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Efficacy and safety of nisoldipine coat-care tablets compared with placebo in the treatment of hypertension
AlH 1996; 9: 119A-123A
POSTERS: Clinical Trials
Gl
G2
EFFICACY AND SAFETY OF NISOLDJPINE COAT-CARE TABLETS COMPARED WITH PLACEBO IN THE TREATMENT OF HYPERTENSION. FO Miiller. LH Opie, DP Myhurgh. C Rosendorff. P Sareli. YK Seedat , DJV Weich, HO Luus. South African Multicenlre Study. A large scale, double-Mind, placeoo.controlled multicentre trial was undertaken to establish the antihypertensive efficacy and tolerability of a controlled - release ('core..,oat· tablet) formulation of the secondgeneration dihydropyridine calcium antagonist. oisoldipine. A total of 208 patients with mild-to-moderate essential hypertension were randomised into one of four treatment groups. to receive either placebo or oilOldipine 10 mg. 20 mg or 30 mg daily. afler a 4-week placebo run·in. Readings were taken at trough plasma levels i.e. 24 hours after previous dosing. Adverse events and laboratory paramelcrs (plasma lipid and glucose levels, and thyroid function) "'ere also monitored. At endpoint (after 6 weeks) mean changes in supine blood pressure from baseline were (systolic/diastolic) 0.9/-2.3. -8.0/S.S. -16.9/9.0 and -IS.0/-10.3 mmHg for the groupa assigned to placebo. oisoldipine 10 mg, 20 mg and 30 mg respectively. The 24 hour ambulatory blood pressure monitoring confirmed these fiodings ...hen the antihypertensive effeet was virtually constant throughout the 27 dosing interval and all 3 dosages were more effective than placebo. Nisoldipine ...as equally effective in all age groups. sexes and ...as at least as effective in blacks as in Caucasians. Adverse effects were DO more common with nisoldipine than ...ilb placebo aIlbough peripheral oedema occnrred more conunonty in patients receiving oisoldipine 30 mg than in other trestment groupa. Nisoldipine cmtrolled - relesse formulation bas a smooth onset of action. it produces a lignificant reduction in blood pressure It trough plasma levels following one~ly administration and il clinically effective st doses of 20-30 mg once daily. All together. the clinical festures of oisoldipine rank alongside those of other second generation calcium antagonists. luch as amIodipine and felodipine. and include reliable blood pressure control. good tolerability. simplicity of dosing and versatibility. KeyWords:
Nisoldipine. Controlled-Relesse.
T....tment of Hypertension
ANTIHYPERTENSIVE EFFICACY AND TOLERABILITY OF A LOW-DOSE RESERPINEITHIAZIDE COMBINATION COMPARED TO AN ACE-INHIBITOR IN FIRST-LINE TREATMENT R Griebenow', DB Pitlrow', G Weidinger', snd E Mutschler. 'Department of Internal Medicine II, UniverSity of Cologne: 'Department of Clinical Research, Sandoz, NOrnberg; 'Department of Pharmacology, J.W Goethe-University, Frankfurt; Germany. We investigated the concept of initial treatment of hypertension with low doses of different antihypertensivss that have different modes of action. a fixsd low-
EN
2p
Week 3 : t.SBP/t.DBP (mmHg) -19.6/-17 0 -61/-9.5 """/""" Normalisers (DBP<90) 64% 29% 'Week"6:"6sBPi6i5Bp"[m'mH'g]""'~2i'5i:l'9:1""~'i''ii':2i:l'1·:6
......;;;;;;;;;..·..
