Yes, clinical trial has been done with Polycap^TM in Secondary prevention of CVD.
TIPS 2 study was conducted in 518 patients with established vascular disease and BP≥130/80. Patients studied in TIPS 2 study had multiple risk factors and stable CVD.

TIPS 2 Polycap^TM was found efficacious and safe in following group of patients with established vascular disease.

• Patients with previous myocardial infarction (>7 days post uncomplicated MI)
• Patients with ischemic heart disease with significant ECG changes
• Patients with a positive stress test, or stable angina
• Patients with cerebrovascular disease
• Patients with previous ischemic stroke
• Patients with transient ischemic attacks

TIPS 2 study found that Polycap^TM can control BP and Lipids in patients with established Vascular Disease and reduces the risk of CHD and stroke and is well tolerated.

TIPS 3 trial (Results published in the NEJM) evaluated the effects of Polycap in the primary prevention of cardiovascular disease and showed that Polycap with Aspirin reduced CVD by 31%, and Polycap alone reduced CVD by 21%.

- Polycap^TM dose is 1-2 capsules once a day for CVD patients for Secondary Prevention.

- Polycap^TM dose is 1 capsule once a day for Primary Prevention in patients at risk of CV events and stroke.

- Polycap^TM is a Low Dose Combination Drug.

- Drug titration with additional therapies can be done along with Polycap^TM.

- Polycap^TM offers 5 proven and safe drugs recommended for Secondary Prevention in low dose. If a clinician needs to add additional dose for Residual Risk Management, it can be done based on patients blood pressure and lipid profile.

• To Treat to Target for BP goals, an additional Angiotensin Receptor Blocker or a calcium channel blocker can be prescribed
• To achieve Lipid Targets, additional dose of simvastatin or ezetimibe or fenofibric acid can be added.

- Therefore, Polycap^TM is not a hindrance for dose titration.

- Dose of Polycap^TM is once a day preferably morning time.

- HCTZ in the morning

- Netherlands study showed that time does not matter!

- Take any fixed time.

- 1 OD in Primary Prevention

- 2 OD or 1 OD in Secondary Prevention

Can Polycap^TM be used in Type 2 Diabetes patients?

• Yes, Polycap^TM can be used in patients with Type 2 Diabetes. TIPS 1 study included 2053 patients and one-third patients in Polycap^TM study group were diabetics. Similar reduction in blood pressure lowering was observed in diabetics.
• The effect of the Polycap^TM on LDL cholesterol was greater in participants with diabetes.
• These findings suggest that the potential relative and absolute benefits of the Polycap^TM on clinical outcomes are likely to be larger in high-risk than in low-risk subgroups.

- Therefore, Polycap^TM is not a hindrance for dose titration.

- If the BP is not controlled by Polycap^TM then increasing any one anti hypertensive drug or addition of another anti-hypertensive can be done.

• Control rates in hypertension are low [29-31].
• In population studies across globe, HT control rates as low as
• 53.1% for the US,
• 41.0% for Canada,
• 33.6% for Germany and
• 29.2% for the UK
• which illustrate that the high control rates reported in randomized controlled trials do not always translate into clinical practice.

- We could give additionally higher dose of Simvastatin or any other (non-statin) lipid lowering drug such as fibrate or ezetimibe or Niacin.

- No since Polycap^TM contains aspirin it cannot be used in Hemorrhagic stroke patients.

- Yes it can be given in asthmatic patients, because at lower doses Atenolol does not loose its selectivity. At higher doses Atenolol (100mg) does lose its selectivity for β receptors and behaves like a non selective molecule.