Post marketing surveillance of triamterene + hydrochlorothiazide In an interim report of a multicentre GP study, 47,465 patients, aged 21 years with essential hypertension and sitting diastolic BP between 90 and 115mm Hg, received ('Maxzide') triamterene + hydrochlorothiazide 50mg + 75mg for 4 weeks. Hypertension was controlled in 22% of patients, mild in 61%, moderate in 12% and severe in 3%. 17.4% of patients were Black. 17.5% of patients did not complete the evaluation because of adverse effects (6.9%), poor response (1.1 %) and reasons unrelated to treatment (9.4%). 26 patients died from unrelated causes. In general, the higher the baseline BP the greater the decrease in BP that was achieved with 'Maxzide' treatment. 79-82% of previously untreated patients (n = 5670) achieved goal BP. Replacing 1 or 2 capsules of 'Oyazide' (triamterene + hydrochlorothiazide 25mg + 50mg n = 1201) or hydrochlorothiazide 50mg (n = 298) with 'Maxzide' resulted in 78-83% of patients achieving goal BP. The incidence of side effects reported was higher in patients receiving 1 tablet of 'Maxzide' (11.9%) than those receiving half a tablet (9.5%) and included fatigue (2.9 and 2.2%, respectively), nausea (2.5 and 1.7%), dizziness (2.3 and 1.9%), muscular symptomatology (1.1 and 1.0%), headache (0.9 and 0.8%), upper gastrointestinal upset (0.8 and 0.6%), rash (0.5 and 0.4%), arrhythmia (0.2 and 0.1 %), water and electrolyte abnormalities (0.2 and 0.1%) and hyperlipaemia/ hypercholesterolaemia (0.02 and 0%). 0.4% of patients developed hypokalaemia (potassium concentration < 3.5 mEq/L) and this was severe 2.8 mEq/L) in 0.06%. Hyperkalaemia (> 5.5 mEq/L) developed in 0.2% of patients many of whom had azotaemia or diabetes mellitus or were receiving concomitant captopril therapy. 31 patients developed azotaemia of whom 2 experienced uremic symptoms. Azotaemia appeared related to age and borderline renal function at the start of the trial. Other adverse effects included renal colic (2 patients), hyperuricaemia (22) frank gout (25) and hyperglycaemia (11). Hollenberg NK. Bannon UA. American Journal of Medicine 80 (Suppl. 4A). 30·36, Apr 1986 2 Reactions'" 24 May 1986 0157-7271 /86/1026-0002/0$01.00/0 © ADIS Press

Post marketing surveillance of triamterene + hydrochlorothiazide

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Post marketing surveillance of triamterene + hydrochlorothiazide

In an interim report of a multicentre GP study, 47,465 patients, aged ~ 21 years with essential hypertension and sitting diastolic BP between 90 and 115mm Hg, received ('Maxzide') triamterene + hydrochlorothiazide 50mg + 75mg for 4 weeks. Hypertension was controlled in 22% of patients, mild in 61%, moderate in 12% and severe in 3%. 17.4% of patients were Black. 17.5% of patients did not complete the evaluation because of adverse effects (6.9%), poor response (1.1 %) and reasons unrelated to treatment (9.4%). 26 patients died from unrelated causes.

In general, the higher the baseline BP the greater the decrease in BP that was achieved with 'Maxzide' treatment. 79-82% of previously untreated patients (n = 5670) achieved goal BP. Replacing 1 or 2 capsules of 'Oyazide' (triamterene + hydrochlorothiazide 25mg + 50mg n = 1201) or hydrochlorothiazide 50mg (n = 298) with 'Maxzide' resulted in 78-83% of patients achieving goal BP. The incidence of side effects reported was higher in patients receiving 1 tablet of 'Maxzide' (11.9%) than those receiving half a tablet (9.5%) and included fatigue (2.9 and 2.2%, respectively), nausea (2.5 and 1.7%), dizziness (2.3 and 1.9%), muscular symptomatology (1.1 and 1.0%), headache (0.9 and 0.8%), upper gastrointestinal upset (0.8 and 0.6%), rash (0.5 and 0.4%), arrhythmia (0.2 and 0.1 %), water and electrolyte abnormalities (0.2 and 0.1%) and hyperlipaemia/ hypercholesterolaemia (0.02 and 0%). 0.4% of patients developed hypokalaemia (potassium concentration < 3.5 mEq/L) and this was severe (~ 2.8 mEq/L) in 0.06%. Hyperkalaemia (> 5.5 mEq/L) developed in 0.2% of patients many of whom had azotaemia or diabetes mellitus or were receiving concomitant captopril therapy. 31 patients developed azotaemia of whom 2 experienced uremic symptoms. Azotaemia appeared related to age and borderline renal function at the start of the trial. Other adverse effects included renal colic (2 patients), hyperuricaemia (22) frank gout (25) and hyperglycaemia (11).

Hollenberg NK. Bannon UA. American Journal of Medicine 80 (Suppl. 4A). 30·36, Apr 1986

2 Reactions'" 24 May 1986 0157-7271 /86/1026-0002/0$01.00/0 © ADIS Press