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TIPS-K= RCT of low strength polycap & of low strength K + supplementation in patients with stable CVD/IHD(Global-NA/India)

Details

a) Background:

A daily single capsule (polycap) of 3 blood pressure (BP) lowering drugs (hydrochlorthiazide, 12.5 mg; atenolol, 50 mg; ramipril, 5 mg) at low doses, simvastatin (20 mg), and aspirin (100 mg) has been demonstrated to be well tolerated and to reduce BP and low-density lipoprotein cholesterol. We examined the incremental effects of 2 (full dose) plus K+ supplementation versus single polycap (low dose) on risk factors and tolerability.

b) Objective

Primary objectives:

1. To evaluate the efficacy of a single dose of low strength Polycap versus two doses of the low strength Polycap in patients with stable cardiovascular disease.
2. To evaluate the tolerability of a single dose of low strength Polycap versus two doses of the low strength Polycap in patients with stable cardiovascular disease
3. To evaluate the tolerability and safety of low dose potassium supplementation compared to no potassium in patients with stable cardiovascular disease.

Secondary objective:

1. To evaluate the efficacy of low strength Polycap, two doses, compared to a single dose in lowering blood pressure and lipids in patients with history of diabetes mellitus.
2. The primary objectives are to evaluate if the POLYCAP [a combination of 3 Bp lowering drugs a statin and aspirin]

c) Methods and Results :

After a run-in period, 518 individuals with previous vascular disease or diabetes mellitus from 27 centers in India were randomly assigned to a single-dose polycap or to 2 capsules of the polycap plus K+ supplementation for 8 weeks. The effects on BP, heart rate (HR), serum lipids, serum and urinary K+, and tolerability were assessed using an intention-to-treat analysis. The full-dose polycap (plus K+ supplementation) reduced BP by a further 2.8 mm Hg systolic and 1.7 mm Hg diastolic, compared with that observed with the low-dose polycap (P=0.003; P=0.001), but there were no differences in HR (0.1 bpm). The differences in total and low-density lipoprotein cholesterol between the full-dose and low-dose polycap was 7.2 mg/dL (P=0.014) and 6.6 mg/dL (P=0.006), respectively, but there were no differences in high-density lipoprotein cholesterol or triglycerides. The rates of discontinuation of the study drug after randomization were similar in the 2 groups (6.9% low dose versus 7.8% full dose).

d) Total recruitment & no. of sites:

518 participants from 27 centres

e) Conclusion:

The full-dose polycap (plus K+ supplementation) reduces BP and low-density lipoprotein cholesterol to a greater extent compared with the low dose, with similar tolerability. Therefore, the full-dose polycap should potentially lead to larger benefits.

f) Publication status (Name & year):

Circulation: Cardiovascular Quality and Outcomes, 1 Jul 2012

g) Publication link: https://pubmed.ncbi.nlm.nih.gov/22787067/

Updated as on: 18 Jul 2022