ボルタレン錠の市販後症例調査成績 （第２報） ３５，６５３例の集計・解析

Abstract

(1) As a part of the PMS for a marketed drug, data on 35, 653 cases treated with Voltaren® tablets were collected from 3, 965 medical institutions nation-wide during the 6 years after its market introduction in 1974, and it's efficacy, safety and prescribed indications in daily practice were reassessed.(2) The most frequent indication for the use of Voltaren® tablets was in the treatment of diseases of the musculo-skeletal system such as rheumatoid arthritis which comprised about half of all cases. Its use in such disase was prescribed widely by the clinical departments of each medical facility studied and its therapeutic utilization was within the approved indications in 75% of all cases. There was a slightly larger number of females than males and adults aged from 16 to 64 years comprised 83% of all patients which included 15% of elderly patients aged more than 65, and about 82% of these cases received a daily dosage of 75 mg (3 tablets) .The duration of treatment was one month or less in 82% of all cases that was one week or less for many acute diseases and more than one year for some chronic ailments. With regard to the severity of disease, 83% of the cases were classified as mild or moderate in severity before treatment.(3) Voltaren®'s clinical efficacy rate (marked improvement or better) was shown to be 62 to 76% in diseases of the musculo-skeletal system with the exception of rheumatoid arthritis in which the clinical efficacy rate was 46%. In post-operative pain and inflammation Voltaren®'s clinical efficacy rate was 82 to 88% and 78 to 92% in diseases such as pelvic inflammation, dysmenorrhea, obstetric after-pains, cystitis, inflammation in the anterior chamber of the eyes, pharyngolaryngitis and the common cold syndrome. Voltaren® achieved a higher efficacy rate in patients whose diseases had only been present for a short time. Good symptomatic improvement rates were obtained in cases of both pain and inflammation.(4) The incidence of adverse reactions was 7.71%, those of the digestive system being predominant at 86% of the total, followed by such adverse reactions as edema, skin eruptions and nervous/psychiatric symptoms. Most adverse reactions occured within one week of the commencement of treatment and the majority were classified as mild or moderate in degree. As consequence of adverse reactions, Voltaren® therapy was discontinued in 44% (1, 207/2, 749) of the total number of adverse reactions and this was consisted of 3.4% of all cases (35, 653 cases) . Several cases were classified as severe or relevant such as gastric ulceration or gastrointestinal bleeding (5), jaundice (2), anuria (3), etc. According to an analysis of background factors the incidence of adverse reactions was significantly higher in the case of females, elderly patients, concomitant therapy with other non-steroidal antiinflammtory drugs, with steroids, and in those patients with chronic diseases.