Pravastatin治療3年間を目標とした長期使用成績調査の結果について

抄録

The present investigation was undertaken to evaluate the long-term safety and efficacy of Pravastatin (trade name Mevalotin; Sankyo), one of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors currently marketed. The investigation was carried out under conditions of general clinical practice at 15 metropolitan private clinics in Tokyo. The subjects of this investigation were 306 hyperlipidemic patients who received Pravastatin during the period of July 1, 1990 through November 30, 1991. Among these, 28 cases were excluded from long-term treatment, at a point 3 months after commencement of medication.
Safety evaluation was performed on all 306 medicated subjects, although the evaluation of efficacy was restricted to 278 cases who continued medication for more than three months. 190 cases (68.3%) continued to receive the Pravastatin administration over 3 years during the specified term. In 88 cases, medication was terminated after more than three months but less than three years. The reasons for termination or drop-out are as follows; attendance was abandoned due to personal reasons (64 cases, 74.7%), drug change (6 cases, 6.8%), changed diet therapy alone (3 cases, 3.4%), and other miscellaneous causes (15 cases, 17%). From the safety aspect, adverse drug events were observed in 6 cases (2.0%) and abnormal laboratory tests were detected in 11 cases (3.6%, 18 items) among all 306 medicated cases. Specifically, the adverse drug events included; gastrointestinal disorders (4 cases), dizziness and dull headache (1 case) and eruption (1 case). The detected abnormal loboratory tests were mainly as follows; an elevation of CPK (5 cases, 1.6%), and an elevation of GOT/GPT and/or γ-GTP (4 cases, 1.3%). No new adverse drug reaction or laboratory abnormality other than those known at the time of government approval were observed during the medicated term. Due to adverse drug events and/or laboratory abnormalities, four cases discontinued their drug regimen during the first 3 months treatment, and in four cases medication was halted after 3 months treatment, although nine other patients continued on medication because of the disappearance of such adverse events and/or laboratory abnormalities.
Concerning efficacy, total-cholesterol, LDL-cholesterol and triglyceride showed significant decreases and HDLcholesterol showed significant increases at each time point examined at 6 months' intervals, compared with baseline values. The levels were maintained for 48 months until the final examination.
Thus, over the three years, the long-term safety and efficacy of Pravastatin were confirmed by this prospective, multiclinical, open clinical trial.