SULAR SUMMARY
SULAR® (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine.
SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
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NEWS HIGHLIGHTS
Published Studies Related to Sular (Nisoldipine)
Comparative efficacy and safety of nisoldipine extended-release (ER) and amlodipine (CESNA-III study) in African American patients with hypertension. [2003.09]
BACKGROUND: This study evaluates the efficacy of the new dihydropyridine calcium antagonist nisoldipine extended-release (ER) compared to amlodipine on ambulatory and clinic blood pressures (BP) and heart rates in African American patients with hypertension... CONCLUSIONS: Nisoldipine ER was as effective as amlodipine in reducing 24-h BP in African-American patients with hypertension, with a similar adverse effect profile. Thus, this new therapy for delivery of a dihydropyridine calcium channel blocker is a useful antihypertensive strategy for African-American patients with hypertension.
Long term effects of nisoldipine on the progression of coronary atherosclerosis and the occurrence of clinical events: the NICOLE study. [2003.08]
BACKGROUND: Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions. Conversely, a meta-analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease. OBJECTIVE: To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events... CONCLUSIONS: Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures.
Comparison of effects of nisoldipine-extended release and amlodipine in patients with systemic hypertension and chronic stable angina pectoris. [2003.02.01]
The efficacy and safety of nisoldipine-extended release (ER) and amlodipine were compared in a 6-week multicenter, randomized, double-blind, double-dummy, parallel group, titration-to-effect trial in patients with stage 1 to 2 systemic hypertension (90 to 109 mm Hg diastolic blood pressure [BP]) and chronic stable angina pectoris...
Usefulness of Nisoldipine for prevention of restenosis after percutaneous transluminal coronary angioplasty (results of the NICOLE study). NIsoldipine in COronary artery disease in LEuven. [2001.01.01]
The NIsoldipine in COronary artery disease in LEuven (NICOLE) study investigates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduces the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty (PTCA)...
Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. [2000.12]
CONCLUSIONS: Long-term treatment with lisinopril or nisoldipine has similar beneficial effects on progression of diabetic nephropathy in hypertensive type 1 diabetic patients.
Clinical Trials Related to Sular (Nisoldipine)
Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular� Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers [Completed]
The objective of this study was to investigate the bioequivalence of nisoldipine
extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release
40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg
tablet) dose administration in healthy adult subjects under fed conditions.
Bioequivalence Study of Nisoldipine Extended-Release Tablets, 30 mg [Completed]
The objective of this study was to investigate the bioequivalence of nisoldipine
extended-release 30 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release
30 mg tablet (manufactured for First Horizon) following a single, oral 30 mg (1 × 30 mg
tablet) dose administration in healthy adult subjects under fasting conditions.
Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg [Completed]
The objective of this study was to investigate the bioequivalence of nisoldipine
extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release
40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg
tablet) dose administration in healthy adult subjects under fasting conditions.
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy [Completed]
The aim of the study was to compare the renoprotective effect of a long acting calcium
antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type
1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to
treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure
and urinary excretion of albumin were measured every 6 months
Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension [Completed]
Plasma renin values determine whether volume or vasoconstrictor (renin) factors predominate
in elevating blood pressure and are useful in selecting effective antihypertensive
therapy. 2,3
The researchers hypothesize that:
1. Plasma renin-guided therapeutics will improve systolic and diastolic blood pressure
control in patients with untreated hypertension as well as in patients with treatment
refractory or resistant hypertension that are managed by Clinical Hypertension
Specialists.
2. Renin-guided therapeutics will reduce the number of medications required to maintain
blood pressure control to <140/90 mmHg in hypertensive patients receiving 3 or more
medications, while under the care of a Clinical Hypertension Specialist.
3. Renin-guided therapeutics selection will reduce the total cost of antihypertensive care
provided by Clinical Hypertension Specialists.
Reports of Suspected Sular (Nisoldipine) Side Effects
Hypersensitivity (4),
Pruritus (4),
Constipation (4),
Abdominal Discomfort (4),
Sedation (4),
Dyspnoea (4),
Rash (4),
Flatulence (2),
Malaise (2),
Oedema Peripheral (2), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Sular has an overall score of 9.50. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Sular review by 66 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure |
| Dosage & duration: | | 10mg*/40mg taken once a day for the period of 2 years |
| Other conditions: | | overweight |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | My blood pressure was out of control. My doctors had prescribed diuretics (limited effectiveness) and other forms of calcium channel blockers. This in my opinion is a wonder drug!My blood pressure had shot up so badly that I would get nosebleeds when working on my knees or bending over.My pressure was in the triple digits at times. |
| Side effects: | | None whatsoever |
| Comments: | | Once daily generally in the morning with a light breakfast |
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| | Sular review by 72 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Mild Depression |
| Dosage & duration: | | 20 mg taken 1 per day for the period of Have taken it for the last several years |
| Other conditions: | | None |
| Other drugs taken: | | Quinapril, toprol | | |
Reported Results |
| Benefits: | |
Lowered blood pressure. This was the last prescribed medication for out of control high blood pressure. Apparently, it takes all three of the medications
to work together. With all of them, my blood pressure is within normal guidelines (or very close), but without any one of them, there is an immediate rise |
| Side effects: | | None, or at least not enough to be bothersome |
| Comments: | | This was the last prescribed medication for out of control high blood pressure. I was first diagnosed with hypertension when I was in my 30's (with no symptoms - routine check-up) Gradually through the years, it has taken more meds. Apparently, it takes all three of these medications to work together. With all of them, my blood pressure is within normal guidelines (or very close), but without any one of them, there is an immediate rise |
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Page last updated: 2006-01-31
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