Normalisel1l (DBP<90)
78%
35%
lii2p
G4
G3 COMBINATION THERAPY WITH ENALAPRIL/FELODIPINE ER (EF) IN ESSENTIAL HYPERTENSION. A FACTORIAL STUDY AH GRADMAN for the Enalapril/Felodipine Factorial Study Group. The We.tern Pennsylvania Hospital, Pittsburgh. Pennsylvania. The dose-response relationships and safety of enalapril (E) and felodipine ER (F) given alone and in combination were evaluated in 707 pt. (mean age 54) with sitting diastolic BP (SiDBP) of 95-115 mmHg. After 4 wks of placebo (P) run-in, pts were randomized to P, F (2.5. 5, 10 mg), E (5. 20 mg) or EF combinations for B wk. according to a double-blind, 3 X 4 factorialdesign protocol. An ANOVA model showed statistically significant (p<0.05) additive BP reducing effects of the two drugs in combination over the entire range of dose. studied. EBtimated StOBP reductions (additiv. model) at
week 8 were;
DOXAZOSIN FOR TIlE TREATMENT OF PATIENTS WITIl HYPERTENStON AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA ~•• Th. Ohio State Uniwnity, Columb... Ohio. Th. objoo1i.. ofthIS multicont«, open.label study wu to dctonni.. tho efficacy and tolerability of doxazosin in the treatment of ben ian prostatio hyperplasia (BPH) in poti.." v.ith conconutant hypertension. Th... lroupa ofBPH poticn" __ dclioed' un_ted hyportonsi... (no ODtihyportonsi.. _ _ ;<4 wooD prior to buoI...~ poorly controllod hyportonsi... (;<4 wooO' ODtlhyportcnsiw tnlatmcll~ sittinl DBP ~ mmHI~ ...11 controllod hyporton (;<4 wooO' ODtlhyportonsivo _tm..,~ silllni DBP <9OmmHll. Do in was ti\rllted _Idy for up to 5 wooks linm I m~day to 16 m~day. accordlRl to I combination of BP ODd BPH oymptom nspon..; poti.." __ malRtalRed OD tho optlmum dose for a further I wooks. Chanles 10 BP ODd BPH oymptoml __ asscssod at maintonanco wooks 4 and I. 212 pati.n" (m....... 64.6 yean) ..... included in thil interim analysil (n-B6 untreated, n-64 poorly controlled, n-62 well controlled). Follov.inl treatment with
doxazollft,
thcro wu • clinically sianificant roduetion from baschno
in BP .n tho poorly controlled ODd un_ted amupI, wh..- changes in BP in tho wclI c:ontrollcd poup wore statistieally ailnifi~ but clinically inial" No
significant changes in heart rate were seen. Untreated
Week 4
Poorly controlled -16.7 -12.0 -11.7 -t26
W.II controlled -B.I -5.7 ".1
Ii standlRg SBP (mmHg) -164 Ii standlRB DBP (mmHB) -11.4 IistandIRISBP(mmHI) -IB.I Ii standlRS DBP(mmHs) -10 l -47 All changeslt&tlstl
_Im..
20 5
0
"_(mol
selected "drug-related" The frequencies of adverse events (AE) in groups receiving P, E, F and EF were. EF Placebo (n=319) s AE 79) (0.6\) 3 (2\ 7 (2\) (0\) cough 3 (2\) 19 (11\1 13 (4\) 1 (1\) Edema
An
CONCLUSIONS, EF is an effective, well-tolerated antIhypertensive drug combination. At each combination dose, both drugs contribute to a .ignificant additive BP reducing effect. In addition, EF i . associated with les8 peripheral edema than F alone. Key Words: felodipine, enalapril. calcium antagonht, ACE inhibl~~r, combination therapy
Key Words:
doxazosi.. hyportonsion. boniln prostatic hyperplasia.
POSTERS: Clinical Trials
Gl
G2
EFFICACY AND SAFETY OF NISOLDJPINE COAT-CARE TABLETS COMPARED WITH PLACEBO IN THE TREATMENT OF HYPERTENSION. FO Miiller. LH Opie, DP Myhurgh. C Rosendorff. P Sareli. YK Seedat , DJV Weich, HO Luus. South African Multicenlre Study. A large scale, double-Mind, placeoo.controlled multicentre trial was undertaken to establish the antihypertensive efficacy and tolerability of a controlled - release ('core..,oat· tablet) formulation of the secondgeneration dihydropyridine calcium antagonist. oisoldipine. A total of 208 patients with mild-to-moderate essential hypertension were randomised into one of four treatment groups. to receive either placebo or oilOldipine 10 mg. 20 mg or 30 mg daily. afler a 4-week placebo run·in. Readings were taken at trough plasma levels i.e. 24 hours after previous dosing. Adverse events and laboratory paramelcrs (plasma lipid and glucose levels, and thyroid function) "'ere also monitored. At endpoint (after 6 weeks) mean changes in supine blood pressure from baseline were (systolic/diastolic) 0.9/-2.3. -8.0/S.S. -16.9/9.0 and -IS.0/-10.3 mmHg for the groupa assigned to placebo. oisoldipine 10 mg, 20 mg and 30 mg respectively. The 24 hour ambulatory blood pressure monitoring confirmed these fiodings ...hen the antihypertensive effeet was virtually constant throughout the 27 dosing interval and all 3 dosages were more effective than placebo. Nisoldipine ...as equally effective in all age groups. sexes and ...as at least as effective in blacks as in Caucasians. Adverse effects were DO more common with nisoldipine than ...ilb placebo aIlbough peripheral oedema occnrred more conunonty in patients receiving oisoldipine 30 mg than in other trestment groupa. Nisoldipine cmtrolled - relesse formulation bas a smooth onset of action. it produces a lignificant reduction in blood pressure It trough plasma levels following one~ly administration and il clinically effective st doses of 20-30 mg once daily. All together. the clinical festures of oisoldipine rank alongside those of other second generation calcium antagonists. luch as amIodipine and felodipine. and include reliable blood pressure control. good tolerability. simplicity of dosing and versatibility. KeyWords:
Nisoldipine. Controlled-Relesse.
