were estimated. The 3-year survival and recurrence rates were estimated using the Kaplan-Meier method. RESULTS: Data of 1726 patients (863 in each group) were analyzed. The average 3-year medical costs were USD 8000 lower in the RFA group than in the hepatectomy group (USD 35,000 vs. USD 43,000). Patients in the RFA group had comparable 3-year overall survival to those in the hepatectomy group (87.6% vs. 90.4%). However, the 3-year recurrence rate was significantly higher in the RFA group than in the hepatectomy group (41.5% vs. 30.8%; hazard ratio = 1.56, 95% confidence interval: 1.31-1.87). CONCLUSIONS: In this 3-year study, patients achieved similar survival rates irrespective of initial treatment, but the RFA group had a lower total medical cost burden than the hepatectomy group. If both treatments are equally feasible, RFA may be a preferable initial curative treatment for primary HCC. However, careful consideration and adequate treatment should be given due to its higher recurrence risk.
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AIM: To examine the treatment patterns and medical costs in real-world practice among patients who received hepatectomy for hepatocellular carcinoma (HCC) in Japan. METHODS: Data of patients who underwent hepatectomy as an initial therapy for primary HCC were extracted from a Japanese medical claims database from April 2008 to December 2019. The types of additional treatments for recurrent HCC and medical costs for up to 3 years from the first hepatectomy were analyzed. The average cumulative cost per patient starting on the date of the first hepatectomy was calculated using the Kaplan-Meier sample-average method. RESULTS: Data from 2 342 patients (median age, 71 years) were analyzed. Overall, 35.6% of patients received at least one HCC treatment within 3 years of the first hepatectomy. The total average cumulative 3-years medical cost was JPY 4 993 300 (95% confidence interval [CI]: 4 804 100 to 5 220 500). Surgical procedures were the most costly components in the first month after hepatectomy, whereas the costs of drugs, which mainly included antiviral and antineoplastic medications, increased thereafter. Patients with advanced stage HCC, hepatitis C, or a higher Charlson Comorbidity Index at hepatectomy, or those who required additional treatment, especially with antineoplastic drugs for recurrent HCC, incurred higher medical costs. CONCLUSIONS: Patients with HCC after hepatectomy experienced a large economic burden, which was more serious for those with advanced stage HCC, higher comorbidities, and hepatitis at baseline and for patients treated with antineoplastic drugs. A treatment selection that considers its medical cost burden would help to reduce some of these economic burdens.
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OBJECTIVE: To examine the efficacy and safety of perampanel (PER) in patients with post-stroke epilepsy (PSE), brain tumor-related epilepsy (BTRE), and post-traumatic epilepsy (PTE) using Japanese real-world data. METHODS: The prospective post-marketing observational study included patients with focal seizures with or without focal to bilateral tonic-clonic seizures who received PER combination therapy. The observation period was 24 or 52 weeks after the initial PER administration. The safety and efficacy analysis included 3716 and 3272 patients, respectively. This post hoc analysis examined responder rate (50% reduction in seizure frequency), seizure-free rate (proportion of patients who achieved seizure-free), and safety in patients included in the post-marketing study who had PSE, BTRE, and PTE in the 4 weeks prior to the last observation. RESULTS: Overall, 402, 272, and 186 patients were included in the PSE, BTRE, and PTE subpopulations, and 2867 controls in the "Other" population (etiologies other than PSE, BTRE, or PTE). Mean modal dose (the most frequently administered dose) values at 52 weeks were 3.38, 3.36, 3.64, and 4.04 mg/day for PSE, BTRE, PTE, and "Other," respectively; PER retention rates were 56.2%, 54.0%, 52.6%, and 59.7%, respectively. Responder rates (% [95% confidence interval]) were 82% (76.3%-86.5%), 78% (70.8%-83.7%), 67% (56.8%-75.6%), and 50% (47.9%-52.7%) for PSE, BTRE, PTE, and "Other," respectively, and seizure-free rates were 71% (64.5%-76.5%), 62% (54.1%-69.0%), 50% (40.6%-60.4%), and 28% (25.8%-30.1%), respectively. Adverse drug reactions tended to occur less frequently in the PSE (14.7%), BTRE (16.5%), and PTE (16.7%) subpopulations than in the "Other" population (26.3%). SIGNIFICANCE: In real-world clinical conditions, efficacy and tolerability for PER combination therapy were observed at low PER doses for the PSE, BTRE, and PTE subpopulations. PLAIN LANGUAGE SUMMARY: To find out how well the medication perampanel works and whether it is safe for people who have epilepsy after having had a stroke, brain tumor, or head injury, we used information from real-life medical situations in Japan. We looked at the data of about 3700 Japanese patients with epilepsy who were treated with perampanel. We found that perampanel was used at lower doses and better at controlling seizures, and had fewer side effects for patients with epilepsy caused by these etiologies than the control group.