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3.2 ขอมลเปรยบเทยบประสทธภาพและความปลอดภย nifedipine SR vs amlodipine ขอมลจาก Micromedex สรปไดวา amlodipine และ nifedipine SR มประสทธภาพในการลดความดนเลอด
ไมตางกน แตผ ปวยใหความรวมมอและทนตอยา amlodipine ซงใหวนละครง ไดดกวา nifedipine SR ซงใหวนละสองครง โดย amlodipine เกดผลขางเคยง เชน บวม หนาแดง ปวดศรษะ นอยกวา(6) SUMMARY: Amlodipine is as effective as sustained-release dosage forms of nifedipine in achieving blood pressure control. Analysis during 24-hour ambulatory monitoring shows a preference for amlodipine for controlling early morning (0600 to 1100 hours) response. Systolic pressure load is similarly controlled with amlodipine or nifedipine GITS, both of which may be superior to nifedipine SR. Compliance with once-daily amlodipine is better than with twice-daily nifedipine dose forms. Amlodipine appears to better tolerated, with a lower incidence of typical dihydropyridine complaints (edema, flushing, headache) (Mounier-Vehier et al, 1998; Lefebvre et al, 1998; Bossini et al, 1997). จากขอมลขางตน ฝายเลขานการฯ จงไดตด nifedipine SR ออกจากรายการยาทเปรยบเทยบส าหรบผ ปวยบวมจาก amlodipine
Thai FDA US FDA EMA Thai FDA US FDA EMA 1 Hypertension 2 Essential hypertension ? ? 3 Systolic hypertension, Isolated 4 Cerebral artery occlusion - Hypertension 5 Hypertension - Kidney disease 6 Hypertensive episode - Intubation 7 Malignant hypertension หมายเหต: - Thai FDA = Thai Food and Drug Administration - US FDA = U.S. Food and Drug Administration
FDA Approval: Adult, no; Pediatric, no Efficacy: Adult, Evidence favors efficacy Recommendation: Adult, Class IIb Strength of Evidence: Adult, Category B See Drug Consult reference: "RECOMMENDATION, EVIDENCE AND EFFICACY RATINGS"
2) Summary: - Monotherapy response rates of 60% to 70% at doses of 5 to 20 mg daily - JNC-VI goal pressures in 32% in observational study; 16% reached diabetic goal 130/85 mmHg on 10-mg
monotherapy without titration - Once-daily dosing
a) In a large (9000 patient) 3-month observational trial of lercanidipine 10 milligrams (mg) daily, diastolic reductions to less than 90 millimeters of mercury (mmHg) were attained by 64%, but control to 140/90 mmHg was achieved by only 32%. Among a subset of diabetics (n=1269), the stricter control goal of 130/85 mmHg was met by only 16%. Safety was good, with a lower incidence of typical dihydropyridine adverse effects. This multi-center, open, surveillance trial recruited patients who were candidates for DHP calcium channel treatment for either untreated (31%) or unresponsive mild-to-moderate hypertension; other comorbidity was not disqualifying. Mean age was 63 years; more than 60% were older than 60-years. A fixed dose of 10 mg daily was used. Mean blood pressure response after 3 months was from 160/96 mmHg to 141/83 mmHg (p=less than 0.001). Of all responders (diastolic pressure less than 90 mmHg), half were identified after the first month, with only 14% additional response with continued treatment. Headache (3%), edema (1%), and flushing (1%) were the most frequent adverse events, most appearing within the first month (Barrios et al, 2002). Manidipine (Micromedex 2012)
B) Essential hypertension (Mild to Moderate) 1) Overview
7
FDA Approval: Adult, no; Pediatric, no Efficacy: Adult, Evidence favors efficacy Recommendation: Adult, Class IIb Strength of Evidence: Adult, Category B See Drug Consult reference: "RECOMMENDATION, EVIDENCE AND EFFICACY RATINGS"
2) Summary: - Numerous open and placebo-controlled trials have demonstrated the efficacy of manidipine for treatment of
essential hypertension; most studies have been of short duration, with limited populations, and further studies are necessary to confirm manidipine's role in treatment(Ogihara et al, 1992; Kumahara et al, 1989a; Aoi & Yamachika, 1989; Arakawa et al, 1989a; Kumahara et al, 1989a; Ogihara et al, 1989a; Okabe et al, 1989; Sotohata et al, 1989a; Takabatake et al, 1993a; Kokubu et al, 1989b; Kaneko, 1989; Nakamura et al, 1992) c) The clinical effects of manidipine (mean dose 10.7 milligrams once daily) were examined in a long-term study (mean period of 12 months) in 92 patients with mild to moderate essential hypertension. The drug consistently lowered systemic blood pressure without changes in pulse rate. Mean systolic and diastolic blood pressures were reduced by 27 to 34 mmHg and 16 to 19 mmHg, respectively (Kokubu et al, 1989b).
#1 Manidipine in combination arm #2 Focused outcome was insulin sensitivity #4 Manidipine in combination arm vs combination arm, non-NLEM #6 Manidipine in combination arm, non-NLEM #7 Manidipine in combination arm vs combination arm, non-NLEM #8 Manidipine in combination arm vs combination arm, non-NLEM #10 Focused Outcome was not manidipine (delapril) #14 Focused outcome was platelet aggregation #17 Manidipine in combination arm vs combination arm, non-NLEM #18 Manidipine in combination arm vs non-NLEM #19 Focused outcome was insulin sensitivity #23 Focused outcome was plasma norepinephrine #27 Focused outcome were cardiovascular autonomic nervous
system and carotid distensibility #31 Focused outcome wast glucose & lipid metabolism
#1 Focused outcome was body water #3 Lercanidipine was in both arms #6 Outcome was not focused on blood pressure #8 Comparators (conventional therapy) were not clear #13 Focused outcome was albuminurea #19 Focused out come was not blood pressure
Lercanidipine (Systematic)
#2, 3 #1 Evaluation of combined lercanidipine/enalapril
Austria (2,2), Brazil (2,1), France (1,4), Germany (2,3), Greece (2,4), Hungary (1,2), Italy (5,7), Philippines (1,1), Spain (2,6), Thailand (1,1)
มจ าหนายเฉพาะ lercanidipine (23 ประเทศ)
Australia (3), Belgium (2), Chile (1), Czech Republic (2), Denmark (7), Finland (3), Hong Kong (1), Indonesia (1), Ireland (6), Israel (3), Malaysia (1), Mexico (2), Netherlands (1), Norway (2), Portugal (5), Singapore (1), South Africa (2), Sweden (1), Switzerland (2), Turkey (1), Ukraine (2), United Kingdom (1), Venezuela (2)
มจ าหนายเฉพาะ manidipine (1 ประเทศ)
Japan (1)
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12. Makani H, Bangalore S, Romero J, Htyte N, Berrios RS, Makwana H, et al. Peripheral edema associated with calcium channel blockers: incidence and withdrawal rate--a meta-analysis of randomized trials. J Hypertens. 2011;29:1270-80.
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