T....tment of Hypertension
ANTIHYPERTENSIVE EFFICACY AND TOLERABILITY OF A LOW-DOSE RESERPINEITHIAZIDE COMBINATION COMPARED TO AN ACE-INHIBITOR IN FIRST-LINE TREATMENT R Griebenow', DB Pitlrow', G Weidinger', snd E Mutschler. 'Department of Internal Medicine II, UniverSity of Cologne: 'Department of Clinical Research, Sandoz, NOrnberg; 'Department of Pharmacology, J.W Goethe-University, Frankfurt; Germany. We investigated the concept of initial treatment of hypertension with low doses of different antihypertensivss that have different modes of action. a fixsd low-
EN
2p
Week 3 : t.SBP/t.DBP (mmHg) -19.6/-17 0 -61/-9.5 """/""" Normalisers (DBP<90) 64% 29% 'Week"6:"6sBPi6i5Bp"[m'mH'g]""'~2i'5i:l'9:1""~'i''ii':2i:l'1·:6
......;;;;;;;;;..·..
Normalisel1l (DBP<90)
78%
35%
lii2p
G4
G3 COMBINATION THERAPY WITH ENALAPRIL/FELODIPINE ER (EF) IN ESSENTIAL HYPERTENSION. A FACTORIAL STUDY AH GRADMAN for the Enalapril/Felodipine Factorial Study Group. The We.tern Pennsylvania Hospital, Pittsburgh. Pennsylvania. The dose-response relationships and safety of enalapril (E) and felodipine ER (F) given alone and in combination were evaluated in 707 pt. (mean age 54) with sitting diastolic BP (SiDBP) of 95-115 mmHg. After 4 wks of placebo (P) run-in, pts were randomized to P, F (2.5. 5, 10 mg), E (5. 20 mg) or EF combinations for B wk. according to a double-blind, 3 X 4 factorialdesign protocol. An ANOVA model showed statistically significant (p<0.05) additive BP reducing effects of the two drugs in combination over the entire range of dose. studied. EBtimated StOBP reductions (additiv. model) at
week 8 were;
DOXAZOSIN FOR TIlE TREATMENT OF PATIENTS WITIl HYPERTENStON AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA ~•• Th. Ohio State Uniwnity, Columb... Ohio. Th. objoo1i.. ofthIS multicont«, open.label study wu to dctonni.. tho efficacy and tolerability of doxazosin in the treatment of ben ian prostatio hyperplasia (BPH) in poti.." v.ith conconutant hypertension. Th... lroupa ofBPH poticn" __ dclioed' un_ted hyportonsi... (no ODtihyportonsi.. _ _ ;<4 wooD prior to buoI...~ poorly controllod hyportonsi... (;<4 wooO' ODtlhyportcnsiw tnlatmcll~ sittinl DBP ~ mmHI~ ...11 controllod hyporton (;<4 wooO' ODtlhyportonsivo _tm..,~ silllni DBP <9OmmHll. Do in was ti\rllted _Idy for up to 5 wooks linm I m~day to 16 m~day. accordlRl to I combination of BP ODd BPH oymptom nspon..; poti.." __ malRtalRed OD tho optlmum dose for a further I wooks. Chanles 10 BP ODd BPH oymptoml __ asscssod at maintonanco wooks 4 and I. 212 pati.n" (m....... 64.6 yean) ..... included in thil interim analysil (n-B6 untreated, n-64 poorly controlled, n-62 well controlled). Follov.inl treatment with
doxazollft,
thcro wu • clinically sianificant roduetion from baschno
in BP .n tho poorly controlled ODd un_ted amupI, wh..- changes in BP in tho wclI c:ontrollcd poup wore statistieally ailnifi~ but clinically inial" No
significant changes in heart rate were seen. Untreated
Week 4
Poorly controlled -16.7 -12.0 -11.7 -t26
W.II controlled -B.I -5.7 ".1
Ii standlRg SBP (mmHg) -164 Ii standlRB DBP (mmHB) -11.4 IistandIRISBP(mmHI) -IB.I Ii standlRS DBP(mmHs) -10 l -47 All changeslt&tlstl
_Im..
20 5
0
"_(mol
selected "drug-related" The frequencies of adverse events (AE) in groups receiving P, E, F and EF were. EF Placebo (n=319) s AE 79) (0.6\) 3 (2\ 7 (2\) (0\) cough 3 (2\) 19 (11\1 13 (4\) 1 (1\) Edema
An
CONCLUSIONS, EF is an effective, well-tolerated antIhypertensive drug combination. At each combination dose, both drugs contribute to a .ignificant additive BP reducing effect. In addition, EF i . associated with les8 peripheral edema than F alone. Key Words: felodipine, enalapril. calcium antagonht, ACE inhibl~~r, combination therapy
Key Words:
doxazosi.. hyportonsion. boniln prostatic hyperplasia.