Table 2.
Clinical studies of metoprolol/hydrochlorothiazide combination tablets
| Reference | Study design/population | Number of patients | Principal findings |
|---|---|---|---|
| Hildemann et al 2002 | Prospective, open-label, 8-week, observational study/hypertensive adults | 14,964 | Mean BP reduction from baseline to week 8 was 24.5/13.6 mmHg. The reduction in BP was consistent whether or not patients were receiving other antihypertensive drugs, which included ACEIs, aldosterone antagonists, alpha-blockers, other beta-blockers, calcium antagonists, and other diuretics. Tolerability was excellent. |
| Geisler 1981 | Open-label study in patients treated with metoprolol/HCT 100/12.5 mg, 1–2 tablets daily for 6 weeks/hypertensive patients. | 12,336 | BP was significantly reduced across all age groups in this large patient population. SBP decreased by 29–30 mmHg and DBP by 13–15 mmHg after 6 weeks treatment. The incidence of AEs was low and similar in all age groups. |
| Goodfellow and Westberg 1981 | Post-marketing surveillance for 3 months of hypertensive patients in general practice. Treatment: metoprolol/HCT 100/12.5 mg, 1–2 tablets daily | 1,446 | After 3 months treatment mean BP was reduced from 181/108 mmHg to 153/91mmHg. Previously untreated patients showed a more marked reduction in BP (33/20 mmHg) than patients previously treated (23/15 mmHg). All age groups showed a similar reduction in SBP and DBP although older patients had a higher BP on entry. The incidence of AEs was similar in all age groups. Treatment was withdrawn in 117 patients due to AEs. The rate of withdrawal was somewhat higher in patients aged over 65 years. Conclusion: The fixed dose combination of HCT and metoprolol constitutes a simple once daily regimen, which is effective, produces few side-effects and is well tolerated by patients of all ages. |
| LaPalio et al 1992 | Prospective, open-label surveillance study. Multicenter outpatient. Patients with mild to moderate hypertension aged 50–75 years. Patients were treated with 100 mg of metoprolol once daily for 4 weeks. If BP was controlled, therapy continued. If not controlled, 25 mg of HCT was added. | 21,692 (approx. 6000 on metoprolol /HCT | After 4 weeks of therapy, mean SBP and DBP decreased from 162/95 to 148/87 mmHg (p < 0.001). 58% of the patients had satisfactory BP control. At 4 weeks 28% were requested to add HCT 25 mg to metoprolol 100 mg. At the end of 8 weeks, mean SBP and DBP decreased to 143/84 mmHg. BP response was similar in all age groups. At the termination of the study, 50% of the patients were continued on monotherapy, and 27% were continued on combined therapy. Overall, there was <5% incidence of medical problems, tolerability was good-excellent for 94% of the patients. Conclusion: Metoprolol administered as monotherapy or in combination with HCT was effective in normalizing BP in a majority of elderly hypertensive patients. Both regimens were well tolerated. |
| Wikstrand et al 1986 | Randomized, double-blind parallel group study of patients with untreated essential hypertension. Patients were treated with either metoprolol 100 mg or HCT 25 mg for 4 weeks. Patients with controlled DBP were treated for a further 4 weeks at the same doses. If DBP remained >95 mmHg then HCT 12.5 mg was added to metoprolol and HCT dose was doubled to 50 mg for another 4 weeks. | 562 Aged 60–75 years | A significant reduction in BP was recorded on both treatment regimens. Both treatment regimens were well tolerated. The dropout rate due to serious side-effects was similar in the 2 groups, 2% in the metoprolol group and 3% in the HCT group. Conclusion: Beginning treatment with metoprolol 100 mg bd and adding HCT 12.5 mg in patients not responding to metoprolol alone appears to be effective and safe in elderly hypertensive patients. |
Abbreviations: ACEI, angiotensin converting enzyme inhibitor; BP, blood pressure; HCT, hydrochlorothiazide; SBP, systolic blood pressure; DBP, diastolic blood pressure; AE adverse event.