EFFECTIVENESS OF NIFEDIPINE GASTROINTESTINAL THERAPEUTIC SYSTEM FOR TREATMENT OF HYPERTENSION - RESULTS OF THE MATH TRIAL

Nifedipine gastrointestinal therapeutic system (GITS), a controlled-re lease delivery system given once a day, was evaluated in a multisite s tudy of mild-to-moderate hypertensive subjects, seated diastolic press ure between 95 and 110 mm Hg, on placebo. Of 1,666 subjects enrolled, 69% were eligible to begin treatment. Therapy with nifedipine GITS was started at 30 mg daily and increased by 30 mg/day each week until the re was a response (seated diastolic pressure < 90 mm Hg and a reductio n of greater-than-or-equal-to 10 mm Hg) or until a maximum dose of 180 mg/day was reached. After titration, responders were kept on active t reatment for 12 more weeks. Seventy-six percent of those treated respo nded, and 88% of the responders completed the 12-week phase. Compariso ns were made among relevant subgroups. Elderly patients (age greater-t han-or-equal-to 65 years) had a significantly higher response rate at a lower average daily dose, compared with younger subjects. Response r ates were > 70% and relatively similar in (a) white and black patients , (b) diabetic and nondiabetic patients, (c) men and women, and (d) no rmal-weight, overweight, and obese patients. Nifedipine GITS had no si gnificant effect on fasting serum glucose or cholesterol fractions. Ed ema and headache were the most often observed adverse effects during t reatment. Incidence of the former was related to dose but occurred wit hout evidence of fluid retention (average body weight fell significant ly by 1% during treatment). As antihypertensive monotherapy given once a day, nifedipine GITS is effective and well tolerated for a wide spe ctrum of hypertensive patients.